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Monday, June 17
 

7:00am PDT

DIA Annual Meeting Orientation
Component Type: Session

First time at the DIA Annual Meeting? We encourage you to attend the Annual Meeting Orientation to learn how to make the most of your time at the meeting and meet fellow first-timers.

Chair

Susan Benedetti

Speakers
avatar for Susan Benedetti

Susan Benedetti

Senior Project Manager, Annual Meeting, DIA, United States

Monday June 17, 2024 7:00am - 8:00am PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  17: Networking Opportunities, Session

10:00am PDT

#SCC: Student Case Competition
Component Type: Session



Speakers
OA

Olivia Atkins

MS Biotechnology Student, Georgetown University, United States
RD

Rama Doddi

MS Regulatory Affairs Student, Northeastern University, United States
VM

Vandana Mandavilli

MS Regulatory Affairs Student, Northeastern University, United States
TS

Tejendra Sri Ajith Nalluri

MS Regulatory Affairs Student, Northeastern University, United States
IN

Ifeoma Njubigbo

PharmD Student, University of Illinois Chicago, United States
KP

Keerthi Pendri

MS Regulatory Affairs Student, Northeastern University, United States
DS

Deeksha Surisetty

MS Biotechnology Student, Georgetown University, United States
BT

Bintou Timbine

PharmD Student, University of Illinois Chicago, United States

Monday June 17, 2024 10:00am - 11:00am PDT
Sails Pavilion San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  17: Networking Opportunities, Session

10:15am PDT

#101 IT: Taimei Technology Innovation Theater: Next-Gen Trials Platform: AI-Native, Collaboration-First, and Site Network
Component Type: Session

AI-Driven Study Building: Experience the revolution in EDC database creation with AI, streamlining study building efficiency. Strategic Orchestration: Explore Trials Brain, a system comprehending project strategies and orchestrating resources for trial management. Collaboration: Explore next-gen trials tech, merging Virtual Site Network (VSN), Remote Monitoring Network (RMN), and Participant Recruitment Network (PRN) for seamless communication, fostering innovation in clinical research.

Chair

Taimei Technology, Inc.

Speaker

Speaker
Shou Yuan

Speaker
Gary Ma


Speakers
avatar for Taimei Technology, Inc.
avatar for Shou Yuan

Shou Yuan

Product Innovation and Global Operations Representative, Taimei Technology Inc., United States
Over 10 years of extensive experience in clinical project and system management Successfully completed 40+ projects in System R&D, DM, and Solution Delivery Specialization in EDC, IWRS, eCOA, CTMS, eTMF, system integration, and migration Proven leadership as a Data Management and... Read More →
avatar for Gary Ma

Gary Ma

President, Taimei Technology Inc., United States
Gary Ma, with over 10 years of experience in the biopharmaceutical industry, currently serves as the SVP, Chief Product Officer, and Head of the Overseas BU at Taimei Technology. Before joining Taimei, he worked at both sponsor and CRO companies, including Hengrui Pharmaceuticals... Read More →

Monday June 17, 2024 10:15am - 10:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

10:15am PDT

#102 IT: Appian Innovation Theater: AI in Life Sciences - Promise or Peril?
Component Type: Session

Brace for impact as Evi Cohen and Juan Jiménez of Appian take you on a thrilling journey into the heart of AI-driven automation in life sciences. Will this powerful technology revolutionize the industry or leave us lost in a regulatory maze? Strap in for a thought-provoking exploration of the opportunities, challenges, and everything in between. Don't miss this electrifying discussion on navigating the future of life sciences!

Chair

Appian

Speaker

Speaker
Evi Cohen, MBA, MS, MSc

Speaker
Juan Jiménez, MBA


Speakers
avatar for Appian

Appian

United States
avatar for Evi Cohen

Evi Cohen

Industry Leader, Life Sciences, Appian, United States
Evi is the Life Sciences Industry Leader at Appian. He is an experienced pharmaceutical executive with an extensive background developing global business portfolios with emphasis on new products, technologies, and IP. Previously, as Global Head of Life Sciences at ServiceNow Evi lead... Read More →
avatar for Juan Jiménez

Juan Jiménez

Lead Software Engineer, Product Strategy, Appian, United States
Juan has been with Appian for four years and currently serves as the Process Automation Technology Lead for Product Strategy. Prior to joining Appian, Juan worked for over 15 years as a consultant and independent contractor, leading customized software development projects for medium... Read More →

Monday June 17, 2024 10:15am - 10:45am PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

10:15am PDT

#103 IT: Mendel AI Innovation Theater: RWD 2.0 - Decoding Patient Journeys at Scale through Clinical AI
Component Type: Session

Discover how healthcare and life sciences companies are leveraging clinical AI to interpret vast datasets at an unprecedented pace, finding the right trial participants more efficiently than ever. This session will share data demonstrating that industry-specific clinical AI outperforms general domain LLMs and explore the science behind creating true, physician-like intelligence - representing a leap in generative real-world data applications.

Chair

Mendel.ai

Speaker

Speaker
Karim Galil, MD


Speakers
avatar for Mendel.ai

Mendel.ai

United States
avatar for Karim Galil

Karim Galil

CEO and Co-founder, Mendel.ai, United States
Karim Galil, MD, is co-founder and CEO of Mendel AI. Mendel’s mission is to make medicine objective by enabling the world’s largest index of patient journeys, leveraging AI that understands medicine like a physician. Dr. Galil’s experience as a physician demonstrated that medicine... Read More →

Monday June 17, 2024 10:15am - 10:45am PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:00am PDT

#104: Reporting of Pre-Market and Post-Market Safety Reports to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-518-L04-P; CME 1.00; RN 1.00

Reporting of pre-market and post market safety reports to be submitted in ICH E2B (R3) format to FDA Adverse Event Reporting System (FAERS). The presenters will discuss system readiness, testing approach, challenges, and lesson learned for reporting premarket and post market safety reports, both from FDA’s and industry’s perspective.

Learning Objectives

Recognize that FDA will go live with E2B R3 standard early next year and will require reporting of Investigational New Drug (IND) and post market safety reports to be submitted in ICH E2B (R3) format to FAERS via the FDA Gateway or using the Safety Reporting Portal; Describe regional data elements, system readiness, testing approach, challenges and lesson learned that are key for post market, IND and IND-exempt BA/BE safety reporting, both from FDA’s and industry’s perspective.

Chair

Suranjan De, MBA, MS

Speaker

Safety Reporting to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards - Industry Prospective
Sheila M Estela, BSN, RN

Safety Reporting to FDA Adverse Event Reporting System (FAERS) Using ICH E2B R3 Standards - Industry Prospective
Subhan Ahmed Sharief


Speakers
avatar for Suranjan De

Suranjan De

Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality... Read More →
avatar for Sheila M Estela

Sheila M Estela

Regional Patient Safety Head US and Canada, Novartis Pharmaceuticals Corporation, United States
I am a Registered Nurse currently working as the Regional Patient Safety Head for US & Canada at Novartis Pharmaceuticals. In this role, I lead a team of almost 70 dedicated PV professionals in the region. Additionally, I hold the position of US Country Patient Safety Head (CPSH... Read More →
SA

Subhan Ahmed Sharief

Director, ArisGlobal LLC, United States

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

11:00am PDT

#106: Machine Learning and Simulations to Facilitate Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-520-L04-P; CME 1.00; RN 1.00

The past decade has seen significant strides in machine learning and AI technologies. This session will provide an in depth investigate the various uses of machine learning and AI-based simulations within clinical development, ranging from data analysis, endpoint selection, the potential improvement of decision making within trial teams by clarifying tradeoffs to clinicians and statisticians, and more.

Learning Objectives

Describe the potential benefits of simulations in clinical trial protocol development and trial analysis, and the benefits of employing machine learning tools throughout clinical development; Discuss the novel approaches to conducting studies with such tools incorporated and relate to the regulatory guidance for adaptive trial design where relevant.

Chair

Raviv Pryluk, PhD

Speaker

Doing More with Less: Using ML to Drastically Improve Trial Simulation and Design
Raviv Pryluk, PhD

Clinical Trial Simulation: the Antidote to Wishful Thinking
Sam Miller, MSc

Digital Twins for Clinical Trials
Charles Fisher, PhD


Speakers
avatar for Raviv Pryluk

Raviv Pryluk

PhaseV, United States
Raviv is the co-founder & CEO of PhaseV, a technology company that leverages causal-ML and advanced software capabilities to support advanced & innovative clinical trials. Raviv holds a B.Sc. and M.Sc. in engineering from the Technion (Cum Laude) and Ph.D. in computational neuroscience... Read More →
CF

Charles Fisher

Founder and Chief Executive Officer, Unlearn.AI, United States
SM

Sam Miller

Head of Strategic Consulting, Exploristics, United Kingdom
Sam has over 25 years’ experience as a statistician in the pharmaceutical industry. At Exploristics, he oversees the Statistical Consulting team. With a BA in Mathematics from the University of Cambridge and an MSc in Statistics from University College London, Sam has broad knowledge... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Session

11:00am PDT

#105: The Intersection of Science, Ethics, and Participant Collaboration in Pediatric Rare Disease Product Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-519-L04-P; CME 1.00; RN 1.00

Experts in pediatric rare disease product development, pediatric ethics and patients/advocates discuss designing studies to best benefit the patient, and how patients/caregivers assess risks and benefits in early phase trials.

Learning Objectives

Discuss the ethical and scientific considerations for designing studies for rare diseases that impact children, including the level of evidence needed to initiate early phase trials; Discuss how patients and caregivers weigh the risks of early-phase studies against the benefits of a potential treatment for their rare disease, especially when there are limited to no other options.

Chair

Donna Snyder, MD

Speaker

Ethical Considerations for Including Children in Rare Disease Trials
Donna Snyder, MD

Update from ORPURM/DRDMG
Mehul Desai, MD

Patient Perspective
Mark Dant

Patient Perspective
Ryan Dant


Speakers
avatar for Donna Snyder

Donna Snyder

Executive Physician, WCG, United States
Donna Snyder, MD, MBE is the Executive Physician of WCG where she contributes subject matter expertise and operational guidance across WCG to ensure that research will be conducted to the highest ethical standards. Prior to WCG, Dr. Snyder served as the leader and Senior Pediatric... Read More →
avatar for Mark Dant

Mark Dant

Volunteer Executive Director, The Ryan Foundation, The Ryan Foundation for Rare Disease Research, United States
Mark is the Founder and Volunteer Executive Director of the Ryan Foundation and is the former Board Chair of the of the EveryLife Foundation for Rare Diseases. Mark and his family founded the Ryan Foundation in 1992 shortly after their only child Ryan was diagnosed with MPS I. Since... Read More →
avatar for Ryan Dant

Ryan Dant

Patient Advocate, The Ryan Foundation for Rare Disease Research, United States
Ryan Dant is a long-time patient advocate diagnosed at the age of three with Mucopolysaccharidosis type 1 (MPS 1), a rare lysosomal storage disorder. When doctor’s predicted Ryan’s life to be cut short due to the disease, Ryan’s parents, Mark and Jeanne, spearheaded the funding... Read More →
avatar for Mehul Desai

Mehul Desai

Medical Reviewer, ORDPURM/DRDMG, OND, CDER, FDA, United States
Mehul Desai M.D. is a medical officer in the Division of Rare Diseases and Medical Genetics (DRDMG), Office of New Drugs (OND), Center for Drug Evaluation Research (CDER), with the US Food and Drug Administration (FDA). Dr. Desai has clinical development experience in both the pharmaceutical... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

11:00am PDT

#109: GCP Renovation: How Will GCP Inspection Change in Europe, Japan, and the US?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-523-L04-P; CME 1.00; RN 1.00

In this session, we will invite speakers from EMA, FDA, and PMDA, and share the latest regulations, perspective to revised ICH guidelines, and challenges to implement the guideline in own region.

Learning Objectives

Recognize direction of revising ICH-GCP guideline; Discuss how to utilize it in real inspection.

Chair

Junko Sato, PhD

Speaker

FDA Update
Kassa Ayalew, MD, MPH

EMA Update
Peter Twomey

PMDA Update
Yoshiaki Nodera, MPharm


Speakers
avatar for Junko Sato

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
avatar for Kassa Ayalew

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with several years of clinical and... Read More →
avatar for Yoshiaki Nodera

Yoshiaki Nodera

Principal Inspector, Office of Non-clinical and Clinical Compliance I, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Yoshiaki Nodera currently serves as a principal inspector of the Office of Non-clinical and Clinical Compliance I in the Pharmaceuticals and Medical Devices Agency (PMDA). He joined PMDA in 2008 and had been working as a reviewer of biotechnological/biological products, medical devices... Read More →
avatar for Peter Twomey

Peter Twomey

Head of Inspections, European Medicines Agency, Netherlands
Peter Twomey is the Head of Inspections at EMA, which supports the supervision of GxP practices, market surveillance, quality defects and recalls and harmonisation and policy development in the inspections area. He is the current Regulatory Chair of the Expert Working Group drafting... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session

11:00am PDT

#112: Regulatory Convergence for CMC Requirements: The Challenges and Benefits of a Single Global Dossier
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-526-L04-P; CME 1.00; RN 1.00

The session will share concrete experiences and expectations for the use of a single global dossier for CMC requirements. The panel will bring perspectives of regulators and industry, connecting the topic to regulatory convergence and reliance.

Learning Objectives

Identify the benefits of a single global dossier strategy for regulatory convergence and reliance initiatives in the area of CMC; Describe experiences from multinational companies with the implementation of harmonized dossier content for global submissions; Analyze and discuss the challenges and opportunities perceived by regulators for the use of a single global dossier for CMC requirements.

Chair

Ana Padua, MSc, RPh

Speaker

ICH M4Q(R2): Opportunity for One Global Dossier
Lawrence Yu, PhD

EMA Update
Evdokia Korakianiti, PhD, MSc

ANVISA Update
Nélio Cézar de Aquino, SR, MSc

Regional Regulatory Hub Strategist Team Lead: Specialty Care Portfolio LatAm
Agustin Brito Del Pino, RPh

Industry Update
Susanne Ausborn, PhD


Speakers
avatar for Nélio Cézar de Aquino

Nélio Cézar de Aquino

General Manager of Medicines, ANVISA, Brazil
Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories... Read More →
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
avatar for Ana Padua

Ana Padua

Director EU Global Regulatory and Scientific Policy, EMD Serono, Switzerland
Ana has over 19 years of pharmaceutical industry experience starting in Analytical Development (2-year) and then Regulatory Affairs area by working for Medley (Brazil), Novartis (Brazil and Switzerland), Parexel (Brazil) and in the last 8+ years for Roche leading the CMC Regulatory... Read More →
avatar for Agustin Brito Del Pino

Agustin Brito Del Pino

Regional Regulatory Hub Team Lead, Pfizer Inc, Uruguay
Pharmaceutical Chemist based in Montevideo, Uruguay. +10 years of experience on the pharmaceutical industry, part of LatAm Regulatory Affairs in Pfizer since year 2014. Part of the Regional Regulatory Hub for the LatAm Region for the last 8 years. Provided strategic regulatory support... Read More →
avatar for Lawrence Yu

Lawrence Yu

Director, Office of New Drug Products, OPQ, CDER, FDA, United States
Lawrence X. Yu, Ph.D., is the Director, Office of New Drug Products, Food and Drug Administration and Rapporteur, ICH M4Q(R2) Expert Working Group. Dr. Yu is also an adjunct Professor at the University of Michigan. Dr. Yu is an Associate Editor of the AAPS Journal. Dr. Yu has authored/co-authored... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session

11:00am PDT

#115: From Intention to Action: Building Diversity, Equity, and Inclusion Initiatives to Create a Culture of Belonging
Component Type: Session
Level: Basic

It is well understood that diversity in the workplace contributes to innovation and improved business outcomes. Interweaving diversity, equity, and Inclusion (DEI) strategies into the work of an organization can improve performance and create thriving workplace cultures. Building such a culture translates into a sense of belonging that inspires employees across the pharmaceutical industry to be more engaged, considering their organization a great place to work and committing to the company mission. While most companies include DEI in their strategic plans, there remains a disconnect between having DEI as a company priority and the actual cultivation of an inclusive workplace. DEI efforts at many companies are limited to only passive learning (e.g., online modules and training) and a shift to a more engaging, fit-for-purpose approach is needed. In this session, we will share case studies of ongoing diversity, equity, and inclusion (DEI) workplace initiatives and we will delve into concrete action plans to translate DEI company priorities.

Learning Objectives

Describe existing diversity, equity, and inclusion (DEI) policies within the workplace to identify strengths and gaps; Discuss DEI initiatives that foster a culture of belonging in the workplace.

Chair

Ruth Milena Gómez Vargas, MS

Speaker

Case Study: Medical Writing Inclusion, Diversity, and Equity Alliance
Ruth Milena Gómez Vargas, MS

The Big Picture: Inclusive Workplaces Benefit Patients
Xoli Belgrave, MSc

Case Study
Carlos Orantes, MBA

Case Study
Karen J Wood


Speakers
avatar for Xoli Belgrave

Xoli Belgrave

Senior Director, Patient Inclusion, Parexel , United States
Xoli has been leading Clinical Trial DEI at Parexel since July 2022. As the Head of Patient Diversity, Equity & Inclusion, she helps customers build a DEI strategy and partners with Clinical Development to operationalize. Xoli has 20+ years of global clinical research experience in... Read More →
avatar for Carlos Orantes

Carlos Orantes

Chief Executive Officer, Alcanza Clinical Research, United States
avatar for Ruth Gómez Vargas

Ruth Gómez Vargas

Senior Medical Writer, MSD, Colombia
Ruth Gómez, M.Sc., is a Regulatory Medical Writer at MSD, with 14 years of experience in scientific research. She has had the opportunity to work across various fields, which has given her a profound appreciation for the power of diversity. At MSD, a whole world of diversity exists... Read More →
avatar for Karen Wood

Karen Wood

Senior Manager Patient Advocacy, Medidata , United States
Karen joined the Patient Insights Team at Medidata, where she champions for patients' rights and well-being. Karen brings a true passion for patients to her role not only because of her professional experience, but from her personal experience as well. It was these experiences that... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  13: ProfDevelopment, Session

12:15pm PDT

#119 IT: RWS Innovation Theater: Accelerate Time-to-Market with Smart, Structured Content, Reuse, and AI
Component Type: Session

Accelerate time-to-market is getting more and more important to our customers in pharma and life sciences. With structured content, we see benefits in the areas of efficiency, speed and consistency. During this session, we will share the benefits that our launching customers experience with the Fonto Integrated Authoring Platform. How AI, structured data and smart reuse contribute to time-to-market acceleration and an increase in efficiency, speed and consistency.

Chair

RWS

Speaker

Speaker
Jan Benedictus, MS, MSc


Speakers
avatar for Jan Benedictus

Jan Benedictus

Managing Director, Fonto, RWS, Netherlands
Jan Benedictus is founder and managing director of Fonto - a user-friendly authoring tool for structured content. Fonto is widely used in content-intense industries such as Publishing, Aviation, Technical Documentation, and increasingly in Pharma and Life Sciences. Jan is actively... Read More →
avatar for RWS

RWS

United States

Monday June 17, 2024 12:15pm - 12:45pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:15pm PDT

#120 IT: Datacubed Health Innovation Theater: The Impact of Digital Tools on Pediatric and Elderly Clinical Trials
Component Type: Session

This presentation highlights the role of patient engagement technologies in boosting retention in clinical studies, particularly among pediatric and elderly groups. It covers case studies on interactive tools for children that enhance participation and digital platforms for the elderly that address mobility and usability, showing how these technologies improve engagement and retention by meeting patient needs.

Chair

Datacubed Health

Speaker

Speaker
Kyle Hogan


Speakers
avatar for Datacubed Health

Datacubed Health

United States
avatar for Kyle Hogan

Kyle Hogan

President, Datacubed Health, United States
Kyle has been dedicated to advancing the voice of the patient through the promise of ePRO/eCOA since 2007, in that time helping deliver over 500 successful trials for CROs and Pharmaceutical companies globally. He is a recognized expert for implementing innovative and patient centric... Read More →

Monday June 17, 2024 12:15pm - 12:45pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:15pm PDT

#121 IT: Castor Innovation Theater: Practical AI - Creating a Future Without Manual Data Re-Entry
Component Type: Session

This year, at DIA, Castor will demonstrate their newest human-in-the loop AI capability, Castor CoPilot. This AI assistant reduces the need for manual data (re-)entry and source data verification, cutting down the time spent on manual, repetitive tasks. This session will be interactive, offering attendees a chance to see Castor CoPilot in action through a live demonstration, emphasizing the practical application and efficiency of Castor's AI solutions in streamlining clinical trials.

Chair

Castor

Speaker

Speaker
Derk Arts, MD, PhD

Speaker
Kristen Harnack


Speakers
avatar for Derk Arts

Derk Arts

Founder & CEO, Castor, Netherlands
Dr. Derk Arts, MD, Ph.D., has 20 years of experience in medicine, research, and technology innovation. He founded Castor in 2012, a clinical trial platform focused on patient-centric solutions and data-driven outcomes. Under his leadership, Castor has recently advanced its AI capabilities... Read More →
avatar for Castor

Castor

Netherlands
avatar for Kristen Harnack

Kristen Harnack

Director of Solutions Consulting, Castor, United States
Kristen Harnack, Director of Solutions Consulting at Castor, is responsible for advising customers on the technical functionality of Castor’s products to provide a seamless and scalable patient experience for clinical trial patients. Prior to Castor, Kristen spent 9 years educating... Read More →

Monday June 17, 2024 12:15pm - 12:45pm PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:15pm PDT

#118 RT: Roundtable Discussion: The Interaction of Science, Ethics, and Patient Collaboration in Pediatric Rare Disease Product Development
Component Type: Session

Join the Bioethics Community for a follow up round table discussion tied to session: The Interaction of Science, Ethics, and Patient Collaboration in Pediatric Rare Disease Product Development (Monday, June 17 | 11:00AM - 12:00PM PDT). Space is limited.

Chair

Lindsay McNair, MD, MPH, MS

Speakers
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →

Monday June 17, 2024 12:15pm - 1:15pm PDT
Ballroom 20 Lobby San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   02: ClinTrials -ClinOps, Session

12:15pm PDT

#POS 1: Professional and Student Poster Session 1
Component Type: Session

Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
IA

Ilyoung Ahn

Scientific Officer, Institute of Food and Drug Safety Evaluation, Korea, Republic of
SA

Salman Alharthi

Head of Formulary Management, Security Forces Hospital, Saudi Arabia
AA

Ashwin Anand

Engagement Manager, Forian, United States
avatar for Jorge Azar

Jorge Azar

Senior Area Regulatory Director for Latin America, AstraZeneca, United States
Jorge Azar is currently Senior Area Regulatory Director for Latin America with 25 years’ experience on different roles at local, regional and global level in the Regulatory Affairs field, including product strategy, regulatory policy and intelligence. Jorge earned a degree in Pharmacy... Read More →
avatar for Jan-Georg Bohlken

Jan-Georg Bohlken

Student, University of Bremen, Germany
I studied biology at the University of Göttingen, with a focus on bioinformatics. While working at the Max-Planck Institute for Experimental Medicine, I discovered my interest in statistics. In April of 2024, I finished my Masters in biostatistics. During an industry internship in... Read More →
avatar for Paul Bolot

Paul Bolot

Global Regulatory Strategist, Bayer Consumer Care AG, Switzerland
Paul Bolot is a PharmD by training, with a Master's degree in International Drug Registration and Development. He worked as a regulatory consultant at PharmaLex for three years. Since 2021, he works at Bayer as Global Regulatory Strategist. His work focuses on Regulatory Science... Read More →
avatar for Tuiana Brown

Tuiana Brown

PharmD Candidate 2025, Chicago State University, United States
My name is Tuiana Brown, a PharmD Candidate (2025) at Chicago State University College of Pharmacy. During my tenure at Chicago State, I began to appreciate research very much. I completed three years of research with the RISE, CAHMPS, and SRTP programs. I also completed an internship... Read More →
avatar for James Browning

James Browning

Director of Biostatistical Programming, Center for Observational Research, Amgen, United States
James Browning, MPH, is a Director of Biostatistical Programming in the Center for Observational Research (CfOR) at Amgen Inc. He has over 15 years of experience conducting observational studies in multiple therapeutic areas with the majority concentrated in oncology. He is skilled... Read More →
avatar for Xianwen Chen

Xianwen Chen

student, University of Macau, Macao
Chen Xianwen is currently a PhD candidate in the Institute of Chinese Medical Sciences at the University of Macau. Her research interests include drug regulatory science and drug policy. In 2020–2022 she obtained her Master’s degree at University of Macau, then she worked as an... Read More →
JC

Joan Cheung

Senior Consultant, NNIT, United States
Joan Cheung received her Doctor of Pharmacy degree from St. John's University and has been recognized by her colleagues in developing a labeling solution with a Product Excellence Award in 2022. She leverages her pharmacy background and technical acumen as a Business Analyst and Project... Read More →
avatar for Constance Chisha

Constance Chisha

PhD Student, University of the Witswatersrand, South Africa
Constance Sakala Chisha is a doctoral candidate pursuing a PhD at the University of the Witwatersrand. She holds a Bachelor’s degree in Pharmacy from the University of Zambia and a Master’s degree in Pharmaceutical Services and Medicines Control from the University of Bradford... Read More →
avatar for Grace Collins

Grace Collins

Regulatory Policy Analyst, Friends of Cancer Research, United States
Grace Collins is a regulatory policy analyst at Friends of Cancer Research where she conducts research to support the organization’s science, policy, and patient advocacy initiatives. In her role, she leads the creation of public data dashboards for assessing trends in oncology... Read More →
SD

Sahith Doppalapudi

Sr. Manager, PV Analytics Center of Excellence, Bristol-Myers Squibb Company, United States
Sahith Doppalapudi holds a master's degree in Chemical Engineering from Oklahoma State University and has accumulated over 14 years of experience in the pharmaceutical industry. Throughout his career, he has served in different roles including Quality Analyst, Validation Lead, and... Read More →
avatar for Christopher Doyle

Christopher Doyle

Senior Director, IBC Services, WCG, United States
Chris is Sr. Director of IBC Services at WCG, where he works with clinical trial stakeholders to ensure research involving gene-based medicines is conducted safely and efficiently. Chris received his PhD in Molecular Genetics and Microbiology from Stony Brook University in 2014. Prior... Read More →
NE

Nora Emmott

Senior Policy Analyst, Duke Margolis Institute For Health Policy, United States
Nora Emmott is the Senior Policy Analyst for the Real-World Evidence Collaborative at Duke-Margolis Center for Health Policy where she works on projects related to patient-generated health data, pharmacogenomics, and precision medicine. She has an MPH with a concentration in Health... Read More →
JF

Jeanine Flanigan

HEOR specialist, Sandoz, United States
Jeanine Flanigan is a HEOR Specialist at Sandoz. She is a graduate of the University of Pittsburgh School of Pharmacy (PharmD '21 and MS '23) and completed a fellowship with Pitt Pharmacy & Sandoz in pharmacoanalytics and outcomes research.
avatar for Kayla Garvin

Kayla Garvin

Sr Regulatory Health Project Manager, FDA, United States
I am a Senior Regulatory Health Project Manager with FDA/CDER’s Office of Medical Policy (OMP). I have an MPH from the University of New England and have been with the Agency for 19 years and with OMP for 15 years. I coordinate the workflow for various cross-Agency programs, including... Read More →
NG

Neda Gharavi

Senior Director Medical Writing & Regulatory Affairs, BioPharma Services, Canada
Dr. Gharavi's career in the pharmaceutical industry has been defined by her unwavering passion for science. With a Pharm D degree and a PhD in Drug Metabolism, she has made significant contributions to pharmaceutical industry. Starting as a Pharmacokinetic Scientist at Apotex, she... Read More →
TG

Tapash Ghosh

TL, FDA, United States
avatar for Nick Henscheid

Nick Henscheid

Senior Scientist, Critical Path Institute, United States
Nick Henscheid completed his PhD in Applied Mathematics in 2018 with a focus on image science and precision medicine. Since 2021 he has worked for the Critical Path Institute developing advanced quantitative modeling solutions for a variety of needs across the drug development li... Read More →
avatar for Li Huang

Li Huang

Principal Biostatistician, Phastar, United States
Li Huang is a principal biostatistician in PHASTAR since 2020. She received Doctor of Dental Surgery (DDS) from Hubei Medical University (China), Master of Science in Dentistry from National University of Singapore (NUS), and Master of Science in Applied Statistics from California... Read More →
avatar for Toshiko Ishibashi

Toshiko Ishibashi

Oncology Medical Science Department, Medical Affairs Division, Daiichi Sankyo Co., Ltd., Japan
Toshiko Ishibashi is an Associate Director of Oncology Medical Science in Medical Affairs at Daiichi Sankyo Co., LTD. since 2020. She served Ono Pharmaceutical Company from 2018 to 2020. She was a Clinical Operations Manager at Abbvie, 2016-2018. She has experience as an assistant... Read More →
RI

Rajashekhar Ittedi

Student, Northeastern University, United States
I am a motivated and aspiring regulatory affairs professional with a strong pharmacy background and clinical research skills. Currently, I am pursuing my Master's degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices at Northeastern University, where I am gaining... Read More →
avatar for Zarnab Jillani

Zarnab Jillani

Medication Error Pharmacovigilance and Risk Management Fellow, FDA, United States
avatar for James Kim

James Kim

Undergraduate Student Researcher, University of Southern California, United States
James is a rising junior studying Neuroscience at the University of Southern California. He is an undergraduate student researcher in the Regulatory Science Team and is studying the use of patient-reported outcome measures in clinical trials for Parkinson's Disease. At school, James... Read More →
avatar for Yueh-Wen Lan

Yueh-Wen Lan

Senior Project Manager, Center for Drug Evaluation, Taiwan
Yueh-Wen Lan, a senior project manager in the Division of Regulatory Affairs and Compliance at CDE Taiwan for more than 6 years, has participated in project management for reviewing cases of clinical trials, generic drug registration, and new drug registration. I hold a Master's Degree... Read More →
avatar for Juan Lara

Juan Lara

Senior Research Analyst, Centre For Innovation In Regulatory Science, Mexico
Juan is a Senior Research Analyst at the Center for Innovation in Regulatory Science. He holds a Bachelor's degree in Pharmaceutical-Biological Chemistry and has diverse experience in quality assurance, production, R&D, and regulatory affairs. Juan supports a wide range of regulatory... Read More →
avatar for Liyang Lyu

Liyang Lyu

Student, University of Macau, Macao
Liyang Lyu, a PhD candidate at the University of Macau, specializes in pharmaceutical patent research, with a primary focus on cancer immunotherapy. She has authored two articles in Nature Biotechnology, focusing on the advancements in iPSC and CAR-T therapies.
avatar for Jessica Miller

Jessica Miller

1st-Year Fellow, Global Regulatory Affairs CMC, GlaxoSmithKline, United States
avatar for Namosha Mohite

Namosha Mohite

Assistant Director, Global Regulatory Affairs, Bayer, United States
Namosha Mohite, PharmD, is a Manager in the Global Regulatory Affairs group at Bayer. In her current role, she serves as a US regulatory strategist for a product in late-stage development and also supports related global regulatory activities. Her background in pharmacy and interest... Read More →
avatar for Nancy Ngum

Nancy Ngum

Student, University of Hertfordshire, United Kingdom
Nancy Yang-Ngum is currently a Doctoral student with the University of Hertfordshire in the United Kingdom. Her research in regulatory science is focused on an assessment of the Regulatory Review Systems in the East Africa Community (EAC) with a view to improving Patients’ Access... Read More →
BN

Bridget Nugent

Science Policy Analyst, FDA, United States
Bridget Nugent, PhD, is a Science Policy Analyst who leads regulatory science initiatives for FDA CDER’s Rare Diseases Team (RDT). Dr. Nugent is a neuroscientist with over 16 years of research and mentorship experience with expertise in rare disease drug development, molecular biology... Read More →
avatar for Ashley Ogawa-Wong

Ashley Ogawa-Wong

Medical Writer, Merck Sharp & Dohme LLC, United States
Ashley is a senior medical writer at Merck & Co., Inc. Since joining medical writing in 2020, Ashley has supported several successful filings to worldwide regulatory agencies. She has authored clinical trial protocols, briefing packages, Investigator’s Brochures, Clinical Study... Read More →
avatar for Mercy Owusu-Asante

Mercy Owusu-Asante

Graduate Student, School of Life and Medical Sciences, University of Hertfordshire, United Kingdom
Mrs Mercy Owusu-Asante is a pharmacist with an MSc in Pharmaceutical Services and Medicines Control obtained from the University of Bradford, UK. In the area of personal professional development, Mercy is pursuing a PhD in Regulatory Science at the University of Herfordshire, UK... Read More →
avatar for Sydney Ringold

Sydney Ringold

Customer Success Manager, Cytel, Inc., United States
Sydney Ringold is a Customer Success Manager at Cytel. She has a diverse background, having received her B.S. in biology and MBA in operations management from the University of Alabama. She has experience in both commercial and research aspects of clinical trials through cofounding... Read More →
avatar for Bhavana Tallavajhula

Bhavana Tallavajhula

Director, Bristol Myers Squibb, United States
Bhavana Tallavajhula is a highly accomplished pharmaceutical professional with over 20 years of experience at Bristol Myers Squibb (BMS). She began her career as a Formulation Scientist, gaining expertise in laboratory work. Driven by a desire to make a tangible impact on patient... Read More →
JV

Jacqueline Vanderpuye-Orgle

Vice President, Parexel, United States
avatar for Shruti Vig

Shruti Vig

Graduate Student, University of Maryland, College Park, United States
Shruti Vig is a fifth-year Ph.D. candidate in the Department of Bioengineering at the University of Maryland. Currently under the mentorship of Dr. Huang Chiao Huang and Dr. Graeme F. Woodworth, her research focuses on developing test methodologies for evaluating the phototoxicity... Read More →
avatar for Stuart Walker

Stuart Walker

Professor and Consultant, Centre for Innovation In Regulatory Science (CIRS), United Kingdom
Professor Stuart Walker, BSC, PhD (London), MFPM, FRSC, FiBiol, FRCPath, is an independent Consultant in Pharmaceutical Medicine and Founder of both the Centre for Medicines Research (CMR) International and the Centre for Innovation in Regulatory Science (CIRS). UK
FY

Felix Yang

US Regulatory Policy Fellow, Genentech, A Member of the Roche Group, United States
Felix Yang, PharmD, is a US Regulatory Policy Post-Doctoral Fellow at Genentech, a member of the Roche Group in conjunction with Howard University. Felix obtained his PharmD from the University of Wisconsin-Madison. During his first year at Roche-Genentech, he has conducted projects... Read More →
avatar for Scarlett Yang

Scarlett Yang

Senior Regulatory Affairs Associate, Gilead Sciences, United States
Scarlett Yang is a Senior Regulatory Affairs Associate at Gilead and supports various regulatory intelligence and policy activities. Scarlett brings partners and stakeholders together across sectors to tackle challenges in drug development. Scarlett holds a PhD in Immunology from... Read More →
JZ

Jiewei Zeng

Associate Director, Abbvie, United States
Dr. Jiewei Zeng is an Associate Director at AbbVie. She had Ph.D. in mathematics with a major in statistics from the University of Illinois at Chicago, where her research focused on developing optimal designs for compartment models. Dr. Zeng has extensive experience working in the... Read More →

Monday June 17, 2024 12:15pm - 2:15pm PDT
Posters Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  18: Posters, Session

12:55pm PDT

#123 IT: IQVIA Innovation Theater: Evolving Clinical Development Approach Amidst a Digital Transformation Wave
Component Type: Session

The rapid transformation of digital edge technologies is fundamentally shifting the solution experience for trial participants, sites, sponsors and clinical research teams. In this presentation, we will share a vision for the future of clinical development processes, that can leverage and drive value generation by maximizing benefits of the ongoing digital transformation wave.

Chair

IQVIA

Speaker

Speaker
Rajneesh Patil, DDS, MBA

Speaker
George Wu


Speakers
avatar for IQVIA

IQVIA

United States
avatar for Rajneesh Patil

Rajneesh Patil

Vice President, Clinical Operations, IQVIA, United States
Rajneesh serves Clinical Operations at IQVIA as Head of Digital Strategy and Analytics Innovation. He is a gold medalist in Dental Surgery from India with Foundations in Public health from Australia and Digital Strategy-Executive from Harvard Business School, USA. At IQVIA, he leads... Read More →
avatar for George Wu

George Wu

Director, Biostatistics, Gilead, United States
George Wu is a Statistical Advisor in Biostatistics at Gilead. He is passionate about developing innovative approaches to improve drug development using his clinical trial experience and statistical expertise. He works on cross-functional initiatives ranging from innovative trial... Read More →

Monday June 17, 2024 12:55pm - 1:25pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:55pm PDT

#124 IT: PPD, part of Thermo Fisher Scientific Innovation Theater: Accelerating Drug Development Through the Convergence of Real-World Data (RWD) and Technology
Component Type: Session

The proliferation of real-world data (RWD) sources and advancements in technology (e.g.,artificial intelligence (AI), wearables) have fueled the use of real-world evidence (RWE)in drug development. Globally diverse, trusted data sources and impactful AI and digital technologies provide faster, more comprehensive curated data for optimized study design and analysis. This intersection provides invaluable insights to help decision makers make smarter, faster decisions to advance and optimize product development.

Chair

PPD, part of Thermo Fisher Scientific

Speaker

Speaker
Peter Wahl, MS

Speaker
Ariel Berger, MPH

Speaker
Gino Pirri

Speaker
John Van Hoy, MBA


Speakers
avatar for PPD, part of Thermo Fisher Scientific
avatar for Ariel Berger

Ariel Berger

Executive Director, Integrated Solutions, Real-World Evidence, Evidera, part of PPD clinical research business of Thermo Fisher Scientific, United States
Ariel’s focus is database analytics where he designs and advises on various RWE and health economics studies, often involving complex methodologies and hybrid designs and disciplines. He has led numerous outcomes research studies, including retrospective database analyses; developed... Read More →
avatar for John Van Hoy

John Van Hoy

Executive Director, Data Science & Advanced Analytics, PPD, part of Thermo Fisher Scientific, United States
John has been in the Life Sciences industry for nearly 20 years, with roles that span clinical trial operations, mgmt. consulting, and functional leadership. John has developed a focus on the use of data and analytics to help sponsors and CROs gain a competitive advantage. He has... Read More →
avatar for Gino Pirri

Gino Pirri

VP Head Product & Technology, PPD, part of Thermo Fisher Scientific, United States
As an executive specializing in eClinical technology, with more than 25-yrs. of experience driving innovation and advancing technology to enhance the clinical trial experience for sites and patients, Gino is at the forefront of spearheading cutting-edge advancements in digital and... Read More →
avatar for Peter Wahl

Peter Wahl

Vice President, Global Head of Scientific Affairs, CorEvitas, part of PPD clinical research business of Thermo Fisher Scientific, United States
Dr. Wahl leads scientific partnerships for Thermo Fisher multi-sponsor registries and guides strategy on new registries and leveraging RWD to support late phase/post-approval studies, including drug safety. He led programs to drive drug discovery and development, including the ClinicoGenomics... Read More →

Monday June 17, 2024 12:55pm - 1:25pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:55pm PDT

#125 IT: Box Innovation Theater: From Data Chaos to Digital Clarity - Defining the Next Generation of Life Sciences with AI and eSignatures
Component Type: Session

Explore the digital overhaul of life sciences, highlighting the power of AI and unstructured data. Discover how e-signatures and AI are transforming research and patient outcomes. Learn to utilize the 90% unstructured data for better compliance and efficiency. Gain insights on AI applications for innovative, efficient decision-making in life sciences, leading to breakthroughs and a new digital era.

Chair

Box, Inc.

Speaker

Speaker
Manu Vohra

Speaker
Kirsten Swingle


Speakers
avatar for Box, Inc.

Box, Inc.

United States
avatar for Manu Vohra

Manu Vohra

Managing Director, Life Sciences, Box, United States
Manu Vohra is the Global lead for Life Sciences and Go-To-Market strategy for Cloud Content Management at Box.com. After two decades deploying ECM solutions in a regulated industry, he's spending his efforts supporting Life Sciences companies to ride the Digital Transformation wave... Read More →
avatar for Kirsten Swingle

Kirsten Swingle

Manager, Regulatory Submission Project Management, Regeneron, United States
Kirsten Swingle is a Manager at Regeneron Pharmaceuticals, where she leads the Clinical Trial Applications Submission Management Team, a part of the Regulatory Submission Project Management Department. Over the past 5 years, she has been instrumental in transforming the company's... Read More →

Monday June 17, 2024 12:55pm - 1:25pm PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

1:35pm PDT

#127 IT: Deloitte Innovation Theater: Turning Vision into Reality - Realizing the Promise of Next-Gen Regulatory Intelligence
Component Type: Session

Regulatory Affairs has always had the potential to transform into an insights-driven function capable of enhancing operations and accelerating the approval process. And now, advanced technologies and AI have exponentially accelerated this transformation. How can the regulatory function best help drive your organization toward a future state? Discover real-life solutions and future possibilities enabled by Regulatory Intelligence during this Q&A-style session.

Chair

Deloitte

Speaker

Speaker
Mukesh Singhal, MBA

Speaker
Camille Chicklis


Speakers
avatar for Camille Chicklis

Camille Chicklis

AI Strategy & Delivery Lead, Deloitte, United States
Camille Chicklis is an Artificial Intelligence Leader in Deloitte's Life Sciences & Health Care practice. She spearheads AI strategy and has extensive experience in productionizing AI solutions, connecting business and technical objectives to help organizations realize the true value... Read More →
avatar for Deloitte

Deloitte

United States
avatar for Mukesh Singhal

Mukesh Singhal

Partner, Deloitte, United States
Mukesh Singhal is a leader in Deloitte’s R&D and Regulatory practices, with over 15 years of industry experience shaping and leading digital transformations across the industry. Mukesh has led a cross-industry Regulatory Intelligence forum since 2018, helping to shape an industry... Read More →

Monday June 17, 2024 1:35pm - 2:05pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

1:35pm PDT

#128 IT: Evernorth Health Services Innovation Theater: Analyzing Online Survey Responsiveness and Participation
Component Type: Session

Member surveys are a method to collect real-world data not found in the claims data. Such insight can be valuable when combined with electronic medical records and claims data, providing a broader view of the patient. By applying socio-economic and demographic factors of patients likely to participate in virtual study or survey, can lead to increased study efficiency. We will share the common socio-economic and demographic factors of survey responders and non-responders.

Chair

Evernorth

Speaker

Speaker
Gene Jay, PharmD


Speakers
avatar for Evernorth

Evernorth

United States
avatar for Gene Jay

Gene Jay

Head of Sales and Account Management, Evernorth Health Services, United States
Dr. Gene Jay is the Director of Clinical Trial Solutions at Evernorth Health Services, an organization championing access to clinical trials for a diverse population of Evernorth healthcare members. In his role, Dr. Jay leads a data analytics group that leverages medical, pharmacy... Read More →

Monday June 17, 2024 1:35pm - 2:05pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

1:35pm PDT

#129 IT: H1 Innovation Theater: Beyond the Numbers - Humanizing Data in Clinical Trials for Inclusive Healthcare Solutions
Component Type: Session

This presentation will challenge conventional notions of data-centric approaches in clinical trials by emphasizing the importance of human narratives and lived experiences. We will explore how incorporating qualitative insights alongside quantitative data can enrich decision-making processes, promote empathy-driven healthcare solutions, and ensure that diverse voices are heard and valued.

Chair

H1

Speaker

Speaker
Ryan Brown, MPA


Speakers
avatar for Ryan Brown

Ryan Brown

Regional Vice President, Trial Landscape, H1, United States
Ryan Brown is the Regional Vice President of Trial Landscape Sales for H1, a cutting-edge health tech company that utilizes AI and DE&I performance data to enable more diverse and effective clinical trials. With 15+ years of experience driving diversity initiatives, Ryan is a sought-after... Read More →
avatar for H1

H1

United States

Monday June 17, 2024 1:35pm - 2:05pm PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

2:15pm PDT

#132: The Cost of Moving the Needle on Clinical Trial Representation: Strategies for Diversity Budget Planning and Resourcing
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-532-L04-P; CME 1.00; RN 1.00

Evidence shows that improving diversity in clinical trials requires early planning. The session presents a cost analysis and case examples from an expert panel on the impact of incorporating patient diversity tactics and resources early in the process.

Learning Objectives

Discuss how to quantify the cost and resources required to execute tactics that increase clinical trial diversity; Explain how the exclusion of patient diversity tactics in budget planning impacts diversity and overall study milestones; Identify considerations that can influence leadership decision-making around diversity during the budget planning process.

Chair

Lloryn Hubbard

Speaker

Industry Update
Ryan Brown, MPA

Industry Update
Steve T. Satek, MBA

Industry Update
Monica Eason


Speakers
avatar for Lloryn Hubbard

Lloryn Hubbard

Head of Patient Diversity, PPD Part of Thermo Fisher Scientific, United States
As head of Patient Diversity at PPD, Lloryn has strategic oversight over the company’s clinical trial health equity efforts and leads a team of specialists focused on optimizing drug development for inclusive patient representation. With 15 years of experience in the pharmaceutical... Read More →
avatar for Ryan Brown

Ryan Brown

Regional Vice President, Trial Landscape, H1, United States
Ryan Brown is the Regional Vice President of Trial Landscape Sales for H1, a cutting-edge health tech company that utilizes AI and DE&I performance data to enable more diverse and effective clinical trials. With 15+ years of experience driving diversity initiatives, Ryan is a sought-after... Read More →
ME

Monica Eason

Clinical Operations Portfolio Leader, Genentech, A Member of the Roche Group, United States
SS

Steve Satek

Executive Vice President, Flourish Research, United States

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Session

2:15pm PDT

#133: ICH M11 Protocol Template: A Global Solution for Global Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-533-L04-P; CME 1.00; RN 1.00

This session will highlight the latest developments of the ICH M11 Clinical Protocol Template including guidelines,protocol template, and technical specification and how these documents will facilitate more efficient and effective trials.

Learning Objectives

Describe the M11 ICH deliverables and the latest developments on ICH M11 guideline, protocol template and technical specification; Describe the types trials and phase that the template encompasses; Discuss the technical specification as a technical representation of the template to facilitate electronic exchange.

Chair

Ron Fitzmartin, PhD, MBA

Speaker

Support of Digital Protocol Initiatives
Chris Decker, MS

The Value of Data: A Regulatory Perspective
Ana Zanoletty Perez

Global Synergy: Enhancing Patient Outcomes and Advancing Clinical Research Through International Protocol HarmonizationT
Vada A. Perkins, DrSc, MSc


Speakers
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →
avatar for Chris Decker

Chris Decker

President and Chief Executive Officer, CDISC, United States
Chris is recognized industry wide as a leading technology and standards expert for designing, developing, and implementing complex process and technology solutions. He brings years of experience serving in various executive-level positions across software development, clinical research... Read More →
avatar for Ana Zanoletty Perez

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands
Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →
avatar for Vada Perkins

Vada Perkins

Vice President, Global Head of Regulatory Intelligence & Policy, Boehringer Ingelheim, United States
Vada A. Perkins is Vice President. Global Head of Regulatory Policy & Intelligence for Boehringer Ingelheim. He is a former FDA Senior Advisor for Regulatory Science with international regulatory policy and strategy expertise in promoting convergence for the assessment of medicinal... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session

2:15pm PDT

#131: Innovative Approaches to the Design of Pediatric Development Programs: What’s New in the Use of Pediatric Extrapolation
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-531-L04-P; CME 1.00; RN 1.00

The ICH E11A guidance advances use of pediatric extrapolation in three areas: (1) role of exposure-response; (2) statistical implications of using external data; and (3) extrapolation of safety. After an overview, these three areas will be explored.

Learning Objectives

Define pediatric extrapolation and three components of extrapolation concept; Describe role of exposure-response in supporting data extrapolation from reference to target pediatric population; Examine the impact of extrapolation on false positive rate of a pediatric clinical trial; Outline impact of pediatric extrapolation on generation of safety data in the target pediatric population.

Chair

Robert "Skip" Nelson, MD, PhD

Speaker

FDA Update on ICH E11A EWG on Pediartic Extrapolation
Lynne Yao, MD

Industry Update
Forrest Williamson, PhD, MS

Industry Update on ICH E11A EWG on Pediatric Extrapolation
Brenda Cirincione, PhD, MS


Speakers
avatar for Robert Nelson

Robert Nelson

Senior Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics... Read More →
BC

Brenda Cirincione

Vice President, Clinical and Quantitative Pharmacology, Vertex, United States
Brenda Cirincione has over 20 years of research experience in Clinical Pharmacology and Pharmacometrics. She received a PhD in pharmaceutical sciences and a MA in statistics from the University of Buffalo, State University of New York, and has experience working in businesses across... Read More →
FW

Forrest Williamson

Director of Pediatrics, Statistical Innovation Center, Eli Lilly and Company, United States
Forrest Williamson is a Director of Pediatrics within the Global Statistical Sciences organization at Eli Lilly and Company, serves as Adjunct Assistant Clinical Professor of Medicine at the Indiana University School of Medicine, and has Professional Statistician accreditation from... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session |   11: Statistics-Data Science, Session |   02: ClinTrials -ClinOps, Session

2:15pm PDT

#134: Shifting Medical Writing Value Propositions with the Use of Technology Tools
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-534-L04-P; CME 1.00; RN 1.00

The explosion of technology and expectations for its use are transforming medical writing. In addition to articulating their value proposition, writers and their managers will have to adapt to this transformation and level-up their skills, in the face of ever-evolving technology and technical challenges. This panel will focus on providing both strategic and tactical considerations for medical writing teams. We will highlight the importance of finding early adopters, developing training for multiple learning styles, building a support network, and surviving the change management process.

Learning Objectives

Discuss how the medical writing role is evolving in the face of technology; Outline the new skillset(s) that medical writers will need and how these change the value proposition of medical writing; Discuss strategies for engaging and training teams through this evolution.

Chair

Robin Whitsell

Speaker

Industry Update
Joanne Hilton, PhD, MBA

Industry Update
Kayla Williams


Speakers
avatar for Robin Whitsell

Robin Whitsell

President, Whitsell Innovations, Inc., United States
Founder and president of Whitsell Innovations, Inc., a medical writing firm headquartered in Chapel Hill, NC, Ms. Whitsell has over 25 years of experience, specializing in global submission strategy, regulatory medical writing, emerging technologies, and data visualization. Prior... Read More →
JH

Joanne Hilton

Executive Director, Medical Writing, GlaxoSmithKline, United Kingdom
Joanne Hilton joined GSK in July 2023 as Executive Director, Medical Writing. With over 20 years' experience in medical communications, she has a track record of building capabilities, driving strategic growth, delivering operational excellence and leading innovation. Her recent focus... Read More →
KW

Kayla Williams

Director and Head, Oncology Medical Writing, Takeda, United States

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  04: MedAffairs-SciComm, Session

2:15pm PDT

#138: Having the End in Mind When Building Quality into Clinical Trials: A Regulatory and Industry Perspective
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-538-L04-P; CME 1.00; RN 1.00

This session will discuss regulatory and industry perspectives on building quality into clinical trials by providing updates to agency policy of risk-based monitoring (RBM), quality risk management (QRM), and quality-by-design (QbD) (e.g., ICH E6R3, ICH E8R1, draft and final guidances), including case examples.

Learning Objectives

Discuss the importance of building quality into clinical trials; Identify a study’s critical quality (CTQ) factors and the importance of involving all stakeholders in their identification; Describe FDA’s expectations for implementing quality-risk management and developing and executing risk-based monitoring plans to focus on CTQ factors with inspection case examples of sponsors, CROs, service providers and clinical investigators.

Chair

Kenneth Getz, MBA

Speaker

MHRA Update
Jason Wakelin-Smith

FDA Update
Elena Boley, MD, MBA, FACP

Industry Update
Michael Torok, PhD


Speakers
avatar for Kenneth Getz

Kenneth Getz

Tufts Center for the Study of Drug Development, Center For the Study of Drug Development, United States
Ken Getz is the Executive Director and a Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. He is also the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical... Read More →
avatar for Elena Boley

Elena Boley

Senior Physician, OSI, OC, CDER, FDA, United States
Dr. Boley is a senior physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation (DCCE)/Office of Scientific Investigations (OSI) in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring... Read More →
avatar for Michael Torok

Michael Torok

Vice President, Global Head of Quality Assurance Programs, Genentech, A Member of the Roche Group, United States
Michael Torok, Ph.D. is the Global Head of Quality Assurance Programs at Genentech/Roche. He is energized and driven by the mission of positioning Quality to be an accelerant in developing new therapeutics, rather than a guardrail or "policemen". To enable this shift, cross-functional... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session

2:15pm PDT

#139: Comparative Perspectives on Regulating AI in Drug Development: US Versus EU
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-539-L04-P; CME 1.00; RN 1.00

Explore US and EU AI drug regulation with experts from regulator, industry, and academic perspectives. Learn about principles, data privacy, transparency, and real-world examples. Gain insights into vital regulatory nuances.

Learning Objectives

Describe the regulatory frameworks in the US and EU; Discuss the practical necessity of regulation in various AI-driven drug development scenarios.

Chair

Jayne Ware, MPH, MSc

Speaker

EMA Update
Steffen Thirstrup, MD, PhD

FDA Update
Tala Fakhouri, PhD, MPH

Industry Perspective
Rose Purcell, JD, MA


Speakers
avatar for Jayne Ware

Jayne Ware

Senior Director, Global Regulatory Policy, Merck Sharp & Dohme LLC , United States
Jayne Ware is a Director for Global Regulatory Policy at Merck. She joined Merck in 2012 after 15 years at the US FDA. Jayne is responsible for coordinating regulatory policy intelligence and advocacy activities for key topic areas at Merck such as digital health issues, safety/pharmacovigilance... Read More →
avatar for Tala Fakhouri

Tala Fakhouri

Associate Director for Policy Analysis, Office of Medical Policy, CDER, FDA, United States
avatar for Rose Purcell

Rose Purcell

Director, Global Regulatory Policy and Innovation, Takeda, United States
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

2:15pm PDT

#137: Options to Consider When Balancing Risk, Timelines, Cost, and Patient Centricity While Meeting Project Optimus Guidelines
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-537-L04-P; CME 1.00; PDU 1.00 PMI 2166YE3LVS; RN 1.00

Review principles of FDA's Project Optimus and discuss the impact on oncology clinical development strategies. Scenario analysis with risk management is needed to balance project cost, timelines, patient centricity and health equity approaches.

Learning Objectives

Describe the essential points of FDA's Project Optimus Guidance and how it may impact drug development; Discuss how project managers and oncology development teams gain insight into options to consider in order to balance cost, timelines, and risk during dose finding/dose optimization in new molecular entities and new indications.

Chair

Nancy Linda Styple

Speaker

Patient Update
Julia Maues, MA

Industry Update
Gary Wilkinson, PhD

Project Management Considerations for Project Optimus
Nancy Linda Styple


Speakers
avatar for Nancy Styple

Nancy Styple

Project Management Leader, Bayer AG, United States
Nancy has been excited to work in Program Management for over 20 years and is a strong advocate for the work that Project Managers and Project Leaders deliver along the value chain in drug development. Nancy starting as a bench research scientist in biotech and has experience in multiple... Read More →
JM

Julia Maues

Patient Advocate, Patient-Centered Dosing Initiative, United States
Julia Maues spearheads the Patient-Centered Dosing Initiative (PCDI), challenging conventional cancer drug dosing practices and prioritizing patient well-being alongside efficacy. She is co-founder of GRASP (Guiding Researchers and Advocates to Scientific Partnerships), an organization... Read More →
GW

Gary Wilkinson

Director of Clinical Pharmacology, Ryvu Therapeutics, Poland

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   05: Patient-Focused Drug Dev, Session |   07: ProjectManagement-StrategicPlanning, Session

2:15pm PDT

#136: In Vitro Diagnostic/Companion Diagnostics Developments in the US and Impact on Global Programs
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-536-L04-P; CME 1.00; RN 1.00

This session will present on the shifting regulatory landscape on diagnostics, including laboratory developed tests. Discussions will focus on a new proposed rule, the FDA’s oncology diagnostics pilot program, and global development implications.

Learning Objectives

Explain recent developments in the In Vitro Diagnostic/Companion Diagnostics (IVD/CDx) regulatory landscape in the US; Discuss regulatory implications of the proposed rule on LDTs; Evaluate the impact of FDA IVD initiatives on global drug development programs

Chair

Stephanie Choi, PhD

Speaker

Insights into FDA's Proposed Rule and LDT Initiatives
Cortez McBerry, PhD

New and Anticipated Trends in IVD and LDT Regulation
Laura DiAngelo, MPH

Impact of Changing IVD/LDT Landscape on Global Drug Development Programs
Megan Doyle, JD, MPH


Speakers
avatar for Stephanie Choi

Stephanie Choi

Director, US Global Regulatory and Scientific Policy (GRASP), EMD Serono, United States
Stephanie Choi, Ph.D. is currently a Director in Global Regulatory and Scientific Policy at EMD Serono. Her current interests relate to regulatory policy in oncology, CDx, and RWE. Prior to EMD Serono, she worked as a regulatory strategist at Jazz Pharmaceuticals supporting early... Read More →
LD

Laura DiAngelo

Research Director, AgencyIQ by POLITICO, United States
Laura DiAngelo is the Director of Regulatory Intelligence for POLITICO's AgencyIQ. She focuses primarily on regulatory intelligence issues impacting the medical device, diagnostics and digital health industries.
avatar for Megan Doyle

Megan Doyle

Associate Vice President, Assistant General Counsel - Diagnostics, Eli Lilly & Company, United States
Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health... Read More →
avatar for Cortez McBerry

Cortez McBerry

Partner, NDA Partners, United States

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   06: TranslationalDelivery Tech-PrecMedicine, Session

2:15pm PDT

#141: Innovation in Manufacturing Globally
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-541-L04-P; CME 1.00; RN 1.00

There is a rapid increase in the use of advanced manufacturing technologies in medicine. The session will provide an overview of the initiatives regulators take and discussion with industry on learnings and the opportunities ahead.

Learning Objectives

Describe the initiatives that regulators take to support the rapid technological growth in medicines manufacture that offers opportunities for better quality of medicines and increased robustness in supply chains leading to increased medicine availability.

Chair

Evdokia Korakianiti, PhD, MSc

Speaker

EU Perspective on Enabling Innovation in Manufacturing
Marcel Hoefnagel, DrSc, PhD, MSc

FDA Perspective on Advanced Manufacturing
Sau L Lee, PhD

Artificial Intelligence/Machine Learning in Pharmaceutical Manufacturing: The Opportunity for a Low-Risk Deployment of AI
Gert Thurau, DrSc, PhD

Decentralized Manufacturing of ATMPs
Ursula Busse, PhD, MBA

Panelist
Benjamin Stevens, PhD, MPH


Speakers
avatar for Ursula Busse

Ursula Busse

Head of Regulatory Affairs, Tigen Pharma SA, Switzerland
Ursula is the Head of Regulatory Affairs at Tigen Pharma, a clinical stage biotech company focused on cell-based cancer therapies. She has over 20 years of experience in Regulatory Affairs, Quality Assurance, Manufacturing and R&D thanks to global leadership roles in both large Pharma... Read More →
avatar for Marcel Hoefnagel

Marcel Hoefnagel

Senior Assessor Biopharmaceuticals, Medicines Evaluation Board , Netherlands
Marcel Hoefnagel is an expert in Biopharmaceuticals working as Senior assessor for the Medicines Evaluation Board (CBG-MEB) the Netherlands. Since 2002 he is a regulator CMC of biopharmaceuticals (registration, GMP and legal aspects) as specialist in vaccines, allergens, biosimilars... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
avatar for Sau Lee

Sau Lee

Deputy Super Office Director, OPQ, CDER, FDA, United States
Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory... Read More →
avatar for Benjamin Stevens

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States
Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →
avatar for Gert Thurau

Gert Thurau

Head of Manufacturing Technology Innovation in CMC Regulatory Policy, F. Hoffmann-La Roche Ltd, Switzerland
Dr. Gert Thurau leads Manufacturing Technology and Innovation Advocacy at Hoffmann-La Roche, Basel, Switzerland. He advocates for advanced technology adoption in GMP manufacturing, including continuous processing, process models, robotics, advanced analytical technology, but also... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session

2:15pm PDT

#142: Causal Inference Methodology in Drug Development
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-542-L04-P; CME 1.00; RN 1.00

This session will explore special topics in causal inference. Presenters will describe trial design and analysis issues in drug development, related to both randomized trials and real-world data (RWD), that may benefit from statistical methodology to allow for better and more accurate generation of evidence with respect to drug treatment effects.

Learning Objectives

Describe various statistical approaches to handle complex design and analysis issues in drug development. Explain use case examples for illustration for causal inference methods.

Chair

Pallavi Mishra-Kalyani, PhD, MS

Speaker

Causal Inference in Clinical Drug Development: Industry Update
Antara Majumdar, PhD

Methodological Challenges and Potential Solutions When Conducting External Control Studies Intended for Causal Inference
Shia Kent

Regulatory Considerations and Case Studies of Externally Controlled Trials
Pallavi Mishra-Kalyani, PhD, MS


Speakers
avatar for Pallavi Mishra-Kalyani

Pallavi Mishra-Kalyani

Deputy Division Director, DBV, OB, CDER, FDA, United States
Pallavi Mishra-Kalyani, Ph.D. is the Deputy Director of the Division of Biometrics V, Office of Biostatistics in the Center for Drug Evaluation and Research (CDER). Since joining the Food and Drug Administration (FDA) in 2015, Dr. Mishra-Kalyani has contributed to the efforts to address... Read More →
SK

Shia Kent

Epidemiologist, Pharmacovigilance Epi and Causal Inference Team, Amgen, United States
avatar for Antara Majumdar

Antara Majumdar

Director, Oncology Statistics, GlaxoSmithKline, United States
Antara is the Director of Statistics at AcornAI by Medidata. Antara is part of a team responsible for implementation of external controls in clinical drug development. Prior to this, Antara worked for Bristol-Myers Squibb for over a decade. Antara has deep and broad experience in... Read More →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session

3:30pm PDT

#144: Paradigm Shift in Adverse Event Report Management and Sharing: The Case, The Need, and Possible Ways Forward
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-543-L04-P; CME 1.00; RN 1.00

The current paradigm of repeated safety report transmission to multiple regulators results in greater noise, duplicative effort, more lag time, and diverted focus from protecting patients and building trust through a shared proactive safety science. Might international collaboration evolve in this era of real-world evidence to no longer require such continual circulation of the same adverse event reports? Might newer technologies be leveraged for a more effective modern system? What are the options and the issues that would need to be considered to realize this future state? A panel of regulators and international stakeholders will discuss the issues.

Learning Objectives

Identify the issue and extent of international replication of safety reports; Discuss the possibility of leveraging modern processes or technical solutions (e.g., blockchain or decentralized networks) to enable more effective international collaboration; Determine how to move this agenda forward by focusing on patient safety in light of challenges and opportunities.

Chair

Andrew Bate, PhD, MA

Speaker

Paradigm Shift in Adverse Event Report Management and Sharing: Industry Update
Mayur A Patel, PharmD

Regulatory Perspective on AE Report Management and Sharing and Future Directions
Phil Tregunno


Speakers
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
MP

Mayur Patel

Vice President, Oncology Therapy Area, Global Patient Safety, AstraZeneca, United States
Mayur Patel is an experienced drug developer and pharmacovigilance professional with over 25 years in biopharmaceutical industry. Currently, Dr. Patel is the Vice President Global Patient Safety in the Oncology Therapy Area at AstraZeneca based in the US. Over his career, he has managed... Read More →
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

3:30pm PDT

#145: Selective Safety Data Collection: As a Tool to Advance Clinical Trial Designs
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-544-L04-P; CME 1.00; RN 1.00

This session is focused on sharing experience with E19 implementation from multiple stakeholders to identify successes and challenges.

Learning Objectives

Describe development of E19 and principles of selective safety data collection; Discuss experiences with E19 implementation from different perspectives; Identify FDA initiatives to promote broader use of E19.

Chair

Mary Thanh Hai, MD

Speaker

EMA Update
Priya Bahri, PhD, RPh

Health Canada Update
Fannie St-Gelais, PhD

Industry Update
Anastasia Lesogor, DrMed

FDA Update
Eileen Craig, DrMed

Implementing Selective Safety Data Collection/E19 More Broadly
Kevin Bugin, PhD, MS, RAC


Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
avatar for Kevin Bugin

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →
avatar for Eileen Craig

Eileen Craig

Clinical Lead , DDLO, OCHEN, OND, CDER, FDA, United States
Eileen Craig, MD joined the FDA’s Division of Metabolism and Endocrinology Products as a clinical reviewer in 2004 and has been a clinical lead for the Lipid Disorders team in the Division of Diabetes, Lipid Disorders, and Obesity (DDLO) since 2023. She has conducted and supervised... Read More →
avatar for Mary Thanh Hai

Mary Thanh Hai

Deputy Director for Clinical, OND, CDER, FDA, United States
Dr. Thanh Hai is currently the Deputy Director for Clinical in the Office of New Drugs Immediate Office. She works directly with the OND Director to oversee the development programs of drugs and biologics regulated by the Center of Drug and Evaluation and Research across 27 review... Read More →
AL

Anastasia Lesogor

Senior Global Program Clinical Program Head, Novartis Pharma AG, Switzerland
Anastasia Lesogor, MD works as Executive Director, Senior Global Program Clinical Head in Global Drug Development at Novartis Pharma. She is responsible for leading the development, registration, approval and life cycle management of RNA-based therapeutics in the atherosclerosis therapeutic... Read More →
avatar for Fannie St-Gelais

Fannie St-Gelais

Manager, Health Product and Food Branch, Health Canada, Canada
Fannie has been with Health Canada for the past 18 years. She has held various positions in the medical device and drug areas, both as a reviewer and a manager, in premarket evaluation and pharmacovigilance. She has represented Health Canada on the ICH E19 working group. She holds... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

3:30pm PDT

#148: Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-547-L04-P; CME 1.00; RN 1.00

This session delves into the latest guidance on real-world data (RWD) and real-world evidence (RWE), offers insights from case studies in which such data were critical for regulatory decisions, and discusses how to prepare the next generation of medical writers for this complex landscape.

Learning Objectives

Analyze the FDA’s current stance and guidance on real-world data (RWD) and real-world evidence (RWE) in regulatory submissions; Compare real-world applications of RWD and RWE, showcased through several case studies; Outline educational strategies for equipping future regulatory and medical writers with the skills and understanding needed to effectively incorporate RWD and RWE into documentation.

Chair

Jeanette Towles, MA

Speaker

Industry Update
Craig Ostroff, PharmD

Navigating the Regulatory Landscape: Real-World Data and Real-World Evidence in Regulatory Documents
Tina Schlecht, PharmD, MBA


Speakers
avatar for Jeanette Towles

Jeanette Towles

President and CEO, Synterex, Inc., United States
Jeanette Towles, MA, RAC, is the CEO of Synterex, Inc., a woman-owned, disability-owned clinical and regulatory consulting firm specializing in agile-based project management methodology, automation, and AI-driven technologies. Prior to that, she held in-house consulting and FTE medical... Read More →
CO

Craig Ostroff

Chief Executive Officer, Mill Street Consulting, LLC, United States
avatar for Tina Schlecht

Tina Schlecht

Chief Pharmacy Officer, RxE2, United States
Tina Schlecht, PharmD, MBA is Chief Pharmacy Officer at RxE2 In. She brings 25 years of experience in pharmacy and industry to RxE2. She began her career at CSM, where she led the growth of CTRP services and went on to be President of Center Point Clinical Services. She also worked... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  04: MedAffairs-SciComm, Session

3:30pm PDT

#157: Be Creative and Innovative: A Simple Step-by-Step Process for You and Your Team
Component Type: Session
Level: Intermediate

Steve Jobs. Elon Musk. Innovators who create new things or solve problems in new ways. But how do you be creative? How can a team come up with new development plans, trial designs, or enrollment strategies? Learn decision science’s proven process.

Learning Objectives

Recognize decision science mindset (expand versus contract, alternative versus value focused); Identify framing and re-framing techniques; Identify and clarify value criteria; Demonstrate value criteria to systematically develop creative solutions.

Chair

Tyler Ludlow, MBA

Speaker

Creativity and Innovation within Clinical Drug Development
Candice Junge, PhD


Speakers
avatar for Tyler Ludlow

Tyler Ludlow

Founder and Chief Decision Scientist, Decision Skills Institute, United States
Tyler helps people turn their decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, he studied decision science at Stanford. He then spent 15 years helping leaders at global 500 firms (including 18 of the top 20 pharma companies), make... Read More →
avatar for Candice Junge

Candice Junge

Executive Director, Neurology Program and Clinical Lead, Ionis Pharmaceuticals, Inc., United States
Candice Junge has over 20 years experience in drug development including preclinical research, clinical development and commercial readiness. She is currently an Executive Director, Neurology Program and Clinical Lead at Ionis Pharmaceuticals and is responsible for end-to-end drug... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  07: ProjectManagement-StrategicPlanning, Session |   13: ProfDevelopment, Session

3:30pm PDT

#152: Innovative Alternative Approaches to Evaluating GCP During the COVID-19 Public Health Emergency and Beyond
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-551-L04-P; CME 1.00; RN 1.00

This session discusses regulator and industry experience with the use of alternative tools to evaluate GCP compliance during the COVID-19 public health emergency and post-pandemic.

Learning Objectives

Discuss the alternative, innovative, risk-based approaches regulators used to evaluate GCP compliance during the COVID-19 public health emergency; Describe the application of these tools in the post-pandemic environment; Explain industry’s perspective on and experiences with regulators' use of alternative approaches to GCP evaluations.

Chair

Emily Gebbia, JD

Speaker

FDA Update
Ling Yang, MD, PhD, FAAFP

Beyond the Pandemic, Sustaining Approaches to GCP Compliance
Paula Walker, MA

Health Canada Update
Jennifer Evans


Speakers
avatar for Paula Walker

Paula Walker

Global Head of Risk Based Quality Management, Roche Products Ltd., United Kingdom
Paula is the Global Head of RBQM at Roche, having started with the company with a Quality Policy focus. Formerly Head of Compliance (GCP/PV/GLP) at the MHRA and Acting Head of Inspectorate, having started in 2009 as a GCP Inspector; spending 13.5 years at the Regulator. Paula has... Read More →
JE

Jennifer Evans

Compliance and Enforcement Specialist, Health Canada, Canada
Jennifer Evans obtained her degree in Biochemistry from the University of Victoria, in British Columbia, Canada. She worked in the pharmaceutical and biotechnology industries in research, clinical and quality roles for 14 years prior to joining Health Canada in 2012 as a compliance... Read More →
avatar for Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise for OSI’s policy efforts, including the development of... Read More →
LY

Ling Yang

Senior Physician, OSI, OC, CDER, FDA, United States
Ling Yang is a senior physician in the Office of Scientific Investigations in FDA’s Center for Drug Evaluation and Research. She has worked at FDA for over 15 years and has extensive experience in GCP compliance evaluation, clinical review and FDA regulation of new drugs, generic... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session

3:30pm PDT

#153: Designing your Regulatory Intelligence Framework: Powered by Artificial Intelligence and Critical Thinking
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-552-L04-P; CME 1.00; RN 1.00

Regulatory intelligence is the key to formulating regulatory strategy. We will share the application of AI and critical thinking in developing science and risk-based strategies for the development and lifecycle management of medicinal product.

Learning Objectives

Apply skills learned in this session to set up regulatory intelligence frameworks for their team and/or company; Develop critical thinking skills that are imperative to the interpretation and proper utilization of intelligence data; Identify how to setup and manage tools and processes for surveilling and monitoring regulatory changes.

Chair

Ana Sengupta, MBA, MS, RAC

Speaker

Designing Regulatory Intelligence Framework: Powered by Critical Thinking
Ana Sengupta, MBA, MS, RAC

Designing Regulatory Intelligence Framework: Powered by Artificial Intelligence
Susan Carino, MBA, MS, PMP, RAC

Designing Regulatory Intelligence Framework: Powered by Artificial Intelligence
Aditi Khurana, MBA, PMP, RAC


Speakers
avatar for Ana Sengupta

Ana Sengupta

Associate Director Regulatory Affairs CMC, Mirum Pharmaceuticals, Inc., United States
Ana Sengupta is the Associate Director of Regulatory Affairs at Mirum Pharmaceuticals, Inc. She has more than 24 years of pharmaceutical industry experience and 14 years of direct experience in regulatory affairs of drugs and biologics. Before working at Mirum Pharmaceuticals, she... Read More →
avatar for Susan Carino

Susan Carino

Director, Program Management, Mammoth Biosciences, United States
Susan Carino is a Director of Program Management with Mammoth Biosciences. She has over 30 years of industry experience in R&D across numerous therapeutic areas. She has led diverse cross-functional program teams engaged in complex product development of pharmaceuticals, biologics... Read More →
avatar for Aditi Khurana

Aditi Khurana

Director, Project Management, Summit Therapeutics, Inc., United States
Aditi Khurana, is the Director of Project Management at Asher Biotherapeutics. She is a Project Management Professional (PMP) and is certified in Global Regulatory Affairs (RAC). She holds a Bachelors in Neuroscience from University of California, Los Angeles (UCLA) and a Masters... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

3:30pm PDT

#154: Impact of Accelerated Pathways on Patients in Five Countries/Regions
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-553-L04-P; CME 1.00; RN 1.00

Several global regulatory authorities have similar expedited pathways in which a regulatory approval can be granted that would fulfill an unmet medical need based on preliminary/early data from clinical studies. This session will use a recent Oncology case study comparing the different outcomes resulting from using these five different systems aiming to accelerate development and speed up availability of new treatments to patients. This will be followed by a panel with senior regulators and a patient representative to discuss the regulatory perspective and experience with accelerated approvals. The objective is to identify potential opportunities that could help to achieve more collaboration and equity of access for patients across multiple countries/regions.

Learning Objectives

Recognize the differences of accelerated pathways in US, EU, Canada, Japan and Australia; Discuss the impact of these pathways on patient access and treatment outcomes; Identify opportunities to increase global collaboration and international patient equity.

Chair

Sunita Zalani, PhD

Speaker

EMA Update
Francesco Pignatti, MD

Health Canada Update
Isabelle Rousse, MSc

PMDA Update
Yoko Aoi, PhD

FDA Update
R. Angelo De Claro, MD

Industry Update
Kathleen Winson, MPH, MS


Speakers
avatar for Yoko Aoi

Yoko Aoi

Deputy Review Director, Office of New Drug V, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Yoko Aoi is a deputy review director of Office of New Drug V responsible for review and scientific advice on oncology drugs. After joining PMDA, Dr. Aoi was involved in review and scientific advice on new drugs for rheumatoid arthritis, asthma, COPD etc. (2011-2016) and planning... Read More →
avatar for R. Angelo De Claro

R. Angelo De Claro

Associate Director for Global Clinical Sciences, Oncology Center of Excellence, FDA, United States
Dr. de Claro is the Division Director for Division of Hematologic Malignancies I with Office of Oncologic Diseases. He provides leadership and scientific direction to staff engaged in the review and evaluation of applications for investigational new drugs and drug approvals. Dr. de... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
IR

Isabelle Rousse

Associate Director, Bureau of Metabolism, Oncology, Reproductive Sciences, PDD, Health Canada, Canada
Isabelle Rousse joined Health Canada in 2006. She holds a Bachelor of Science in Biomedical Sciences and a Master of Science in Physiology from University of Montreal. At Health Canada, she has been a Scientific Evaluator in the Marketed Pharmaceuticals Bureau (MPB) within the Marketed... Read More →
KW

Kathleen Winson

Executive Group Director, Product Development Regulatory, Genentech, A Member of the Roche Group, United States
Kathleen Winson is an Executive Group Director in Regulatory at Genentech/Roche, where she oversees regulatory strategy for the Oncology Lung and GU programs. She has been involved in clinical research for over 24 years accumulating a broad breadth of experience in pharmaceutical... Read More →
avatar for Sunita Zalani

Sunita Zalani

Vice President, Regulatory Affairs, Oncology, Merck & Co., Inc., United States
Sunita Zalani, PhD is the Vice President and Therapeutic Area Head for Oncology and In-vitro diagnostics in Global Regulatory Affairs and Clinical Safety at Merck. In her current role, she has responsibilities for formulation and execution of global regulatory strategy for the oncology... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

3:30pm PDT

#156: Data Insight Generation: Leveraging Data Visualization in Study Planning, Monitoring, Exploration, Reporting, and Submission
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-555-L04-P; CME 1.00; RN 1.00

In this session, we will present various interactive graphics and new concept meetings that can be used to provide informative data insights and to enhance clinical trials execution from planning, monitoring, reporting, and regulatory submission.

Learning Objectives

Identify information of interest in an interactive way, which can greatly enhance clinical trials execution from planning, monitoring, reporting, and regulatory submission; Describe how to generate additional, broader, and deeper insights in helping accelerate the understanding of the clinical trial data, and further drive the understanding of disease development and patient journey.

Chair

Erya Huang, PhD

Speaker

Industry Update
Melvin Slaighter Munsaka, PhD, MEd, MS

Industry Update
Neetu Sangari, PhD, MEd, MS

Industry Update
Matthew Kumar, MSc


Speakers
avatar for Erya Huang

Erya Huang

Associate Director Statistics, Bayer AG, United States
Dr. Huang is the Associate Director at Bayer U.S. LLC. She has many years of experiences working on global drug developments and registrations. She is also the main contact person of the data visualization app center in Bayer North America since 2016, being passionate about introducing... Read More →
MK

Matthew Kumar

Associate Director, Lead Computational Scientist, Bayer, Canada
Matthew Kumar is a Lead Computational Scientist at Bayer within the Oncology Digitalization and Computational Sciences group, located in Mississauga, Ontario, Canada. Matthew brings with him over 10 years’ experience as a data scientist and statistician, spanning multiple areas... Read More →
avatar for Melvin Munsaka

Melvin Munsaka

Senior Director, Head Safety Statistics, AbbVie, United States
Melvin S. Munsaka is a Senior Director and Head of the Safety Statistics at AbbVie in the Statistical Sciences and Analytics Department. He has a PhD in Mathematical Statistics from Queen’s University in Canada. He has been in the industry for more than 25 years. He co-leads the... Read More →
avatar for Neetu Sangari

Neetu Sangari

President/CEO, Pragya Tech Leaders, United States
Dr. Neetu Sangari is an influential Data Analytics Pharma leader, contributing to the Pharma industry, driving change, simplification, and delivering value through innovation. She has over 18 years of Progressive experience in the Pharmaceutical Industry, Clinical Research Organizations... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session

3:30pm PDT

#151: Elevate Leadership: Harnessing the Five Superpowers
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-550-L04-P; CME 1.00; PDU 1.00 PMI 2166LI6KQZ; RN 1.00

Embark on a transformative journey to unlock leadership superpowers! Discover the secrets to excel, empower, and inspire. Challenge perceptions and unleash your inner leadership superhero with engaging discussions, and real-world examples.

Learning Objectives

Discuss compassionate leadership's impact on culture and success; Describe how to empower teams for self-organization and ownership; Identify how to cultivate a culture of continuous learning and foster team connection, diversity, and inclusion; Determine how to nurture growth for team members' personal and professional thriving.

Chair

Vidya Narayanaswamy, MBA, MSc

Speaker

Elevate Leadership: Harnessing the Five Superpowers
Vidya Narayanaswamy, MBA, MSc

Elevate Leadership: Harnessing the Five Superpowers
Sushma D.A. Hallock, MBA


Speakers
avatar for Vidya Narayanaswamy

Vidya Narayanaswamy

Consultant, IPM, United States
Vidya Narayanaswamy is a consultant at Integrated Project Management (IPM). She is a seasoned Project Manager with an MBA specializing in Leadership and Management from the University of Laverne and a Specialization in Strategic leadership and Management from University of Illinois... Read More →
avatar for Sushma D.A. Hallock

Sushma D.A. Hallock

Project Management and Operations, Biogen, United States
Dr. Sushma D.A. Hallock is an expert at The Art of Relationships, believing leadership stems from a balance between the mind, body, and spirit. She holds an MBA in Health Sector Management & Leadership and Organizational Transformation from Questrom School of Business and a Master’s... Read More →

Monday June 17, 2024 3:30pm - 4:30pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  13: ProfDevelopment, Session |   07: ProjectManagement-StrategicPlanning, Session

4:45pm PDT

#158 IT: InSilicoTrials Technologies Innovation Theater: Are Human Patients Needed for Clinical Trials, Tomorrow?
Component Type: Session

Chart your new horizons by pioneering on the edge of Gen AI-powered In Silico Data Modeling. Proven case studies will be shared in a panel session from regulatory, sponsor and CRO perspectives. Learn how InSilicoTrials has enhanced drug dosing, trial performance, and patient safety across targeted populations. Discover significant reductions in time and costs—achieving up to a 90% efficiency in specific R&D activities—while upholding the highest standards of patient safety.

Don't miss the chance to receive an autographed complimentary copy of the publication "Toward Good Simulation Practice," co-authored by our CEO, Luca Emili, with the contribution of 13+ FDA leaders. This book is a cornerstone in promoting reliable and efficient In Silico Trials solutions, reflecting a major stride in medical research and development.

Chair

InSilicoTrials

Speakers
I

Monday June 17, 2024 4:45pm - 5:15pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

4:45pm PDT

#159 IT: Infosys Innovation Theater: Gen AI Led Innovations for Clinical and Regulatory Landscape
Component Type: Session

How Infosys partnered with clients to drive productivity, improved outcomes, phenomenal breakthroughs for protocol design, patient recruitment/management, trial operations, document generation, and submission.

Chair

Infosys Technologies Ltd.

Speaker

Speaker
Subhro Mallik

Speaker
Henry Hoffman

Speaker
Naeiry Vartevan

Speaker
Sunil Agarwal, MS


Speakers
SA

Sunil Agarwal

Associate Partner – Life Sciences NAM Lead Infosys Consulting, Infosys, United States
Strategic data science leader enhancing pharmaceutical business outcomes through advanced analytics and management. Expert in global team leadership and transformative program development.
HH

Henry Hoffman

Senior Vice President, R&D, BASE Life Sciences - an Infosys company, Switzerland
avatar for Infosys Technologies Ltd.
SM

Subhro Mallik

EVP - Global Head of Life Sciences, Infosys, United States
Subhro Mallik is EVP and Head of the Life Sciences business unit at Infosys. He leads a team of client partners and sales executives to grow Infosys business in existing and new clients. He brings rich experience of growing new businesses, building teams, and ensuring profitable growth... Read More →
NV

Naeiry Vartevan

VP, US R&D, BASE Life Sciences, United States
With over 17 years of experience, she is a highly energetic, entrepreneurial and enthusiastic business development professional. She has helped small companies/ startups in the healthcare/life sciences space grow over the last decade.

Monday June 17, 2024 4:45pm - 5:15pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

4:45pm PDT

#160 IT: Certara Innovation Theater: Technology-Enabled Writing - Use CoAuthor™ as your Fully Integrated GenAI Medical Writing Platform
Component Type: Session

CoAuthor™ is the ultimate solution for fast-tracking drug development timelines and improving efficiency in the content generation process. Our AI-powered authoring platform combines the capabilities of Structured Content Authoring and Generative Artificial Intelligence to automate repetitive tasks and streamline the content generation process.
With CoAuthor, writers can integrate data directly into documents, ensuring consistency and traceability while using a GenAI assistant to accelerate content generation from complex data inputs. The latest enhancements include the ability to create custom document templates and the application of style guides, providing a seamless integrated experience using MS Word. CoAuthor is the ultimate companion tool that can help you achieve your goals with ease and confidence. Trust in CoAuthor to improve your document quality, increase efficiency, and adhere to industry best practices and lean authoring techniques.

Chair

Certara

Speaker

Speaker
Demetrius Carter, MBA

Speaker
Christopher Bouton, PhD


Speakers
avatar for Christopher Bouton

Christopher Bouton

Senior Vice President, Head of AI, Certara, United States
Christopher Bouton is Senior Vice President and Head of AI at Certara. Prior to Certara, Bouton was the Founder & CEO of Vyasa Analytics (acquired by Certara in 2022), an AI analytics company. Bouton previously founded Entagen, which was acquired by Thomson Reuters. Before those... Read More →

Monday June 17, 2024 4:45pm - 5:15pm PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session
 
Tuesday, June 18
 

8:00am PDT

#201: Considerations for Identification of Drug-Induced Liver Injury
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-556-L04-P; CME 1.00; RN 1.00

Identification of drug-induced liver injury (DILI) is hindered by the lack of a structured, standardized approach to its identification and evaluation. This leads to inefficiencies for both sponsors and regulators. Guidance related to data submission for DILI evaluation can improve the efficiency of regulatory review, for example, by reducing the number of information requests sent by the FDA to industry sponsors. Ultimately, improved strategies for DILI data gathering and submission will also improve the accuracy of DILI risk assessment. This session will provide an in-depth discussion of the challenges for reviewing clinical data and suggest potential strategies to improve the DILI identification process. Topics that will be covered include (1) regulatory guidance on structured DILI data submission, (2) how interactive data visualizations tools can enhance the ability to detect potential cases of DILI and (3) the approach to populations with elevated transaminases at baseline and why the modified eDISH (mDISH) approach has important limitations.

Learning Objectives

Describe the regulatory guidance for how to submit structured data pertaining to drug-induced liver injury (DILI) data; Discuss how to utilize interactive visualization tools to identify potential cases of DILI; Identify the challenges for detecting DILI when liver tests are abnormal at baseline.

Chair

James Buchanan, PharmD

Speaker

Regulatory Guidances for Submitting Structured DILI Data
Y. Veronica Pei, MD, MEd, MPH

Use of Interactive Visualization Tools to Identify Potential Cases of DILI
James Buchanan, PharmD

Addressing the Challenges of DILI Detection in Clinical Trials with Abnormal Baseline Liver Tests
Paul Hayashi, MD, MPH


Speakers
avatar for James Buchanan

James Buchanan

President, Covilance LLC, United States
Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and... Read More →
avatar for Paul Hayashi

Paul Hayashi

Physician Lead, DILI Team, Division of Hepatology and Nutrition, OND, CDER, FDA, United States
I am Physician Lead, DILI Team, FDA. I got my BA in microbiology at UCLA and MD at UC San Diego. After residency and gastroenterology training at UC Davis, I completed a research fellowship at the NIH and a transplant fellowship at the University of Colorado. I received an MPH at... Read More →
avatar for Y. Veronica Pei

Y. Veronica Pei

Acting Associate Director, Biomedical Informatics and Regulatory Review Science, FDA, United States
Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

8:00am PDT

#204: Wearable Sensors and Digital Health Technologies for Tracking Neurological and Neuromuscular Disorders
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-559-L04-P; CME 1.00; RN 1.00

Neurological disorders are complex and multifaceted, with symptoms that can vary widely. Wearable sensors and digital health technologies enable objective collection of data at the patients' home, providing unprecedented ways for tracking diseases.

This session will include presentations from several NIH-funded and Investigator-initiated studies focused on collecting digital measures of disease progression, including in patients with progressive supranuclear palsy, Parkinson disease, Alzheimer’s and ALS, and their potential impact on clinical trials and care for individuals with neurological disorders.

Learning Objectives

Demonstrate innovative wearable sensors and digital technologies capable of accurately detecting and monitoring neurological disease symptoms; Identify methods for seamlessly integrating wearable sensors with existing healthcare systems to ensure continuity of care.

Chair

Ashkan Vaziri, PhD

Speaker

NIH Update
Yuan Luo, PhD

Academic Update
Bijan Najafi, PhD, MSc

Industry Update
Sharon Tamir

Industry Update
Ashkan Vaziri, PhD


Speakers
AV

Ashkan Vaziri

Co-founder and CEO, Biosensics LLC, United States
Dr. Vaziri is a Founder and CEO of BioSensics, a biomedical firm focused on the development of wearable sensors and digital health platforms for clinical trials and research. Dr. Vaziri’s work presents a unique combination of academic research, product development, and small business... Read More →
avatar for Yuan Luo

Yuan Luo

Program Director, AD/ADRD Biomarkers, Division of Neuroscience, National Institute on Aging, NIH, United States
Dr. Yuan Luo is a Program Director of the Clinical Interventions and Diagnostics Branch in the Division of Neuroscience at National Institute on Aging, NIH. She oversees the Division’s technology portfolio, such as using wearable, sensors technology for early detection, monitoring... Read More →
avatar for Bijan Najafi

Bijan Najafi

Professor of Surgery; Director, Clinical Research, Baylor College of Medicine, United States
Dr. Bijan Najafi, Professor of Surgery at Baylor College of Medicine, specializes in digital health and biotechnologies. He's the Director of Clinical Research in Vascular Surgery and Co-Director of Center to Stream Healthcare in Place (C2SHIP). Recognized by Tucson Local Media in... Read More →
ST

Sharon Tamir

Digital Healthcare Innovation, Business and Research Strategy, MT-Pharma, United States
Sharon Tamir, Leading the Digital Healthcare Innovation team at MT-Pharma since Jan2023. Prior to that she worked as a VP Program Leader of the Neuro-oncology and the Myelofibrosis programs at Karyopharm Therapeutics. Sharon Brings over a decade of experience in drug development... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session

8:00am PDT

#206: Early Engagement to Enhance the Incorporation of Patient Experience Data in Drug Development Programs and Regulatory Decision-Making
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-561-L04-P; CME 1.00; RN 1.00

Integrating patient-experience data (PED) in medicines regulation for better patient-centered outcomes is a priority for medicines regulators, including the FDA and the EU network. The FDA’s program on patient-focused drug development (PFDD) has yielded 4 scientific guidelines on PED, while in the EU work is ongoing to produce a reflection paper outlining pathways for progress, marking an initial step toward smoother PED integration in medicine development. The session will present the US and EU's position in this regard and draw on the experience in applying existing guidance to date.

Learning Objectives

Describe the work done by FDA’s Patient-Focused Drug Development (PFDD) program on scientific guidelines on patient-experience data (PED), challenges and future outlook; Describe how work is progressing in the EU to foster the generation and use of patient-experience data in medicines regulatory decision-making.

Chair

Steffen Thirstrup, MD, PhD

Speaker

US Patient Representative
Karin Hoelzer, DVM, PhD

Co-Chair
Robyn Bent, MS, RN

EMA Update
Juan Garcia-Burgos, MD, PhD

EMA Update
Rosa Gonzalez-Quevedo

US Industry Representative
Maria Apostolaros, JD, PharmD, MS, RPh

EU Industry Representative
Solange Corriol-Rohou, DrMed, MD, PhD


Speakers
avatar for Maria Apostolaros

Maria Apostolaros

Deputy Vice President, Science and Regulatory Advocacy, PhRMA, United States
Dr. Maria Apostolaros is currently a Senior Director of Science and Regulatory Advocacy at PhRMA, the US industry association representing the country’s leading innovative biopharmaceutical research companies devoted to discovering and developing medicines that enable patients to... Read More →
avatar for Robyn Bent

Robyn Bent

Director, Patient Focused Drug Development, OCD, CDER, FDA, United States
Robyn Bent is the director of CDER’s Patient-Focused Drug Development (PFDD) Program, an effort to systematically obtain patient input and facilitate the incorporation of meaningful patient input into drug development and regulatory decision making. Prior to joining FDA, Robyn held... Read More →
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for Juan Garcia-Burgos

Juan Garcia-Burgos

Head of Public and Stakeholders Engagement Department, European Medicines Agency, Netherlands
Juan García Burgos is a Qualified Medical Doctor from Autonoma University in Madrid, specialised in urology. Juan worked as a urologist surgeon at the Maranon hospital in Madrid. He joined the European Medicines Agency in 2002 and was responsible for coordinating the preparation... Read More →
RG

Rosa Gonzalez-Quevedo

Scientific Research Officer, European Medicines Agency, Netherlands
KH

Karin Hoelzer

Senior Director, Policy and Regulatory Affairs, NORD, United States
Dr. Karin Hoelzer directs Policy and Regulatory Affairs for the National Organization for Rare Disorders (NORD®). She works closely with pharmaceutical and biotech partners to ensure public policy supports innovative approaches and new treatments, and adequately incorporates patient... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session

8:00am PDT

#208: Good Data Governance Practices: Regulatory and Industry Perspectives
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-563-L04-P; CME 1.00; RN 1.00

In this session, the speakers will emphasize the importance of involving data scientists in the identification of a critical to quality factor’s and will discuss implementation of risk proportionate processes and procedures related to these data governance procedures to address the risks to the critical to quality factors. The speakers will their perspectives related to good data governance practices and provide updates to policy related to data governance (e.g., ICH E6R3, ICH E8R1, 21 CFR part 11) and inspection case examples of clinical trials to illustrate the impact of poor data governance procedures.

Learning Objectives

Discuss the importance of good data governance practices; Identify a study’s critical to quality factors related to data governance processes and procedures; Discuss the importance of involving the data scientist in the identification of a study’s critical to quality factors; Describe inspection case examples to illustrate regulatory expectations for data governance and the use of technology in clinical trials.

Chair

Kassa Ayalew, MD, MPH

Speaker

Update from the Danish Medicines Agency
Lisbeth Bregnhoj, PhD, MPharm

Update from Industry
Prasanna Rao

Update from the FDA
Cheryl Grandinetti, PharmD


Speakers
avatar for Kassa Ayalew

Kassa Ayalew

Director, DCCE, OSI, Office of Compliance, CDER, FDA, United States
Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with several years of clinical and... Read More →
avatar for Lisbeth Bregnhoj

Lisbeth Bregnhoj

Medicines Inspector, GCP, Danish Medicines Agency (DKMA), Denmark
Lisbeth is a GCP inspector at the Danish Health and Medicines Agency. She also has experience as a clinical trial assessor, experience from a research and hospital perspective (Clinical pharmacology at a University Hospital) and from the medicinal industry as a GCP auditor. Lisbeth... Read More →
avatar for Cheryl Grandinetti

Cheryl Grandinetti

Clinical Pharmacologist, OSI, OC, CDER, FDA, United States
Dr. Grandinetti is a reviewer in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring activities and... Read More →
avatar for Prasanna Rao

Prasanna Rao

Sr. Director, Global Head, AI/ML, Clinical Data Sciences, Pfizer Inc, United States
Prasanna Rao is a distinguished AI practitioner and industry thought leader, currently serving as the Senior Director, Global Head of AI/ML, Clinical Data Sciences, Pfizer R&D. With over 30 years of experience in information technology and analytics, including more than a decade in... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session

8:00am PDT

#211: PMDA Town Hall
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-566-L04-P; CME 1.00; RN 1.00

PMDA strives and implements various supports to promote regulatory sciences and accelerate product developments based on “4Fs” concept of priorities. In this session, PMDA will share the latest information on its policies and initiatives.

Learning Objectives

Recognize latest information on the Pharmaceuticals and Medical Devices Agency’s activity and Japanese regulations in medical products area; Describe how to develop medical products in Japan; Discuss issues on medical products regulation with senior PMDA officials.

Chair

Daisuke Tanaka, PhD

Speaker

PMDA Update
Daisuke Koga, MSc, RPh

Industry Update
Atsushi Tsukamoto, PhD, MSc

Panelist
Yoshiaki Uyama, PhD, RPh


Speakers
avatar for Daisuke Tanaka

Daisuke Tanaka

Office Director, Office of International Programs, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Tanaka joined the Ministry of Health, Labour and Welfare (MHLW) in April 2001 and was involved in orphan drug designation and new drug approval as well as amendment of the Pharmaceutical Affairs Law. Subsequently, he worked in several organisations including European Medicines... Read More →
avatar for Daisuke Koga

Daisuke Koga

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan
Mr. Daisuke Koga is Director, Office of International Regulatory Affairs, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the areas of drugs, medical devices... Read More →
avatar for Atsushi Tsukamoto

Atsushi Tsukamoto

Head is Therapeutic Area Strategies, Daiichi Sankyo, United States
Atsushi is the Corporate Officer and Head of Therapeutic Area Strategy in Daiichi Sankyo, to manage multiple therapeutic area strategy. Prior to that, he was VP of New Drug Regulatory Affairs (RA) at Daiichi Sankyo. He has been global project manager for nearly 20 years (in JPN... Read More →
avatar for Yoshiaki Uyama

Yoshiaki Uyama

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science researches in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH... Read More →
avatar for Cynthia Verst

Cynthia Verst

President, R&D Solutions D&DI; 2023 President, IQVIA, United States
Dr. Verst is president, Design and Delivery Innovation, Research & Development Solutions at IQVIA. She is responsible for driving innovation and transformation throughout the trial lifecycle. Having previously served as president of both clinical operations and real world and late... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

8:00am PDT

#212: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-567-L04-P; CME 1.00; RN 1.00

The session will provide an update on ICMRA's Pharmaceutical Quality Knowledge Management project, including an overview of learnings from the pilots on collaborative assessment of post-approval changes and hybrid inspections by multiple authorities.

Learning Objectives

Describe the various workstreams of the ICMRA PQKM project, and their potential to support increased regulatory convergence and reliance with regards to product quality assessments and inspections; Summarise learnings arising from the ICMRA pilots on collaborative assessment of post-approval changes and hybrid inspections; Discuss potential for expansion and operationalization of the pilots.

Chair

Theresa Mullin, PhD

Speaker

Collaborative Assessment Pilot: Regulators’ Perspective
Sau L Lee, PhD

Collaborative Assessment Pilot: Regulators’ Perspective
Sean Barry, PhD

Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Stelios Tsinontides, PhD, MA

Collaborative Hybrid Inspection Pilot (CHIP): Regulator's Perspective
Brendan Cuddy, MSc

Pilot Programs: Industry's Perspective
Susanne Ausborn, PhD

Pilot Programs: Industry's Perspectives
Srivdya Srikant, MS

Panel Discussion: Pilot Programs
Evdokia Korakianiti, PhD, MSc

Panel Discussion: Pilot Programs
Yasuhiro Kishioka, PhD


Speakers
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
avatar for Sean Barry

Sean Barry

Senior Pharmaceutical Assessor, Health Products Regulatory Authority (HPRA), Ireland
Sean is a Senior Biologicals Assessor at the Irish health authority, HPRA, where he reviews CMC data for new product applications, scientific advices, clinical trials, and variations for mAbs, recombinant proteins, vaccines, and cell & gene therapies. Sean is chair of the Biologicals... Read More →
avatar for Brendan Cuddy

Brendan Cuddy

Lead Scientific Officer, European Medicines Agency, Netherlands
Brendan Cuddy joined the European Medicines Agency in October 2002. He was Head of the Manufacturing and Quality Compliance Service at the Agency from 2014 – 2020. Brendan is currently the Chairman of the Good Manufacturing and Distribution Practice Inspectors Working Group (GMDP... Read More →
avatar for Yasuhiro Kishioka

Yasuhiro Kishioka

Reviewer Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... Read More →
avatar for Evdokia Korakianiti

Evdokia Korakianiti

Head of Quality and Safety of Medicines, European Medicines Agency, Netherlands
Evdokia has joined the Agency in 2002. Since 2020, she is leading the Quality and Safety Department, which ensures that patients take medicine that are safe, are of the best possible quality and are manufactured in compliance with EU and international standards. She leads the Agency’s... Read More →
avatar for Sau Lee

Sau Lee

Deputy Super Office Director, OPQ, CDER, FDA, United States
Dr. Lee is currently Deputy Super Office Director for Operations who oversees research, quality surveillance, policy, quality assurance, and administrative operation functions in CDER’s Office of Pharmaceutical Quality. Dr. Lee has been with the FDA since 2005, serving as a regulatory... Read More →
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
avatar for Srivdya Srikant

Srivdya Srikant

Director, Global Regulatory Affairs- CMC, Gilead Sciences, United States
Srividya (Vidya) Srikant is a Director in Regulatory CMC (RA CMC) at Gilead Sciences Inc. Prior to joining Gilead Sciences, Vidya spent over 20 years with other pharmaceutical companies including Genzyme, Takeda, and GSK. She has extensive experience in CMC developing, managing, and... Read More →
avatar for Stelios Tsinontides

Stelios Tsinontides

Office Director, OPMA, OPQ, CDER, FDA, United States
Dr. Stelios Tsinontides is the Office Director of the Office of Pharmaceutical Manufacturing Assessment (OPMA). OPMA evaluates facilities, process design, and control strategies to assess capabilities of manufacturers to produce quality pharmaceutical and biotechnology products at... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session

8:00am PDT

#213: Beyond Traditional Trials: Real-World Data for External Controls, with Focus on Cancer Drug Applications
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-568-L04-P; CME 1.00; RN 1.00

Advanced cancers pose a dilemma between evidentiary requirements and speedy access to innovative agents. We present the results of a survey with regulators and discuss factors that influence acceptability of real-world data and possible optimal submission strategies.

Learning Objectives

Describe the challenges of drug development with evidence using external controls; Discuss regulators’ attitudes about real-world evidence and opportunities for addressing the challenges; Identify strategies using real-world evidence to maximize impact on the regulatory decision.

Chair

Francesco Pignatti, MD

Speaker

Real-World Data to Support Benefit-Risk Assessment: Regulatory Perspective
Douwe Postmus, PhD, MSc

External Comparators Using Real-World Data: Results of a Simulation Study
Gerd Rippin, DrSc

The Role and Impact of Real-World Data in Cancer Drug Applications
Catherine C. Lerro, PhD, MPH


Speakers
avatar for Catherine Lerro

Catherine Lerro

Senior Pharmacoepidemiologist, Oncology Center of Excellence, FDA, United States
Dr. Lerro is a senior pharmacoepidemiologist in the Oncology Center of Excellence at the US FDA. Prior to joining the FDA, she trained at the National Cancer Institute in the Division of Cancer Epidemiology and Genetics. She holds a doctorate degree and masters in public health from... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
avatar for Douwe Postmus

Douwe Postmus

Assistant Professor & Seconded National Expert, University Medical Center Groningen & EMA, Netherlands
Dr Douwe Postmus is employed as an assistant professor at the Department of Epidemiology of the University Medical Center Groningen, The Netherlands. His research focuses on applying quantitative modeling techniques to decision making problems in health care, including regulatory... Read More →
avatar for Gerd Rippin

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany
Dr. Gerd Rippin is a trained statistician, receiving his statistics degree in 1995 from the University of Dortmund, Germany (equivalent to BSc and MSc), and his Dr. of Sciences (equivalent to PhD) in 1999 from the University of Mainz, Germany. Dr. Rippin has worked as a medical statistician... Read More →

Tuesday June 18, 2024 8:00am - 9:00am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session

9:15am PDT

#215 IT: Clario Innovation Theater: Responsibly Advancing the Use of Artificial Intelligence (AI) in Clinical Trials - Current Landscape, Common Misconceptions, and Future Opportunities
Component Type: Session

AI can help optimize operations, strengthen patient privacy, and improve data quality while reducing risks of human error in clinical trials. However, AI must be used responsibly and governed by the highest ethical principles with regard for data privacy and reducing bias in algorithm performance. Delve into the transformative role of AI in clinical trials: current industry status, common misconceptions, proactively tackling bias and navigating the evolving regulatory landscape.

Chair

Clario

Speaker

Speaker
Todd Rudo, MD

Speaker
Gaurav Josan

Speaker
Lauren Misztal

Speaker
Brian Dolan


Speakers
avatar for Clario

Clario

United States
avatar for Gaurav Josan

Gaurav Josan

Senior Vice President, R&D, Clario, United States
Gaurav Josan leads the R&D team at Clario as Sr. Vice President focused on innovation and next generation technology solutions including AI capabilities. She has more than 2 decades of experience working in the Clinical Trials space leading strategic technology initiatives. She is... Read More →
avatar for Lauren Misztal

Lauren Misztal

SVP, General Counsel, Clario, United States
Lauren is a business-oriented and solutions-driven legal advisor who draws on close to two decades of experience successfully resolving complex legal and regulatory issues. As Clario’s General Counsel, Lauren focuses on setting the Company’s global legal strategy and leads teams... Read More →
avatar for Todd Rudo

Todd Rudo

EVP & Chief Medical Officer, Clario, United States
Dr. Rudo provides medical and scientific leadership at Clario. He is passionate about leveraging scientific resources to support customer success with focused efforts on developing expertise across a range of therapeutic areas. His team provides expert consulting on scientific and... Read More →
avatar for Brian Dolan

Brian Dolan

Vice President Artificial Intelligence and Machine Learning, Fortrea, United States
Brian is a mathematician, inventor and cyberneticist with decades of experience building enterprise grade artificial intelligence products. Equally comfortable in product, sales and technology roles, he excels at translating complex business problems into tractable mathematical solutions... Read More →

Tuesday June 18, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

9:15am PDT

#216 IT: Zelta by Merative Innovation Theater: Revolutionizing Research - The Impact of Machine Learning and Automation in eClinical Platforms
Component Type: Session

Getting the most out of AI in clinical data management means deploying it strategically with the goal of maximum, measurable outcomes. This presentation will delve into what these solutions look like when effectively scaled and applied; why traditional machine learning is more suited to driving ROI in your operations than generative AI; and how Zelta’s integrated ML models, analytics, and automation tools are helping to drive new efficiencies in clinical trials.

Chair

Merative

Speaker

Speaker
Walker Bradham


Speakers
avatar for Walker Bradham

Walker Bradham

Sr Director, Product Management & Design, Merative, United States
Walker Bradham is the Product Management Lead for Zelta, Merative’s clinical trials solutions business. He brings 20 years of experience defining, designing, and deploying web applications to the marketplace, and leads the product roadmap for all EDC/CDMS and eCOA offerings. A champion... Read More →
avatar for Merative

Merative

United States

Tuesday June 18, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

9:15am PDT

#217 IT: Lokavant Innovation Theater: Prescriptive Study Planning: Optimizing Clinical Trials for Time Efficiency, Cost Savings, and Quality
Component Type: Session

Explore the power of prescriptive analytics in clinical trial planning and feasibility. Learn how Lokavant's innovative approach can prescribe the next best course of action to help refine and optimize study parameters that predict timelines, control costs, and improve quality.

Chair

Lokavant

Speaker

Speaker
Rohit Nambisan


Speakers
avatar for Lokavant

Lokavant

United States
avatar for Rohit Nambisan

Rohit Nambisan

CEO & Co-Founder, Lokavant, United States
Trained as a neuroscientist, Rohit Nambisan is a product executive with experience leading product development organizations in pharma, medical devices, personalized medicine, health IT, healthcare data and analytics, and AI. Prior to co-founding and leading Lokavant, Rohit was most... Read More →

Tuesday June 18, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

10:00am PDT

#225: Regulatory Guidance and Papers on Technology Innovations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-576-L04-P; CME 1.00; RN 1.00

This session will describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development. The session will discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development. Attendees will hear from industry experts on the topics and their potential implementation and impacts to the field.

Learning Objectives

Describe and identify emerging technology innovations and health authority papers, guidance, and discussion on their use in regulatory filings and development; Discuss emerging artificial intelligence (AI) trends, structured content authoring, and structured data including their development, use, risks, and potential future in pharmaceutical development; Describe potential implementation and impacts to the field.

Chair

David Meats

Speaker

AI and Technology Trends and Regulation Introduction
David Meats

Regulation Guidance and Concensus Papers
Madhavi Gidh-Jain, PhD

Regulation Guidance
Louise Lind Skov, PhD


Speakers
avatar for David Meats

David Meats

Director, Regulatory Services Management, Certara, United States
David Meats is a Director of Regulatory Services and Medical Affairs at Certara. He has been a medical writer and manager for 23 years working in oncology, immuno-oncology, endocrinology, musculoskeletal, cardiac, hepatic, renal, and infectious disease therapeutic areas on nearly... Read More →
avatar for Madhavi Gidh-Jain

Madhavi Gidh-Jain

Global Medical Writing and Document Management Head, Sanofi, United States
Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices... Read More →
avatar for Louise Lind Skov

Louise Lind Skov

Head of Content Digitalisation, Novo Nordisk A/S, Denmark
Louise is Head of Content Digitalisation at Novo Nordisk. In her current role at Novo Nordisk, Louise plays a pivotal role in advancing the way clinical and regulatory documents are managed and processed. Leading the digital transformation effort, she heads the development of innovative... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  04: MedAffairs-SciComm, Session

10:00am PDT

#227: How to Ensure Compliance in a Changing Regulatory Environment: A Regulators Perspective
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-578-L04-P; CME 1.00; RN 1.00

Hear the thoughts of regulators regarding how they see the future direction of travel for GCP Inspections. Learn about changes to compliance strategies and collaboration initiatives which are underway or in the pipeline.

Learning Objectives

Describe challenges currently faced by regulators regarding clinical trial inspections; Discuss strategies being developed by Health Authorities including future initiatives, direction of travel, and collaborative relationships.

Chair

Jason Wakelin-Smith

Speaker

FDA Update
Emily Gebbia, JD


Speakers
avatar for Emily Gebbia

Emily Gebbia

Associate Director for Regulatory Development, OSI, OC, CDER, FDA, United States
Emily Gebbia is the Associate Director of Regulatory Development in the Office of Scientific Investigations (OSI) in CDER’s Office Compliance at the U.S. FDA. Emily provides strategic leadership and subject matter expertise for OSI’s policy efforts, including the development of... Read More →
avatar for Junko Sato

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session

10:00am PDT

#228: Access Consortium and Project Orbis: Experiences from Industry and Regulatory Authorities and Recommendations for Improvement
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-579-L04-P; CME 1.00; RN 1.00

Results from international industry experience surveys on the Access Consortium and Project Orbis followed by a panel discussion, involving health authorities, to discuss recommendations and next steps to improve and promote these schemes.

Learning Objectives

Recognize the benefits and challenges of international collaborative initiatives from both the industry and regulatory authority perspectives; Discuss the recommendations to improve these schemes; Describe how to influence your own organization to adopt or increase usage of these schemes.

Chair

Sarah Powell, RAC

Speaker

Results of Industry Survey of Orbis Projects
Sarah Powell, RAC

Results of Industry Survey on Access Program
Tse Siang Kang, PhD


Speakers
avatar for Sarah Powell

Sarah Powell

President, Powell Regulatory Services, United States
Ms. Powell is the President of Powell Regulatory Services. Sarah has 30+ years of experience in pharmaceutical and related regulated industries (Clinical, Quality Control, Regulatory Affairs and Regulatory Operations). In the past 23 years as a consultant, she has assisted clients... Read More →
avatar for Tse Siang Kang

Tse Siang Kang

Head of Regulatory Affairs, North, East, West Asia, Global Regulatory, Pfizer Pte Ltd, Singapore
Dr. Tse Siang Kang is the Head of Regulatory Sciences in North, East and West Asia cluster, Pfizer Global Regulatory Sciences. In addition to his role in managing a diverse Asia team in Pfizer. Dr Kang also has a particular interest in publishing emerging Regulatory Sciences topics... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

11:00am PDT

#234 RT: Roundtable Discussion: Interactive Safety Graphics in the Regulatory Decision-Making Process
Component Type: Session

Join the Clinical Safety & Pharmacovigilance/Statistics & Data Science Community for a follow up round table discussion tied to session: Interactive Safety Graphics in the Regulatory Decision-Making Process (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.

Chair

Greg Ball, PhD

Speakers
avatar for Greg Ball

Greg Ball

Safety Data Scientist, ASAPprocess, United States
Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded... Read More →

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   01: ClinSafety-PV, Session

11:00am PDT

#233 RT: Roundtable Discussion: The State of Real-World Evidence for Regulatory Decision-Making - Views from FDA, EMA, and PMDA
Component Type: Session

Join the Real-World Evidence Community for a follow up round table discussion tied to session: The State of Real-World Evidence for Regulatory Decision-Making - Views from FDA, EMA, and PMDA (Monday, June 17 | 2:15pm - 3:15 PM PDT). Space is limited.

Chair

Jingyu (Julia) Luan, PhD

Speakers
avatar for Jingyu (Julia) Luan

Jingyu (Julia) Luan

Executive Regulatory Science Director, BioPharmaceuticals R&D, AstraZeneca, United States
Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing... Read More →

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   09: Regulatory, Session

11:00am PDT

#232 RT: Roundtable Discussion: Innovation in Manufacturing Globally
Component Type: Session

Join the Digital Acceleration/Regulatory Affairs/Statistics & Data Science Community for a follow up round table discussion tied to session: Innovation in Manufacturing Globally (Monday, June 17 | 2:15PM - 3:15PM PDT). Space is limited.

Chair

Brett Howard, JD, PhD

Speakers
avatar for Brett Howard

Brett Howard

Senior Director, US Regulatory Policy, USP, United States
Brett Howard is a Senior Director of US Regulatory Policy at the US Pharmacopeia, where he manages USP's regulatory efforts concerning pharmaceutical quality, covering both large and small molecules. Prior to joining USP, he spent the previous decade working for chemical and pharmaceutical... Read More →

Tuesday June 18, 2024 11:00am - 12:00pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   10: RegCMC-Product Quality, Session

11:15am PDT

#235 IT: Deloitte Innovation Theater: Drug Safety Unfiltered - Why Isn’t the Needle Moving?
Component Type: Session

Technologies such as AI, automation and GenAI have the capability to transform the Safety function. But adoption has been uneven so far. Dive into the issues and explore the “why” behind barriers to adoption. Discover where early adoption pioneers stand now and join a Q&A around what it will take to really move the needle on transformation in Safety.

Chair

Deloitte

Speaker

Speaker
Amanda Bowles, MS

Speaker
Kelly Traverso


Speakers
avatar for Amanda Kirby Bowles

Amanda Kirby Bowles

Managing Director, Deloitte, United States
Amanda helps organizations transform their business by innovating in process and technology to help protect patients, manage risk, and drive value. Amanda has in-depth experience in patient safety, pharmacovigilance, and regulatory affairs -- including operations strategy, global... Read More →
avatar for Deloitte

Deloitte

United States
avatar for Kelly Traverso

Kelly Traverso

R&D Business Development, Deloitte, United States
Kelly has more than 20 years’ experience in the areas of Quality, Pharmacovigilance, R&D, and Regulatory Affairs with large, global Biotech and Pharmaceutical companies. She is a Subject Matter Expert on the topics of process assessment and gap analyses, governance model design... Read More →

Tuesday June 18, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:15am PDT

#236 IT: UiPath Innovation Theater: AI Powered Automation - Reducing Time to Market for Life Sciences
Component Type: Session

As the cost, complexity and timelines for the development of new drugs and devices continues to grow, AI-powered automation is emerging as a powerful solution to reduce time to market by orchestrating clinical data, simplifying regulatory submissions, eliminating manual and paper-based processes, and automating data and solution testing. AI-powered automation allows organizations to improve time to market while reducing errors, ensuring visibility, and enabling compliance across R&D.

Chair

UiPath

Speaker

Speaker
Joe Miles


Speakers
avatar for Joe Miles

Joe Miles

Industry Director, Life Sciences, UiPath, United States
As a global Healthcare and Life Sciences industry leader over the past several decades, I have assisted organizations in enabling digital transformation for life sciences organizations across operational, financial and compliance. Most recently, I have led the UiPath Life Sciences... Read More →
avatar for UiPath

UiPath

United States

Tuesday June 18, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:15am PDT

#237 IT: Snowflake Innovation Theater: Secure and Efficient Gen-AI to Accelerate Research and Development
Component Type: Session

In the era of AI-enabled research & development, managing and analyzing large-scale data efficiently is crucial, yet traditional systems often fall short in scalability, performance, and collaboration. Learn how Snowflake enables life sciences organizations to build a data foundation, collaborate with the ecosystem and leverage industry-leading AI models safely and cost-effectively. Demo includes use cases around: Protein Similarity & Function Prediction, Gen-AI Clinical Trial Assistant, & more.

Chair

Snowflake

Speaker

Speaker
Lisa M. Arbogast


Speakers
avatar for Lisa Arbogast

Lisa Arbogast

Industry Principal, Life Sciences, Snowflake, United States
Lisa is an accomplished Life Sciences executive with over 35 years of experience in consulting, innovative business models, and global data-driven solutions that solve both technology and business challenges within biopharmaceuticals, diagnostics, and medtech. Her passion is to mobilize... Read More →
S

Snowflake

United States

Tuesday June 18, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:15am PDT

#POS 2: Professional Poster Session 2
Component Type: Session

Professional and Student Posters provide an opportunity for methodology (“how to”), case study, and research to be presented to a diverse group of scientific professionals who are actively involved in the discovery, development, and lifecycle management of pharmaceuticals, biotechnology, medical devices, and healthcare-related products.

Speakers
MA

Malak Almutairi

Researcher, Saudi Food and Drug Authority, Saudi Arabia
I am a researcher specialized in regulatory research with a master's degree in pharmacy and Pharmaceutical Sciences. I have been working in the SFDA (Saudi Food and Drug Authority) for several years now, and my focus has been on ensuring the safety and efficacy of pharmaceutical products... Read More →
avatar for Daniel Alvarez

Daniel Alvarez

Principal Medical Director, Health Equity and Inclusive Research (HEIR), Genentech, A Member of the Roche Group, United States
Dr. Daniel Alvarez earned his medical degree from the Institute of Medical Science of Havana, Cuba in 2002 and the University of Costa Rica in 2006. He also holds a master's degree in Science of Pharmaceutical Medicine from Hibernia College, Ireland, in 2016 and a Diploma in Pharmacoeconomics... Read More →
CA

Celeste Amadei

Product Manager, PAK Biosolutions, United States
avatar for Cheng Chi Chen

Cheng Chi Chen

Clinical Reviewer, Center For Drug Evaluation, Taiwan
Cheng Chi Chen, Clinical Reviewer, Division of New Drugs, CDE, Taiwan Cheng Chi Chen has been a Clinical Reviewer in Division of New Drugs at CDE Taiwan for more than 1 years. Cheng Chi Chen is a Pharmacist and holds a Master’s degree in Clinical Pharmacy from National Yang Ming... Read More →
avatar for Renata Costa

Renata Costa

Specialist, LIBBS FARMACEUTICA, Brazil
Renata Watanabe Costa has a degree in Biomedicine, with a postgraduate degree in Research and Development of Medicines and a Master's in Sciences from the Federal University of Sao Paulo (Brazil). She has 13 years of experience in the pharmaceutical industry in the areas of Medical... Read More →
avatar for Samantha Cotter

Samantha Cotter

Safety Evaluator, FDA, United States
Dr. Samantha Cotter is a pharmacist and safety evaluator in the Division of Pharmacovigilance within the Office of Surveillance and Epidemiology at the US Food and Drug Administration (FDA). Samantha has over 20 years of clinical pharmacy experience, and 12 years in research at the... Read More →
avatar for Matt D'Ambrosio

Matt D'Ambrosio

Policy Analyst, Duke-Margolis Institute For Health Policy, United States
Matt D'Ambrosio is a policy analyst with the Duke-Margolis Institute for Health Policy's Biomedical Innovation portfolio. He primarily works with the Institute's Real-World Evidence Collaborative--providing support on workstream deliverables and stakeholder engagement. Matt is based... Read More →
avatar for Tiffany Dominic

Tiffany Dominic

Risk Management Fellow, Pfizer, United States
Tiffany Dominic is a Post-Doctoral Risk Management Fellow at Pfizer, in conjunction with Rutgers University. She graduated with her Doctor of Pharmacy degree in May 2022 from St. John's University College of Pharmacy and Health Sciences. As a risk management fellow, she takes part... Read More →
PE

Pierre Engel

Senior Director Business Development, Centogene Gmbh, Germany
With over 15 years of sales and delivery experience in the field of epidemiology and real world evidence (RWE), I am a passionate leader in healthcare innovation and a trusted partner for global pharma accounts. As a Senior Principal Epidemiology at CENTOGENE, I am responsible for... Read More →
avatar for Emily Epstein

Emily Epstein

Clinical Behavioral Health Specialist, Weill Cornell Medicine, United States
Emily Epstein, LMSW, is a Clinical Behavioral Health Care Specialist at Weill Cornell Medicine's Genetics and Personalized Cancer Prevention Program (GPCP). The GPCP is committed to identifying individuals living at an increased lifetime risk for cancer, conducting research, and creating... Read More →
SE

Samuel Ewusie

Associate Director, Safety Evidence and Science, Bristol-Myers Squibb Company, United States
A registered pharmacist with a PharmD and an MS in Global Clinical and Pharmacovigilance Regulations, experienced in Clinical Drug Safety and Pharmacovigilance, Risk Management including Risk Evaluation and Mitigation Strategy (REMS), Pharmacoepidemiology and Research Data analys... Read More →
MA

Majdi Al Gharsan

Director, Director of Medical Services, Ministry of Defence, Saudi Arabia
YG

Yogesh Gulati

Senior Safety Physician, Soterius, India
CH

Cheryl Hergert

University of Southern California, United States
With over 25 years of experience working with small and large companies, Cheryl is familiar with product development for medical devices, pharmaceuticals, and combination products. Her experience ranges from product feasibility testing to product launch. She has held positions in... Read More →
avatar for Hisahiro Ito

Hisahiro Ito

Head of Project Management Office, National Cancer Center Japan, Japan
avatar for Frank Jaeger

Frank Jaeger

Independent Consultant, Nanodose Therapeutics, United States
Frank Jaeger is an accomplished C-suite leader with over 25 years of biopharmaceutical tenure from seed-stage to large global pharma, in small and large molecules, and from pre-launch to in-market experience. His career spans across R&D, Medical Affairs, Business Development, Commercial... Read More →
SH

Sung Hoon Jung

Professor, The Catholic University of Korea, Korea, Republic of
SK

Sung-Goo Kang

Clinical Professor., St.Vincent's Hospital, The Catholic University of Korea, Korea, Republic of
avatar for Sarah Kang

Sarah Kang

Safety Evaluator, FDA, United States
Sarah Kang is a safety evaluator in the Division of Pharmacovigilance (DPV) within the Office of Surveillance and Epidemiology at the United States Food and Drug Administration in Silver Spring, Maryland. She has over 9 years of experience as a clinical pharmacist and over 8 years... Read More →
avatar for Joseph Laudano

Joseph Laudano

Medical Director, IQVIA, United States
Joseph B. Laudano BS Pharm, Pharm D – Medical Director, IQVIA Inc. Joe has over 35 years’ experience in Pharma. Before joining IQVIA, he was VP, Medical Affairs at Pharmaspectra, VP Medical Affairs at Alliqua Biomedical and Senior Director of Medical Affairs & Global Head of Publication... Read More →
avatar for Christina Mack

Christina Mack

Chief Scientific Officer, Real-World Solutions, IQVIA, United States
Christina Mack is Chief Scientific Officer of IQVIA real world solutions. An epidemiologist and engineer by training, she is responsible for driving scientific and technical innovation that directly impacts patient health. Recognized as a 2023 PharmaVoice100 Honoree, she’s committed... Read More →
LM

Laura Magda

Director of Clinical Trials, SRI International, United States
AM

Andrew Marley

Senior Epidemiologist, Parexel, Spain
avatar for Hotaka Maruyama

Hotaka Maruyama

Division of PharmacoEpidemiology, Office of Pharmacovigilance ?, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
I am a reviewer of pharmacoepidemiology division and have a few years' experience in the office of pharmacovigilance I at Pharmaceuticals and medical devices agency(PMDA).
avatar for Timothe Menard

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland
Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →
avatar for Mehdi Najafzadeh

Mehdi Najafzadeh

Senior Director, Medidata AI, United States
Mehdi NajafZadeh, PhD, is Senior Director at Medidata AI. Before joining Medidata AI, he was an Assistant Professor of Medicine in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, and the... Read More →
avatar for Raphael Pareschi

Raphael Pareschi

Patient Safety Lead/ Head of Pharmacovigilance Brazil, Roche, Brazil
Raphael has more than 16 years of experience in Pharmacovigilance, beginning at Sanofi Brazil, where he acted in roles of increasing responsibility within local PV organization, responsibilities including oversight of case management, PSUR management and RMP management. Raphael also... Read More →
IP

Izabela Pedro

Clinical Research Associate, Hospital Israelita Albert Einstein, Brazil
avatar for Gerd Rippin

Gerd Rippin

Senior Director, Biostatistics, Real-World Solutions, IQVIA, Germany
Dr. Gerd Rippin is a trained statistician, receiving his statistics degree in 1995 from the University of Dortmund, Germany (equivalent to BSc and MSc), and his Dr. of Sciences (equivalent to PhD) in 1999 from the University of Mainz, Germany. Dr. Rippin has worked as a medical statistician... Read More →
avatar for Bruna Sampaio

Bruna Sampaio

Manager, Data management, Hospital Israelita Albert Einstein, Brazil
Bruna has over 14 years of professional experience with technology and data operations. Working in clinical research for almost 10 years, she is experienced in EDC Systems (first as a system analyst and later as an end-user), data management, and data analytics. Currently, she is... Read More →
CS

Chris Schneiderman

Epidemiologist, Abbvie, United States
SS

Samantha Seepersad-Nayee

AD, Excision Biotherapeutics, United States
avatar for Alexandru Socolov

Alexandru Socolov

Senior Data Scientist, Medidata Solutions, United States
Alexandru is a Senior Data Scientist at Medidata AI focused on building advanced analytical solutions to make clinical trials safer, cheaper and faster. With the background in operations research, mathematical optimization and machine learning, Alexandru applies newest techniques... Read More →
avatar for Hiroya Taniguchi

Hiroya Taniguchi

Department of Clinical Oncology, Aichi Cancer Center Hospital, Japan
avatar for Brittin Wagner

Brittin Wagner

Senior Research Scientist, PointClickCare, Canada
Brittin Wagner is Senior Research Scientist at PointClickCare. She holds a PhD is in Sociology, PhD Minor in Social Statistics from the University of Washington, with postdoctoral training in health services research & development. She has a longstanding commitment to measurement... Read More →
avatar for Matt Wampole

Matt Wampole

Director, Solution Consulting, Clarivate, United States
Matt Wampole is the Director of Solution Consulting at Clarivate where he and his team supports clients from discovery to launch of new medical interventions. His 20 years of experience covered a broad range of topics across drug discovery and optimization, clinical trial optimization... Read More →
avatar for Susan Watson

Susan Watson

Associate Director, Bioethics, Eli Lilly and Company, United States
Susan Briggs Watson, Ph.D. is an Associate Director of Bioethics at Eli Lilly and Company. She received a PhD in clinical psychology from Indiana University-Purdue University at Indianapolis (IUPUI) and completed Georgetown University's Intensive Bioethics Course 38. She has worked... Read More →
SW

Sam Willcox

Section Manager - Large Molecule Bioanalysis, ACM Global Laboratories, United Kingdom
Sam graduated from the University of Hull with a BSc in Human Biology in 2009. Since graduating he has worked for the last 15 years in regulated bioanalysis supporting the drug development industry. Expert in the field of bioanalysis of large molecules via ligand binding assays he... Read More →
avatar for Rebecca Williams

Rebecca Williams

Senior Clinical Trials Subject Matter Expert, Essex, Part of Emmes Group, United States
Rebecca Williams, PharmD, MPH, is a Clinical Trials Subject Matter Expert with Essex, Part of Emmes Group. In this role she supports strategic policy and data initiatives with the National Cancer Institute’s Coordinating Center for Clinical Trials. Prior to this role she was the... Read More →
avatar for Xiaofeng Xiang

Xiaofeng Xiang

Sr. Medical Compliance Manager, Bayer Healthcare Company Limited, China
MV

Mui Van Zandt

VP/Global Head, Data Strategy, Access and Enablement, IQVIA, United States
FZ

Feng Zhou

Medical Compliance, Bayer Healthcare Co., Ltd., China

Tuesday June 18, 2024 11:15am - 1:15pm PDT
Posters Exhibit Hall San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  18: Posters, Session

11:55am PDT

#238 IT: IQVIA Innovation Theater: An Ecosystem Approach to Site Tech Overload
Component Type: Session

With too many systems and not enough staff, research sites are turning down studies they find unworkable. How can we get the clinical trial ecosystem in balance so that everyone benefits, most importantly patients in need?

In this panel, leaders across the ecosystem will discuss viable strategies to make a real impact on site tech overload. Learn about One Home for Sites, an initiative that’s bringing the industry together to increase clinical trial capacity and help all stakeholders succeed.

Chair

IQVIA Technologies

Speaker

Speaker
Gareth Dabbs

Speaker
Michael Rosenblatt

Speaker
Aruna Adhikari-Thapa

Speaker
Brad Hightower

Speaker
Erik Johs


Speakers
avatar for IQVIA Technologies

IQVIA Technologies

United States
avatar for Gareth Dabbs

Gareth Dabbs

Vice President, Global Product Strategy, IQVIA, United States
avatar for Aruna Adhikari-Thapa

Aruna Adhikari-Thapa

Senior Director, Product Strategy, IQVIA Technologies, United States
Aruna Adhikari-Thapa is a seasoned technology strategist with 20+ years of experience in software product management. She excels in leading cross-functional teams, shaping product strategies, justifying investments, and launching innovative solutions to address complex business challenges... Read More →
avatar for Brad Hightower

Brad Hightower

Chief Executive Officer, Hightower Clinical, United States
Brad has worked at the site-level in clinical research for almost 15 years and is the former Executive Director of the Oklahoma Heart Hospital Research Foundation. Brad has since started his own integrated site network, Hightower Clinical, and hosts the Note to File podcast — a... Read More →
avatar for Michael Rosenblatt

Michael Rosenblatt

Managing Director, Greenhouse Consulting, United States
avatar for Erik Johs

Erik Johs

Vice President, Platform Engineering, Medidata Solutions, United States
Erik Johs is the Vice President of Platform Engineering at Medidata Solutions. With over 15 years of hands-on experience, he has honed his expertise in scalable infrastructure, cloud-native architectures, and DevOps practices. Erik’s leadership is marked by a relentless focus on... Read More →

Tuesday June 18, 2024 11:55am - 12:25pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:55am PDT

#239 IT: Fortrea Innovation Theater: Teamwork Makes the Dream Work - How Partnering to Develop Practical Solutions that Address Site and Patient Challenges is Changing the Clinical Trial Landscape
Component Type: Session

Without patients, there are no trials. Without the sites to conduct studies, there are no trials. This simple truth drives inclusivity initiatives, and the surge in technology “solutions”. In this panel discussion, we bring together voices from across the clinical trial ecosystem and demonstrate how teamwork comprised of medical expertise, market access insight, patient voice, site advisory boards, and technology partnerships work together with developers and CROs to make teamwork the dream work.

Chair

Fortrea

Speaker

Speaker
Elizabeth Seyfert

Speaker
Jared Katz

Speaker
Stuart Cotter


Speakers
SC

Stuart Cotter

VP, Product Strategy, Advarra, United States
Stuart Cotter is the Vice President of Product Strategy and Innovation at Advarra. In this role, he collaborates with current customers and the research community to understand their challenges and translates those challenges into solution-based enhancements to our product offerings... Read More →
avatar for Fortrea

Fortrea

United States
avatar for Jared Katz

Jared Katz

Sr. Director, Development Cloud Strategy, Veeva Systems, United States
Jared is the director of strategy for Vault Connections and is responsible for defining the Vault Connections vision and strategy to drive adoption and customer success. He has over 10 years of experience in life sciences in services and strategy roles including: architecting solutions... Read More →
avatar for Elizabeth Seyfert

Elizabeth Seyfert

Head of Site Engagement and Partnership Delivery, Fortrea, United States
Elizabeth has over 18 years of industry experience and has held varying leadership positions across regulatory, start up and clinical delivery functions. Elizabeth currently oversees site partnership and relationship management at Fortrea with a primary focus on supporting clinical... Read More →

Tuesday June 18, 2024 11:55am - 12:25pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:55am PDT

#240 IT: UBC Innovation Theater: RWD Enrichment Studies - Linking Pre and Post-Trial Data to Inform Product Strategy
Component Type: Session

Capturing data on the patient’s healthcare journey prior to and following participation in a clinical trial builds a more complete understanding of their healthcare journey and increases the overall evidence yield. This presentation explores the value and challenges of tokenization and linkage to diverse secondary healthcare data as well as a case study highlighting the real-world application of this approach.

Chair

UBC

Speaker

Speaker
Irene Cosmatos, MS

Speaker
Jeff Lowry


Tuesday June 18, 2024 11:55am - 12:25pm PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:35pm PDT

#241.1 IT: Flatiron Health Innovation Theater: The Time is Now - Pragmatic Approaches to Prospective Evidence Generation
Component Type: Session

Flatiron Health and the Clinical Trials Transformation Initiative (CTTI) share a bold vision for a more streamlined approach to running clinical trials. Critical to this vision is developing trials that are patient-centered, integrated into current healthcare processes, and maximally leveraging all available data, among other imperatives. Join us for a practical discussion around how to implement these streamlined practices into your trials through a combination of data, technology, and services.

Chair

Flatiron Health

Speaker

Presenter
Sara Bristol Calvert, PharmD

Presenter
Joshua Buddle


Speakers
JB

Joshua Buddle

Director, Clinical Operations, Flatiron Health, United States
avatar for Sara Calvert

Sara Calvert

Director of Projects, Clinical Trials Transformation Initiative (CTTI), United States
Dr. Sara Bristol Calvert is currently the Director of Projects at the Clinical Trials Transformation Initiative (CTTI). Prior to this role, she was a CTTI Senior Project Manager which included leading projects in Diversity in Clinical Trials, Single IRB, Registry Trials, HABP/VABP... Read More →
avatar for Flatiron Health

Flatiron Health

United States

Tuesday June 18, 2024 12:35pm - 1:05pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:35pm PDT

#242 IT: PCM Trials Innovation Theater: Mastering the Logistics of Mobile Visits in Global Decentralized Trials
Component Type: Session

As the landscape of clinical trials continues to evolve, mobile visits play an increasingly crucial role in ensuring the success of global trials. With more than 80 years of combined experience in logistics and the execution of complex decentralized trials, these industry veterans will share actionable steps to overcome hurdles in distributing supplies, managing samples, and delivering compliant mobile visits to meet the logistical challenges associated with decentralized clinical trials (DCTs).

Chair

PCM Trials

Speaker

Speaker
Ellen Weiss

Speaker
Kevin Meek

Speaker
Mike Sweeney

Speaker
Chris Thompson


Speakers
avatar for Kevin Meek

Kevin Meek

Director, Supply Chain Operations, PCM Trials, United States
Through expert facilitation, Kevin brings together individual subject matter experts to create cross-functional teams to focus on end-to-end results. He developed these skills in the largest health payer system in the country managing dozens of partner solutions by establishing operational... Read More →
avatar for Mike Sweeney

Mike Sweeney

Global Head of Strategy, CGT & DTP, QuickSTAT, France
For over three decades Mike has successfully developed and delivered customer-focused solutions in a variety of leadership and cross-functional roles within global life sciences logistics. As a trusted leader, collaborator, and personalized supply chain expert, he has driven innovative... Read More →
avatar for Chris Thompson

Chris Thompson

Senior Operations Manager, Woodley Trial Solutions, United Kingdom
In his role as Senior Operations Manager, Chris oversees all aspects of solutions and service delivery for clients. This includes rental of laboratory equipment; point-of-care testing devices; Dexcom CGM devices; high-tech connectivity products; plus ancillaries & kitting, all of... Read More →
avatar for PCM Trials

PCM Trials

United States
avatar for Ellen Weiss

Ellen Weiss

Strategy, Decentralized Trials, Emeritus, PCM Trials, United States
Ellen Weiss is an expert in connecting CROs and sponsors with right-sized hybrid and remote solutions to collect complete data. She has spoken on understanding the logistical support necessary for IMP delivery and dosing, sample collection, logistic options and best use cases. She... Read More →

Tuesday June 18, 2024 12:35pm - 1:05pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

12:35pm PDT

#243 IT: ProductLife Group Innovation Theater: Navigating the AI “boom” - A Methodological Framework to Create New Value Streams in your Specific Regulatory Affairs Context
Component Type: Session

The publication of Large Language Models has shed light on AI more than ever, and opened new opportunities – and risks. It has been challenging the vendor’s ecosystem. It becomes more and more complex to get a systemic view and define a strategic roadmap in this ever-changing environment. In this session, we will address such challenges by proposing and illustrating a methodological framework stemming from research in complex system engineering and design. The goal is to identify and develop AI value potential that will best fit your needs and context, in a frugal approach to avoid AI and tools “overload”.

Chair

Productlife Group

Speaker

Speaker
Gabriele Breda, PhD


Speakers
avatar for Gabriele Breda

Gabriele Breda

Research & Innovation Director, ProductLife Group, France
Gabrièle Breda is the Director of Research & Innovation at ProductLife Group (PLG). Graduated from Ecole Normale Supérieure of Paris, with a PhD in Neurosciences, Gabrièle has been managing collaborative Research & Innovation in Healthcare Engineering at Altran and Capgemini Engineering... Read More →
PG

Productlife Group

Productlife Group, France

Tuesday June 18, 2024 12:35pm - 1:05pm PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

1:15pm PDT

#244: Evidence Generation to Support Regulatory Decision-Making: Shift of the Trend over Time
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-582-L04-P; CME 1.00; RN 1.00

This session will discuss the recent shifts in evidence-based regulatory decision-making, to include types of evidence used to support decisions. Future requirements for evidence generation to support regulatory decision-making will be considered.

Learning Objectives

Describe the need for evidence generation to support regulatory decision-making; Discuss the changing evidence landscape supporting regulatory decision-making; Identify what is needed in the future.

Chair

Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Speaker

The Changing Trends in the Evidence Supporting Major Regulatory Decisions (Products Withdrawals) in Europe
Saad Shakir, DrMed, MD, FFPM, FISPE, FRCP

Quantitative Measurement of the Public Health Impact of Medicines Withdrawals and Suspensions in Europe
Samantha Lane, MSc

Industry Update
Andrew Bate, PhD, MA

Industry Update
Jeremy Jokinen, PhD, MS


Speakers
avatar for Saad Shakir

Saad Shakir

Director, Drug Safety Research Unit, United Kingdom
Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director... Read More →
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
avatar for Jeremy Jokinen

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States
Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring... Read More →
avatar for Samantha Lane

Samantha Lane

Head of Research, Centre of Pharmacovigilance Sciences, Drug Safety Research Unit, United Kingdom
Samantha Lane is a Senior Research Fellow and the Head of Research for the Centre of Pharmacovigilance Sciences at the Drug Safety Research Unit. Samantha leads study design and statistical analysis and has experience with the CPRD electronic health records database. She has a background... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

1:15pm PDT

#252: Ensuring Inspection Readiness for Clinical Trials Using Decentralized Clinical Trial Design Features
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-590-L04-P; CME 1.00; RN 1.00

The speakers will discuss regulatory and industry perspectives on sponsor and investigator responsibilities when incorporating decentralized clinical trials features in a trial to ensure trial participant safety, data reliability and quality and inspection readiness.

Learning Objectives

Describe various design features of decentralized clinical trials (DCT), including use of digital health technologies for remote data capture; Discuss what sponsors should do upfront in the planning and during the conduct of the trial and where the risks to data integrity lie in trials incorporating DCT features; Discuss the core elements of an FDA inspection; Identify steps to ensure inspection readiness for clinical investigators and sponsors.

Chair

Cara Alfaro, PharmD

Speaker

FDA Update
Cara Alfaro, PharmD

Industry Update
Jonathan Andrus, MS

MHRA Update
Jason Wakelin-Smith


Speakers
avatar for Cara Alfaro

Cara Alfaro

Senior Pharmacologist, OSI, OC, CDER, FDA, United States
Dr. Alfaro received her B.S. in pharmacy from Purdue University and her Pharm.D. from the Ohio State University. She completed a residency and research fellowship in psychiatric pharmacy at the University of Texas Health Science Center at San Antonio. In 1998, she joined NIH as a... Read More →
avatar for Jonathan Andrus

Jonathan Andrus

Co-CEO, CRIO, United States
Mr. Andrus brings over 25 years of executive management, operational, quality, and business experience to CRIO. Most recently he served as Chief Strategy Officer for Clinical Ink. Prior to that, he served as Senior Vice President for BioClinica (now Clario), where he led the e-clinical... Read More →
avatar for Jason Wakelin-Smith

Jason Wakelin-Smith

Expert GCP Inspector and Head of Compliance Expert Circle, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Jason Wakelin-Smith joined the MHRA in November 2006 as a GCP Inspector becoming a Senior GCP & GLP Inspector in 2015, a Lead Senior GCP & GLP Inspector in 2017 and the Expert Inspector for GCP in April 2022. Jason has a broad range of experience within the MHRA compliance teams having... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  02: ClinTrials -ClinOps, Session |   08: RD Quality-Compliance, Session

1:15pm PDT

#248: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-586-L04-P; CME 1.00; RN 1.00

This session will provide perspectives from stakeholders on successes and limitations from practical examples and discuss principles and best practices for maximizing the potential while managing the risks moving forward.

Learning Objectives

Describe the current state of the use of artificial intelligence (AI) in the medicinal product lifecycle including its opportunities and challenges; Discuss principles and best practices to maximize potential of AI while managing risks.

Chair

Hilmar Hamann, PhD

Speaker

EMA Update
Lorenzo De Angelis, PhD

Industry Update
Carlyn Crisostomo, MBA

Industry Update
Alexandra (Zan) Cha, PhD, MA

Industry Update
Timothe Menard, PharmD, MSc


Speakers
LD

Lorenzo De Angelis

Platform Architect, European Medicines Agency, Netherlands
Lorenzo De Angelis studied Physics in Sapienza University of Rome, where he graduated cum laude in July 2014. He then moved to the Netherlands, where he obtained his physics PhD in December 2018, with a thesis entitled "The Singular Optics of Random Light". Afterwards, he joined the... Read More →
avatar for Alexandra (Zan) Cha

Alexandra (Zan) Cha

Principal, Chief Technology Office, Booz Allen Hamilton, United States
Zan brings 20+ years of experience in health AI / analytics, and IT /product / ops management, applied to medical devices, pharmaceuticals, supply chain, clinical trials, insurance tech, chronic disease management, and population health & wellness. She is currently focused on advancing... Read More →
CC

Carlyn Crisostomo

Vice President, Head of R&D AI Strategy and Execution (RAISE), Amgen, United States
avatar for Hilmar Hamann

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands
Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →
avatar for Timothe Menard

Timothe Menard

Global Head, Quality Excellence Digital | Bioethics Coach (Data Ethics), F. Hoffmann-La Roche Ltd, Switzerland
Started in drug safety at Merck KGaA, joined Roche as a GCP/PV auditor. Transitioned to analytics; now heads Quality Excellence Digital. Focuses on digital & analytics for core quality deliverables. Co-founded the Inter coMPany quALity Analytics consortium to drive data/quality policy... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session |   09: Regulatory, Session

1:15pm PDT

#249: Topics Related to the Oncology Real-Time Oncology Review Process
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-587-L04-P; CME 1.00; RN 1.00

This session focuses on the oncology real-time oncology review (RTOR) process and the considerations compared to a standard oncology submission, medical writing processes, and potential time savings.

Learning Objectives

Describe the Real-Time Oncology Review (RTOR) program and processes; Describe industry's experience with RTOR; Understand how RTOR can impact global submission planning.

Chair

Britta Jacobsen, PhD

Speaker

FDA Update
Jennifer J. Lee, PharmD, RAC

Industry RTOR Experience and Lessons Learned
Linda Bowen, MSc, RAC

FDA Real Time Oncology Review: Planning Considerations from a Medical Writing Standpoint
Michael Gyulay


Speakers
avatar for Linda Bowen

Linda Bowen

Chief of Staff, Oncology Regulatory Strategy, Pfizer Inc, United States
Linda has spent the last 30 years in regulatory strategy, policy, and intelligence roles at Seagen, Sanofi, Bayer, and GSK. She most recently was Chief of Staff, Pfizer Oncology Regulatory Strategy, a role she also had at Seagen. She has also been an Assistant Adjunct Professor in... Read More →
avatar for Michael Gyulay

Michael Gyulay

Director, Medical Writing, Oncology and I-Oncology, EMD Serono, United States
Michael has nearly 20 years of industry experience in Medical Writing and currently is a manager of oncology medical writing leads, leading staff to deliver high quality operational and regulatory documentation and driving best writing and review practices. Prior to his time at EMD... Read More →
avatar for Britta Jacobsen

Britta Jacobsen

Medical Writer and Consultant, Whitsell Innovations, Inc. , United States
Britta is a scientist and medical writer with 26 years of experience in medical research and oncology. Her postdoctoral training piqued her interest in in steroid hormone receptors and preclinical breast cancer research. The opportunity to work on efficacy testing of novel drug combinations... Read More →
avatar for Jennifer Lee

Jennifer Lee

Senior Health Scientist, Oncology Center of Excellence, FDA, United States
Jennifer J. Lee, PharmD, RAC is a Sr. Health Scientist in the Oncology Center of Excellence (OCE) at the US Food & Drug Administration (FDA). In this role, she provides regulatory and strategic support for several of the OCE’s initiatives, including the Pediatric Oncology program... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  04: MedAffairs-SciComm, Session

1:15pm PDT

#245: The European Clinical Trials Environment Under the Accelerating Clinical Trials (ACT EU) Initiative: Two Years On
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-583-L04-P; CME 1.00; RN 1.00

Accelerating Clinical Trials in the EU (ACT EU) and the successful launch of the clinical trial regulation have modernized the clinical trial environment. This session is focused on how Europe is embracing the change and will also present other international initiatives offering opportunities for collaboration.

Learning Objectives

Describe how ACT EU, together with other EU initiatives, is providing a platform to optimize clinical research and development, and fostering innovation through joint collaborations between member states, ethics committees, and stakeholders, bringing tangible benefits for patients, sponsors, and regulators; Discuss other international clinical trial initiatives and potential areas of collaboration.

Chair

Ana Zanoletty Perez

Speaker

Academic Update
Sara Bristol Calvert, PharmD

Patient Advocate Perspective
Deborah Collyar

WHO Update
Marion Laumonier, MSc


Speakers
avatar for Kevin Bugin

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
Dr. Kevin Bugin is the Deputy Director of Operations in the Office of New Drugs (OND) in FDA’s Center for Drug Evaluation and Research (CDER). In addition, he leads the CDER Center for Clinical Trial Innovation (C3TI) which aims to promote the implementation of innovative clinical... Read More →
avatar for Sara Calvert

Sara Calvert

Director of Projects, Clinical Trials Transformation Initiative (CTTI), United States
Dr. Sara Bristol Calvert is currently the Director of Projects at the Clinical Trials Transformation Initiative (CTTI). Prior to this role, she was a CTTI Senior Project Manager which included leading projects in Diversity in Clinical Trials, Single IRB, Registry Trials, HABP/VABP... Read More →
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR), United States
Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic... Read More →
avatar for Marion Laumonier

Marion Laumonier

Technical Officer, Regulatory Convergence and Networks, World Health Organization (WHO), Switzerland
Marion Laumonier is currently Technical Officer in the Regulatory Convergence and Networks team at the WHO in Geneva, Switzerland. Marion Laumonier joined the WHO in 2021 and has over 20 years of experience gained in different settings, pharmaceutical industries and non-profit organizations... Read More →
avatar for Ana Zanoletty Perez

Ana Zanoletty Perez

Head of Clinical Trials Transformation workstream, European Medicines Agency, Netherlands
Ana qualified as a pharmacist and following various roles managing clinical trials for the biopharmaceutical industry joined EMA in 2006. At EMA she spent her initial years coordinating initial marketing authorisation procedures, and later transitioned into the management of post-authorisation... Read More →

Tuesday June 18, 2024 1:15pm - 2:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

2:15pm PDT

#259 RT: Roundtable Discussion: Be Creative and Innovative - A Simple Step-by-Step Decision Science Based Process for You and Your Team
Component Type: Session
Level: Intermediate

Join the Professional Education, Training & Development/Project Management Community for a follow up round table discussion tied to session: Be Creative and Innovative - A Simple Step-by-Step Decision Science Based Process for You and Your Team (June 17 | 3:30-4:30PM PDT). Space is limited.

Learning Objectives

identify ways to apply concepts and techniques from the session

Chair

Tyler Ludlow, MBA

Speakers
avatar for Candice Junge

Candice Junge

Executive Director, Neurology Program and Clinical Lead, Ionis Pharmaceuticals, Inc., United States
Candice Junge has over 20 years experience in drug development including preclinical research, clinical development and commercial readiness. She is currently an Executive Director, Neurology Program and Clinical Lead at Ionis Pharmaceuticals and is responsible for end-to-end drug... Read More →
avatar for Tyler Ludlow

Tyler Ludlow

Founder and Chief Decision Scientist, Decision Skills Institute, United States
Tyler helps people turn their decision burdens into opportunities for growth. After earning a degree in applied math and an MBA, he studied decision science at Stanford. He then spent 15 years helping leaders at global 500 firms (including 18 of the top 20 pharma companies), make... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   07: ProjectManagement-StrategicPlanning, Session |   13: ProfDevelopment, Session

2:15pm PDT

#257 RT: Roundtable Discussion: Good Data Governance Practices - Regulatory and Industry Perspectives
Component Type: Session

Join the Good Clinical Practices & QA Community for a follow up round table discussion tied to session: Good Data Governance Practices and the Importance of Incorporating Input from the Data Scientist in Quality by Design (Tuesday, June 18 | 8:00AM - 9:00AM PDT). Space is limited.

Chair

Terry Katz, MS

Speakers
avatar for Terry Katz

Terry Katz

Senior Director, Biostatistics and DM Planning and Functional Excellence, Daiichi Sankyo, United States
Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   08: RD Quality-Compliance, Session

2:15pm PDT

#258 RT: Roundtable Discussion: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability
Component Type: Session

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: Supporting Regulatory Convergence and Reliance Through a Pharmaceutical Quality Knowledge Management Capability (Tuesday, June 18 | 8:00am - 9:00AM PDT). Space is limited.

Chair

Demetra Macheras, MBA

Speakers
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →

Tuesday June 18, 2024 2:15pm - 3:15pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   09: Regulatory, Session |   10: RegCMC-Product Quality, Session

2:30pm PDT

#259.1 IS: Arnold Venture Innovation Session: Better Drug Information for Payers, Physicians, and Patients
Component Type: Session

Shared decision-making between patients and their healthcare providers about their treatments is important, and these complex decisions can be facilitated by presenting knowledge in an intuitive manner about the benefit/risk of various therapies based on the insights learned during the clinical investigation. This session will critically consider scientific issues related to communicating drug information advances expeditiously and safely.

Chair

Arnold Ventures

Speaker

Speaker
Rita F. Redberg, MD, MSc, FACC

Speaker
Steven Woloshin


Speakers
avatar for Rita Redberg

Rita Redberg

Director, Women's Cardiovascular Services; Professor of Medicine, UCSF Medical Center, United States
Dr. Redberg is a general Cardiologist and interested in preventive cardiology. Her research interests are in our use of medical procedures and devices. She studies the regulatory process for medical devices and the strength of evidence that supports them, particularly high-risk devices... Read More →
avatar for Steven Woloshin

Steven Woloshin

Professor, Dartmouth Institute, United States
Dr. Steven Woloshin is co-director of the Center for Medicine and Media at The Dartmouth Institute and a general internist. He and Lisa Schwartz co-created the drug facts box, drug-benefit and harm-data summaries shown in clinical trials to improve consumer decision-making. The FDA's... Read More →
AV

Arnold Ventures

United States

Tuesday June 18, 2024 2:30pm - 3:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  17: Networking Opportunities, Session

2:30pm PDT

#260 IT: Milliman IntelliScript Innovation Theater: Pre-Screening for Clinical Trials - The Revolution Starts in 3, 2, 1…
Component Type: Session

Pre-screening trial participants is tough when you don’t have access to full medical records. Instead, collect a HIPAA authorization and let Milliman IntelliScript retrieve and interpret prescription and medical data. Just upload name, zip, and DOB to access our proprietary data on most US residents. Filter by customizable inclusion and exclusion criteria in seconds for easier, more accurate pre-screening. Randomize more participants, realize more revenue, and push more trials to completion.

Chair

Milliman IntelliScript

Speaker

Speaker
Alyssa Vincze


Speakers
avatar for Milliman IntelliScript
avatar for Alyssa Vincze

Alyssa Vincze

Principal and Director, R&D, Milliman IntelliScript
Alyssa is an actuary serving as Principal and Director of R&D with Milliman IntelliScript, a company with a long history of disruptive innovation in the life and health insurance sectors. She recently led product development for IntelliScript’s clinical trials solution, adapting... Read More →

Tuesday June 18, 2024 2:30pm - 3:00pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

2:30pm PDT

#261 IT: Parexel Innovation Theater: FSP Partnership - A Foundation for Innovation and Patient-Guided Development
Component Type: Session

Optimal outsourcing is not a one-size-fits-all approach. FSP outsourcing has evolved beyond its origins as an efficiency model to manage clinical development labor demands to provide greater control over data, processes and resource allocation. Pfizer recently transitioned from predominately full-service outsourcing to an FSP model while adopting new job roles that prioritize patients and sites. Learn how Pfizer & Parexel created resource efficiencies & agility across a global study portfolio.

Chair

Parexel

Speaker

Speaker
Liz Rogers, MSc


Speakers
avatar for Parexel

Parexel

United States
LR

Liz Rogers

Head of Global Site and Study Operations, Pfizer , United States
As Vice President and Worldwide Head of Global Site and Study Operations at Pfizer, Liz is responsible for leading the management and oversight of global investigator site planning and clinical trial execution. Global Study and Site Operations supports the delivery of the Pfizer portfolio... Read More →

Tuesday June 18, 2024 2:30pm - 3:00pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

2:30pm PDT

#262 IT: Weave Innovation Theater: Minutes, Not Months - How to Draft an Efficient IND
Component Type: Session

Drafting an effective IND is critical to your organization’s valuation and success. How would being able to do so in minutes rather than months free up you and your team? Learn how you can focus on other key objectives and activities by automating tedious tasks and leveraging your expertise where it matters most: getting therapies to market.

Chair

Weave AI

Speaker

Speaker
Brandon Rice


Speakers
avatar for Brandon Rice

Brandon Rice

CPO, Weave, United States
I am Brandon and I lead Product at Weave. We are building AutoIND, an AI-powered software platform to streamline every aspect of IND preparation. I am deeply committed to building products that positively impact human lives, create meaningful value for our customers, and are delightful... Read More →

Tuesday June 18, 2024 2:30pm - 3:00pm PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

3:15pm PDT

#263: Risk Management Planning- Some Twenty Years Later: Where we Started, How Far we have Come and a Modern Path Forward
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-595-L04-P; CME 1.00; RN 1.00

This session provides an opportunity to pause and reflect on how far we have come and discuss areas for future focus, innovation, and key influential drivers for change from a scientific, technological and patient-centric perspective.

Learning Objectives

Describe the evolution in the use of risk management principles in the context of patient safety; Discuss the role of real-time information and collaboration/engagement as the catalyst for action in risk management; Identify current limitations and challenges; List specific case examples from a public health and patient safety perspective; Discuss opportunities for future innovations.

Chair

Rania Mouchantaf, PhD

Speaker

FDA Update
Gerald Dal Pan, MD, MHS

MHRA Update
Alison Cave, PhD

Effectiveness of Interventions: Successes and Challenges
Yola Moride, PhD, FISPE

Industry Update
Mamiko Kasho

EMA Update
Priya Bahri, PhD, RPh


Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
avatar for Alison Cave

Alison Cave

Chief Safety Officer, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Dr Cave joined the Medicines and Healthcare products Regulatory Agency (MHRA) in July 2021 as the Chief Safety Officer with responsibility for the safety of medicines and devices in the UK. She holds a BSc Honours degree and PhD from the University of London and has significant academic... Read More →
avatar for Mamiko Kasho

Mamiko Kasho

Executive Director, Global PV Management Dept., Global Safety HQs, Eisai Co., Ltd., Japan
Mamiko Kasho is Executive Director of Global Pharmacovigilance Management in Global Safety HQ of Eisai Co., Ltd, and has been involved in global PV area since she joined the company in 2007. Mamiko has been responsible for PV agreements with licensing partners for 15 years and at... Read More →
avatar for Yola Moride

Yola Moride

President, YolaRX Consultants, Canada
Prof. Yola Moride has a strong track record of methodological expertise in pharmacoepidemiology and therapeutic risk management. She is Research Professor at Rutgers University and President of YolaRX Consultants. She received a PhD in Epidemiology from McGill University and a Post-doctoral... Read More →
avatar for Rania Mouchantaf

Rania Mouchantaf

A/Executive Director, Marketed Pharmaceuticals Bureau, MHPD, Health Canada, Canada
Dr. Rania Mouchantaf is A/Executive Director at the Marketed Health Products Directorate at Health Canada with over 17 years of experience in the area of pharmacovigilance. Before entering the public service she worked in the private sector, however her interest in pharmacovigilance... Read More →
avatar for Gerald Dal Pan

Gerald Dal Pan

Director, Office of Surveillance and Epidemiology, CDER, FDA, United States
Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

3:15pm PDT

#266: Exploiting Real-World Data From Social Media in Patient-Focused Drug Development
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-692-L04-P; CME 1.00; RN 1.00

Social media is an important new source of real-world data (RWD) for patient-focused drug development. This session will present a review of considerations from an industry and regulators perspectives when listening to social media from patients.

Learning Objectives

Summarize the work done by group of experts from companies’ members; Discuss the challenges and opportunities of exploiting real-world data (RWD) from social media listening for R&D purposes and regulatory submissions; Propose best practices.

Chair

Thierry H Escudier, MSc

Speaker

Industry Update
Sarah Lyons

Academic Update
Philipp Cimiano, PhD

Industry Update
Vishakha Sharma, PhD


Speakers
PC

Philipp Cimiano

Head of Semantic Computing Group, Director, Joint AI Center, Bielefeld University, Germany
Philipp is an expert in Artificial Intelligence and Natural Language Processing. He graduated in computer science and obtained his PhD and habilitation from KIT. Since 2009, he is full professor for computer science at Bielefeld University. He leads the Semantic Computing group and... Read More →
avatar for Thierry Escudier

Thierry Escudier

Chairman, Strategic Consulting, DCRIPT, France
Leader in Clinical Research, with more than 30 year’s experience in Corporate R&D pharma organizations , Thierry has been promoting patient engagement strategy across the Industry. Thierry is now acting as an independent consultant providing strategic consulting and is very much... Read More →
avatar for Sarah Lyons

Sarah Lyons

Vice President, Data Transformation and AI Platforms, DTA and AI, IQVIA, Canada
Sarah Lyons is a Vice President responsible for IQVIA’s Data Transformation & AI Platforms serving healthcare and life science organizations globally with capabilities spanning privacy-enhancing technologies, natural language processing, and AI-enabled language solutions. In addition... Read More →
avatar for Vishakha Sharma

Vishakha Sharma

Senior Principal Data Scientist, Roche, United States
Vishakha Sharma, senior principal data scientist at Roche Diagnostics Information Solutions, leads NLP and ML initiatives, improving navify product portfolio for enhanced patient care. Vishakha has authored over 50 peer-reviewed publications and given 20+ invited talks. She serves... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session

3:15pm PDT

#270: Something Borrowed Something New for Effective Project Management: Adopting Different Thinking Approaches and New Technologies in Life Science Project Management
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-602-L04-P; CME 1.00; PDU 1.00 PMI 2166XALVLX; RN 1.00

Many project management methodologies, alternative thinking approach and new technologies can be applied to life science project management and bring many benefits. In this session, the adoption of Design Thinking and Generative AI, two of the emerging topics in health care industry, into life science project management will be discussed. The session will also demonstrate, with case studies, the possibilities of implementing new thinking approach for effective project management, team leading and efficient business process development. We will also examine practical applications of Generative AI in project management from optimizing scheduling, resource planning, and risk management. Reflecting on the current adoption efforts, this session provides a platform to explore possibilities to leverage new thinking and technologies to enhance life science project management.

Learning Objectives

Critique how many project management methodologies, thinking approaches, and new technologies can be applied to life science projects, and they may bring various benefits into the practice; Implement applicable methodologies and protocol new technologies in real-world practice.

Chair

Char Leung

Speaker

Industry Update
Rune Bergendorff, MSc


Speakers
avatar for Char Leung

Char Leung

Director, Development Program Management, Genmab, United States
Char Leung is a Director, Development Program Management at Genmab where she leads the operationalization of drug development strategies. Prior to Genmab, Char spent 9 years at Janssen R&D managing biologics discovery and development projects with increasing responsibilities. Char... Read More →
avatar for Rune Bergendorff

Rune Bergendorff

Partner, International Life Sciences, Implement Consulting Group, Denmark
Rune Bergendorff, Partner at Implement Consulting, boasts two decades of consultancy experience spanning Europe and the US. Educated in IT and business, his focus is centered on delivering sustainable digital transformations that drive business impact and value. Over the past 15 years... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session |   07: ProjectManagement-StrategicPlanning, Session

3:15pm PDT

#271: How Will the Increasing use of Real-World Evidence for Regulatory Decision-Making Impact QA Strategies and GCP Inspections?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-603-L04-P; CME 1.00; RN 1.00

This session will bring regulators and industry quality experts together to explore how quality management systems can be developed to meet the challenges real-world evidence presents to QA activities and regulatory inspection expectations.

Learning Objectives

Evaluate quality challenges associated with the use of real-world evidence as part of regulatory studies; Discuss how to apply proportionate risk-based quality assurance activities which meet regulatory expectations.

Chair

Andrew Gray, PhD

Speaker

FDA Update
L'Oreal Walker

FDA Update
Lee H. Pai-Scherf, MD

Industry Perspective
Abi Seifert, MBA


Speakers
avatar for Andrew Gray

Andrew Gray

Director, QA Clinical Therapeutic Area Head, Johnson & Johnson, United Kingdom
Andrew is a member of Johnson and Johnson's R&D Quality organisation where he has responsibility for risk-based audit strategies across the company’s clinical therapeutic areas. With an active interest in the use of RWE for regulatory decision making, Andrew was responsible for... Read More →
avatar for Lee Pai-Scherf

Lee Pai-Scherf

Senior Physician, GCP Assessment Branch, DCCE, OSI, OC, CDER, FDA, United States
Lee H. Pai-Scherf, MD, Senior Physician, OSI, Office of Compliance, CDER, FDA Dr. Pai-Scherf is a Senior Physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory... Read More →
avatar for Abi Seifert

Abi Seifert

Global Head Country Development Quality, Novartis , United States
Abi has worked in the Pharma industry for over 25 years, serving in clinical development in both QA and operational roles. Her career started in clinical study monitoring and GCP auditing and evolved into roles that defined strategy around project management, process excellence and... Read More →
LW

L'Oreal Walker

Supervisory Consumer Safety, OBIMO, ORA, FDA, United States
L'Oreal Walker is a seasoned professional with over two decades of experience in regulatory compliance and oversight. Currently serving as a Supervisory Investigator in the Office of Bioresearch Monitoring West Division within the Office of Regulatory Affairs at the FDA, L'Oreal leads... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session

3:15pm PDT

#272: This is Your Pilot Speaking: The Journey from Regulatory Pilot Program Innovation to Routine Practice
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-604-L04-P; CME 1.00; RN 1.00

This panel will explore the blue skies of global regulatory pilot programs, including initiatives on real-world evidence (RWE), model-informed drug development (MIDD), innovative trials, and endpoints. Panelists will educate the audience on new opportunities and best practices for future pilot success.

Learning Objectives

Critique new opportunities to participate in regulatory pilot programs at FDA and globally; Outline key lessons learned from pilot program case studies and experiences; Identify best practices to increase the likelihood of success for future pilot programs.

Chair

Andrew Emmett, MPH

Speaker

Moderator
Danielle Friend Economo, PhD

PDUFA VII Rare Disease Endpoint Advancement Program
Mary Jo Salerno, MPH, MS

Learnings from FDA PDUFA VII Advancing Real-World Evidence Program
Yueqin Zhao, PhD

Industry Update
Donna Boyce, MS, RAC

Industry Update
Rasika Kalamegham, PhD


Speakers
avatar for Danielle Friend Economo

Danielle Friend Economo

Senior Director, US Head Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
Dr. Danielle Friend received her Ph.D. in neuroscience in 2013 from the University of Utah. After completing her graduate work, Danielle conducted postdoctoral research at the National Institutes of Health. In 2016, Danielle was selected as a Science and Technology Policy Fellow with... Read More →
avatar for Andrew Emmett

Andrew Emmett

FDA Liaison | US Regulatory Policy and Global Intelligence, Pfizer Inc, United States
Andrew Emmett is Pfizer's FDA Liaison and Executive Director for U.S. Regulatory Policy & Global Intelligence. In his role, Andrew develops and advocates for Pfizer policy positions to enhance the regulatory environment for biomedical innovation. He leads key initiatives on real-world... Read More →
avatar for Donna Boyce

Donna Boyce

Head and Senior Vice President of Global Regulatory Sciences, Pfizer Inc, United States
Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the... Read More →
avatar for Rasika Kalamegham

Rasika Kalamegham

Head, US Regulatory Policy, Genentech, A Member of the Roche Group, United States
Rasika Kalamegham, Ph.D, is Head of U.S. Regulatory Policy at Genentech. She oversees all FDA related policy work related to the pipeline and serves as the principal representative to Congressional and advocacy relations for regulatory policy. She plays an active role in many trade... Read More →
MJ

Mary Jo Salerno

Science Policy Analyst, ORDPURM, OND, CDER, FDA, United States
Mary Jo Salerno currently works as a science policy analyst on the Rare Diseases Team in FDA CDER's Office of New Drugs. Mary Jo has broad FDA regulatory, policy, and program development and management experience, including previous positions in FDA Europe Office, CDER Office of Biostatistics... Read More →
YZ

Yueqin Zhao

Lead Mathematical Statistician, OB, OTS, CDER, FDA, United States
Yueqin Zhao is a lead mathematical statistician in Office of Biostatistics, Center for Drug Evaluation and Research, FDA. Her research interests include benefit-risk assessment, signal detection, and statistical methods in observational studies.

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

3:15pm PDT

#273: How to Provide Necessary Medicinal Products to Children?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-605-L04-P; CME 1.00; RN 1.00

In this session, speakers share the efficacy of exsiting pediatric regulation and discuss future collaboration to promote pediatric drug development worldwide

Learning Objectives

Describe the pediatric regulation of Japan and ASEAN; Discuss collaboration to promote pediatric drug development in these countries.

Chair

Junko Sato, PhD

Speaker

PMDA Update
Michiyo Sakiyama, MD

Industry Upate
Robert "Skip" Nelson, MD, PhD

FDA Update
Gerold Wharton


Speakers
avatar for Junko Sato

Junko Sato

Associate Executive Director, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Sato joined the Pharmaceuticals and Medical Devices Agency (PMDA) in 1998, and she is currently the Associate Executive Director. She has work experiences in new drug review for 11 yrs, risk management for 3 yrs, and international area for 11 yrs. She also worked in U.S. FDA as... Read More →
avatar for Robert Nelson

Robert Nelson

Senior Director, Pediatric Drug Development (CHILD), Johnson & Johnson, United States
Robert “Skip” Nelson, MD, MDiv, PhD. is currently Senior Director, Pediatric Product Development in the Child Health Innovation Leadership Department (CHILD) at Johnson & Johnson. Previously, he was the Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics... Read More →
MS

Michiyo Sakiyama

Associate Senior Scientist for Clinical Medicine, Office of Vaccines and Blood, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Michiyo Sakiyama, MD is an Associate Senior Scientist for Clinical Medicine of the office of Vaccines and Blood Products at the Pharmaceuticals and Medical Devices Agency (PMDA). She is a pediatrician and currently involved in reviewing vaccines against infectious diseases, blood... Read More →
avatar for Gerold Wharton

Gerold Wharton

Program Analyst, Office of Clinical Policy and Programs, OC, FDA, United States

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

3:15pm PDT

#267: Evolution of Electronic Product Information in LATAM: Challenges and Opportunities to Improve the Value of Healthcare
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-599-L04-P; CME 1.00; RN 1.00

This session provides a comprehensive overview of the status/evolution of the concept of electronic product information (ePI) in LATAM from multiple perspectives, including industry, international regulatory bodies, and various stakeholders involving patients and healthcare professionals (HCPs). It also reviews some of the relevant initiatives undertaken in Low to Medium income countries and their benefits and potential.

Learning Objectives

Identify the impact of electronic product information (ePI) hybrid pilots and regulatory framework evolution in LATAM countries; Discuss relevant initiatives undertaken in Low to medium income countries; Examine industry motivations and challenges in implementing ePI pilots; Describe the evolving landscape (efforts of HA's based on international standard for ePI, regulatory advancements made to ensure an optimal experience for patients/ HCPs, implications of these challenges on healthcare.

Chair

Leonardo Semprun Semprun, RPh

Speaker

Electonic Product Information Regulatory Evolution in Brazil
Nélio Cézar de Aquino, SR, MSc

Electronic Product Information in Low to Middle Income Countries
Rutendo Kuwana, RPh

Industry Outlook in Brazil: Exploring eLabeling Perspectives
Rosana M. Mastellaro, PharmD, RPh

Considerations for Implementation and Adoption of Digital Labels
Maria Cristina Mota Pina, MBA


Speakers
avatar for Leonardo Semprun

Leonardo Semprun

Global Regulatory Policy Lead-LatAm, MSD, Panama
Leonardo Semprún is currently Senior Director, Global Regulatory Policy at MSD. In this role, Leonardo is responsible to define and execute a regional regulatory policy plan that addresses current and future needs, while also advocating for and anticipating regulatory change with... Read More →
avatar for Nélio Cézar de Aquino

Nélio Cézar de Aquino

General Manager of Medicines, ANVISA, Brazil
Nélio Cézar de Aquino is the General Manager of Medicines at the Brazilian Health Regulatory Agency (Anvisa). He has held various positions at Anvisa, including General Manager of Information Technology, Ports, Airports, Borders, and Customs Warehouses, Public Quality Control Laboratories... Read More →
RK

Rutendo Kuwana

Team Lead, Incidents and Substandard/Falsified Medical Products, World Health Organization (WHO), Switzerland
Rutendo is leading the Incidents and Substandard/Falsified (ISF) medical products team at the World Health Organization (WHO) since June 2021. The ISF team is part of the Regulation and Safety (REG) Unit of the Regulation and Prequalification (RPQ) department that is within the Access... Read More →
avatar for Rosana Mastellaro

Rosana Mastellaro

Director, Technical Regulatory Affairs and Innovation, Sindusfarma, Brazil
Pharmacist, She is currently Director of Technical Regulatory Affairs and Inovation at Sindusfarma. She has worked for 17 years in the pharmaceutical industry. Specialist in Project Management. She acts in defense of the pharmaceutical industrial sector and coordinates regulatory... Read More →
avatar for Maria Cristina Mota Pina

Maria Cristina Mota Pina

Head, Regulatory Policy for Emerging Markets -Japan and Australia, AbbVie, United States
Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   03: Data-Tech, Session

3:15pm PDT

#275: Securing the Chain: US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-607-L04-P; CME 1.00; RN 1.00

With efforts in the US and Europe to increase supply chain transparency and prevent drug shortages, this forum focuses on recent and pending regulatory updates. We examine actions taken to mitigate product shortages following an unpredicted event impacting product shortages and lack of supply predictability.

Learning Objectives

Define the impact of US and European legislation updates on supply chain integrity and efforts to promote domestic manufacturing; Recognize how regulatory actions to prevent and mitigate product shortages are aimed at improving patient access and transparency across the supply chain; Discuss a case study on how the partnership between industry and regulatory can mitigate unpredictability.

Chair

Demetra Macheras, MBA

Speaker

Industry Update
Tony Lakavage, JD

Patient Perspective
Laura Bray


Speakers
avatar for Demetra Macheras

Demetra Macheras

Director, Regulatory Policy and Intelligence - Regulatory Affairs, AbbVie, United States
Demetra Macheras is currently Director, Regulatory Policy and Intelligence at AbbVie. She assesses and coordinates comments on proposed regulatory policies for the U.S., Canada, ICH, and WHO regulatory environments and ensures appropriate AbbVie personnel are aware of emerging and... Read More →
LB

Laura Bray

Founder and Chief Executive Officer, Angels for Change, United States
avatar for Tony Lakavage

Tony Lakavage

Senior Vice President, Global External Affairs, USP, United States
Anthony Lakavage is Senior Vice President, Global External Affairs, and Secretary, USP Convention and Board of Trustees. In his role, Mr. Lakavage oversees Global Communications, U.S. and International Public Policy and Regulatory Affairs, Global Stakeholder Engagement, Board and... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session

4:30pm PDT

#277: FDA's Approach in Harmonize Surveillance for Drugs and Biologics Safety and Quality Data
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-609-L04-P; CME 1.00; RN 1.00

This session will introduce a novel FDA approach that harmonizes surveillance for drugs and biologics safety and quality data, creating a cohesive end-to-end review and data management framework to support both safety and quality data regulated by the FDA.

Learning Objectives

Describe FDA’s harmonized surveillance process for drugs and biologics safety and quality data with an integrated database approach; Identify the significant gain in efficiencies and effectiveness in drugs and biologics safety and quality reviews at FDA for both pre-market and post-market operations.

Chair

Sri Mantha, MBA, MS

Speaker

Industry Update
Sean Darcy

Industry Update
Andrew Bate, PhD, MA


Speakers
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
SD

Sean Darcy

Principal, Darcy Consulting Group, United States
avatar for Sri Mantha

Sri Mantha

Director, Office of Strategic Programs, CDER, FDA, United States
Sridhar (Sri) Mantha is currently Director of the Office of Strategic Programs (OSP) at the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration. As the Director of OSP, Sri leads center-wide strategic and operational planning, performance analysis, and... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

4:30pm PDT

#278: Regulatory, Pharmacoepidemiologic, and Pharmacovigilance Considerations Related to the Safety of Drugs Used During Pregnancy
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-610-L04-P; CME 1.00; RN 1.00

Pregnant individuals are underrepresented in research. This session provides an overview of how the evolving regulatory framework, pharmaco-epidemiology, and clinical trials can advance evidence generation and contribute to pregnancy labeling.

Learning Objectives

Discuss important global advances in the collection of data in drugs and biological products used during pregnancy; Identify the evolving regulatory framework, and the value of premarket and postmarketing safety data that can lead to improved labeling information for drugs and biological products used in pregnancy; Describe stakeholder efforts to include pregnant individuals in clinical trials.

Chair

Martine Dehlinger-Kremer, PhD

Speaker

Assessment of Drugs Used During Pregnancy: Current Status
Martine Dehlinger-Kremer, PhD

Safety of Drugs Used During Pregnancy: Regulatory Considerations and Updates
Lynne Yao, MD

Post-Marketing Approval Safety Studies: The Role of Pregnancy Registries
Christina Chambers, PhD, MPH

Evaluation of Drug Use During Pregnancy: Post-Marketing Surveillance and Beyond - Time for a Paradigm Shift
Laura Shaughnessy, PhD


Speakers
avatar for Martine Dehlinger-Kremer

Martine Dehlinger-Kremer

Vice President Scientific Affairs, Pediatric Subject Matter Expert, ICON Plc, Germany
Dr. Dehlinger-Kremer’s has over 30 years experience in research industry, including 30 years of experience in global regulatory affairs, medical affairs, and pediatric leadership. Prior joining ICON, she served in executive leadership roles at global CROs, gained experience in global... Read More →
avatar for Christina Chambers

Christina Chambers

Distinguished Professor, Pediatrics, University of California San Diego, United States
Dr. Christina Chambers is a Professor in the Department of Pediatrics, School of Medicine at UC San Diego. She is Chief of the Division of Environmental Science and Health, and Co-Director of the Center for Better Beginnings. She is the principal investigator of MotherToBaby Pregnancy... Read More →
LS

Laura Shaughnessy

Clinical Program Director, UCB Biosciences, United States
In 2012, Laura joined UCB and has dedicated more than the last decade to the Women of Childbearing Age Programs (WoCBA). This groundbreaking program presents an exceptional opportunity to enhance the quality of life and family planning for women living with severe medical conditions... Read More →
avatar for Lynne Yao

Lynne Yao

Director, Division of Pediatric and Maternal Health, Office of New Drugs, CDER, FDA, United States
Lynne Yao, M.D., is the Director, Division of Pediatrics and Maternal Health in the Office of New Drugs, Center for Drug Evaluation and Research. The Division of Pediatrics and Maternal Health oversees quality initiatives which promote and necessitate the study of drug and biological... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

4:30pm PDT

#284: Collaboration in an Expanding Regulatory Landscape for Pharmacovigilance
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-616-L04-P; CME 1.00; RN 1.00

Understanding the safety of medicines and the risks imposed by their use is of interest to regulators around the world. This poses challenges for industry who are faced with meeting the regulatory requirements and expectations of multiple Healthcare Agencies from across the globe. This challenge is becoming greater still as more countries start to enter the world of PV.

This session will focus on how regulators are working together to share information and intelligence and how experienced regulatory agencies are working with nations currently establishing pharmacovigilance regulations to implement these and develop the skills and knowledge required to ensure compliance and establish accepted best practice.

Learning Objectives

Describe the challenges faced by industry from a global perspective and gain insight into how regulatory agencies are working together to combat some of these issues; Discuss information and educate countries where PV is an emerging concept; Discuss areas where processes can be improved to make global PV more aligned and less challenging for industry and regulators alike.

Chair

Sophie Radicke, MSc

Speaker

FDA Update
Carolyn A Volpe, PharmD, MS

Update from Ghana
Adela Ashie

MHRA Update
Sarah Vaughan


Speakers
avatar for Adela Ashie

Adela Ashie

Principal Regulatory Officer, Food and Drugs Authority, Ghana
Adela Ashie is a pharmacist with over 15 years of experience in Pharmacovigilance. She holds a master’s in international health (MPH IH) from the University of Nottingham, United Kingdom and is currently Head of the Vigilance Unit under the Safety Monitoring Department of the Food... Read More →
avatar for Sophie Radicke

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →
avatar for Sarah Vaughan

Sarah Vaughan

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation... Read More →
CV

Carolyn Volpe

Team Leader, OSI, OC, CDER, FDA, United States
CAPT Carolyn Volpe is a licensed pharmacist and serves as the Team Leader for the Pharmacovigilance Compliance Team in FDA’s Center of Drug Evaluation and Research Office of Compliance Office of Scientific Investigations. She has over 14 years’ experience at FDA in post-marketing... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session |   08: RD Quality-Compliance, Session

4:30pm PDT

#281: Harnessing Real-World Evidence in Regulatory Decision-Making: Update on DARWIN EU, Use of Real-World Evidence in New Applications in the EU
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-613-L04-P; CME 1.00; RN 1.00

A rapidly changing landscape has led to an increased use of real-world evidence (RWE) in regulatory decision making, as a complement to randomized clinical trials (RCTs), impacting how medicines are developed and assessed. The session will present where we are and discuss the exciting future ahead.

Learning Objectives

Describe how real-world data (RWD) is being leveraged to generate real-world evidence (RWE) in support of regulatory assessment and decision-making processes in Europe; Discuss the progress of DARWIN EU, and a high-level overview of the use of RWE in recent applications in EU and see how the generation of meaningful evidence can support safer and more effective treatments for patients.

Chair

Steffen Thirstrup, MD, PhD

Speaker

EMA Update
Sabine Haubenreisser, PhD, MSc

Industry Update
Laura T. Pizzi, PharmD, MPH

Patient Update
Dave deBronkart

Industry Update
Brian Bradbury, DrSc, MA


Speakers
avatar for Brian Bradbury

Brian Bradbury

Vice President, Center for Observational Research, Amgen, United States
Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous... Read More →
avatar for Dave deBronkart

Dave deBronkart

Patient Advocate, E-Patient Dave, LLC, United States
"e-Patient Dave" deBronkart is a cancer survivor and former high tech marketer, a founding member of the HL7 FHIR Patient Empowerment Workgroup, the BMJ patient advisory panel, and the Society for Participatory Medicine. He was the Mayo Clinic’s 2015 Visiting Professor in Internal... Read More →
avatar for Sabine Haubenreisser

Sabine Haubenreisser

Principal Scientific Administrator, Stakeholders and Communication Division, European Medicines Agency, Netherlands
Sabine Haubenreisser is a pharmacologist with special interest in scientific cooperation and regulatory convergence to the benefit of public health, through engagement with external stakeholders, the European network of experts and international partners and regulators. She has held... Read More →
avatar for Laura Pizzi

Laura Pizzi

Chief Science Officer, ISPOR, United States
avatar for Motiur Rahman

Motiur Rahman

Senior Epidemiologist, Real World Evidence Analytics, OMP, CDER, FDA, United States
Motiur Rahman is a Senior Epidemiologist at Real-World Evidence (RWE) Analytics in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA). His responsibilities include developing guidance, improving internal Agency processes... Read More →
avatar for Steffen Thirstrup

Steffen Thirstrup

Chief Medical Officer, European Medicines Agency, Netherlands
Steffen Thirstrup is a medical doctor and board certified specialist in clinical pharmacology and therapeutics. He holds a PhD in pharmacology and has a long background in clinical internal medicine. He is an adjunct professor at the Faculty of Health Sciences, University of Copenhagen... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session

4:30pm PDT

#285: Remote Regulatory Assessments: Examining Another Tool in the FDA Regulatory Toolbox
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-617-L04-P; CME 1.00; RN 1.00

This session will describe the evolution of remote regulatory assessments (RRA’s), FDA’s authority to conduct an RRA in lieu of an inspection, the process for conducting an RRA, and recent RRAs conducted as part of the FY23 BIMO program

Learning Objectives

Describe what a remote regulatory assessments is and FDA’s authority to conduct a remote regulatory assessment; Describe the steps taken by the agency and site before, during, and after a remote regulatory assessment is conducted; Discuss FY23 metrics including recently conducted remote regulatory assessments.

Chair

Jan Hewett, BSN, JD

Speaker

FDA Update
Kavita C. Dada, PharmD

Industry Perspective on Remote Assessments
James Riddle

Health Canada Update
Jennifer Evans


Speakers
KD

Kavita Dada

Associate Director for Regulatory Operations, OSI, OC, CDER, FDA, United States
JE

Jennifer Evans

Compliance and Enforcement Specialist, Health Canada, Canada
Jennifer Evans obtained her degree in Biochemistry from the University of Victoria, in British Columbia, Canada. She worked in the pharmaceutical and biotechnology industries in research, clinical and quality roles for 14 years prior to joining Health Canada in 2012 as a compliance... Read More →
avatar for Jan Hewett

Jan Hewett

Regulatory Counsel for Policy, OSI, CDER, FDA, United States
Jan Hewett joined the U.S. Food and Drug Administration's Center for Drug Evaluation and Research -Office of Compliance- Office of Scientific Investigations office as Regulatory Counsel (Policy) in February 2015. Prior to joining OSI, Jan served as the Director of the Yale University... Read More →
avatar for James Riddle

James Riddle

Senior Vice President, Global Review Operations, Advarra, United States
JJames Riddle is the Senior Vice President of Global Review Operations at Advarra, the world’s largest provider of ethics, safety, and compliance oversight reviews services. With 25+ years’ experience providing support to the clinical research community, Riddle has operational... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

4:30pm PDT

#290: Charting the Biosimilars Beat Drop: The Latest Updates in the Biosimilars Landscape, Coverage, and Adoption in the US
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-621-L04-P; CME 1.00; RN 1.00

This session will provide an overview of today’s biosimilars landscape, explore trends in uptake, describe innovative programs from industry disruptors, and report perspectives from key stakeholders through their primary market research.

Learning Objectives

Summarize results of current payer and provider research on barriers to biosimilar coverage and adoption, with a focus on product interchangeability; Describe the challenges and solutions of real-world data (RWD) and real-world evidence (RWE) in decision-making; Identify a framework for operational readiness in biosimilar management.

Chair

Charlie Dragovich, RPh

Speaker

Industry Update
Chara Reid, PharmD, RPh

Industry Update
Catherine Lockhart, PharmD, PhD, MS


Speakers
avatar for Charlie Dragovich

Charlie Dragovich

Board of Directors, California Academy of Managed Care Pharmacy, United States
Charlie Dragovich, BSPharm, is a market access consultant currently serving on the Board of Directors on California AMCP. Mr. Dragovich previously led the development of new programs and services at the Academy of Managed Care Pharmacy (AMCP) to facilitate payer and manufacturer communication... Read More →
CL

Catherine Lockhart

Chief Science Officer, Biologics and Biosimilars Collective Intelligence Consortium, United States
Cate Lockhart, PharmD, PhD is the Executive Director of the Biologics and Biosimilars Collective Intelligence Consortium where she is responsible for all programs of this multi-stakeholder research collaboration. She is a proven leader in health economics and outcomes research (HEOR... Read More →
avatar for Chara Reid

Chara Reid

Director, Specialty Practice Network, Immunology, Cencora (formerly AmerisourceBergen), United States
Chara Reid is a National Sales Director for AmerisourceBergen. In this role she leads a national sales team that call on multi-specialty infusion practices. She graduated with her bachelor’s degree in biology in 1998 from Northern Illinois University. Then went on to Midwestern... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  12: Value-Access, Session

4:30pm PDT

#283: The Value of Project Management in Driving Drug Discovery Success: A Comparison Between Small Versus Large Pharmaceutical Companies
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-615-L04-P; CME 1.00; PDU 1.00 PMI 2166M3MMI2; RN 1.00

The session will provide an overview of projct management (PM) in discovery and early development and contrast to the application of PM skills in later stages. The session will include best practices for driving impact with discovery and early development functional areas.

Learning Objectives

Describe the value of project management (PM) on discovery teams and early in the drug development lifecycle; Compare adaptations for PM in discovery versus development in both large pharma and smaller biotech settings; Discuss best practices for driving impact with discovery and early development functional areas.

Chair

Elizabeth Somers, MS

Speaker

The Value of Project Management in Driving Drug Discovery Success - Small Company Perspective
Stuart Ince, PhD


Speakers
avatar for Elizabeth Somers

Elizabeth Somers

Executive Director, Global Project and Alliance Management, Merck Sharp & Dohme LLC, United States
Liz is an Executive Director in Global Project and Alliance Management at Merck focusing on Discovery PM. She manages a team focused on Discovery projects including complex collaborations which leverages her experience managing complex cross functional drug development programs and... Read More →
avatar for Stuart Ince

Stuart Ince

Vice President, Program Leadership, Accent Therapeutics, Inc, United States
Stuart Ince Ph.D. is a drug discovery and development executive with 22 years of experience in pharmaceutical R&D. He started his career in medicinal chemistry, advancing to a project lead for discovery projects in lead optimization at Bayer AG. Subsequently he progressed to drug... Read More →

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  13: ProfDevelopment, Session |   07: ProjectManagement-StrategicPlanning, Session
 
Wednesday, June 19
 

8:00am PDT

#301: Risk Minimization in the EU: New Guidance, New Collaborations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-622-L04-P; CME 1.00; RN 1.00

Risk minimization is a key area of pharmacovigilance.This session presents revised EU guidance and discusses multidisciplinary and multistakeholder approaches to implementation.

Learning Objectives

Summarize new EU-regulatory guidance on risk minimization measures and its implications for stakeholders; Recognize underpinning rationales and concepts from implementation science, engagement frameworks, mixed methods and digital opportunities; Identify successful collaborations across stakeholders for implementing risk minimization measures in healthcare.

Chair

Priya Bahri, PhD, RPh

Speaker

Industry Update
Meredith Smith, PhD, MPA, FISPE

Patient Update
Regina Mariam Kamoga, MPA


Speakers
avatar for Priya Bahri

Priya Bahri

Senior Lead (Pharmacovigilance and Risk Management Guidance and Policy), European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
avatar for Regina Mariam Kamoga

Regina Mariam Kamoga

Executive Director, Community Health And Information Network ( CHAIN), Uganda
She is passionate about patient centered healthcare and patient safety and her work puts emphasis on patient, family, community engagement and empowerment at the grassroots level. One of her key roles is as a WHO Patient Safety champion and she is a member of the WHO’s Patients... Read More →
avatar for Meredith Smith

Meredith Smith

Senior Director, Implementation Science Pillar Lead, Evidera, Inc, United States
Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

8:00am PDT

#302: Have a Safe Trip: Clinical and Patient Alignment in Clinical Trials with Psychedelics
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-623-L04-P; CME 1.00; RN 1.00

This discussion will provide the setting and background of clinical trials of psychedelics and issues to consider. The session will provide details with a clinical trial participant providing example feedback and insight from that perspective.

Learning Objectives

Discuss the conflicted background of psychedelic clinical trials; Discuss reasonable expectations for clinical trial progression; Identify one participant’s perspective from two clinical trials; compare and contrast the participant perspective with standard clinical outcomes.

Chair

Currien MacDonald, MD

Speaker

Panelist
Sara Reed, MA


Speakers
avatar for Currien MacDonald

Currien MacDonald

Medical Chair Director, WCG, United States
Dr. Currien MacDonald has lead the medical chairs at WCG for the past 7 years. Prior to that, Dr. MacDonald served for four years as the medical director for Aspire IRB, another WCG company. After graduating top of his class from the University of Minnesota Medical School, Dr. MacDonald... Read More →
avatar for Sara Reed

Sara Reed

Video Production, Consultant, United States
Sara Reed holds a MFA in Documentary Media from Northwestern University. With over a decade of freelance video production experience spanning the U.S., Canada, Central/South America, and Africa, she’s contributed to projects for renowned clients such as Discovery, HBO, NASA, and... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

8:00am PDT

#309: FDA Oncology Center of Excellence: Are Sponsors Taking Full Advantage of OCE Regulatory Policy “Projects?”
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-630-L04-P; CME 1.00; RN 1.00

The FDA Oncology Center of Excellence "Projects" address gaps in oncology drug development and present opportunities as well as challenges for industry. Learn from FDA and industry experts the value of these initiatives and how and when to join in.

Learning Objectives

Recognize high-value FDA OCE priorities and projects that impact industry; Identify how and when to engage with these FDA initiatives to produce optimal results for industry, patients, and other stakeholders; Describe how to advance opportunities for harmonization of these high-value OCE Projects with global Health Authorities.

Chair

Sabrina Girty, JD

Speaker

FDA Overview and Perspective on OCE Projects
Tamy Kim, PharmD

From Policy to Practice: Maximizing Collaboration to Support Oncology Innovation
Mark Stewart, PhD

Industry Case Study: Implementing OCE Projects in Drug Development
Vandana Pathak, MS, RAC


Speakers
avatar for Sabrina Girty

Sabrina Girty

Executive Director, Global Regulatory Affairs, Oncology, Merck & Co., Inc., United States
Sabrina Girty is an Executive Director in Global Regulatory Affairs, Oncology at Merck & Co. Inc and leads a team of global regulatory strategy professionals across the esophageal, gastric, colorectal and head & neck cancer programs. At Merck, her team secured global marketing authorizations... Read More →
avatar for Tamy Kim

Tamy Kim

Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence, FDA, United States
Tamy Kim is the Director for Regulatory Affairs and Policy at FDA's Oncology Center for Excellence and the Associate Director for Regulatory Affairs in the Office of Oncologic Diseases (OOD). Dr. Kim is responsible for developing policies and procedures affecting the review of products... Read More →
avatar for Vandana Pathak

Vandana Pathak

Director Global Regulatory Affairs, Amgen, United States
Vandana Pathak, MS, RAC is a Director, Global Regulatory Affairs - Oncology at Amgen Inc. She leads global regulatory teams to drive global regulatory strategy and provides regulatory leadership to cross-functional teams to develop and execute global regulatory product strategies... Read More →
avatar for Mark Stewart

Mark Stewart

Vice President, Science Policy, Friends of Cancer Research, United States
Mark Stewart is vice president of science policy at Friends of Cancer Research (Friends), an advocacy organization based in Washington, DC that drives collaboration among partners of every healthcare sector and creates and implements policies ensuring patients receive the best treatments... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

8:00am PDT

#307: Partnering with Regulatory Authorities to Unlock the Value in Digital Health Products
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-628-L04-P; CME 1.00; RN 1.00

Discussion of partnering with regulators to get novel digital health products through the approval processes. Learn insights from industry and regulators for creative, strategic, and flexible thinking on regulation of novel technologies.

Learning Objectives

Discuss the challenges of introducing novel digital technologies to FDA; Describe tactics to build better partnerships with regulators.

Chair

Rebecca Joy James, MBA, RAC

Speaker

Panelist
Anindita Saha

Panelist
James Wabby, MHS

Panelist
Adam Cargill, MS

Panelist
Wes Gerbig, PhD, MS


Speakers
RJ

Rebecca James

Director - Advisory, KPMG, LLC, United States
Rebecca is a Director in the Life Sciences consulting group at KPMG based out of Chicago, IL. She has over 14 years of experience in both consulting and industry roles with companies from pharmaceutical, medical device, and nutritional industries with an emphasis in Regulatory Affairs... Read More →
AC

Adam Cargill

Director, QARACA, MediView XR, Inc., United States
Adam Cargill, MS RAC, is the Vice President of Quality, Regulatory, and Clinical for MediView XR. In his role he is accountable for the oversight of all regulatory, clinical, and quality functions. Responsibilities include overseeing the company’s global regulatory, clinical, and... Read More →
WG

Wes Gerbig

Director, Global Regulatory Affairs, Drug Delivery and Digital Health, Eli Lilly and Company, United States
avatar for Anindita Saha

Anindita Saha

Associate Director Strategic Initiatives, Digital Health Center of Excellence, FDA, United States
Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations... Read More →
avatar for James Wabby

James Wabby

Global Head, Regulatory Affairs, Emerging Technologies and Combination Products, AbbVie, United States
James Wabby is the Global Head, Regulatory Affairs - (CoE) Emerging Technologies, Devices, and Combination Products at AbbVie in Irvine, California. He has 22 years of experience in increasing quality compliance and regulatory affairs responsibilities within the GxP regulated environment... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   06: TranslationalDelivery Tech-PrecMedicine, Session

9:15am PDT

#314 IT: IQVIA Innovation Theater: Pre-Approval Access - Strategies for Providing Investigational Product to Patients Beyond Clinical Trials
Component Type: Session

This session on Pre-Approval Access (PAA) will address key considerations and challenges for provision of investigational products to patients outside of clinical trials, and before these therapies are approved by regulators. We will focus on key decisions and success factors for organizations to consider when developing their company’s philosophy on this type of access. We will also highlight pragmatic decisions that play into the development of efficient Pre-Approval Access programs.

Chair

IQVIA

Speaker

Speaker
Barbara Isquith Arone, MS

Speaker
Ana Tediosi


Speakers
avatar for IQVIA

IQVIA

United States
avatar for Barbara Isquith Arone

Barbara Isquith Arone

Vice President, Evidence Generation for Medical Affairs, IQVIA, United States
Barbara has worked within late phase research for 20+ years, 18 with IQVIA. She is responsible for the development and support of market facing and operational aspects of the following study types: disease and product registries, natural history studies, low interventional and pragmatic... Read More →
avatar for Ana Tediosi

Ana Tediosi

Head of Expanded Access Strategy, WEP Clinical, United Kingdom
With over 10 years of experience in the pharmaceutical industry, Ana is a recognized expert in the field of Expanded Access Programs (EAP). Her expertise lies in oncology, hematology, Rare Diseases, and she has held various roles in the big Pharma (BMS, Roche, Menarini-Stemline... Read More →

Wednesday June 19, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

9:15am PDT

#315 IT: ArisGlobal Innovation Theater: Unleashing the Power of Automation and Understanding the Promise of GenAI in Pharmacovigilance and Regulatory Affairs
Component Type: Session

In the rapidly evolving life sciences landscape, the integration of next-generation technologies is essential to innovation, improving efficiencies, and ensuring safety, compliance, and efficacy of drugs. In this keynote panel, hear from leaders at ArisGlobal and top pharam, as they discuss tangible automation use cases and their practical implications. Whether you are with a large organization aiming to scale automation and leverage GenAI or a smaller organization looking to begin leveraging automation within your workflows, you’ll find value in hearing the unique journeys our panelists and their organizations have taken - You’ll also learn about the benefits that they are seeing as a result.

Chair

ArisGlobal, LLC

Speaker

Panelist
Hans van Leeuwen, PhD

Panelist
Claudia Schaffer, RN


Speakers
avatar for Art Brown

Art Brown

Marketing, ArisGlobal, United States
HV

Hans van Leeuwen

Head of Regulatory Operations, Astellas Pharma Europe BV, Netherlands
avatar for ArisGlobal, LLC

ArisGlobal, LLC

United States
avatar for Claudia Schaffer

Claudia Schaffer

Sr. Director, Head Case and Vendor Management, EMD Serono, Germany
Claudia is an accomplished leader with over 17 years of experience in pharmacovigilance. Her journey started with handling ICSRs and quickly progressed to leadership roles where she gained expertise in diverse areas such as vendor management, business process management, system implementation... Read More →
avatar for Karthick Sukumaran

Karthick Sukumaran

Technology Enablement Director, Roche, United States

Wednesday June 19, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

9:15am PDT

#315.1 IT: HCL Innovation Theater
Component Type: Session



Chair

HCL Technologies

Speakers
HT

HCL Technologies

United States

Wednesday June 19, 2024 9:15am - 9:45am PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

10:00am PDT

#319: Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-637-L04-P; CME 1.00; RN 1.00

This session will discuss how the ISO IDMP standards have a pivotal role in enhancing global pharmacovigilance and improving visibility in the product supply chain. The collaborative efforts of the Global IDMP Working Group reflect the need to advance this critical endeavor.

Learning Objectives

Define IDMP standards and explain their benefits when globally implemented; Describe the role of the unique global IDMP identifiers in data exchange of medicinal product information; Discuss the impact of global IDMP identifiers on different use cases in the medicinal product life cycle, for example, pharmacovigilance and drug shortages, supply chain integrity.

Chair

Malin Kristina Fladvad, PhD, MSc

Speaker

Unlocking the Potential of IDMP: Global Use Cases
Ron Fitzmartin, PhD, MBA

Unlocking the Potential of IDMP for Global Exchange of Medicinal Products Data
Hilmar Hamann, PhD


Speakers
avatar for Malin Fladvad

Malin Fladvad

Portfolio Officer, Uppsala Monitoring Centre, Sweden
Malin Fladvad is a Portfolio officer at Uppsala Monitoring Centre (UMC). In this position she is responsible for the WHODrug Product Portfolio which dictionaries and applications are used in clinical trials and safety monitoring worldwide. Malin is also engaged in various efforts... Read More →
avatar for Ron Fitzmartin

Ron Fitzmartin

Senior Informatics Advisor, Office of Regulatory Operations, CBER, FDA, United States
Ron Fitzmartin is Senior Informatics Advisor, Office of Regulatory Operations, Center for Biologics Evaluation and Research, Food and Drug Administration. In this role Ron provides policy and strategy consultation and support on a wide range of topics focused on electronic regulatory... Read More →
avatar for Hilmar Hamann

Hilmar Hamann

Head of Information Management, European Medicines Agency, Netherlands
Dr. Hilmar Hamann is the Head of Information Management at the European Medicines Agency where he focuses on transforming technology capabilities for the Network of Regulatory Agencies in the EU and its stakeholders to become an all-digital, efficient and data-driven Network of the... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session |   03: Data-Tech, Session

10:00am PDT

#324: Using Data Analytics for Good Pharmacovigilance Practices
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-642-L04-P; CME 1.00; RN 1.00

This session will consist of perspectives and case studies of how data-driven solutions are being leveraged to support the development of quality assurance strategies for pharmacovigilance activities and to generate quality evidence in relation to Good Pharmacovigilance Practice (GVP) compliance.

Learning Objectives

Investigate the use of data-driven solutions to develop quality assurance strategies for Good Pharmacovigilance Practice (GVP) activities and to generate quality evidence in relation to GVP compliance.

Chair

Kiernan Trevett, MSc

Speaker

Industry Update
Michelle Ruiz

Industry Update
John Okudjeto, MSc

MHRA Update
Sophie Radicke, MSc


Speakers
avatar for Kiernan Trevett

Kiernan Trevett

Principal Quality Lead, PDQ Quality Assurance Process GVP, Genentech, A Member of the Roche Group, United States
Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP... Read More →
avatar for John Okudjeto

John Okudjeto

Manager, Pharmacovigilance QA, Janssen Research & Development LLC, United States
John Okudjeto is a quality assurance professional with over ten years of experience in pharma and medical device manufacturing, supply change management, and pharmacovigilance auditing. John completed a Bachelor of Science in Biology/Chemistry from Georgia State University in 2010... Read More →
avatar for Sophie Radicke

Sophie Radicke

Head of GPvP and Senior Pharmacovigilance Inspector, Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom
Sophie is the Head of the MHRA GPvP Compliance Team and a senior pharmacovigilance inspector. She became an inspector 2018 and has since led a number of complex and technically diverse inspections. In her current role, she is responsible for ensuring the operational delivery of pharmacovigilance... Read More →
MR

Michelle Ruiz

Principal Quality Data Analyst, Genentech, A Member of the Roche Group, United States
Michelle is a Principal Quality Data Analyst in Genentech's Product Development Quality organization. In her current role, Michelle focuses on identifying areas in the Pharmacovigilance domain where data analytics can transform business processes, as well as designing and delivering... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session |   08: RD Quality-Compliance, Session

10:00am PDT

#320: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-638-L04-P; CME 1.00; RN 1.00

Join us for a candid tour of three journeys toward integrating AI into key use cases. We share real-world metrics, best practices, and lessons learned as our teams evolve from traditional document development to effective digital solutions. This session focuses on practical ways in which medical writing organizations are using AI technologies to enable new ways of working, achieve business value, and get drugs to market faster.

Learning Objectives

Compare approaches to incorporating artificial intelligence (AI) in key use cases; Identify potential solutions to challenges within your organization; Appraise your organization’s plans for AI implementation.

Chair

Regina Lynn Preciado

Speaker

Evolution of Technology and Exploring Use of Generative AI in Medical Writing
Madhavi Gidh-Jain, PhD

Using GenAI to Write First Draft of Clinical Study Reports
John Henry April, III, MA

Evolve or Perish: Embracing Automation in Medical Writing
Waheed Jowiya, PhD


Speakers
avatar for Regina Lynn Preciado

Regina Lynn Preciado

Senior Director of Content Strategy Solutions, Content Rules, Inc., United States
Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech... Read More →
avatar for John April

John April

Senior Director, Adaptive Content Strategy, Global Scientific Communications, Eli Lilly and Company, United States
Twenty-five years of drug development experience focused on medical writing. Highlights include developing content reuse and generative AI strategies for Lilly, retooling Lilly's medical writing staff to structure its content, leading a medical writing start-up in India, designing... Read More →
avatar for Madhavi Gidh-Jain

Madhavi Gidh-Jain

Global Medical Writing and Document Management Head, Sanofi, United States
Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices... Read More →
avatar for Waheed Jowiya

Waheed Jowiya

Digitalisation Strategy Lead, Novo Nordisk A/S, Denmark
Waheed is a Digitalisation Strategy Lead at Novo Nordisk. In his role at Novo Nordisk, Waheed has been instrumental in shaping the digitalisation strategy for the company's content creation initiatives. Waheed has played a crucial role in developing the strategy for scaling and deployment... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  04: MedAffairs-SciComm, Session

10:00am PDT

#321: The ChatBot Will See You Now: Ethical Considerations in Incorporating AI into Informed Consent
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-639-L04-P; CME 1.00; RN 1.00

Generative AI is gaining traction in trial communications, with goals of expediency and efficiency. New technologies should incorporate patient views and ethical frameworks to keep human interactions that are desirable, necessary, and useful.

Learning Objectives

Describe the ethical framework that encompasses informed consent for clinical research; Evaluate goals for the use of artificial intelligence (AI) in clinical trials and how these goals interact with ethical goals for consent; Discuss how to incorporate patient and participant needs and perspective into AI-assisted clinical trial information and communication.

Chair

Lindsay McNair, MD, MPH, MS

Speaker

Patient Perspective Update
Deborah Collyar

Industry Update
Karla Childers, MS

Industry Update
Catina O'Leary, PhD


Speakers
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →
avatar for Deborah Collyar

Deborah Collyar

President, Patient Advocates In Research (PAIR), United States
Deborah Collyar is founder and president of Patient Advocates in Research (PAIR), “where research meets reality.” Her leadership in patient engagement and advocacy started in the 1990s after her first cancer diagnosis. She applies business leadership, IT, communication and strategic... Read More →
CO

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media, United States
Catina O’Leary, PhD, is President and CEO at Health Literacy Media (HLM), a St. Louis based nonprofit that develops and distributes health literate and accessible health and science communications with a wide range of global partners. Before joining HLM in 2012, Catina was Assistant... Read More →
avatar for Catina O'Leary

Catina O'Leary

President and Chief Executive Officer, Health Literacy Media, United States

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session

10:00am PDT

#323: Driving Capacity Building, Equity, and Geographic Expansion in Clinical Trials
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-641-L04-P; CME 1.00; PDU 1.00 PMI 2166PJJJ85; RN 1.00

90% of trials are performed in higher-income countries. In this session, the audience will learn directly from stakeholders about establishing infrastructure in low and/or middle income countries (LMICs) and how building capacity can improve quality of care and outcomes for patients.

Learning Objectives

Describe global research expertise and identifying gaps on a local level; Identify approaches to translate local research expertise to global research excellence; Recognize successful strategies for long-term sustainability and growth.

Chair

Muhammad Ali Hameed, CPA, MBA

Speaker

Facilitator
Twanna L Davis, MBA

Facilitator
Jeanine Condo Condo


Speakers
JC

Jeanine Condo

Chief Executive Officer, CIIC-HIN, Rwanda
avatar for Twanna Davis

Twanna Davis

Global Head, Clinical Trial Services, Executive Advisor - Purpose Africa, Purpose Life Science, Canada
Twanna Davis is the Head of Clinical Trial Solutions at Purpose Life Sciences. In her role, Twanna oversees all functional services necessary to execute full-service global clinical trials. She has over 25 years of experience in clinical operations, directing multiple applicable services... Read More →
MA

Muhammad Ali Hameed

Chief Operating Officer, Population Health Research Institute, Canada

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   07: ProjectManagement-StrategicPlanning, Session

10:00am PDT

#326: Bringing Transformational Treatments to Patients: Regulatory Convergence and Reliance on Cell and Gene Therapy Products
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-644-L04-P; CME 1.00; RN 1.00

In this session, we will discuss international efforts to promote regulatory convergence and expand the use of reliance to bring these highly complex therapies to market earlier, particularly in less developed countries.

Learning Objectives

Describe how international harmonization, collaboration, and reliance principles can be effectively applied to the regulation of cell and gene therapies; Discuss the key considerations and regulatory challenges associated with bringing complex, innovative medicines such as cell and gene therapy products to less experienced, emerging markets.

Chair

Ginny Beakes-Read, BSN, JD

Speaker

FDA Update
Julia Tierney, JD

WHO Update
Samvel Azatyan, MD, PhD

PMDA Update
Yasuhiro Kishioka, PhD

Industry Update
Maria Antonieta Tony Roman, MPharm

EMA Update
Anabela Marcal, PharmD


Speakers
avatar for Samvel Azatyan

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland
Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →
avatar for Ginny Beakes-Read

Ginny Beakes-Read

Head, Global Regulatory Policy and Intelligence, Johnson & Johnson Innovative Medicine, United States
Ms. Beakes-Read is VP, Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the policy group, which works to shape the regulatory environment to support innovative drug development and patient access to new therapies. Before that, Ginny was at Amgen leading the... Read More →
avatar for Yasuhiro Kishioka

Yasuhiro Kishioka

Reviewer Director, Office of Cellular and Tissue-based Products, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Kishioka is a Review Director of the Office of Cellular and Tissue-based Products, PMDA. In this role, he is responsible for the assessment of gene therapy products and the quality of biotechnological/biological products. Since joining PMDA in 2008, Dr. Kishioka has been involved... Read More →
avatar for Anabela Marcal

Anabela Marcal

EMA Liaison Official to the US FDA, European Medicines Agency, Netherlands
Anabela holds a degree in pharmacy and a professional certification in hospital pharmacy. Anabela had joined the EMA in 1999. During her career at the Agency she held a number of roles in various areas, including Head of Committees and Inspections and Head of Clinical Trials. Currently... Read More →
avatar for Maria Antonieta Roman

Maria Antonieta Roman

Head Regulatory Policy Emerging Markets LATAM, Novartis, Mexico
Degree in Pharmacy, Master of Science (pharmacy) UNAM; Diploma in Clinical development and regulatory affairs, Universidad Anahuac; diploma in public health by the Swiss School of Public Health. 32 years of experience in various areas in the Pharmaceutical industry like R&D, quality... Read More →
avatar for Julia Tierney

Julia Tierney

Deputy Center Director for Strategy, Policy, and Legislation, CBER, FDA, United States
JULIE TIERNEY is the Deputy Center Director for Strategy, Policy and Legislation for the Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER). Ms. Tierney has held several senior roles in the Office of the Commissioner and CBER during her... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   09: Regulatory, Session

10:00am PDT

#327: Enabling Innovation and Regulatory Agility to Address Sustainability, Environment, and Climate Goals
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-645-L04-P; CME 1.00; RN 1.00

This session will include the regulator and industry perspective on the Green Deal initiative and chemical agenda and will have discussions on identified case study areas of expected heavy impact where panelists from industry, SMEs, and regulators will come together to share concerns and discuss opportunities and solutions on how to manage a more sustainable and environmentally future – for example through regulatory tools which enable innovation to address the challenges.

Learning Objectives

Identify insights into how manufacturers and regulators can collaborate to deliver a revolution without risks to the supply of medicines.

Chair

Ana Padua, MSc, RPh

Speaker

EMA Update
Veronika Jekerle, PhD, RPh

Sustainability and CMC (Chemistry, Manufacturing and Controls)
Benjamin Stevens, PhD, MPH

Industry Update
Anders Vinther, PhD, MSc


Speakers
avatar for Ana Padua

Ana Padua

Director EU Global Regulatory and Scientific Policy, EMD Serono, Switzerland
Ana has over 19 years of pharmaceutical industry experience starting in Analytical Development (2-year) and then Regulatory Affairs area by working for Medley (Brazil), Novartis (Brazil and Switzerland), Parexel (Brazil) and in the last 8+ years for Roche leading the CMC Regulatory... Read More →
avatar for Veronika Jekerle

Veronika Jekerle

Head of Pharmaceutical Quality, European Medicines Agency, Netherlands
Veronika Jekerle hold the position as Head of Office for EMA’s Pharmaceutical Quality Office in the Human medicines Division at European Medicines Agency. The office manages pharmaceutical quality aspects for all human medicines across the lifecycle from early development to post-authorisation... Read More →
avatar for Benjamin Stevens

Benjamin Stevens

Director CMC Policy and Advocacy, GlaxoSmithKline, United States
Ben Stevens is a Director of CMC Policy and Advocacy at GlaxoSmithKline and has nearly 15 years of drug discovery and regulatory experience. Prior to GSK, Ben was a Director of Regulatory Affairs CMC at Alnylam, a Principal Consultant at PAREXEL and an acting Branch Chief in the Office... Read More →
avatar for Anders Vinther

Anders Vinther

Founder and Chief Executive Officer, QBA Leaders, United States
Anders Vinther, Ph.D, has established and grown companies, merged organizations, led Quality functions as Chief Quality Officer, chaired organizations and programs, and led culture change at large and small scale. Anders has more than 30 years work experience in the pharmaceutical... Read More →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  10: RegCMC-Product Quality, Session

11:00am PDT

#329 RT: Roundtable Discussion: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle
Component Type: Session

Join the Regulatory Affairs Community for a follow up round table discussion tied to session: The Evolving Role of Artificial Intelligence in the Medicinal Product Lifecycle (Tuesday, June 18 | 1:15PM - 2:15 PM PDT). Space is limited.

Chair

Brooke Casselberry, MS, RAC

Speakers
avatar for Brooke Casselberry

Brooke Casselberry

Vice President, Advisory and Delivery, Epista Life Sciences, United States
Brooke is known for her pivotal roles in collaborating with Sponsor Companies, Health Authorities, and Technology Developers. She has maintained focus on leveraging cutting-edge technologies as a catalyst for regulatory advancements, optimization, and collaboration for global go-to-market... Read More →

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   03: Data-Tech, Session |   09: Regulatory, Session

11:00am PDT

#330.1 RT: Roundtable Discussion: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases
Component Type: Session

Join the Medical Writing Community for a follow up round table discussion tied to session: AI Process in Medical Writing, AI Utilization, and AI Real-World Use Cases (Wednesday, June 19 | 10:00AM-11:00AM PDT). Space is limited.

Chair

Regina Lynn Preciado

Speakers
avatar for Regina Lynn Preciado

Regina Lynn Preciado

Senior Director of Content Strategy Solutions, Content Rules, Inc., United States
Regina Lynn Preciado is the Senior Director of Content Strategy Solutions at Content Rules. She leads content strategy teams to help pharma and biotech organizations adopt structured content successfully. She has 25+ years of experience in structured content strategy for pharma/biotech... Read More →

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 D/ Zone 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   04: MedAffairs-SciComm, Session

11:00am PDT

#330 RT: Roundtable Discussion: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation
Component Type: Session

Join the Meaningful Change Working Group Community for a follow up round table discussion tied to session: Securing the Chain - US and EU Legislative Reforms and Regulatory Actions for Drug Shortage Mitigation (Tuesday, June 18 | 3:15 PM - 4:15 PM PDT). Space is limited.

Chair

Chaitanya Koduri

Speakers
CK

Chaitanya Koduri

Director, International Government and Regulatory Engagement, US Pharmacopeia, United States

Wednesday June 19, 2024 11:00am - 12:00pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   10: RegCMC-Product Quality, Session |   09: Regulatory, Session

11:15am PDT

#331.1 IT: Syneos Health Innovation Theater: From Formula One to Fortnite - Clinical Trials Fast-Track to Innovation
Component Type: Session

The world’s fastest time series database and analytics engine, and video game-style trainings are accelerating clinical trial efficiency, reducing costs, enhancing CRA performance, and speeding time to market in life-changing therapies. Learn how these technologies are being applied today to optimize site selection, predict enrollment rates, reduce environmental impact and identify trial risks earlier, and how future use cases will tackle patient selection and predicting drug efficacy.

Chair

Syneos Health

Speaker

Speaker
Bob Zambon, PhD

Speaker
Greg Christie


Speakers
avatar for Paula Bain

Paula Bain

President of Clinical Delivery Services, Syneos Health, United States
Leading Clinical Delivery Services, Ms. Bain oversees Biometrics, Global Regulatory Affairs Solutions, Regulatory Intelligence and Medical Writing at Syneos Health. She has more than 35 years of clinical development experience, with a passion for science and creating integrated technology... Read More →
avatar for Greg Christie

Greg Christie

Chief Product Officer, StudyKIK, a Syneos Health Company, United States
Greg Christie is a leader in human-centered product development and design, earning accolades for contributions to clinical research technology such as a SCOPE Award, a nomination for the Prix Galien UK 2023 Award for StudyKIK’s apps and a 2023 PM360 ELITE 100 Award in the Tech-Know... Read More →
avatar for Syneos Health

Syneos Health

United States
avatar for Bob Zambon

Bob Zambon

Vice President, Technology Strategy and Strategic Partnerships, Syneos Health, United States
Dr. Zambon is VP, Technology Strategy & Strategic Partnerships at Syneos Health. He leads the development and operationalization of strategic solutions for clients to help address their key R&D and commercial needs by integrating data, technology, analytics, and various partnerships... Read More →

Wednesday June 19, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:15am PDT

#331.2 IT: OM1 Innovation Theater: Revolutionizing Prospective Studies and Registries with Automation and AI
Component Type: Session



Chair

OM1

Speaker

Speaker
Richard Gliklich, MD


Speakers
avatar for Richard Gliklich

Richard Gliklich

Chief Executive Officer, OM1, United States
Dr. Richard Gliklich is the CEO of OM1, Inc., a real-world data, outcomes and technology company focused on using data and AI to accelerate medical research and personalize medicine, especially in chronic conditions. OM1 develops extensive data networks of participating practices... Read More →
avatar for OM1

OM1

United States

Wednesday June 19, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:15am PDT

#331.3 IT: N-Power Medicine Innovation Theater: A Unifying Platform to Unlock the Value of Cancer Patient Data for Both Clinical Trials and Routine Care
Component Type: Session

N-Power Medicine partners with oncology clinics to implement a purpose-built platform for accelerated and better-informed drug development. This first-of-its-kind integrated platform provides a single workflow across routine care and clinical trials. By enabling greater physician participation in research and thus deeper access to the full patient population, the platform helps sites achieve more predictable trial production and create unique SOC data that is fit-for-purpose for drug development

Chair

N-Power Medicine

Speaker

Speaker
Mark Lee


Speakers
avatar for Mark Lee

Mark Lee

CEO, N-Power Medicine, United States
Dr. Lee was most recently Senior Vice President and Global Head for Personalized Healthcare, Product Development at Genentech/Roche. Prior to joining Genentech, Mark was a member of the founding leadership team and Head of Clinical Development and Medical Affairs at GRAIL, where his... Read More →
NM

N-Power Medicine

United States

Wednesday June 19, 2024 11:15am - 11:45am PDT
Exhibit Hall Theater #3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

11:55am PDT

#332.2 IT: Wipro Innovation Theater
Component Type: Session



Chair

Wipro

Speakers
W

Wipro

United States

Wednesday June 19, 2024 11:55am - 12:25pm PDT
Exhibit Hall Theater #2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

1:15pm PDT

#345: Regulatory Considerations in Trial Design for Cell and Gene Therapies
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-648-L04-P; CME 1.00; RN 1.00

Cell and gene therapies have enormous potential to address unmet medical need. The application of validated clinical trials design tools along with biomarkers to assess safety and endpoints can help address regulatory uncertainty.

Learning Objectives

Discuss regulatory considerations for cell and gene therapies including the use of data modeling in clinical trial design and the application of biomarkers both for safety assessment and measures of outcome; Discuss how to plan for meeting regulatory requirements and be able to incorporate these plans into your company’s drug development plans.

Chair

Kanwaljit Singh, MD, MBA, MPH

Speaker

Regulatory Considerations for Development of Pediatric Cell and Gene Therapies: FDA Update
Najat Bouchkouj, MD

Regulatory Consideration for Pediatric Cell and Gene Therapies - Industry Perspective
Paulla Dennis

Path from Bench-to-Bedside for a Cell and Gene Therapy Drug Product
Stephanie Cherqui, PhD


Speakers
avatar for Najat Bouchkouj

Najat Bouchkouj

Associate Director for Pediatrics (Acting), Office of Clinical Evaluation, FDA, United States
Dr. Najat Bouchkouj is the Acting Associate Director for Pediatrics in the Office of Clinical Evaluation, OTP, CBER, FDA. Dr. Bouchkouj joined the FDA in 2016. She earned her medical degree from Damascus University, Syria and completed a residency in Pediatrics at the State University... Read More →
avatar for Stephanie Cherqui

Stephanie Cherqui

Director, UC San Diego Gene Therapy Initiative, University of California San Diego, United States
Stephanie Cherqui is Professor in the Department of Pediatrics, Division of Genetics at the University of California San Diego. She is also the Director of the UC San Diego Gene Therapy Initiative. Her laboratory primarily centers on two research areas: the development of hematopoietic... Read More →
PD

Paulla Dennis

Senior Director, Rare Diseases, Advanced Therapies, and Pediatrics, Fortrea, United States
• Paulla Dennis, Senior Director, is a leading member of the Rare Disease, Advanced Therapies, and Paediatric Team (RAPT) with over 20 years in the clinical research industry. Paulla has expertise in global phase I through IV pediatric and rare disease operational strategy and planning... Read More →
avatar for Kanwaljit Singh

Kanwaljit Singh

Executive Director, International Neonatal Consortium, Critical Path Institute, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  06: TranslationalDelivery Tech-PrecMedicine, Session |   09: Regulatory, Session |   02: ClinTrials -ClinOps, Session

1:15pm PDT

#346: A Clinical Research Workforce in Crisis: Imperatives for a Sustainable Staffing Model
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-649-L04-P; CME 1.00; RN 1.00

The clinical research workforce crisis threatens to undermine the entire drug development ecosystem. This session will discuss the glaring disconnect between the visionary discourse on how to revolutionize the clinical research enterprise and the sober recognition that operationalization of any such vision rests on the shoulders of a workforce that’s in dire straits. It will feature a variety of industry leaders who will frame the issue and share lessons, solutions, and workforce development models that can be emulated globally to help build the next generation of clinical researchers--diverse and research ready.

Learning Objectives

Discuss the extent of the clinical research workforce crisis, including a diminishing pool of experienced clinical research professionals a ‘war for talent’ that is driving high and unsustainable turnover; Identify factors contributing to this crisis; Describe promising steps that can help with future workforce development.

Chair

Susan Landis

Speaker

Industry Update
Jimmy Bechtel, MBA

Industry Update
Meghan McKenzie, MA

Academic Update
Jonathan Watanabe, PharmD, PhD


Speakers
avatar for Susan Landis

Susan Landis

Executive Director, Association of Clinical Research Professionals (ACRP), United States
Susan Landis serves as the Executive Director for the Association of Clinical Research Professionals. Prior to joining the Association, Susan led Strategic Engagement & Marketing Communications for the Duke Clinical Research Institute (DCRI). While at Duke, Susan established and led... Read More →
avatar for Jimmy Bechtel

Jimmy Bechtel

Vice President, Site Engagement, Society for Clinical Research Sites (SCRS), United States
Jimmy brings experience from both the site and sponsor sides of the clinical research industry to his critical role with SCRS. Jimmy provided a variety of support within the site spectrum as a data specialist, patient recruiter and operations manager. On the pharma side where he worked... Read More →
avatar for Meghan McKenzie

Meghan McKenzie

Patient Inclusion and Head, Equity, Chief Diversity Office, Genentech, A Member of the Roche Group, United States
Meghan McKenzie works in Patient Inclusion and Health Equity in Genentech’s Chief Diversity Office (CDO). She develops strategies to drive greater inclusion of racial and ethnically representative patient populations in clinical research and to advance health equity. Genentech’s... Read More →
avatar for Jonathan Watanabe

Jonathan Watanabe

Associate Dean, Pharmacy Assessment and Quality | Prof, Clinical Pharmacy, University of California Irvine, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  07: ProjectManagement-StrategicPlanning, Session |   13: ProfDevelopment, Session |   02: ClinTrials -ClinOps, Session

1:15pm PDT

#351: Revolutionizing Quality Management: Harnessing the Power of AI for Enhanced Decision Making and Continuous Improvement
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-654-L04-P; CME 1.00; RN 1.00

This session explores four use cases of AI's potential to revolutionize quality management (QM) decision making and enhance organizational processes. Discover how AI is being implemented within QM and AI's role in identifying trends and driving improvement initiatives.

Learning Objectives

Describe the role of AI for quality management (QM) decision making, with a focus on advanced data analysis and pattern recognition, quality risk management, inspection readiness and drive continuous improvement initiatives; Identify practical use cases of AI in enterprise QMS, metadata extraction, risk assessment, and knowledge management systems, showcasing the benefits of AI integration.

Chair

Oliver Fink, MS

Speaker

AI Embedded Capabilities in an Enterprise Quality Management System
Michael Pelosi, MA, MBA, MSc

Augmenting Quality Assurance Activities with AI
Oeystein Kjoersvik, MS, MSc

AI Use Cases in Regulatory Monitoring
Haleh Valian, PhD


Speakers
OF

Oliver Fink

Head Learning, Processes and Digitalization, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany
avatar for Oeystein Kjoersvik

Oeystein Kjoersvik

Technology Auditor and Quality Projects Lead, Merck Sharp & Dohme LLC, Czech Republic
Oeystein Kjoersvik is currently a Technology Auditor and Quality Projects lead at Merck, one of his focuses is AI within QA. Oeystein also served as a Machine Learning SME for TransCelerate's Intelligent Automation team. Prior to his current role, he held the role of Product Owner... Read More →
MP

Michael Pelosi

Director, Quality Analytics, Astellas, United States
Mike is the Astellas lead for strategy, implementation and integration of analytics and digital transformation capabilities and services across the Quality Assurance function.
HV

Haleh Valian

Head of Decision Quality Analytics and Innovation, Biogen, United States
Haleh is the Biogen's Head of R&D Decision, Quality Analytics and innovations. She has more than 21 years of expertise utilizing advanced analytics to solve challenging business problems relating to process optimization in a variety of industries, including pharma, healthcare, and... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 17AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  08: RD Quality-Compliance, Session

1:15pm PDT

#353: ICH M15 Model Informed Drug Development: Steps Toward Harmonized Guidance
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-656-L04-P; CME 1.00; RN 1.00

Model Informed Drug Development (MIDD) can enhance the efficiency of drug development and regulatory decision-making. The ICH M15 guideline aims to enable the further integration and consistent use of MIDD. This session will cover the draft guideline in greater detail.

Learning Objectives

Discuss the draft guideline and what may be new to drug developers and the regulatory community, including the concept of a risk-based assessment, the value of multidisciplinary team alignment on MIDD strategy, and early alignment with regulators; Identify current approaches, best practices, and future opportunities to enhance development and decision-making.

Chair

Erin Greene, JD

Speaker

Industry Perspective
Malidi Ahamadi

Regulatory Perspective
Hao Zhu, PhD

Industry Perspective
Mark C. Peterson, PhD


Speakers
avatar for Erin Greene

Erin Greene

US Lead, Global Regulatory Policy and Innovation, Takeda, United States
Experienced leader in Global Regulatory Policy and Intelligence with a demonstrated history of working in the pharmaceutical and healthcare industries. Graduated from American University, Washington College of Law with an emphasis on FDA regulation and health law and policy.
MA

Malidi Ahamadi

US Head, Modeling and Simulation, Sanofi, United States
MP

Mark Peterson

Senior Director, Modeling and Simulation, Vertex Pharmaceuticals, United States
Dr. Mark C. Peterson works at Vertex Pharmaceuticals as a Senior Director in Clinical & Quantitative Pharmacology. Prior to that, he was at Pfizer (9 years), Biogen (2 years) and Amgen (8 years). Dr. Peterson received a Bachelor of Sciences in Pharmacy (1992) and a Doctorate in Pharmaceutical... Read More →
avatar for Hao Zhu

Hao Zhu

Division Director, Division of Pharmacometrics, OCP, OTS, CDER, FDA, United States

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 16AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

1:15pm PDT

#354: ICMRA Post-Pandemic: Regulators Looking into the Future
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-657-L04-P; CME 1.00; RN 1.00

ICMRA regulators will share their views on the opportunities and challenges brought by some of the main innovative concepts and technologies they are facing, including artificial intelligence, evolving clinical trials, and real-world evidence in the authorization of advanced therapy medical products (ATMPs).

Learning Objectives

Identify how regulators are working on maximizing the opportunities offered by artificial intelligence while minimizing the risks; Discuss new concepts for enhanced clinical trials (e.g.: platform CTs, decentralized CTs); Describe opportunities and challenges brought by the use of real-world evidence data for authorization of advanced therapy medical products.

Chair

Emer Cooke, MBA, MSc

Speaker

Panelist
Anthony Lawler, MD, MBA

Panelist
Antonio Barra Torres, MD

Panelist
Lorraine Nolan, PhD

Panelist
Daisuke Koga, MSc, RPh

Panelist
Robert M. Califf, MD


Speakers
avatar for Emer Cooke

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands
Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
avatar for Anthony Lawler

Anthony Lawler

Deputy Secretary, Health Products Regulation Group, Therapeutic Goods Administration, Australia
Professor Tony Lawler is the Head of the Australian Therapeutic Goods Administration, which works to safeguard and enhance the health of all Australians through effective, timely and risk-proportionate regulation of therapeutic goods, and the control of drug imports, exports and production... Read More →
avatar for Antonio Barra Torres

Antonio Barra Torres

President Director, ANVISA, Brazil
Mr. Barra, President-Director of Anvisa, graduated in Medicine from Foundation Souza Marques in 1986 and had his residency in Vascular and Endovascular surgery done at Marcílio Dias Naval Hospital (HNMD) in Rio de Janeiro. MBA in Health Services Administration at Federal University... Read More →
avatar for Lorraine Nolan

Lorraine Nolan

Chief Executive, Health Products Regulatory Authority , Ireland
Dr Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming... Read More →
avatar for Daisuke Koga

Daisuke Koga

Director, Office of International Regulatory Affairs, Ministry of Health, Labour and Welfare (MHLW), Japan
Mr. Daisuke Koga is Director, Office of International Regulatory Affairs, Pharmaceutical Safety Bureau, Ministry of Health, Labour and Welfare (MHLW) of Japan. He started his career in 1996 at the Ministry of Health and Welfare of Japan. He worked in the areas of drugs, medical devices... Read More →
avatar for Robert Califf

Robert Califf

Commissioner, FDA, United States
Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6A San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session

1:15pm PDT

#350: ICH Efforts to Incorporate Patient’s Perspective to Enhance Quality, Relevance, Safety and Efficacy of Drug Development
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-653-L04-P; CME 1.00; RN 1.00

Discussion of ICH work to harmonize recommendations for inclusion of patient’s perspective in drug development. Patient group representatives will also highlight key considerations for clinical research and development of international standards.

Learning Objectives

Discuss ICH’s portfolio for inclusion of patient’s perspective in drug development and outline specific case examples; Describe the patient perspective in clinical research and identify key considerations that may be relevant for the international community in developing standards; Evaluate linkages between ICH’s mission and key interests of patient, health care professional, and life science communities.

Chair

Amanda Marie Roache, MS

Speaker

Moderator
Theresa Mullin, PhD

ICH E22 Patient Preference Studies
Brett Hauber, PhD, MA

ICH Patient Engagement
Francesco Pignatti, MD

Patient Perspective on Engagement to Inform Drug Development
Nicholas Brooke, MBA


Speakers
avatar for Nicholas Brooke

Nicholas Brooke

Executive Director, Patient Focused Medicines Development (PFMD), PFMD, Belgium
Nicholas Brooke is the Founder and Executive Director of The Synergist, an incubator and managing organization to multi-stakeholder platforms that brings key players together with the express aim of solving significant societal problems through collective actions. The Synergist also... Read More →
BH

Brett Hauber

Senior Director, Patient Preference Elicitation, Pfizer Inc, United States
avatar for Theresa Mullin

Theresa Mullin

Associate Center Director - Strategic Initiatives, CDER, FDA, United States
Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
avatar for Amanda Roache

Amanda Roache

Senior Director, Science and Regulatory Advocacy, Pharmaceutical Research and Manufacturers of America (PhRMA), United States
Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 11AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   05: Patient-Focused Drug Dev, Session

2:15pm PDT

#356 RT: Roundtable Discussion: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent
Component Type: Session

Join the Bioethics Community for a follow up round table discussion tied to session: The Chatbot Will See You Now - Ethical Considerations in Incorporating AI in Informed Consent (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

Chair

Karla Childers, MS

Speakers
avatar for Karla Childers

Karla Childers

Head, Bioethics-Based Science and Technology Policy, Johnson & Johnson, United States
Karla Childers is Head, Bioethics-based Science & Technology Policy in the Johnson & Johnson Office of the Chief Medical Officer. Her primary responsibility is leading and coordinating various bioethics-based, science policy projects since 2013. Her longest running responsibility... Read More →

Wednesday June 19, 2024 2:15pm - 3:15pm PDT
Ballroom 20 A/ Zone 1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   05: Patient-Focused Drug Dev, Session

2:15pm PDT

#357 RT: Roundtable Discussion: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience
Component Type: Session

Join the Digital Acceleration Community for a follow up round table discussion tied to session: Leveraging Cloud-Based Technologies to Accelerate Reliance and Convergence - An Industry and Regulatory Agency Experience (Wednesday, June 19 | 10:00AM - 11:00AM PDT). Space is limited.

Chair

Cesar Vinces

Speakers
avatar for Cesar Vinces

Cesar Vinces

EU Interim and International Policy Lead, Accumulus Synergy, United States
Cesar serves as Interim EU & International Policy Lead at Accumulus Synergy within Regulatory Innovation. He engages with industry experts, national regulators, and global organizations to foster policy changes and develop strategies that enhance regulatory frameworks, promoting industry... Read More →

Wednesday June 19, 2024 2:15pm - 3:15pm PDT
Ballroom 20 BC/ Zone 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  16: Community Rounds, Session |   09: Regulatory, Session |   03: Data-Tech, Session

2:30pm PDT

#358.1 IT: DIA Innovation Theater: The 2024 DIA Science Priorities - Inspired by the Original Olympic Games Motto "Faster, Higher, Stronger"
Component Type: Session

Discussion of the new DIA Science Priorities and our approach for establishing new avenues for collaborative research and regulatory harmonization through information sharing and multi-stakeholder consensus building, with patients in the center of our agenda.

Chair

Maria Vassileva, PhD

Speaker

Speaker
Chockalingam Palaniappan, PhD


Speakers
avatar for Chockalingam Palaniappan

Chockalingam Palaniappan

Life Sciences Innovation Executive, United States
Member of the DIA Board of Directors and also serves as the Co-chair for the DIA Science Policy Advisory Committee. He is an accomplished global life sciences innovation executive with more than 20 years of leadership experience across three multinational corporations, GE Healthcare... Read More →
avatar for Maria Vassileva

Maria Vassileva

Global Head of Science and Scientific Strategy, DIA, United States
Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association... Read More →

Wednesday June 19, 2024 2:30pm - 3:00pm PDT
Exhibit Hall Theater #1 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  19: InnovationTheaters, Session

3:15pm PDT

#360: More than Meets the Eye: AI’s Potential to Identify Skin Manifestations of Internal Disease in Patients of Color
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-660-L04-P; CME 1.00; RN 1.00

Unlocking AI's potential to facilitate diversity in clinical trials demands inclusive images capturing skin manifestations of internal diseases across races and ethnicities. Join our panel to learn more about inclusive innovation in AI solutions.

Learning Objectives

Discuss the importance of photographs and images in AI algorithms to identify internal diseases impacting patients of color and how that supports clinical trial enrollment; Identify the questions to ask of AI solution providers to ensure imagery is inclusive; Describe what’s being done to improve imagery in AI learning to drive clinical trial diversity.

Chair

Pamela Simpkins, MBA

Speaker

Patient Update
Tricha Shivas, MS

Industry Update
Lionel Phillips, MBA

Industry Update
Brian H Johnson


Speakers
avatar for Pamela Simpkins

Pamela Simpkins

Managing Partner, Mezzopointe. LLC, United States
Biopharma R&D executive with 26+ years in the industry and nearly a decade as an institutional investor. Expert in R&D Finance with a proven track record in accelerating development of key pipeline assets to achieve regulatory approval and market authorization. Built, led and sold... Read More →
BJ

Brian Johnson

Vice President, R&D Technology, Takeda, United States
avatar for Lionel Phillips

Lionel Phillips

President, Inside Edge Consulting, United States
avatar for Tricha Shivas

Tricha Shivas

Chief of Staff and Strategy, Foundation For Sarcoidosis Research, United States
Tricha Shivas joined the Foundation for Sarcoidosis Research (FSR) in December of 2020. As the Chief of Staff and Strategy, she works with various stakeholders including individuals living with sarcoidosis. Through her career she has built strong stakeholder relations, created comprehensive... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session |   11: Statistics-Data Science, Session |   02: ClinTrials -ClinOps, Session

3:15pm PDT

#366: The Intersection of Patient-Experience Data and Benefit-Risk Analysis
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-666-L04-P; CME 1.00; RN 1.00

This session will explore how patient experience data (PED) can be used to inform benefit-risk analysis. The panel will include discussion on regulators’ views and incorporation of PED and successful case examples.

Learning Objectives

Describe the role patient experience data (PED) plays in benefit-risk analysis; Identify how to develop PED in a way that can inform regulatory decision-making; Discuss if and how new diversity and inclusion regulations will impact the development of PED and regulators’ interpretation of benefit-risk.

Chair

Allison Martin, MS
Victoria DiBiaso, BSN, MPH, RN

Speaker

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: FDA Update
Michelle Campbell, PhD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: EMA Update
Francesco Pignatti, MD

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: Industry Update
Jill Yersak

The Intersection of Patient-Experience Data and Benefit-Risk Analysis: patient Update
Hollie Schmidt, MS


Speakers
avatar for Allison Martin

Allison Martin

Director, Regulatory Science and Policy, North America, Sanofi, United States
As a Director on Sanofi’s Regulatory Science and Policy North America team, Allison is responsible for advancing regulatory science and strategically engaging in regulatory policy efforts. In this role, Ms. Martin collaborates with internal and external stakeholders to identify... Read More →
avatar for Michelle Campbell

Michelle Campbell

Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER, FDA, United States
Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously... Read More →
avatar for Victoria DiBiaso

Victoria DiBiaso

Global Head, Patient Informed Development and Health Value Translation, Sanofi, France
Vicky has 25+ years of clinical research experience. She holds a Master of Public Health, is a nurse by training. Her work has been published in The Wall Street Journal, she has been recognized as one of the Top 20 Industry Innovators, through integrating patient communities into... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
avatar for Hollie Schmidt

Hollie Schmidt

Vice President of Scientific Operations, Accelerated Cure Project, United States
Hollie Schmidt is the VP of Scientific Operations at the Accelerated Cure Project, a research-focused patient advocacy organization for MS. She has planned, developed, and directed numerous initiatives aimed at creating research resources and bridging different stakeholder communities... Read More →
JY

Jill Yersak

Head, US ALS Patient Advocacy and Engagement, Amylyx Pharmaceuticals, United States

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   09: Regulatory, Session

3:15pm PDT

#364: Unlocking Success: Mastering the Pharmaceutical Asset Lifecycle Journey
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-664-L04-P; CME 1.00; PDU 1.00 PMI 216658O27Z; RN 1.00

In this session, we will provide an overview of lifecycle management for an asset from patent filing to loss of exclusivity. Critical success factors require early planning, rigorous prioritization, organizational alignment, cross-functional buy-in and collaboration, and retention of enterprise memory over the long lifecycle of an asset. Program managers will gain insight into their unique role as champions of process and people, ensuring therapies reach patients faster. Proven strategies from case study examples will outline key decision points at each stage of product development, identify tools for strengthening cross-functional team planning, ensure quality oversight, and enhance successful delivery of the product lifecycle strategy.

Learning Objectives

Identify the concept of pharmaceutical lifecycle management and its role in bringing lifesaving therapies to patients efficiently; Discuss the challenges of pharmaceutical lifecycle management, such as siloed department planning and lack of resources; Describe the role of project management in ensuring continuity of lifecycle management and the execution of the product strategy.

Chair

Susan Carino, MBA, MS, PMP, RAC

Speaker

Unlocking Success: Mastering the Pharmaceutical Asset Lifecycle Journey: Industry Update
Aditi Khurana, MBA, PMP, RAC


Speakers
avatar for Susan Carino

Susan Carino

Director, Program Management, Mammoth Biosciences, United States
Susan Carino is a Director of Program Management with Mammoth Biosciences. She has over 30 years of industry experience in R&D across numerous therapeutic areas. She has led diverse cross-functional program teams engaged in complex product development of pharmaceuticals, biologics... Read More →
avatar for Aditi Khurana

Aditi Khurana

Director, Project Management, Summit Therapeutics, Inc., United States
Aditi Khurana, is the Director of Project Management at Asher Biotherapeutics. She is a Project Management Professional (PMP) and is certified in Global Regulatory Affairs (RAC). She holds a Bachelors in Neuroscience from University of California, Los Angeles (UCLA) and a Masters... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  07: ProjectManagement-StrategicPlanning, Session

3:15pm PDT

#363: Implementing Changes To Drug-Device Combination Products Globally
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-663-L04-P; CME 1.00; RN 1.00

Industry and regulators will collaborate to discuss current challenges and future opportunities to streamline post approval changes to combination products.

Learning Objectives

Describe current regulatory frameworks for lifecycle management changes to combination products; Compare differences in expectations for submissions of post-approval changes globally; Discuss the utilization of harmonized guideline, ICH Q12, for management of post approval changes to combination products globally.

Chair

Chelsea O'Connell, MS, RAC

Speaker

FDA CBER Perspective on Postmarket Changes to CBER-Led Combination Products
Andrea Gray, PhD

Industry Perspective on the Latest ICH Q12 Training Module 8
Andrew Chang, PhD

Industry Perspective on Postmarket Changes to Combination Products: Global
Amy Wise, MBA

PMDA Update: Postmarket Changes to Combination Products in Japan
Keisuke Tanaka, PhD

Industry Perspective on Postmarket Changes to Combination Products: US
Lori-Anne Boville


Speakers
avatar for Chelsea O'Connell

Chelsea O'Connell

Director, Global Regulatory and R&D Policy, Amgen, United States
Chelsea O’Connell, MS, RAC, joined Amgen in 2011 and is currently a Global Regulatory and R&D Policy Director, where she advances strategic regulatory policy goals by engaging with regulatory authorities, industry, professional associations, and other stakeholders across various... Read More →
avatar for Andrew Chang

Andrew Chang

Vice President, Quality and Regulatory Compliance, Novo Nordisk, United States
Dr. Andrew Chang is a multifaceted quality and CMC leader with 28 years well-rounded medical product regulatory and industry experiences. He is a board director for CASSS-Sharing Science Solutions and PDA, respectively. Andrew has served as a member of the planning committee for DIA... Read More →
AW

Amy Wise

Associate Director, RA Device and Combination Products, AbbVie, United States
Amy Wise is an Associate Director Regulatory Affairs Device and Combination Products at AbbVie. Amy has been in the pharmaceutical industry for 25 years with 15 years in regulatory affairs, 5 years in quality and 5 years in pharmaceutical sciences. She has successfully provided the... Read More →
avatar for Andrea Gray

Andrea Gray

Biomedical Engineer Advisor, CBER, FDA , United States
Andrea Gray is a Biomedical Engineer Advisor in the Regulatory Operations Branch of the Division of Regulatory Operations and Programs (DROP) in the Office of Regulatory Operations (ORO), Center for Biologics Evaluation and Research (CBER). She specializes in regulatory review of... Read More →
KT

Keisuke Tanaka

Reviewer, Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Dr. Tanaka is Reviewer of the Office of Cellular and Tissue-based Products, PMDA. He received his Ph, D. from Osaka University in Bioorganic chemistry with emphasis in nucleic acid therapy. Since joining PMDA in 2021, he has worked in the Office of Cellular and Tissue-based Products... Read More →
avatar for Lori-Anne Boville

Lori-Anne Boville

Group Director, Pharma Technical Regulatory, Device and Combination Products, Genentech, A Member of the Roche Group, United States
She is a Regulatory Affairs Expert in Biologics products, Medical Devices & Combination Products at Genentech. Lori has over 20 years of Biopharmaceutical product development, analytical testing, commercial quality, regulatory affairs and medical device experience. She has successfully... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   06: TranslationalDelivery Tech-PrecMedicine, Session

3:15pm PDT

#368: Harnessing the Power of Artificial Intelligence (AI) in Clinical Research From Knowledge Graphs to Generative AI
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-668-L04-P; CME 1.00; RN 1.00

This session discusses usage of a variety of artificial intelligence (AI) solutions (knowledge-based expert systems, generative AI, machine learning) across the clinical research lifecycle from drug discovery to patient recruitment, data quality management, and submission. We will go over specific problems that lend themselves to AI and how we go about building scalable solutions with emphasis on explainability, reliability, and validity.

Learning Objectives

Discuss the use of generative artificial intelligence (AI) and machine learning in clinical research and measures taken to insure validity and reliability; Describe the role of knowledge graph (KG) in building AI systems.

Chair

Katy Ghantous, PhD, MS

Speaker

Industry Update
John Overington

Industry Update
Joe Mullen, PhD, MS

Academic Update
Ramona Lynn Walls, PhD


Speakers
KG

Katy Ghantous

Senior Director, Data Science, Medidata Solutions, United States
avatar for Joe Mullen

Joe Mullen

Head of Data Science and Professional Services, SciBite, United Kingdom
Leading SciBite's data science and professional services team, Joe is dedicated to helping customers unlock the full potential of their data using SciBite's semantic stack. Joe spearheads R&D initiatives within the team, pushing the boundaries of what is possible. Joe's expertise... Read More →
avatar for John Overington

John Overington

Chief Data Officer, Exscientia, United Kingdom
John Overington is Chief Data Officer at Exscientia & has over 35 years experience of drug discovery & design, data science & machine learning; encompassing innovation and leadership positions in pharma, academia & biotech sectors. After a degree in Chemistry, a PhD in protein structure... Read More →
avatar for Ramona Walls

Ramona Walls

Executive Director of Data Science, Data Collaboration Center, Critical Path Institute, United States
Ramona Walls, Ph.D. is Executive Director of Data Science at the non-profit Critical Path Institute (C-Path). She oversees multiple efforts including C-Path’s Data and Analytics Platform, development of a rare disease knowledge graph, and expansion and modernization of C-Path’s... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session

3:15pm PDT

#361: Recruitment Optimization in Clinical Trials: Looking Towards an Adaptive Future
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-661-L04-P; CME 1.00; RN 1.00

Recruitment is a significant building block of clinical trials and also one of the greatest challenges, often having a direct influence on trial success or failure. In-efficiencies associated with patient recruitment may lead to prolonged trial durations, increased costs, and delays in bringing effective treatments to market. This session will explore methods for predicting the effect of different recruitment patterns on trial progression, outcomes and likelihood of the trial to meet its goals and present newly available technologies and trial design measures for successfully advancing recruitment.

Learning Objectives

Describe the considerations of recruitment rate optimization in clinical trials and adaptive trials in particular; Discuss the available technologies and methodologies for optimizing recruitment via dedicated software, patient advocacies, databases and registries and the evaluation of trade-offs between trial duration and sample size requirements within a variety of adaptive trial designs as compared with standard fixed designs.

Chair

Raviv Pryluk, PhD

Speaker

Time is Life: Leveraging Innovation in Clinical Trials for Rapid Recruitment
Tanya Russell, PhD, MS, RPh

Potential for Leveraging AI/ML in Pre-Trial Recruitment Modelling
Jenny Higley, MS

Demystifying Site Engagement: Leveraging an Omnichannel Approach with Data-Driven Clinical Analytics
Sanghita Bhattacharya, PhD

Optimizing Clinical Trial Site Selection: Balancing Recruitment Efficiency and Population Diversity
Raviv Pryluk, PhD


Speakers
avatar for Raviv Pryluk

Raviv Pryluk

PhaseV, United States
Raviv is the co-founder & CEO of PhaseV, a technology company that leverages causal-ML and advanced software capabilities to support advanced & innovative clinical trials. Raviv holds a B.Sc. and M.Sc. in engineering from the Technion (Cum Laude) and Ph.D. in computational neuroscience... Read More →
avatar for Sanghita Bhattacharya

Sanghita Bhattacharya

Associate Director Data Science , Feasibility and Analytics, Clinical Operations, Johnson & Johnson Innovative Medicine, United States
Sanghita leads the DS strategy and Pathway for clinical trial feasibility for Cardiovascular Metabolism and Pulmonary Hypertension Therapeutic Areas in Janssen R&D Data Science. Sanghita has been within the healthcare sector for 14 years, with experience in both MedTech as well as... Read More →
JH

Jenny Higley

Director, Head of Feasibility CoE, Biogen, United States
Jenny has 20 years of clinical research experience and is currently the Director of the Feasibility Center of Excellence at Biogen, where she has worked for the past four years. Jenny’s career also includes CRO and ARO experience from IQVIA, Syneos Health, and the Duke Clinical... Read More →
TR

Tanya Russell

Vice President, Integration Lead, Pfizer Inc, United States
Tanya Russell recently moved into a new role as Vice President, CD&O Integration Lead supporting the R&D integration of Seagen and Pfizer into one Pfizer Oncology department. For the last 3+ years, Tanya was Pfizer’s Oncology and Rare Disease Clinical Operations Head with accountability... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session |   03: Data-Tech, Session |   02: ClinTrials -ClinOps, Session

4:30pm PDT

#370: Critical Appraisal of Artificial Intelligence Solutions for Pharmacovigilance
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-669-L04-P; CME 1.00; RN 1.00

Artificial intelligence solutions may support and enhance human decision-making and information processing throughout pharmacovigilance. This session aims to outline best practices and potential pitfalls in their use.

Learning Objectives

Recognize key challenges in assessing artificial intelligence solutions and interpreting evaluations of their performance; Describe some best practices for critical appraisal of artificial intelligence solutions; Identify the need for consideration of human computer interactions.

Chair

Jim Barrett, PhD, MSc

Speaker

MHRA Update
Phil Tregunno

FDA Update
Monica Munoz, PharmD, PhD

Industry Update
Andrew Bate, PhD, MA


Speakers
JB

Jim Barrett

Senior Data Scientist, Uppsala Monitoring Centre (UMC), Sweden
Jim is a senior data scientist at Uppsala Monitoring Centre (UMC), where he has worked for the past 4 years. In that time, Jim has worked on several projects including advanced signal detection methods, tools to facilitate analysis of large case series and NLP methods for mining structured... Read More →
avatar for Andrew Bate

Andrew Bate

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom
Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12... Read More →
avatar for Monica Munoz

Monica Munoz

Division Director, Division of Pharmacovigilance-I, OSE, CDER, FDA, United States
CAPT Monica Muñoz is the Director of the Division of Pharmacovigilance-I within US FDA’s Center for Drug Evaluation and Research. Since joining FDA in 2010, she has served as a safety reviewer, managed review teams, and provided oversight for pharmacovigilance initiatives. Her... Read More →
avatar for Phil Tregunno

Phil Tregunno

Deputy Director - Patient Safety Monitoring, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

4:30pm PDT

#373: Patient-Centric Approaches in Summaries and Data Return
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-672-L04-P; CME 1.00; RN 1.00

Join us for a multi-stakeholder discussion to learn more about the practical tools and considerations available to help sponsors get started or improve their participant communications including lay protocol synopses, lay summaries, and participant data return.

Learning Objectives

Recognize the problems in explaining benefit and risk to patients and lay audiences; Define meaningful communication of information to research participants; Identify how evolving collaborations, proactive planning, interoperability, digital health advancements, and secure data management enable participant data return options that do not compromise data integrity, confidentiality, or submission timelines.

Chair

Jean Sposaro, MHS, LLM

Speaker

Individual Participant Data Return: Feasible, Personal, and Actionable Options to Support Informed Decision-Making
Jean Sposaro, MHS, LLM

Patient Perspective
T.J. Sharpe, PMP


Speakers
avatar for Jean Sposaro

Jean Sposaro

Director, Global Drug Development Operations, Industry Collaborations, Bristol-Myers Squibb Company, United States
Healthcare Provider, Researcher, Patient Advocate, Bioethics, Pharmaceutical Law & Policy Professional advancing science through impactful collaboration with stakeholders across the R&D ecosystem to "co-create a healthier future". Optimizing global collaborations as enablers of innovation... Read More →
avatar for T.J. Sharpe

T.J. Sharpe

Patient Engagement Expert, Consultant, United States
T.J. Sharpe is a speaker, writer, and patient expert consultant working with top pharmaceutical companies and clinical research stakeholders seeking sustained, ingrained, consistent patient engagement.  A Stage IV melanoma survivor given two years to live, his continuation from survivorship... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session

4:30pm PDT

#371: Using Influencers to Recruit Hard-to-Engage Populations
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-670-L04-P; CME 1.00; RN 1.00

Influencers are community connectors that can be leveraged to expand patient recruitment, particularly for hard-to-engage populations. We will discuss how influencers can engage patient audiences for clinical trial participation.

Learning Objectives

Discuss the power of influencer marketing to improve clinical trial participation, including among diverse populations; Describe how to build an effective influencer campaign — matching the right influencer to your objectives; Develop effective digital assets; Identify how to maximize exposure among a captivated audience.

Chair

Sarah McKeown-Cannon

Speaker

Industry Update
Lara Lane


Speakers
LL

Lara Lane

Director, Clinical Operations, Ironwood Pharmaceuticals, United States
As Director of Clinical Operations at Ironwood, Lara is responsible for developing and executing clinical operations program strategies, ensuring the delivery of high-quality results. With 20+ years of expertise in the industry, her work experience has spanned across clinical sites... Read More →
SM

Sarah McKeown-Cannon

Vice President, Growth, Publicis Health, United States
Sarah McKeown-Cannon (she/her/hers) provides innovative patient recruitment and engagement solutions that enrich study experiences and deliver measurable results. She is driven by her commitment to making a difference in people's lives, by understanding all the dimensions that make... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   02: ClinTrials -ClinOps, Session

4:30pm PDT

#376: Challenges in Quality Control for Cell and Gene Therapy Development: Regulatory Perspectives and Best Practices
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-675-L04-P; CME 1.00; RN 1.00

This session will describe key challenges in quality assessment for cell and gene therapies, focusing on challenges related to raw materials; discuss regulatory perspectives; and present best practices to control and evaluate raw materials.

Learning Objectives

Identify the key current challenges in quality control for cell and gene therapy development; Explain global regulators’ perspectives on quality control, including raw material selection, control, and qualification; Discuss best practices, including standards and reference materials, to support the development and manufacture of cell and gene therapies.

Chair

Fouad Atouf, PhD

Speaker

Qualification and Selection of Raw Materials During Early Stage of Development
Mo Heidaran, PhD

Perspective on the Selection of Raw Materials for Cell Therapy Manufacturing
Haritha Vallabhaneni, PhD

Cell and Gene Therapy Products: Global Regulatory Perspective
Michael Day, PhD


Speakers
avatar for Fouad Atouf

Fouad Atouf

Senior Vice President, Global Biologics, United States Pharmacopeia (USP), United States
Dr. Atouf has over 20 years’ experience in research, product development, characterization and quality assessment of biologics including cell and gene therapies (CGT). At USP, he heads the Biologics program and oversees standards development, stakeholder engagement and external... Read More →
avatar for Michael Day

Michael Day

Senior Director, Regulatory Science, VCLS, United States
As a Senior Director, Regulatory Science and Head of Cell and Gene Therapies at VCLS, Michael (Mike) is responsible for providing both regulatory strategy and CMC consulting services to clients for global product development ranging from small molecule drugs to biologics and advanced... Read More →
avatar for Mo Heidaran

Mo Heidaran

Chief Regulatory Scientist, Cellx Inc., Consulting, United States
Dr. Mo Heidaran is currently Chief Regulatory Scientist at Cellx Inc. He previously worked as Head of Translational and Regulatory Strategy at GCTx (GC Therapeutics). He is a recognized expert in the development of cell and gene therapies with more than 9 years of experience at the... Read More →
avatar for Haritha Vallabhaneni

Haritha Vallabhaneni

Biological Reviewer, Office of Cellular Therapy and Human Tissue CMC, CBER, FDA, United States
Dr. Vallabhaneni is a CMC Reviewer in the Division of Cell Therapy 1, CBER, FDA. She is involved in CMC review of regulatory applications involving cellular therapy products. She has extensive research experience in stem cells previously working on multiple research projects investigating... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 6E San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session |   06: TranslationalDelivery Tech-PrecMedicine, Session |   10: RegCMC-Product Quality, Session

4:30pm PDT

#377: Industry and Regulatory Experience in Implementing The E9(R1) Estimand Framework
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-676-L04-P; CME 1.00; RN 1.00

This session will include a case study in a short-term depression trial with repeated measurements of continuous outcomes and two types of intercurrent events, and evaluate the four developed data-generating models. Can we jointly generate outcomes and intercurrent events that are associated for a generic phase 3 trial in simulation studies? What data-generating models can be used to achieve this?

Learning Objectives

Describe phase 3 randomized controlled trial data (clinical outcomes and intercurrent events) and model the association between efficacy outcomes and intercurrent events; Discuss how this research is needed to enable analytical or simulation studies that can investigate estimands and strategies on datasets generated under the same data-generating models; Identify how to implement the E9(R1) estimand framework.

Chair

Marian Mitroiu, PhD

Speaker

EMA Update
Francesco Pignatti, MD

FDA Update
Cesar Daniel Torres, PhD, MS

MEB Update
Laura Rodwell, PhD


Speakers
avatar for Marian Mitroiu

Marian Mitroiu

Associate Director Biostatistics, Biogen, Switzerland
Marian is from Romania. In 2015-2016 he did a traineeship at EMA in London at the Biostatistics and Methodology Office. In 2017, he started his doctoral studies at Julius Center, UMC Utrecht and Utrecht University. He worked in parallel at CBG-MEB, being part of the Methodology Working... Read More →
avatar for Francesco Pignatti

Francesco Pignatti

Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In... Read More →
avatar for Laura Rodwell

Laura Rodwell

Statistical Assessor, Dutch Medicines Evaluation Board, Netherlands
Laura has been working in research and biostatistics in one way or another for the past 20 years. After starting her career in crime research she became more interested in medical research and clinical trials. She completed her Master of Biostatistics in 2010 and a PhD in Biostatistics... Read More →

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  11: Statistics-Data Science, Session
 
Thursday, June 20
 

8:00am PDT

#401: Harnessing Real-World Data to Generate Real-World Evidence for Regulatory Grade Safety Studies
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-677-L04-P; CME 1.00; RN 1.00

Session will focus on considerations with successful as well as unsuccessful use cases for generating regulatory grade safety studies using secondary data under new FDA Guidance.

Learning Objectives

Describe considerations when using secondary data to generate real-world evidence for regulatory-grade post-marketing studies; Describe key elements to consider when implementing feasibility assessment to identify real-world data sources.

Chair

Alicia Gilsenan, PhD, MS, RPh, FISPE

Speaker

FDA Update
Marie Bradley, PhD, MPH, MPharm

Value of Real-World Data/Real-World Evidence to Assess Potential Safety Signal: Use Case- Ophthalmology
Angelika Manthripragada, PhD, MPH


Speakers
avatar for Alicia Gilsenan

Alicia Gilsenan

Vice President, Epidemiology, RTI Health Solutions, United States
Alicia Gilsenan, PhD, is Vice President, Epidemiology within RTI-HS and a licensed pharmacist. Dr. Gilsenan’s primary area of expertise is pharmacoepidemiology and therapeutic risk management and the structured benefit-risk assessment of medications. Since joining RTI in 1997, she... Read More →
MB

Marie Bradley

Senior Advisor Real-World Evidence Analytics, OMP, CDER, FDA, United States
Dr. Marie Bradley is a Senior Advisor on the Real-World Evidence Analytics team in the Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDA. Her responsibilities related to real-world evidence (RWE) include serving as technical lead for externally conducted... Read More →
AM

Angelika Manthripragada

Director, Pharmacoepidemiology, Global Patient Safety, Regeneron, United States
Angelika Manthripragada is a Director in the Pharmacoepidemiology group in Global Patient Safety at Regeneron, where she leads the epidemiological strategy and support in the areas of Neurology/Pain and Ophthalmology. Prior to joining Regeneron, she worked in the observational research... Read More →

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session

8:00am PDT

#407: Leveraging Statistical Approaches in Drug Safety Analysis
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-683-L04-P; CME 1.00; RN 1.00

Safety analyses play a pivotal role in drug development, ensuring the protection of patients while advancing innovative pharmaceuticals to market. This statistical session will discuss the critical aspects of safety analysis including the shortcomings of the way we estimate safety signals today focusing on the incorporation of advanced statistical methodologies for signal detection and wider evaluation of specific events such as adverse events of special interest. Additionally, the session will delve into regulatory considerations and best practices for presenting safety analyses to regulatory agencies. Understanding the expectations and requirements of regulatory bodies is essential for successful drug development, and the session will provide valuable guidance in this regard.

Learning Objectives

Describe key aspects in planning safety analyses, and their pivotal role in ensuring the safety of pharmaceutical products; Discuss regulatory considerations and best practices for presenting safety analyses to regulatory agencies; Identify quantitative assessment and characterization of adverse events of special interest (AESIs) in the drug lifecycle; Discuss the shortcomings of the way we currently estimate safety outcomes and a call to action to change that.

Chair

George Kordzakhia, PhD

Speaker

Industry Update
Melvin Slaighter Munsaka, PhD, MEd, MS

Industry Update
Michael A. Fries, PhD, MA

FDA Update
Cesar Daniel Torres, PhD, MS


Speakers
GK

George Kordzakhia

Statistical Sciences Senior Director, AstraZeneca, United States
M.S Applied Mathematics, Purdue University, 1998 Ph.D. Statistics, University of Chicago, 2003 VIGRE Assistant Professor, UC Berkeley, 2003-2006 Mathematical Statistician, FDA, 2006-2021 Statistical Sciences Senior Director, Astra Zeneca, 20022-2024
MF

Michael Fries

Head, Biostatistics, CSL Behring, United States
Michael has been the head of biostatistics at CSL Behring since 2022. He has worked in the industry since 1999. He has also held several academic appointments, including a Visiting Assistant Professor at the School of Computer Science and DePaul University. Michael is a workstream... Read More →
avatar for Melvin Munsaka

Melvin Munsaka

Senior Director, Head Safety Statistics, AbbVie, United States
Melvin S. Munsaka is a Senior Director and Head of the Safety Statistics at AbbVie in the Statistical Sciences and Analytics Department. He has a PhD in Mathematical Statistics from Queen’s University in Canada. He has been in the industry for more than 25 years. He co-leads the... Read More →
avatar for Cesar Torres

Cesar Torres

Senior Mathematical Statistician, OB, OTS, CDER, FDA, United States
Cesar received his B.S. in Probability & Statistics at the University of California, San Diego, before completing his graduate studies at the University of Washington’s Department of Biostatistics. He now works at the FDA’s Center for Drug Evaluation and Research as a reviewer... Read More →

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  01: ClinSafety-PV, Session |   11: Statistics-Data Science, Session

8:00am PDT

#408: Targeting Hope for Oncology Patients: Perceptions and Considerations for Genetic Testing and Precision Medicine
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-684-L04-P; CME 1.00; RN 1.00

This session provides new thinking and examples of how to design and implement qualitative research around genetic testing and precision medicine for oncology patients.

Learning Objectives

Discuss approaches to designing, executing, and analyzing qualitative research around patient perceptions of genetic testing and precision medicine; Discuss unmet needs around patient education and the integration of genetic counselor into care team; Examine the application of a behavioral framework to understand decision to get a genetic testing for oncology patients.

Chair

Wesley D Peters, MS

Speaker

Measuring Value in Oncology: Are we Keeping Pace with Science?
Solange Corriol-Rohou, DrMed, MD, PhD

Targeting Hope for Oncology Patients: Perceptions and Considerations for Genetic Testing and Precision Medicine
Jennifer Malinowski, PhD, MS


Speakers
avatar for Solange Corriol-Rohou

Solange Corriol-Rohou

Senior Director, Global Regulatory Affairs & Policy, R&D, Europe, AstraZeneca , France
Pulmonologist and immuno-allergist by training, Solange joined AstraZeneca R&D in 2004 and is currently Sr. Global Policy Director, with responsibilities in the Respiratory/Infection, Oncology and Vaccine/Immune therapies franchises. Over the past 20 years, moving from the French... Read More →
avatar for Wesley Peters

Wesley Peters

Research Specialist II, Patient Experience, Evidera/Thermo Fisher Scientific, United States
Wes Peters is a public health professional with over 7 years of experience in the Life Science industry. Wes received his Master of Science in Public Health (MSPH) from the Johns Hopkins Bloomberg School of Public Health with a focus in Health Education and Health Communication. Currently... Read More →
JM

Jennifer Malinowski

Director, Access and Policy Research, Johnson & Johnson Innovative Medicine, United States
Dr. Malinowski is a sought-after expert for precision medicine and genomics, bioethics, health economics and outcomes research, and is a certified clinical guideline methodologist. A proven leader, she has substantial experience building a culture of engagement and inclusion across... Read More →

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   12: Value-Access, Session

9:15am PDT

#411: Generative AI-Driven Clinical Data Management: A Myth or a Reality?
Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-686-L04-P; CME 1.00; RN 1.00

This session will discuss use of generative AI to transform clinical data operations across the clinical trials lifecycle across use cases such as integration, summarization, translation, content generation, and knowledge extraction. The use of generative AI will be discussed for applications such as smart data review and edit checks, workflow automation, and real-time data transformation.

Learning Objectives

Discuss the challenges associated with existing clinical data platforms; Identify specific uses cases where such challenges exist in study startup, study conduct, and study closeouts; Describe how generative AI will transform the clinical data platform to operate seamlessly driving faster patient recruitment and efficient site selection or trial conduct.

Chair

Lichen Shen

Speaker

Creating Production Grade (Gen)AI-Powered Software for Clinical Trials
Lichen Shen

Industry Update
Sharmin Nasrullah, MS


Speakers
SN

Sharmin Nasrullah

General Manager, Life Sciences, Clinical, Salesforce, United States
avatar for Lichen Shen

Lichen Shen

Senior Director of Product R&D, Medidata, United States
Lichen imagines a world without diseases and monsters. He innovates in commercial tech, national defense intelligence, and life sciences industry. One of his current roles is co-leading the (Generative) AI Platform as a Service and the next generation clinical trial data platform... Read More →

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 6D San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  03: Data-Tech, Session

9:15am PDT

#410: The Impact of Racial Discrimination on the Patient Clinical Trial Experience
Component Type: Session
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-685-L04-P; CME 1.00; RN 1.00

The session will share findings from a recent mixed-method study that examined the different types of racial microaggressions patients experience while participating in clinical trials and how these interactions affect their experience.

Learning Objectives

Describe findings from a recent study examining common forms of racial discrimination experienced by patients in clinical trials; Discuss the impact that these interactions can have on patient-reported outcomes, including patient trust and willingness to participate in another study at that site or location; Discuss evidence-based solutions that can reduce exclusion in clinical trials.

Chair

Jennifer Kim, PhD

Speaker

How Microaggressions Can Impact the Patient Experience in Clinical Trials
Sharon Rivera Sanchez

Research Perspective: The Science of Exclusion in Clinical Trials
Ruby Madison Ford, MPH

Amplifying the Patient Voice: Incorporating the Patient Experience
Perla Nunes

Industry Update
Rodney Winley

Industry Update
Elizabeth Rosenkrands-Lange, MPH, MS


Speakers
avatar for Ruby Ford

Ruby Ford

Research Analyst, Tufts School of Medicine, United States
avatar for Jennifer Kim

Jennifer Kim

Research Assistant Professor, Tufts Center for the Study of Drug Development, United States
I'm a Research Assistant Professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine. My research focuses on health and work equity, examining how diversity, equity and inclusion dynamics impact individual, group, and organizational outcomes... Read More →
avatar for Sharon Rivera Sanchez

Sharon Rivera Sanchez

Patient Advocate and Founder, Trials of Color, United States
I am Sharon Rivera-Sanchez, founder & CEO of Trials of Color and Saving Pennies 4 A Cure, non-profits 501-C3 organizations founded in 2018, & Trials of Color in 2022. The mission is to educate, advocate, and empower cancer patients with a primary focus on Diversity in Clinical trials... Read More →
avatar for Perla Nunes

Perla Nunes

Patient Advocate, Community Outreach and Clinical Research DEI Consultant, United States
Ms. Nunes' research career began at Hoffmann-LaRoche, where she worked in drug discovery. In NC she worked in at at the Cannon Research Center of Atrium Health focusing on preclinical and clinical research areas related to oncology and immunology. She worked at Duke University's CTSI... Read More →
ER

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, United States
RW

Rodney Winley

Senior Director, R&D Patient Partnerships, CSL Behring, United States

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  05: Patient-Focused Drug Dev, Session |   02: ClinTrials -ClinOps, Session

9:15am PDT

#412: Unleashing Biopharma Potential: Maximizing Consortia Engagement with Strategic Change Management
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-687-L04-P; CME 1.00; PDU 1.00 PMI 21664WZFGG; RN 1.00

Through strong sponsorship, stakeholder management, and communication practices, many companies have been more effective at bringing innovation and new learnings from external organizations and consortia back into their respective companies.

Learning Objectives

Recognize how dedicating resources can enable your organization to enhance talent and innovation, increase value, and maximize your investment in consortia participation; Discuss the application of best practices around communicating new solutions/tools and events to the right internal stakeholders to maximize uptake; Describe building a coalition of internal champions to support collaboration.

Chair

John Richard Dobbins, MEd

Speaker

Industry Update
Sarah McKay Tremethick

Industry Update
Toni Spears, BSN

Industry Update
John Z. Sun, PhD, MBA, PMP


Speakers
avatar for John Dobbins

John Dobbins

Program Manager, Portfolio Change Management, Transcelerate Biopharma Inc., United States
John Dobbins is an experienced change management practitioner and former educator. For the past two and half years, John has been the Program Manager of Portfolio Change Management at TransCelerate BioPharma Inc., a collaborative biopharma consortium. Within TransCelerate, he supports... Read More →
avatar for Toni Spears

Toni Spears

Program Lead, Industry Collaborations, Sanofi, United States
Toni Spears is an industry leader whose passion for clinical research was ignited while treating patients in the hospital setting. With over 21 years at Sanofi, Toni’s early experience managing global studies & leading clinical teams built the foundation for involvement in external... Read More →
avatar for John Sun

John Sun

Program Lead, Global Clinical Operation, Development, Novartis Pharmaceuticals Corporation, United States
John is a Program Lead at Novartis, and had served as Global Analytics Project Manager and Global Program Team Director in different franchises. Before Novartis, he held positions at Whitehall-Robins, Kos Pharmaceuticals, Schering-Plough, and Sanofi-Aventis. John has actively volunteered... Read More →
avatar for Sarah Tremethick

Sarah Tremethick

Global Consortia Program Lead, Product Development Industry Collaborations, Roche Products Limited
Sarah is a catalyzer for change who connects like-minded people across the biopharmaceutical community to solve common challenges. She’s a Roche leader responsible for mobilizing a diverse team of innovators from across the organization, passionate to solve problems and disrupt... Read More →

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  07: ProjectManagement-StrategicPlanning, Session

9:15am PDT

#413: What is the Value of Reference Agency Assessment Reports in Enabling Reliance and What do Relying Agencies Require?
Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-688-L04-P; CME 1.00; RN 1.00

Challenges remain in the implementation of reliance. This session will bring together stakeholders to discuss the utilisation of assessment reports, and recommend ways to ensure effective and efficient systems in the future.

Learning Objectives

Recognize the value of assessment reports in enabling reliance; Describe current use of public and non-public information for enabling regulatory reviews; Discuss how documentation and information sharing could improve to ensure reliance becomes successful.

Chair

Magda Bujar, PhD, MSc

Speaker

WHO Update
Samvel Azatyan, MD, PhD

Reference Agency Viewpoint
Emer Cooke, MBA, MSc

Relying Agency Viewpoint
Patricia Oliveira Pereira Tagliari, LLM, MPH

Industry Viewpoint
Susanne Ausborn, PhD


Speakers
avatar for Magda Bujar

Magda Bujar

Senior Manager, Regulatory Programme and Strategic Partnerships, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Dr Magda Bujar is Senior Manager, Regulatory Programme and Strategic Partnerships and has over 8 years’ experience working in Regulatory Policy and Science. She has co-authored a number of publications and has presented and chaired at major scientific meetings including those of... Read More →
avatar for Susanne Ausborn

Susanne Ausborn

Global Head International Regulatory Policy, Roche, Switzerland
Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global... Read More →
avatar for Samvel Azatyan

Samvel Azatyan

Team Lead, Regulatory Convergence and Networks (RCN/REG), World Health Organization (WHO), Switzerland
Dr Samvel Azatyan is a Paediatrician with a PhD in clinical pharmacology and medical products regulation. Over his more than 24 years at WHO, he has had a wide range of leadership roles associated with the regulation of medical products, including supporting regulatory collaboration... Read More →
avatar for Emer Cooke

Emer Cooke

Chair, ICMRA; Executive Director, European Medicines Agency, Netherlands
Ms Cooke is Executive Director of the EMA and Chair of ICMRA. Starting her mandate as ED in June 2020 amid a public health crisis of unprecedented scale she announced “My number one priority will be to drive forward EMA’s response to the pandemic and the work already ongoing to... Read More →
avatar for Patricia Oliveira Pereira Tagliari

Patricia Oliveira Pereira Tagliari

Associate Director, ANVISA, Brazil
Patricia Oliveira Pereira Tagliari holds a master’s degree in Public Health (Global Health and Health Diplomacy) from the National School of Public Health (2014), specializations in Health Regulation and Surveillance (2010) and Health Law (2007), both from Fiocruz, and a degree... Read More →

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 6C San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  09: Regulatory, Session
 
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  • 00: Plenary
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech
  • 04: MedAffairs-SciComm
  • 05: Patient-Focused Drug Dev
  • 06: TranslationalDelivery Tech-PrecMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics-Data Science
  • 12: Value-Access
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  • 17: Networking Opportunities
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  • Featured Topics
  • Artificial Intelligence (AI)
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  • Diversity Equity and Inclusion (DEI)
  • Ethics
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  • Patient Focused
  • Rare Disease
  • Real-World Data (RWD)- Real-World Evidence (RWE)
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