DIA 2024 Global Annual Meeting: Full Schedule

11:00am PDT

#110: Modernizing CDER’s New Drugs Review Program (NDRP): A Progress Update

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-524-L04-P; CME 1.00; RN 1.00

In 2017, CDER began modernizing the New Drugs Regulatory Program. This session shares progress updates and offers dialogue to enhance the program's key areas.

Learning Objectives

Describe the impetus for modernizing CDER’s Drug Regulatory Program (NDRP); Identify the NDRP strategic objectives and their associated initiatives; Discuss the progress and outcomes of two NDRP workstreams: Advisory Committees and Investigational New Drugs

Chair

Yoni Tyberg, MHA

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Meghana Chalasani, MHA

Panelist
Michael Monteleone, MS, RAC

Panelist
Andrew Emmett, MPH

Speakers

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 →

Meghana Chalasani

Associate Director for Clinical Trial Innovation, Office of New Drugs, CDER, FDA, United States

Meghana Chalasani is the Associate Director for Clinical Trial Innovation in the Office of New Drugs (OND) in U.S. FDA’s Center for Drug Evaluation and Research (CDER). She is the program manager for the CDER Center for Clinical Trial Innovation and also co-leads the New Drugs Regulatory... Read More →

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 →

Michael Monteleone

Associate Director for Labeling, OND, CDER, FDA, United States

Mr. Michael Monteleone is currently an Associate Director for Labeling in the Office of New Drugs at CDER, FDA. Michael has also held positions in Regulatory Affairs and Project Management throughout his 15 year tenure at the FDA.

Yoni Tyberg

Associate Director of Special Programs, Office of New Drugs, CDER, FDA, United States

Yoni Tyberg is the Associate Director of Special Program Staff (SPS) at the Office of New Drugs within CDER. In this role, Yoni supports the strategic planning, project development and execution of the New Drug Regulatory Program Modernization efforts across OND and CDER. He had also... Read More →

Monday June 17, 2024 11:00am - 12:00pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives
Level Intermediate
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Forum

2:15pm PDT

#140: The State of Real-World Evidence for Regulatory Decision-Making: Views from FDA, EMA, and PMDA

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-540-L04-P; CME 1.00; RN 1.00

This session will be a panel discussion with senior leaders from FDA, EMA, and PMDA who are closely involved with real-world evidence (RWE) initiatives within their respective agencies. An open Q&A with leaders in RWE from FDA, EMA, PMDA, will be included.

Learning Objectives

Describe current perspectives of regulators from several agencies on the use of real-world evidence (RWE) for regulatory decision-making; Discuss from examples of successful use of RWE in regulatory decision-making and how they can be applied; Identify current initiatives and programs regarding RWE in each regulatory agency.

Chair

Charles Lee, MBA, MS

Speaker

FDA Update
Motiur Rahman, PhD, MPharm, MS

EMA Update
Sabine Haubenreisser, PhD, MSc

PMDA Update
Yuki Ando, PhD

Speakers

Charles Lee

Executive Regulatory Science Director, AstraZeneca, United States

Charles is currently Executive Regulatory Science Director at Astrazeneca. He oversees Global Regulatory science and strategy for therapeutic products in the renal, cardiovascular, diabetes, and NASH disease areas. Prior to this role, Charles was a Product Development Team Leader... Read More →

Yuki Ando

Principal Senior Scientist for Biostatistics, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Dr. Yuki Ando is a Senior Scientist for Biostatistics of the Pharmaceuticals and Medical Devices Agency (PMDA), Japan. She has over 20 years' experience as Biostatistics Reviewer, and currently she is responsible for the biostatistics review and consultation in the new drug and device... Read More →

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 →

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 →

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

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Regulator Perspectives, Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Regulator Perspectives,Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Forum

3:30pm PDT

#149: Effective Patient / Industry Collaboration: Valuing Patient Lived Experience To Inform Trial Design

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-548-L04-P; CME 1.00; RN 1.00

This “talk-show” style forum is driven by the patient voice to collaborate on clinical research through the eyes of patients, advocates, and caregivers. It illuminates barriers and burdens and provides solutions for industry to raise awareness, participation, and retention in clinical trials.

Learning Objectives

Describe how empowered patient decision making contributes to increased enrollment and engagement in clinical trials; Discuss value proposition for industry to involve patients early and give examples of metrics to quantify and measure: Idxentify unique challenges and wins in the clinical research space, including pediatric trials.

Chair

Aman Khera, MBA

Speaker

Panelist
Stacy Hurt, MBA, MHA

Speaker
Mario Estevez

Speakers

Stacy Hurt, MBA, MHA

Chief Patient Officer, Parexel International, United States

Stacy Hurt, MHA, MBA is an award-winning 25 year pharma executive who bridges the industry/consumer gap as a stage IV cancer survivor and 24/7 caregiver to her son with a rare disease. Her unique professional and personal experience position her as an esteemed patient advocate as... Read More →

Aman Khera

Vice President, Regulatory Science & Innovation, Worldwide Clinical Trials, Canada

Aman Khera has earned her nickname: Rebel Regulator, a clinical research professional, with nearly 3 decades of experience in life sciences clinical research, advising biotech and pharma companies. With a deep foundation in global regulatory affairs and the life sciences industry... Read More →

Mario Estevez

Patient Caregiver and Project Alive, United States

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

05: Patient-Focused Drug Dev, Forum

Format Forum
Level Intermediate
Featured Topics Patient Focused
Level Intermediate
Feature Topics Patient Focused
Credit Type ACPE, CME, RN
Tags Forum

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

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 →

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 →

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 →

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 →

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 →

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 →

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 →

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 →

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

Format Session
Level Advanced
Featured Topics Regulatory Reliance
Level Advanced
Feature Topics Regulatory Reliance
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#221: Improving Patient Access to Clinical Trials Through Decentralization and Flexible Design: Lessons from Oncology

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-572-L04-P; CME 1.00; RN 1.00

Improving access and minimizing burdens are critical to ensuring diverse representation in clinical trials. Panelists will discuss efforts to improve patient access to oncology clinical trials through streamlined protocols and decentralized elements.

Learning Objectives

Describe the impact of incorporating decentralized elements (DE) into oncology clinical trials (CTs) on data integrity, patient safety and regulatory approvals; Explain how DE elements increase patient access and recognize opportunities to implement DE; Identify ongoing barriers to implementing DE into CT protocols and solutions to address operational challenges in expanding access to care.

Chair

Suanna S. Bruinooge, MPH

Speaker

How Sponsors, CROs, and Sites Can Work Together
Craig H Lipset, MPH

Meta-Analysis of Trials During COVID
Joseph Unger, PhD, MS

Implementing Trials in Large Healthcare System
Ramya Thota

Speakers

Suanna Bruinooge

Chief and Division Director, Research Strategy and Operations Center, American Society of Clinical Oncology, United States

Suanna Bruinooge, MPH, is the Chief and Division Director of Research Strategies and Collaborations in ASCO’s Center for Research and Analytics (CENTRA). CENTRA generates and analyzes oncology data to foster innovation in research and patient care and help develop evidence related... Read More →

Craig Lipset

Managing Partner, Clinical Innovation Partners, United States

Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the... Read More →

Ramya Thota

Associate Professor, Intermountain Medical Oncology - IMC, United States

Dr. Thota is a GI medical oncologist at Intermountain Health, Utah. She finished her subspecialty Hematology and Medical Oncology fellowship training from Vanderbilt University, Nashville, Tennessee. She receives research funding from American Cancer Society Clinician Scientist Development... Read More →

Joseph Unger

Associate Professor, Fred Hutchinson Cancer Center, United States

Dr. Joseph Unger is a biostatistician and health services researcher. He uses big data to understand more about cancer patients’ treatment outcomes and disparities, especially as they pertain to barriers to participating in clinical trials. He has been at the forefront of efforts... Read More →

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

05: Patient-Focused Drug Dev, Forum | 02: ClinTrials -ClinOps, Forum

Format Forum
Level Intermediate
Featured Topics Decentralized Clinical Trials (DCTs), Patient Focused
Level Intermediate
Feature Topics Decentralized Clinical Trials (DCTs),Patient Focused
Credit Type ACPE, CME, RN
Tags Forum

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

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 →

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 →

Carlyn Crisostomo

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

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 →

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

Format Session
Level Intermediate
Featured Topics Artificial Intelligence (AI), Regulator Perspectives
Level Intermediate
Feature Topics Artificial Intelligence (AI),Regulator Perspectives
Credit Type ACPE, CME, RN
Tags 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

Industry Update
Donna Boyce, MS, RAC

Industry Update
Rasika Kalamegham, PhD

Speakers

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 →

Andrew Emmett

FDA Liaison | US Regulatory Policy and Global Intelligence, Pfizer Inc, United States

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 →

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 →

Mary Jo Salerno

Science Policy Analyst, ORDPURM, OND, CDER, FDA, United States

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

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#279: Accelerating Innovation Through Design: Integrating Real-World Data into Clinical Trials

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-611-L04-P; CME 1.00; RN 1.00

In this forum, speakers from regulatory, industry, and research organizations will discuss methodological considerations and evaluate various innovative use cases in different settings that integrate real-world data (RWD) in clinical designs.

Learning Objectives

Discuss global regulatory guidance, frameworks, and best practices for real-world data (RWD) in innovative hybrid study designs for regulatory purposes; Describe innovative approaches and statistical methods for integrating RWD and clinical trial data for clinical decision-making; Appraise use cases where RWD have been used in hybrid study designs to support clinical and regulatory development.

Chair

Rachele Hendricks-Sturrup, DrSc, MA, MSc

Speaker

Panelist
Mehmet Burcu, PhD, MS

Panelist
Christina Mack, PhD, MPH

Panelist
Catherine C. Lerro, PhD, MPH

Speakers

Rachele Hendricks-Sturrup

Research Director, Real-World Evidence, Duke-Robert J. Margolis, MD, Center for Health Policy, United States

Rachele Hendricks-Sturrup, DHSc, joins Duke-Margolis as the Research Director leading the Center’s Real-World Evidence (RWE) portfolio, including managing its RWE Collaborative. She is a scientist/researcher, health policy and industry professional, journalist, and academician within... Read More →

Mehmet Burcu

Senior Director, Epidemiology, Merck & Co., Inc., United States

Dr. Mehmet Burcu is a Senior Director in the Department of Epidemiology at Merck & Co., Inc., Rahway, NJ, United States. He currently leads a team of epidemiologists to support clinical development and regulatory decision making in Oncology. He has expertise in large, automated database... Read More →

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 →

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 →

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

05: Patient-Focused Drug Dev, Forum | 03: Data-Tech, Forum | 11: Statistics-Data Science, Forum | 02: ClinTrials -ClinOps, Forum

Format Session
Level Intermediate
Featured Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Level Intermediate
Feature Topics Real-World Data (RWD)- Real-World Evidence (RWE)
Credit Type ACPE, CME, RN
Tags Forum

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

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 →

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 →

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 →

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

Format Session
Level Advanced
Featured Topics Regulator Perspectives
Level Advanced
Feature Topics Regulator Perspectives
Credit Type ACPE, CME, RN
Tags Session

10:00am PDT

#318: Defining an Inclusive Clinical Trials Approach in Europe

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-636-L04-P; CME 1.00; RN 1.00

This forum will address industry challenges in the recruitment and retention of underserved populations in clinical research, and explores how regulators, physicians, sponsors and others can work together to develop solutions to tackle health equity.

Learning Objectives

Identify a proposal for addressing underrepresentation of underserved populations in Europe; Describe regulatory and industry perspectives in addressing recruitment and retention challenges for multi-regional clinical trials; Discuss best practices that can help shape inclusivity of clinical trials across borders.

Chair

Ambily Banerjee, PhD

Speaker

ACT-EU Efforts from EMA Perspective
Ana Zanoletty Perez

Evolving FDA Perspective Based on Learningd from DAP Submissions on What Diversity Looks Like
M. Khair ElZarrad, PhD, MPH

Industry Perspective of Community Engagement in Europe: A Case Study
Monique Adams, PhD, MS

CT Network One-Pager v2
Nicholas Brooke, MBA

Speakers

Ambily Banerjee

Senior Director/Head of Diversity in Clinical Trials, Johnson and Johnson Innovative Medicine, United Kingdom

After a decade as an academic scientist, following a Ph.D. in Molecular Biology, Ambily moved to GSK Regulatory Affairs, where she held increasingly senior roles in Global Regulatory Affairs and Internal Audit. She also led the race and ethnicity Employee Resource Group, EMBRACE... Read More →

Monique Adams

Executive Director, Global Head Diversity and Inclusion in Clinical Trials, Sanofi, United States

Monique Adams is the Executive Director, Global Head of Diversity and Inclusion in Clinical Trials, or DICT, at Sanofi where she drives the pharmaceutical company’s vision, strategy, and implementation of a holistic framework for DICT. Monique has a Ph.D. in Pharmacology from the... Read More →

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 →

M. Khair ElZarrad

Director, Office of Medical Policy, CDER, FDA, United States

Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple... Read More →

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 →

Wednesday June 19, 2024 10:00am - 11:00am PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 02: ClinTrials -ClinOps, Forum

Format Forum
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI)
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI)
Credit Type ACPE, CME, RN
Tags Forum

1:15pm PDT

#352: Applying Machine Learning and Artificial intelligence for Predicting Product Profile Approvability (PoPPA)

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-655-L04-P; CME 1.00; RN 1.00

This will be an interactive panel discussion with experts sharing examples how AI/ML can be used to create solutions for better regulatory decision-making and predicting regulatory success. Risks and benefits of using this approach will be discussed.

Panelists will include world-renowned experts on drug development, drug regulations, decision science and data analytics.

Learning Objectives

Evaluate how AI/ML can be used to help with regulatory decision making; Analyze scenarios using case studies by world’s leading expert on drug development, cloud computing, and predicting regulatory success; Compare risks and benefits for using this evolving technology.

Chair

Romi Singh, PhD

Speaker

Panelist
Kilian Weiss

Panelist
Subha Madhavan, PhD, FACMI

Panelist
Lily Li, JD

Speakers

Romi Singh

Head, Regional Regulatory Sciences, Asia, Pfizer Inc, United States

Dr. Rominder (Romi) Singh has extensive scientific and management experience at top biopharmaceutical companies--Pfizer, Amgen, Merck and GlaxoWellcome. His experience spans across drug development—drug discovery to commercialization. He is recognized as an expert on international... Read More →

Lily Li

Founder and President, Metaverse Law, United States

Lily Li is the founder and president of Metaverse Law, a firm that focuses exclusively on privacy, AI, and cybersecurity law. She advises mid-sized, public, and multinational clients on a broad range of AI and data protection matters, such as the CCPA, GDPR, NIST AI Framework, Biden... Read More →

Subha Madhavan

Vice President and Head of AI/ML, Global Biometrics and Data Management, Pfizer Inc, United States

Subha Madhavan heads up AI/ML, Quantitative and Digital Sciences within Global Product Development at Pfizer. Prior to joining Pfizer, she was Head of Data Science and AI within Oncology R&D Strategy at AstraZeneca Pharmaceuticals. She has initiated and successfully directed several... Read More →

Kilian Weiss

General Manager, Veeva Link, Veeva, Germany

As general manager of Veeva Link, Kilian is responsible for the strategic direction, growth, and customer success of Veeva’s global Link Platform. He is also responsible for Veeva’s European Data business and commercial strategy. Before joining Veeva, Kilian founded Mederi, a... Read More →

Wednesday June 19, 2024 1:15pm - 2:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Artificial Intelligence (AI)
Level Intermediate
Feature Topics Artificial Intelligence (AI)
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#365: Embedding Diversity and Inclusion into Global Clinical Research: Where Have we Been and Where are we Going?

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-665-L04-P; CME 1.00; RN 1.00

Adequate enrollment of underrepresented groups continues to be a challenge in a complex, global regulatory and research ecosystem. Review and assess evolving expectations and processes in the US, Canada, and other regulatory systems, what has been implemented, what adjustments have been made, what has worked, and what hurdles or differences remain.

Learning Objectives

Describe the background and underlying requirements to FDA’s and other health authorities’ diversity and inclusion policies and guidance; Discuss how different stakeholders have implemented and reacted to implementation of new and evolving policies; Identify areas where views or expectations diverge; Discuss and describe what has worked, what has not; Identify how this area might change in future.

Chair

Alexis Miller, JD

Speaker

FDA Update
Karen Hicks, DrMed

Health Canada Update
Alysha Croker, PhD

UK Update
Naho Yamazaki, PhD

Patient Update
Loriana Hernandez-Aldama

Speakers

Alexis Miller

Acting Global Lead, Global Regulatory Policy and Intelligence, Merck & Co., Inc., United States

Alexis Reisin Miller leads Global Regulatory Policy at Merck & Co., Inc., helping to shape the regulatory and policy environments on topics like evolution in regulatory science and policy frameworks, upholding expedited pathways, leveraging RWE and other tech opportunities, embedding... Read More →

Alysha Croker

Director, Centre for Policy, Pediatrics and International Collaboration, BRDD, Health Canada, Canada

Dr. Alysha Croker is the Director of the Centre for Policy, Pediatrics and International Collaboration, Health Products and Food Branch, Heath Canada. In this position, Dr. Croker is responsible for developing ways to increase access to safe and effective health products for pediatric... Read More →

Loriana Hernandez-Aldama

Patient Advocate|2x Survivor| Founder, ArmorUp for Life, Armorup For Life, United States

Loriana is a 2x cancer survivor, international motivational speaker, award-winning journalist, podcast host, and author of "Becoming the Story: The Power of Prehab." Bold, transparent, and honest, Loriana has emerged as a game-changer in healthcare, advocating globally for transformative... Read More →

Karen Hicks

Deputy Director, Office of Medical Policy, CDER, FDA, United States

Dr. Hicks is the Deputy Director of the Office of Medical Policy in the Center for Drug Evaluation and Research (CDER) at the United States Food and Drug Administration (FDA). She oversees regulation and policy development for CDER and participates in cross-cutting agency initiatives... Read More →

Naho Yamazaki

Deputy Director, Policy and Partnerships, Health Research Authority, United Kingdom

Naho is Deputy Director, Policy and Partnerships at the Health Research Authority (HRA), where she is leading on a range of policy and engagement initiatives for the HRA to make it easy to do research that people can trust. This includes pushing for change to increase diversity and... Read More →

Wednesday June 19, 2024 3:15pm - 4:15pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Diversity Equity and Inclusion (DEI)
Level Intermediate
Feature Topics Diversity Equity and Inclusion (DEI)
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#375: Sustainability of Rare Disease Drug Development

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-674-L04-P; CME 1.00; RN 1.00

Panelists will reflect on the past forty years of the orphan drug act including advancements and impediments. The panel will discuss what is needed in the future to continue to advance rare disease drug development to treat as many patients as possible.

Learning Objectives

Discuss the outcomes, challenges, and opportunities in the next forty years of the Orphan Drug Act; Identify policy advancements that need to be made to continue innovative rare disease drug development.

Chair

Darcy Frear, PhD

Speaker

Panelist
Katherine Donigan, PhD

Panelist
Patroula Smpokou, MD

Panelist
Karin Hoelzer, DVM, PhD

Panelist
Julia Tierney, JD

Speakers

Darcy Frear

Associate Director, Bridgebio, United States

Dr. Darcy Frear is currently the associate director for Regulatory Policy and Intelligence at BridgeBio. Prior to joining BridgeBio in 2022, Darcy began her regulatory career at Genentech supporting program management in oncology and US regulatory policy. Subsequently, she joined... Read More →

Katherine Donigan

Senior Director, Science and Regulatory Policy, Sarepta, United States

Dr. Katherine Donigan is currently a Senior Director of Science and Regulatory Policy at Sarepta Therapeutics. Prior to joining Sarepta, Dr. Donigan was a Senior Director of Science and Regulatory at Biotechnology Innovation Organization (BIO) and spent 7 years in regulatory policy... Read More →

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 →

Patroula Smpokou

Lead Physician, Division of Rare Diseases/Medical Genetics, OND, CDER, FDA, United States

Patroula Smpokou, MD, is a board-certified pediatric clinical geneticist working in the Division of Rare Diseases and Medical Genetics at CDER. Her work involves the clinical review and regulation of products intended for rare genetic diseases. Prior to joining FDA, she was a practicing... Read More →

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 4:30pm - 5:30pm PDT
Room 6F San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Intermediate
Featured Topics Rare Disease
Level Intermediate
Feature Topics Rare Disease
Credit Type ACPE, CME, RN
Tags Forum