DIA 2024 Global Annual Meeting: Full Schedule

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

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 →

Carlos Orantes

Chief Executive Officer, Alcanza Clinical Research, United States

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 →

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

Level Basic
Featured Topics Diversity Equity and Inclusion (DEI)
Level Basic
Feature Topics Diversity Equity and Inclusion (DEI)
Tags Session

1:30pm PDT

#126 CH: AI Enhanced Contact Center: Risks to Consider for Medical and Patient Information Exchange

Component Type: Workshop
Level: Basic

The use of AI is highly praised, but risks must be addressed to protect the public (patients) from unethical influence, incorrect information, and privacy breaches.

Learning Objectives

Discuss examples of AI use in Medical Information contact center; Describe the risks associated with AI use and its impact on the public (patients).

Chair

Valerie Huh, PharmD, MBA

Speakers

Valerie Huh

Associate Director, Global Innovation and Implementation, Propharma Group, United States

Valerie Huh brings over 20 years of expertise in the pharmaceutical, healthcare, and education sectors. She holds a Pharm.D and an MBA, and she is passionate about leveraging advanced technology and new ways of working to improve operational efficiency. In her current role, she is... Read More →

Monday June 17, 2024 1:30pm - 2:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Workshop | 15: Content Hubs, Workshop

Level Basic
Level Basic
Tags Workshop

2:15pm PDT

#143: Unveiling the Secrets of Success: An Executive Panel with Insights to Navigating your Career Journey

Component Type: Forum
Level: Basic

This forum is designed to inspire, provide insights for robust career planning, and targeted for anyone interested in further development regardless of the stage of their career. Join industry and executive leaders as they answer your career questions.

Learning Objectives

Describe how to approach career planning with a focus on experiences, transferrable skills, and cross-training; Discuss how to use mentoring relationships as a career catapult; Differentiate development from promotion/advancement and use that in career planning; Identify how to mentally deal with uncertainty and benefit from lateral moves and from keeping an open mind.

Chair

Leslie Sam

Speaker

Panelist
David Fryrear, MS

Panelist
Jeremy Jokinen, PhD, MS

Panelist
Paula Walker, MA

Panelist
Niam Vora, PharmD

Speakers

Leslie Sam

President, Leslie Sam and Associates, LLC, United States

With 25 years+ of clinical trial research and quality, leadership and six sigma black belt roles, Leslie Sam, President, Leslie Sam and Associates, LLC, collaborates with clients to transform their clinical quality management system design and implementation. She was sought out by... Read More →

David Fryrear

Executive Vice President and Head of Quality Assurance, Astellas, United States

David Fryrear, M.S., is Executive Vice President and Head of Quality Assurance for Astellas. He has responsibility for providing the global vision, leadership and strategic direction for Quality Assurance, from the earliest stages of research, through clinical development and commercialization... Read More →

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 →

Niam Vora

Pharmacist, Srx Health Solutions, Canada

Niam Vora is a PharmD graduate from the University of Illinois Chicago. For the past two years, he has served as the National Student President for DIA Student Chapters across the United States. He has also completed a Schweitzer Fellowship, through which he implemented the United... Read More →

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 →

Monday June 17, 2024 2:15pm - 3:15pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Forum

Format Forum
Level Basic
Featured Topics Student Programming
Level Basic
Feature Topics Student Programming
Tags Forum

8:00am PDT

#202: Behavioral and Educational Strategies for Avoiding Falsified Medicine Exposure (BE SAFE)

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-557-L04-P; CME 1.00; RN 1.00

Counterfeit drugs are important public health concern that impact both developed and LMICs. The session is to understand the current landscape and global impact of these and hear from industry, regulators and others on best approaches to address this

Learning Objectives

Discuss the significance and current landscape of counterfeit (falsified) medicines; Describe the economic, socio-economic and pervasive health threats to the global population from counterfeit products; Identify the current interventions implemented by regulators, industry, policy makers to combat this; Recognize new approaches to develop more focused programs that address the root cause.

Chair

Lubna Merchant, PharmD, MS

Speaker

Academic Update
Saifuddin Ahmed, MD, PhD

WHO Update
Rutendo Kuwana, RPh

FDA Update
Sangeeta Chatterjee

Patient Perspective
Regina Mariam Kamoga, MPA

Speakers

Lubna Merchant

Director, Risk Management Center of Excellence, Pfizer Inc , United States

Lubna is a Director in the Risk Management Center of Excellence at Pfizer, Inc., where she is responsible for the strategy and implementation of risk management plans globally. Dr. Merchant provides global leadership in delivering innovative and strategic risk management excellence... Read More →

Saifuddin Ahmed

Professor, Department of Population, Family, and Reproductive Health, Johns Hopkins University, United States

Sangeeta Chatterjee

Deputy Office Director, Office of Drug Security, Integrity, Response, OC, CDER, FDA, United States

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 →

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 →

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

01: ClinSafety-PV, Forum

Format Forum
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags Forum

8:00am PDT

#214: Unlocking Artificial Intelligence's Latest Development: Chat GPT for Beginners

Component Type: Workshop
Level: Basic

Join our beginner-friendly Chat GPT workshop! Designed to provide both an overview and hands-on experience, this session will delve into the fundamentals of ChatGPT technology. From understanding its underlying principles to practical applications, participants will gain insight into AI-driven conversations. Through interactive demonstrations and guided exercises, attendees will get firsthand experience in leveraging ChatGPT's capabilities. Whether you're new to AI or seeking practical insights, this session promises to equip you with valuable knowledge and skills

Learning Objectives

Describe the basics of artificial intelligence, large language models, and ChatGPT; Identify with using hands-on experience by interacting with ChatGPT through guided exercises; Discuss best practices for interacting with the technology as well get an overview of ethical considerations and potential limitations of ChatGPT technology; Assess the impact its already creating in pharma R&D, and what are the use cases that you can get started with.

Chair

Ankush Chandna, MSc

Speaker

Facilitator
Anjali Shah, PharmD

Facilitator
Ankush Chandna, MSc

Speakers

Ankush Chandna

Data Science Lead, Research and Development Excellence, ZS Associates , United States

Anjali Shah

Executive Director, Business Capabilities and Innovation, WWPS, Bristol-Myers Squibb Company, United States

Anjali Shah, PharmD has 15+ years experience in the biopharmaceutical industry in a variety of therapeutic, operational and leadership roles across Medical Affairs and Patient Safety. Inspired by the opportunity to enable safe and informed use of medicines, Anjali is currently involved... Read More →

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

13: ProfDevelopment, Workshop

Format Workshop
Level Basic
Featured Topics Artificial Intelligence (AI), Student Programming
Level Basic
Feature Topics Artificial Intelligence (AI),Student Programming
Tags Workshop

10:00am PDT

#220: Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-571-L04-P; CME 1.00; RN 1.00

Many rare diseases share the same underlying molecular etiology that are therapeutically targetable. Basket trial design based on molecular etiology enables more patients to gain access to clinical trials and accelerate identification of new therpies

Learning Objectives

Recognize the potential of basket trial design in rare disease; Apply basket trial design in rare diseases with share molecular etiologies.

Chair

David Andrew Pearce, PhD

Speaker

Shared Platforms Approaches/Technologies for Rare Diseases
Philip (P.J.) Brooks, PhD

Targeting Shared Molecular Etiologies to Accelerate Drug Development for Rare Diseases
Christina Waters, PhD, MBA

Speakers

David Pearce

President of Innovation and Research/Chair International Rare Disease Research, Sanford Health, United States

David Pearce is President of Innovation & Research for Sanford Health. He completed his undergraduate Bachelor of Science Degree with honors in biological sciences at Wolverhampton Polytechnic in 1986. He gained his PhD in 1990 at the University of Bath, UK Dr. Pearce has been researching... Read More →

Philip (P.J.) Brooks

Deputy Director, Division of Rare Diseases Research Innovation, National Center for Advancing Translational Sciences (NCATS), NIH, United States

Philip J. (P.J.) Brooks is the deputy director of NCATS’ Division of Rare Diseases Research Innovation. Brooks represents NCATS in the NIH-wide Gene Therapy Working Group, the Regenerative Medicine Innovation Project and the International Rare Diseases Research Consortium (IRDiRC... Read More →

Christina Waters

Chief Executive Officer and Founder, RARE Science, Inc., United States

Dr. Christina Waters has been responsible for leading medical research in a broad range of organizations ranging from academia and disease – focused non-profits to biotech and large pharmaceutical companies. Her broad range of experience in basic, translational and clinical research... Read More →

Tuesday June 18, 2024 10:00am - 11:00am PDT
Room 5AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

02: ClinTrials -ClinOps, Forum

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

12:30pm PDT

#241 CH: Practical (and Real) AI and Advanced Automation in New Product Planning and Clinical Development

Component Type: Workshop
Level: Basic

Realizing the value of AI and Advanced Automation tools is no longer hypothetical - real value is being created by the thoughtful application of these tools. We will explore pragmatic examples and opportunities within this working session.

Learning Objectives

Create a pragmatic approach for developing and implementing AI and Advanced Automation tools within their organizations; Describe how to develop a plan, implement and calculate and measure ROI for such tools.

Chair

Bryan Katz, MBA

Speakers

Bryan Katz

Chief Strategy Officer, Propharma Group, United States

Tuesday June 18, 2024 12:30pm - 1:00pm PDT
Content Hub Sails Pav San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

15: Content Hubs, Workshop | 02: ClinTrials -ClinOps, Workshop

Level Basic
Level Basic
Tags Workshop

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

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 →

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 →

Jeremy Jokinen

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States

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

Format Session
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags 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

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 →

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 →

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 →

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

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

3:15pm PDT

#264: Enhancing Adoption of Innovative Approaches in Clinical Trials

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-596-L04-P; CME 1.00; RN 1.00

This forum will explore the U.S. FDA Center for Drug Evaluation and Research's portfolio of clinical trial innovation activities, including its newly established CDER Center for Clinical Trial Innovation (C3TI). C3TI serves as a central hub supporting innovative approaches to clinical trials aimed at improving the efficiency of drug development. Speakers from the FDA will elaborate on C3TI and its role in supporting innovative clinical trial designs. The FDA presenters will be joined by industry and patient speakers for a panel discussion on opportunities to enhance implementation and adoption of innovative approaches in clinical trials, aiming to ensure patient-centric trial design, improve the efficiency of clinical trials, increase the participation of diverse populations, and, in turn, accelerate the development of safe and effective new drugs.

Learning Objectives

Discuss key challenges or barriers to implementation and adoption of innovative approaches in clinical trial design, conduct, and execution; Discuss strategies to enhance implementation and adoption of innovative approaches in clinical trial design, conduct, and execution.

Chair

Meghana Chalasani, MHA

Speaker

Panelist
Kevin Bugin, PhD, MS, RAC

Panelist
Ella Balasa

Panelist
Michelle Rohrer, PhD

Panelist
Allison Cuff Shimooka, MBA

Speakers

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 →

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 →

Michelle Rohrer

Senior Vice President, Global Head of Product Development Regulatory and Policy, Genentech Roche, United States

Michelle Rohrer, PhD is Global Head of Product Development Regulatory and Policy. Michelle has worked at the company for 27 years, starting as a post-doctoral fellow. She has worked as a clinical scientist, team leader, and regulatory strategist. In 2013, Michelle was named by the... Read More →

Ella Balasa

Patient Advocate and Engagement Consultant, Balasa Consulting, United States

Ella Balasa is a patient advocate, consultant, and a person living with cystic fibrosis. She has committed her time to empowering patients and advancing healthcare strategies. She speaks publicly about the value of patient perspective and has a passion for distilling clinical information... Read More →

Allison Cuff Shimooka

Chief Operating Officer, TransCelerate Biopharma Inc, United States

Allison is Chief Operating Officer of TransCelerate BioPharma Inc. In this role, Allison is responsible for shaping and delivering on TransCelerate’s strategic vision: to advance collaboration in driving efficient, effective and high-quality delivery of new medicines through the... Read More →

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

05: Patient-Focused Drug Dev, Forum | 09: Regulatory, Forum | 02: ClinTrials -ClinOps, Forum

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

3:15pm PDT

#269: For Whom the Cell Tolls: Ethics in the Era of Precision Medicine

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-601-L04-P; CME 1.00; RN 1.00

This session will discuss how precision medicine will combine medicine and technology in unique ways to maximize healthcare services and outcomes. At the heart of the issue lie ethical concerns related to privacy, informed consent, and social justice.

Learning Objectives

Analyze latest ethical expectations and challenges; Discuss potential future innovation platforms providing significant benefit to be gained from precision medicine; Recognize the bioethical challenges and opportunities ahead.

Chair

James Wabby, MHS

Speaker

Bioethics Cases and Policy Development
Terry David Church, DrSc, MA, MS

Ethical Frontiers: Navigating Transplant and Genetic Ethical Considerations in Patient Care
Amanda Burkhardt, PhD

Speakers

Amanda Burkhardt

Assistant Professor, Alfred E. Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States

Prior to joining USC Mann faculty, Amanda M. Burkhardt was an adjunct assistant professor at the University of California, Irvine, in the School of Medicine, Department of Physiology & Biophysics; and lecturer in the Department of Biological Sciences at California State University... Read More →

Terry Church

Assistant Professor, Alfred E Mann School of Pharmacy and Pharma Sciences, University of Southern California, United States

Dr. Terry David Church is currently an Assistant Professor in Regulatory and Quality Sciences at the University of Southern California, Mann School of Pharmacy and Pharmaceutical Sciences. He is Assistant Director of Pharmacy Undergraduate Programs. Prof. Church's academic focus is... Read More →

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 →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 1AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

06: TranslationalDelivery Tech-PrecMedicine, Forum

Format Forum
Level Basic
Featured Topics Ethics
Level Basic
Feature Topics Ethics
Credit Type ACPE, CME, RN
Tags Forum

3:15pm PDT

#276: The Promise of Disease Progression Modeling to Bring Treatments to Patients Sooner

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-608-L04-P; CME 1.00; RN 1.00

The impact of disease progression modeling (DPM) on medical product development has yet to be fully realized. This forum will describe DPM and its current applications in clinical trials and highlight the value of DPM to advance decision making and clinical development efficiency.

Learning Objectives

Describe disease progression modeling (DPM) and its current applications in clinical trials; Define the value of DPM to enhance decision making throughout the medical product development lifecycle; Discuss multi-stakeholder effort to advance clinical trial and medical product development efficiency through the increased recognition, value, and consistent use of DPM.

Chair

Summer Starling, DrPH, MPH

Speaker

Panelist
Herbert Pang, PhD, MBA

Panelist
Karthik Venkatakrishnan, PhD

Panelist
Jenny Chien, PhD

Speakers

Summer Starling

Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States

Jenny Chien

Associate Vice President, Global PK/PD and Pharmacometrics, Eli Lilly and Company, United States

Dr. Chien is an associate VP and a scientific lead in the Global PK/PD and Pharmacometrics Department at Eli Lilly and Company. She received her Ph.D. degree in Pharmaceutical Sciences from the University of Washington, Seattle in 1997. Dr. Chien is recognized for her expertise in... Read More →

Herbert Pang

Expert Statistical Scientist, Genentech, A Member of the Roche Group, United States

Herbert (Herb) Pang is an Expert Statistical Scientist at Genentech/Roche. His research interests include real-world evidence for drug development, machine learning, biomarker discovery, -omics data, and the design and analysis of clinical trials. Herb obtained his PhD in Biostatistics... Read More →

Karthik Venkatakrishnan

Vice President, Global Head of Quantitative Pharmacology, EMD Serono, United States

Karthik Venkatakrishnan is Vice President and Global Head of Quantitative Pharmacology at EMD Serono, Inc., Billerica, MA, with accountability for leadership of Clinical Pharmacology, Translational M&S, and Pharmacometrics. Previously, he held roles in Clinical Pharmacology at Pfizer... Read More →

Tuesday June 18, 2024 3:15pm - 4:15pm PDT
Room 14AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

11: Statistics-Data Science, Forum

Format Forum
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags Forum

4:30pm PDT

#282: Shame and Blame: Our Words are a Barrier to Clinical Research are a Care Option

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-614-L04-P; CME 1.00; RN 1.00

Clinical research creates future clinical care. Let's lead in compassionate communication inviting more participation. Patient, site, and patient-focused drug development (PFDD) experts share and invite your participation in improving access through our words.

Learning Objectives

Identify the shame and blame negative words and phrases and their negative impact on patients; Recognize opportunities to improve the patient experience in clinical research as a care option through more compassionate word choice; Describe how to plan and justify optimization of protocol, informed consent, and participant communication language.

Chair

Lani Hashimoto

Speaker

Panelist
Jamie Troil Goldfarb

Panelist
Eddilisa Martin

Panelist
James Duhig, PhD

Speakers

Lani Hashimoto

Associate Director, Patient Engagement, Novartis Pharmaceuticals Corporation, United States

Lani Hashimoto is dedicated to connecting patients to research. Lani's lived experience as a clinical trial participant and caregiver further inspire her professional pursuits. She credits the Cystic Fibrosis Foundation as a key influence in her passion for patient engagement. At... Read More →

James Duhig

Global Head, Office of Health Literacy, AbbVie, United States

Dr. James (Jay) Duhig, Ph.D., is Global Head of the Office of Health Literacy for AbbVie. Dr. Duhig is an expert in the application of human factors and health literacy in the investigation of medication errors and in the development of drug and device instructional materials for... Read More →

Jamie Goldfarb

Director, Patient Recruitment Strategy, Trialbee, United States

Eddilisa Martin

Co-Founder and Chief Executive Officer, M&B Sciences Inc., United States

Tuesday June 18, 2024 4:30pm - 5:30pm PDT
Room 15AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum

Format Forum
Level Basic
Featured Topics Patient Focused, Student Programming
Level Basic
Feature Topics Patient Focused,Student Programming
Credit Type ACPE, CME, RN
Tags Forum

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

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 →

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

Format Session
Level Basic
Featured Topics Student Programming
Level Basic
Feature Topics Student Programming
Credit Type ACPE, CME, PMI, RN
Tags 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

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 →

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

Format Session
Level Basic
Featured Topics Ethics
Level Basic
Feature Topics Ethics
Credit Type ACPE, CME, RN
Tags 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

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 →

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 →

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 →

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

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

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 →

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 →

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 →

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

Format Session
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags 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

Oliver Fink

Head Learning, Processes and Digitalization, Boehringer Ingelheim Pharma Gmbh & Co. KG, Germany

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 →

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.

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

Format Session
Level Basic
Featured Topics Artificial Intelligence (AI), Risk Management
Level Basic
Feature Topics Artificial Intelligence (AI),Risk Management
Credit Type ACPE, CME, RN
Tags 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

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 →

Brett Hauber

Senior Director, Patient Preference Elicitation, Pfizer Inc, United States

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 →

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 →

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

Format Session
Level Basic
Featured Topics Patient Focused, ICH
Level Basic
Feature Topics Patient Focused,ICH
Credit Type ACPE, CME, RN
Tags 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

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 →

Brian Johnson

Vice President, R&D Technology, Takeda, United States

Lionel Phillips

President, Inside Edge Consulting, United States

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

Format Session
Level Basic
Featured Topics Artificial Intelligence (AI), Decentralized Clinical Trials (DCTs)
Level Basic
Feature Topics Artificial Intelligence (AI),Decentralized Clinical Trials (DCTs)
Credit Type ACPE, CME, RN
Tags 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

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 →

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 →

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 →

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

Format Session
Level Basic
Level Basic
Credit Type ACPE, CME, RN
Tags Session

4:30pm PDT

#378: From X to Z: Unleashing the Power of Multigenerational Collaboration in Life Sciences – The Basics for All

Component Type: Workshop
Level: Basic

Unlock the secrets of workplace success! Learn to harness the strengths of each generation and build a cohesive and successful team. Don't miss out on the opportunity to learn valuable insights and strategies for managing a diverse workforce.

Learning Objectives

Explore the unique characteristics and differences among different generations in the workplace; Discuss practical ideas on how to effectively manage and create a harmonious and productive work environment; Describe how to dispel the myths and stereotype of each generation.

Chair

Tywnia Brewton

Speaker

Facilitator
Leslie Sam

Speakers

Tywnia Brewton

Executive Director, Human Resources, Astellas , United States

Tywnia Brewton is a seasoned Human Resource Executive who established herself as an employee Advocate... Proactive Problem Solver... Leader... Effective Negotiator... Consummate HR Partner. Tywnia specializes in improving individual and organization performance. She has over 25 years... Read More →

Leslie Sam

President, Leslie Sam and Associates, LLC, United States

Wednesday June 19, 2024 4:30pm - 5:30pm PDT
Room 8 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

13: ProfDevelopment, Workshop

Format Workshop
Level Basic
Featured Topics Student Programming
Level Basic
Feature Topics Student Programming
Tags Workshop

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

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 →

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 →

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

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

8:00am PDT

#406: More Nuanced Clinical Outcomes from Person-Generated Health Data: The New Frontier

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-682-L04-P; CME 1.00; RN 1.00

Person-generated data offers nuanced effectiveness measures for clinical and regulatory decision-making for new medical products, like the wearable-derived digital clinical outcome assessment for Duchenne muscular dystrophy. What's next?

Learning Objectives

Describe practical applications of person-generated health data, and key business and regulatory perspectives on opportunities and challenges; Explain the value of this type of information to patients, clinicians, and colleagues to help inform decision-making.

Chair

Nancy A Dreyer, PhD, MPH, FISPE

Speaker

Panelist
Christina Mack, PhD, MPH

Panelist
Paul Strijbos, PhD

Panelist
Jeffrey Nahum Siegel, DrMed, MD

Panelist
Martha Azer, PharmD, RPh

Speakers

Nancy Dreyer

Founder, Dreyer Strategies LLC, United States

Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing... 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 →

Paul Strijbos

Senior Principal Neurotech Innovation Leader, F. Hoffmann-La Roche Ltd, Switzerland

Paul is a PhD neuroscientist with over 25 years of clinical development experience across the product lifecycle. He works as Neurotechnology Innovation Leader in the late stage Neuroscience organization of F. Hoffmann-La Roche in Basel and focusses on the development, validation and... Read More →

Martha Azer

Associate Director, Global Regulatory Policy & Intelligence, Johnson & Johnson, United States

Martha Azer is an Associate Director of Global Regulatory Policy and Intelligence at Johnson & Johnson. She leads the US policy work on Digital Health and Artificial Intelligence & Machine Learning as well as Precision Medicine to help shape the regulatory policy landscape to provide... Read More →

Jeffrey Siegel

Director, Office of Drug Evaluation Sciences, OND, CDER, FDA, United States

Jeffrey Siegel is the Director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research... Read More →

Thursday June 20, 2024 8:00am - 9:00am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

05: Patient-Focused Drug Dev, Forum | 09: Regulatory, Forum

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

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

Ruby Ford

Research Analyst, Tufts School of Medicine, United States

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 →

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 →

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 →

Elizabeth Rosenkrands-Lange

Senior Director/ Head of US Regulatory Scientific Policy, EMD Serono, United States

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

Format Session
Level Basic
Featured Topics Patient Focused, Diversity Equity and Inclusion (DEI)
Level Basic
Feature Topics Patient Focused,Diversity Equity and Inclusion (DEI)
Credit Type ACPE, CME, RN
Tags Session

9:15am PDT

#414: Regulatory Affairs of the Future: Is Now

Component Type: Forum
Level: Basic
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-689-L04-P; CME 1.00; RN 1.00

Global regulatory affairs is a critical function at the key interface between the innovation from our pipelines and patients. The world around us is changing very rapidly leading to implications and opportunities for regulatory affairs. We must evolve. But how?

Learning Objectives

Identify what global changes are leading to an evolved regulatory affairs organization; Discuss what skillset global regulatory affairs professionals of the future will need.

Chair

Lina AlJuburi, PharmD, MSc

Speaker

FDA Update
M. Khair ElZarrad, PhD, MPH

Academic Update
Maria Florez, MA

Industry Update
Nicole Mahoney, PhD

Speakers

Lina AlJuburi

Head, Global Regulatory Science and Policy - North America, Sanofi, United States

A background in pharmacy and an interest in drug development and regulation led me to the US FDA where I spent several years within CDER, Office of New Drugs. By far the hardest decision, in 2012, I transitioned to the private sector in the field of Regulatory Science and Policy... 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 →

Maria Florez

Senior Consultant, Tufts Center For the Study of Drug Development, Tufts Univers, United States

Maria Florez studies the practices, strategies, attitudes, and incentives driving innovation in the pharmaceutical R&D process, as well as the impact of digital transformation in clinical research. Maria has been a researcher, consultant, and advisor in the healthcare sector for over... Read More →

Nicole Mahoney

Executive Director US Regulatory Policy & Intelligence, Novartis Pharmaceuticals Corporation, United States

Nicole Mahoney is an Executive Director for Regulatory Policy at Novartis, and global regulatory policy lead for data and digital technologies, including real-world evidence and artificial intelligence. Prior to Novartis, she led Regulatory Policy at Flatiron Health, helping support... Read More →

Thursday June 20, 2024 9:15am - 10:15am PDT
Room 6B San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

09: Regulatory, Forum

Format Forum
Level Basic
Featured Topics Student Programming
Level Basic
Feature Topics Student Programming
Credit Type ACPE, CME, RN
Tags Forum