DIA 2024 Global Annual Meeting: Full Schedule

8:00am PDT

#305: All the Ways Medical Affairs Supports Product Development: From Clinical Trials to Product Launch

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-626-L04-P; CME 1.00; RN 1.00

Wondering what a medical affairs team does? This session will dive into some of the different roles within medical affairs, their responsibilities, and how these roles support a product over the course of its development.

Learning Objectives

Recognize how the medical affairs function can support a product across all stages of development; Describe different roles within medical affairs and how they connect to each other and to the broader organization.

Chair

Sejal Vora, PharmD

Speaker

All the Ways Medical Affairs Supports Product Development: Field Perspective
Nital Patel, PharmD, MBA

All the Ways Medical Affairs Supports Product Development: Publication Planning
Wendy Tin, PharmD, RPh

Speakers

Sejal Vora

Director, Medical Information, BeiGene, United States

Sejal Vora has over 20 years of industry experience within Medical Affairs, including Medical Information, Publication Planning, Investigator Initiated Research, and serving as a medical reviewer for promotional and medical review committees. She earned her PharmD at the University... Read More →

Nital Patel

Consultant, United States

Nital Patel has over 12 years of experience within Medical Affairs, including Medical Training and Operations, Field Medical, and as Executive Medical Director. She earned both her PharmD and MBA at Drake University in Des Moines, Iowa. Nital completed a 2-year Regulatory Fellowship... Read More →

Wendy Tin

Associate Director, HIV PrEP Scientific Publications, Gilead Sciences, United States

Wendy Tin is a pharmacist by training with more than 6 years of experience in the pharmaceutical industry. After graduating from UC Berkeley with a BA in molecular and cell biology, Wendy attended UCSF and earned her PharmD degree. Prior to industry, Wendy worked as a pharmacist in... Read More →

Wednesday June 19, 2024 8:00am - 9:00am PDT
Room 7AB San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA

04: MedAffairs-SciComm, Forum

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

1:15pm PDT

#349: Study Design for Cell and Gene Therapy Trials: Regulatory Overview, Challenges, and Updates

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-652-L04-P; CME 1.00; RN 1.00

This forum provides a general view and challenges of the study design in cell and gene therapy trials. A panel of experts interpret FDA guidance, share their own experience for study design, and discuss the trends in this area.

Learning Objectives

Describe regulatory principles of the trial design for cell and gene therapy products; Identify specific design elements such as selection of study population; Discuss the selection of control, safety monitoring; Discuss challenges and new trends.

Chair

Yao-Yao Zhu, MD, PhD

Speaker

Panelist
Katherine A. High, MD

Panelist
Vaishali Popat, MD, MPH

Clinical Considerations for Oncology Cell and Gene Therapy Trials
Ke Liu, MD, PhD

Speakers

Yao-Yao Zhu

Regulatory Affairs Director, AstraZeneca, United States

Yao-Yao Zhu, MD, PhD, has over 15 years of regulatory experience. She is currently a Regulatory Affairs Director for cardiovascular, renal, and metabolic diseases at AstraZeneca (AZ). Prior to AZ, she was a head of Global Regulatory Affairs at Biosion for antibody products in oncology... Read More →

Katherine High

Co-Founder and Former President, Sparks Therapeutics; Visiting Professor, Rockefeller University, United States

Dr. Katherine High is the former President at Spark Therapeutics, a biotech company that she co-founded in 2013. Under Dr. High’s leadership, Spark received FDA approval of the first AAV gene therapy product in the US, a treatment for a rare form of congenital blindness. Dr. High... Read More →

Ke Liu

Chief Development Officer, Marengo Therapeutics, United States

As Chief Development Officer of Marengo Therapeutics, Ke Liu joins Marengo with over 20 years of experience in the field of oncology, immuno-oncology, and cell and gene therapy, most recently serving as Senior Vice President and led the key regulatory activities at Sana Biotechnology... Read More →

Vaishali Popat

Branch Chief, Office of Clinical Evaluation,Office of Therapeutic Products, CBER, FDA, United States

Dr. Vaishali Popat is an Associate Director for Biomedical Informatics in the Office of New Drugs, Immediate Office. Dr. Popat is the OND lead on biomedical informatics issues in areas such as safety analytics, staff training on the use of new review tools to make the evaluation of... Read More →

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

09: Regulatory, Forum | 02: ClinTrials -ClinOps, Forum | 04: MedAffairs-SciComm, Forum

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

8:00am PDT

#404: Meeting in the Middle: Best Practices for Collaboration Between Medical Affairs and Clinical Development

Component Type: Forum
Level: Intermediate
CE: ACPE 1.00 Application UAN: 0286-0000-24-680-L04-P; CME 1.00; RN 1.00

Medical affairs and clinical development enhance the scientific credibility of the company (and its products) with established and emerging clinical investigators These collaborations may also improve study recruitment techniques.

Learning Objectives

Design new activities which require participation from both medical affairs and clinical development; Demonstrate how the medical affairs team can provide real-world data to help inform study designs and execution; Critique case studies of successful collaborations.

Chair

J. Lynn Bass, PharmD, RPh

Speaker

Industry Update
J. Lynn Bass, PharmD, RPh

Industry Update
Rebecca A. Vermeulen, RPh

Industry Update
Sonja Wesley Hokett, PharmD, MS, MSc

Speakers

J. Lynn Bass

Senior Director, Medical Science Liaisons, BridgeBio, United States

In her 25+ years of industry experience, Lynn has served in both individual and leadership positions within Medical Affairs at both large and start-up companies. She is currently Sr. Director, Medical Science Liaisons at BridgeBio, where she is building and leading a field medical... Read More →

Sonja Hokett

Executive Director/Head of Medical Managed Care, BioXcel Therapeutics, United States

Residing in Branson, Missouri, Sonja holds PharmD degree from the University of Louisiana Monroe, Master of Science degree in Hospital Pharmacy Administration from the University of Houston, and Executive Master's degree Health Economics, Policy & Management from the London School... Read More →

Rebecca Vermeulen

Vice President, Global Patient Networks | PD Medical Affairs, Genentech, A Member of the Roche Group, United States

Rebecca Vermeulen, RPh, brings a variety of experiences to her role as VP of Strategy for Patients and Society, Product Development, at Hoffman La Roche. She has served in numerous functions including Medical Affairs, Clinical Research, Sales, Medical Communications, Medical Science... Read More →

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

02: ClinTrials -ClinOps, Forum | 04: MedAffairs-SciComm, Forum

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