11:30–11:40 AM

Welcome and Announcements
Enter this season: https://fdli.zoom.us/j/85475642113

11:40 AM–12:40 PM

Incorporating Patient Experience into Drug Development and FDA Policy (Part 1)
Joseph F. Lamendola, Senior Director, Faegre Drinker Consulting
David R. Zook, Chair, Faegre Drinker Consulting

Enter this session: https://fdli.zoom.us/j/85475642113

12:45–1:30 PM

Incorporating Patient Experience into Medical Product Development: Fireside Chat
Robyn Bent
, Director, Patient-Focused Drug Development Program, Center for Drug Evaluation and Research (CDER), FDA
Elizabeth Hart, Branch Chief, Division of Clinical Evaluation and Pharmacology/Toxicology (DCEPT), Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), FDA
Kerry Jo Lee, Associate Director for Rare Diseases, Office of New Drugs, Center for Drug Evaluation and Research (CDER), FDA
Vasum Peiris
, Chief Medical Officer and Director, Pediatrics and Special Populations, Center for Devices and Radiological Health (CDRH), FDA
Moderated by Peter J. Pitts, President, Center for Medicine in the Public Interest

Enter this session: https://fdli.zoom.us/j/81544527107

1:30–1:45 PM


1:45–2:30 PM

What Patient Organizations Should Know About Regulation of Cell & Gene Therapies
Eva A. Temkin, Partner, King & Spalding LLP
Elaine H. Tseng, Partner, King & Spalding LLP

Enter this session: https://fdli.zoom.us/j/84402995027

2:30–2:45 PM


2:45–3:45 PM

Patient Access to Other Agencies and Lawmakers
Karin Hoelzer, Director, Policy and Regulatory Affairs, National Organization for Rare Disorders (NORD)
Cara Tenenbaum, Principal, Strathmore Health Strategy

Enter this session: https://fdli.zoom.us/j/86063275532

3:50–4:50 PM

Accelerated Approval Expedited Pathways
Amy Abernethy, President, Clinical Studies Platform, Verily Life Sciences LLC
Joe Franklin, Head of Strategic Affairs, Clinical Studies Platform, Verily Life Sciences LLC

Enter session here: https://fdli.zoom.us/j/85412837323

CLE Information


This event is pending approval in Ohio. To obtain credit, please email [email protected] at the end of the conference and include your state bar number along with how many credits you wish to obtain. FDLI will certify your attendance for you. An evaluation is required to obtain credit.


This event is pending approval in Virginia. Please email [email protected] to request a Virginia form. You will need to certify your attendance online at www.vsb.org. Retain the Certificate of Attendance for two years.

Other States

These CLE approvals may also be honored by other states; please check with your bar association for guidance. At the end of the conference, please email [email protected] to receive a certificate of attendance.