Essentials of the FDA Landscape for Patient Organizations
February 7–8, 2024 I Virtual Course
For 501(c)(3) Patient or Disease Organizations Only
Required Pre-Course Work
ProgressForPatients.org Advocacy Education Course
(90 minutes)
An online advocacy education program and community working to help patients, advocates, and caregivers acquire the necessary tools to effectively communicate with drug researchers, developers, and regulators.
Preliminary Agenda
Agenda Subject to Change
All Times Listed in Eastern Time
Wednesday, February 7
11:00–11:10 AM
Welcome and Announcements
Paige Samson, Director, Innovative Programs and Publications, FDLI
11:10 AM–12:10 PM
Navigating FDA as a Patient Advocate
Joseph F. Lamendola, Senior Director, Faegre Drinker Consulting
David R. Zook, Chair, Faegre Drinker Consulting
12:10–12:30 PM
Break
12:30–1:10 PM
Engaging with FDA: Opportunities and Boundaries
Shawn Shermer, FDA Patient Listening Session Program Lead, Office of the Commissioner, FDA
1:10–1:40 PM
Break
1:40–2:40 PM
Understanding the Regulation of Cell and Gene Therapies
Eva A. Temkin, Partner, King & Spalding LLP
Elaine H. Tseng, Partner, King & Spalding LLP
2:40–2:50 PM
Break
2:50–3:50 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
3:50–4:00 PM
Break
4:00–5:00 PM
Accelerated Approval Expedited Pathways
Daniel A. Kracov, Partner, Arnold & Porter LLP
Thursday, February 8
11:00 AM–12:00 PM
Incorporating Patient Experience into Medical Product Development: Fireside Chat
Celia M. Witten, Deputy Director, Center for Biologics Evaluation and Research (CBER), FDA
Moderated by Peter J. Pitts, President, Center for Medicine in the Public Interest
12:00–12:15 PM
Break
12:15–1:45 PM
Patient Access to Treatments
Richard Klein, Director, Expanded Access Programs & Policy, GE2P2 Global Foundation
1:45–2:00 PM
Break
2:00–3:00 PM
Interactions with Industry: Opportunities and Boundaries
Susan Lee, Partner, Goodwin Proctor LLP
Tiffany Patrick, VP, Head of Patient Advocacy, Alnylam Pharmaceuticals
3:00–3:10 PM
Break
3:10–4:00 PM
Hot Topics
Remy Brim, Principal, BGR Group
Kate Rawson, Senior Editor, Prevision Policy LLC
Moderated by Ryan M. Hohman, Vice President, Public Affairs, Friends of Cancer Research
4:00 PM
Course Adjournment