Regulatory Working Group Webinar
Clinical Development for Rare Diseases: A Primer for Rare Disease Patients and Advocates
Wednesday, March 29th
1:00 pm ET/10:00 am PT
Join us as we provide an overview of the clinical development process for rare diseases. The EveryLife Foundation’s Community Congress will host a panel of experts to provide insight into the world of drug development. This webinar is free to attend but registration is required to obtain login information.
Agenda:
- Introduction to Community Congress and Regulatory Science Working Group
- Max Bronstein, Chief Science Policy and Advocacy Officer, EveryLife Foundation for Rare Diseases
- Lynne McGrath, Vice-President of Regulatory Affairs, RegenXBio
- Isabelle Lousada, CEO and President, Amyloidosis Research Consortium
- Importance of Natural History Studies and Patient Registries
- Overview of Rare Disease Clinical Development Process – Phases and Timelines of Drug Development, Unraveling Industry Jargon, importance of Endpoints
- Special Approval Pathways and Incentives – Accelerated Approval, Fast Track, Priority Review, Breakthrough, Orphan Drug Act Incentives
- Early Access and Right to Try
- David Farber, Partner, King & Spalding
Throughout the year, the Foundation holds quarterly Community Congress meetings in addition to our in-person meeting, scheduled for November 16 in Washington D.C. For more information on the EveryLife Foundation’s Community Congress, visit the program’s homepage.
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