
Global Expedited Programs For Cell and Gene Therapies
Overview
Gene and cellular therapies hold tremendous promise for addressing some of the most problematic diseases, including those without treatment options and rare genetic conditions. Developers of these therapies should work with regulators beginning at the earliest stages of development. The interactions with regulators on how to design the development program allows for a facilitation of the approval process and ultimately bringing the treatment to the patients. In the U.S., there are three programs designed to promote product development: fast track, breakthrough therapy, and Regenerative Medicine Advanced Therapy (RMAT) designations. The US (accelerated approval), EU (conditional marketing approval) and Japan (conditional and term-limited approval) also offer conditional approval mechanism for expediting the registration pathway of promising therapies. As regulatory authorities continue to issue new guidelines that assist with the interpretation of the regulations, it is critical for sponsors to stay current with evolving standards and best practices.
Meet the Speaker
Kimberley Buytaert-Hoefen, PhD.
A seasoned professional with 25 years of research and development and commercial pharmaceutical, gene and cellular therapy, medical device industry pre-clinical and clinical experience. As a former FDA Investigator, performed surveillance for cause, pre-approval establishment, and post-marketing adverse drug experience reporting inspections.
Key Learning Objectives:
- Provide a review of these expedited regulatory pathways
- Review best practices for successful implementation
- Provide a discussion of attendee specific questions
Date: Tuesday, October 6, 2022
Time: 10 am EDT / 7 am PDT / 16:00 CEST
Duration: 60 minutes
Ideal for East Coast US and EU
Date: Tuesday, October 13, 2022
Time: 2 pm EDT / 11 am PDT / 20:00 CEST
Duration: 60 minutes
Ideal for West Coast US