FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy

FDA discusses key issues in reviewing first-in-human clinical protocols for cellular and gene therapy products for the treatment of cancer. FDA also shares pitfalls to avoid when describing these studies and lessons learned from successful oncology and gene therapy products.
Presenter:
Peter Bross, MD, Chief (Acting), Oncology Branch, Division of Clinical Evaluation and Pharmacology/Toxicology, Office of Tissues and Advanced Therapies (OTAT), CBER

Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/oncology-therapy-development-workshop-pivotal-steps-and-avoiding-pitfalls-start-ups-03302021
-------------------- 
FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.  

Upcoming Training - https://www.fda.gov/cdersbia
SBIA Listserv - https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_352
SBIA 2021 Playlist - https://youtube.com/playlist?list=PLey4Qe-UxcxYS1MaTusSgyifQDqdeepyD
SBIA LinkedIn: https://www.linkedin.com/showcase/cder-small-business-and-industry-assistance
SBIA Training Resources - https://www.fda.gov/cdersbialearn
Twitter - https://twitter.com/FDA_Drug_Info
Email - CDERSBIA@fda.hhs.gov  
Phone - (301) 796-6707 I (866) 405-5367

Видео FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy канала U.S. Food and Drug Administration