Are Shared Platforms Part of the Future of Product Development?
Wednesday, May 29, 2024 08:00 AM - 09:00 AM
Room 205-207
Regulation & Policy
Roundtable
Organized by: ISCT Global Regulatory Task Force
Moderator(s)
Panelists
A shared platform for product development can offer significant reductions in resources and time. As progress in platform development for gene replacement is made, assess whether there is regulatory room to allow for data sharing across different genetic disorders to minimize clinical trials and optimize patient access.
Key Learning Objectives
1. Discuss what clinical studies need to be repeated for each new product/indication.
2. How can clinical studies be developed in situation where there may be limited patients worldwide.
Moderator(s)
- Bambi Grilley, RPh, RAC, CIP, CCRC, CCRP, Baylor College of Medicine, Center for Cell and Gene Therapy, United States
Panelists
- Ramandeep Kuar Virk, MD, PhD, Health Sciences Authority, United States
- Michael Rosu-Myles, PhD, Health Canada, Canada
- Wern-Chir Liao, PhD, Taiwan Food and Drug Administration (TFDA), Taiwan
A shared platform for product development can offer significant reductions in resources and time. As progress in platform development for gene replacement is made, assess whether there is regulatory room to allow for data sharing across different genetic disorders to minimize clinical trials and optimize patient access.
Key Learning Objectives
1. Discuss what clinical studies need to be repeated for each new product/indication.
2. How can clinical studies be developed in situation where there may be limited patients worldwide.
Bambi Grilley
Professor, Pediatrics; Director, Clinical Research and Early Product Development
Baylor College of Medicine
Moderator
Professor, Pediatrics; Director, Clinical Research and Early Product Development
Baylor College of Medicine
Moderator
