Accelerating iPSC-based Therapeutic Development: The Case for Harmonizing Regulatory Requirements
Wednesday, May 29, 2024 02:15 PM - 03:15 PM
Room 202-204
Regulation & Policy
Roundtable
Organized by: ISCT iPSC Committee
Moderator
Develop evidence-based guidelines for the therapeutic development of iPSC-based therapeutics globally.
Key Learning Objectives
1. Understanding the current regulatory landscape for iPSC-derived cell products.
2. Identifying challenges and opportunities in harmonizing regulatory guidelines internationally.
3. Exploring strategies to expedite the safe and effective translation of iPSC therapies into clinical practice.
Moderator
- Wanxing Cui, MD, PhD, CABP(H), Cell Therapy Manufacturing Facility MedStar Georgetown University Hospital, United States
- Zhaohui Ye, PhD, Office of Tissues and Advanced Therapies, Division of Cellular and Gene Therapies, Gene Transfer and Immunogenicity Branch, FDA, United States
- Shinichi Noda, PhD, Pharmaceuticals and Medical Devices Agency (PMDA) , Japan
- Pille Säälik, PhD, Estonian State Agency of Medicines (SAM), Estonia
- James McBlane, PhD, UK Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Develop evidence-based guidelines for the therapeutic development of iPSC-based therapeutics globally.
Key Learning Objectives
1. Understanding the current regulatory landscape for iPSC-derived cell products.
2. Identifying challenges and opportunities in harmonizing regulatory guidelines internationally.
3. Exploring strategies to expedite the safe and effective translation of iPSC therapies into clinical practice.
