Overcoming Regulatory Hurdles to Product Platforms: Leveraging Pre-Clinical Studies Effectively
Wednesday, May 29, 2024 10:45 AM - 11:45 AM
Room 208-209
Regulation & Policy
Roundtable
Organized by: ISCT Global Regulatory Task Force
Moderator
Develop pre-clinical studies that pre-empt regulatory challenges for platform-developed products.
Key Learning Objectives
To provide opportunity for consideration and discussion of non-clinical aspects relevant to regulatory approvals regarding:
Moderator
- Dominic Wall, PhD, FFSc (RCPA), Cell Therapies Pty Ltd, Australia
- Andreas Marti, PhD, Swiss Agency for Therapeutic Products (Swissmedic), Switzerland
- Matthew M. Hewitt, BA, PhD, Charles River Laboratories, United States
- Nathan Manley, PhD, Dark Horse Consulting Group, United States
- Shinichi Noda, PhD, PMDA, Japan
Develop pre-clinical studies that pre-empt regulatory challenges for platform-developed products.
Key Learning Objectives
To provide opportunity for consideration and discussion of non-clinical aspects relevant to regulatory approvals regarding:
- Pre-clinical and non-clinical studies to design and set up a platform-developed product
- How the regulatory impacts of proposed changes (such as new media in manufacturing) could be pre-empted, assessed and managed flexibly across the platform to support production and clinical use of each of the therapeutic products.
- The possibilities and limitations of non-clinical studies for assessing comparability, and how new technology and new methods can be incorporated into risk assessments.
