ROUNDTABLE The What, Why and When in your Bioassay Development Strategy
Wednesday, May 31, 2023 10:45 AM - 11:45 AM
Room 243
GRP
Roundtable
Moderator
Christopher Bravery, PhD, Director, Advanced Biologicals Ltd, UK
Panelists
Steven R. Bauer, PhD, Wake Forest Institute for Regenerative Medicine (WFIRM), USA
Steven Oh, PhD, Acting Director, Division of Cell Therapy 1 & 2, US Food and Drugs Administration (FDA), USA
Christiane Niederlaender, PhD, Vice President Technical CMC, Parexel International, UK
Donald Fink, PhD, Master Practice Expert, Regulatory, Dark Horse Consulting, USA
Session Description
The characterization of biological materials requires bioassays to measure their relevant biological function; in the case of an active substance (active ingredient) these are called potency assays. This session will discuss the need for bioassays in the characterization of starting materials, intermediates, and the active substance, to understand the different needs.
Learning Objectives
Christopher Bravery, PhD, Director, Advanced Biologicals Ltd, UK
Panelists
Steven R. Bauer, PhD, Wake Forest Institute for Regenerative Medicine (WFIRM), USA
Steven Oh, PhD, Acting Director, Division of Cell Therapy 1 & 2, US Food and Drugs Administration (FDA), USA
Christiane Niederlaender, PhD, Vice President Technical CMC, Parexel International, UK
Donald Fink, PhD, Master Practice Expert, Regulatory, Dark Horse Consulting, USA
Session Description
The characterization of biological materials requires bioassays to measure their relevant biological function; in the case of an active substance (active ingredient) these are called potency assays. This session will discuss the need for bioassays in the characterization of starting materials, intermediates, and the active substance, to understand the different needs.
Learning Objectives
- What attributes should be considered/designed into a potency bioassay, i.e., for an iPSC derived product?
- When and where might bioassays be best used for starting materials (e.g., donated cells/tissues, vector) or other intermediates (e.g., cell bank, stored intermediate)
- Bioassays for products with less clear MOA – is there such a thing?
Steven R. Bauer PhD
Chief Regulatory Science Affairs Program Officer
Wake Forest Institute for Regenerative Medicine
Panelist
Chief Regulatory Science Affairs Program Officer
Wake Forest Institute for Regenerative Medicine
Panelist
