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Session Details

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Potency Assays: From Assay Design to Clinical Validation
Friday, September 6, 2024 09:15 AM - 10:15 AM  
F2
Roundtable Session
Moderator:
  • Massimiliano Gnecchi, MD, PhD, University of Pavia, Italy
Panelists:
  • Hendrik Jan Ankersmit, MD, University of Vienna, Austria
  • Jonathan Campbell, PhD, MetBio Scientific Consulting, United Kingdom
  • Paula Salmikangas, PhD, NDA, an SSI Strategy Co., Finland
Advanced Therapy Medicinal Products (ATMPs) based on somatic cells expanded in vitro, with or without genetic modification, is a rapidly growing area of drug development. Potency assays are a fundamental aspect of the quality control of the end cell products and ideally may become useful biomarkers of efficacy in vivo. In this session we aim to summarize the state of the art regarding potency assays used for the assessment of the quality of the major ATMPs used in clinical settings and discuss the appropriateness of potency tests as a parameter for the validation of a given cell therapy. Participants will be invited to provide their opinion on the possible alternatives to proposed to the authorities that supervise the authorizations for the clinical use of new ATMPs. 

Session Objectives:
  1. Understanding how a potency assay works
  2. Understanding the challenges related to potency assays 
  3. Discussing about possible alternatives to current potency assays
  4. Discussing how regulatory agencies view potency assays

 
Massimiliano Gnecchi
Professor of Cardiology
 University of Pavia & IRCCS Policlinico San Matteo
 Moderator
Hendrik Jan Ankersmit MD, MBA
CEO Aposcience AG
 Medical University of Vienna
 Panelists
Jonathan Campbell
Consultant
 MetBio Scientific Consulting
 Panelists
Paula Salmikangas PhD
Director of Biopharmaceuticals and ATMPs
 NDA Advisory Services Ltd
 Panelists
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