Jean-Marc Poudrel, PhD

Head of Regulatory Affairs at PolyPeptide Group

Speaker

Jean-Marc Poudrel is currently Head of Regulatory Affairs at PolyPeptide SA (Belgium), a major CDMO for Synthetic Peptides Manufacturing. In this role, he manages all types of regulatory applications to different health authorities, in order to support customers in their clinical phases (IND/IMPD) and commercial applications (NDA/MAA and ANDA).

He received his Ph.D. in Organic and Medicinal Chemistry from the University of Montpellier (France) in 1997. After a 3-year post-doctoral fellowship in Sydney (Australia), he joined the peptide CDMO industry at UCB-Bioproducts in 2001 as Head of Analytical Services. In this function he set-up a state-of-the-art mass spectrometry laboratory to support characterization of peptides intermediates and products and was responsible for method validation and stability studies.

As part of Lonza in 2006 he became Head of Analytical Development with oversight on both in-process control and analytical development laboratories, focusing on the development and validation of analytical methods for starting materials, process intermediates and active pharmaceutical ingredients, as well as setting up of release specifications.

From 2011, he moved into Customer Project Management, first with Lonza then with the Polypeptide Group. His role was to lead and coordinate multidisciplinary teams developing manufacturing processes and control strategies to successfully bring peptide APIs from toxicological and clinical phases to commercialization. He was also responsible for establishment of project scope, budget and timeline as well as for project execution with cross-functional oversight.