Patrick Larcier leads the Clinical Development and Pharmacovigilance activities, focusing on the development of drugs and biologics, as well as Companion Diagnostic (CDx) tests. Patrick brings a global view in product development. His expertise lies in the design and implementation of regulatory strategies at all stages of clinical development for complex and innovative medicinal products. Patrick leads a multidisciplinary team who designs, prepares and manages clinical trial applications for all phases. The co-development of IVDs and drugs is his most recent area of interest.
Patrick works specifically on:
- the early phases of development (First-in human and Phase 2 studies),
- the preparation of interactions with EU Regulatory Agencies and FDA to obtain advice and obtain feedback on developments plans (via Scientific Advice/Protocol Assistance procedures qualification procedures, pre IND, End of Phase 2 meetings, pre-submission meetings…).
Within the framework of these regulatory activities, Patrick has worked extensively with key opinion leaders (KOLs), in the context of managing expert panels and collecting scientific and medical advices on the development plans. Patrick has significant experience in the development of monoclonal antibodies, recombinant proteins, therapeutic vaccines and IVDs/CDx tests, specifically in the areas of Oncology, CNS (Multiple sclerosis, Alzheimer’s disease) and Auto-Immune Diseases (Rheumatoid arthritis, inflammatory bowel diseases and Lupus), AIDS and tropical diseases.
Prior to joining VCLS, Patrick was Vice-President, Clinical and Regulatory Affairs at TcLand Expression and Vice-President, Drug Development, at Neovacs. Before, Patrick was Associate Director, Regulatory Affairs, at Biogen International, and worked at Quintiles, as Senior Project Manager, and Parexel, as Project Manager. Patrick was also Clinical Trial Manager at SmithKline Beecham International, and worked as a CRA at Roussel Uclaf and Abbott International Laboratories.
Patrick obtained his Pharm. D., from the University of Dijon (France) and a Certificate in Methodology of Clinical Trials (CESAM) at the ‘Pierre et Marie’ Curie University in Paris, France. Patrick also holds a Master of Business Administration from the ESSEC Business School in Paris (Paris).
