Dr Seraphin Kuate, PhD, MBA, RAC, Assoc. Director, Global CMC, Biologics, Boehringer Ingelheim
Dr. Kuate has more than 15 years of combined experience in biotechnology research and CMC Regulatory Affairs for biologics and biotechnology-based products. He currently works for Boehringer Ingelheim as Associate Director, Global CMC Regulatory Affairs, where he is responsible for the development of CMC regulatory strategy for global development of biosimilars, innovator biologics, and gene therapy products.
Prior to joining Boehringer Ingelheim, Dr. Kuate worked for other biopharmaceutical companies, where he was responsible for the development of CMC and clinical regulatory affairs strategy for global development and life cycle management of biosimilar and innovator biologics products.
Before he moved to the pharmaceutical industry, Dr. Kuate worked for the US Food and Drug Adminstration (FDA) as CMC reviewer for cell and gene therapy products, where he reviewed quality sections of gene therapy regulatory dossiers, and also conducted research on the development and characterization of cell-based assays for the detection of replication- competent lentiviruses in lentiviral vector preparations.