Lamine is a decisive and strategic regulatory affairs scientist and senior manager with twenty years experience in global pharmaceutical industry and clinical regulatory development. He is a Content-expert in translational medicine covering small molecule and biologic drug development in, autoimmune disorders, infectious disease indications with emphasis on therapeutic area strategy and competitive landscape. His regulatory expertise covers five regulatory jurisdictions: North and South America, Europe, South East Asia and Africa.
He have been a global regulatory affairs leader for diverse programs that required hands on work on INDs, CTAs, IMPDs, NDA submissions, as well as pre-IND, End-of-Phase2 and pre-NDA meetings with the FDA, EMA and other international regulatory agencies. He have submitted successfully and globally fourteen INDs/CTAs in which four first-in-human (FIH) studies in diverse fields including antivirals, immunology, oncology and inflammation. He was one of four key functional area champions in the development of a novel regulatory policy for telemedicine during his tenure at Genentech, Roche (South San Francisco, CA).
His background is in biology and toxicology. He completed his veterinary training at l’Ecole Veterinaire de Maison Alfort in France. During residency, he worked for the most prestigious equine clinic in Paris under the management of Dr. Richard Corde. He completed three masters: European Regulatory Affairs, Pharmacoeconomics at University of Lille II in (France) and a master in biology at University of Paris V France.
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