Peter Caetano is Ipsen’s Global Regulatory Affairs Director in Oxford, and a Biotech entrepreneur, co-founder of Oncoinsight in London. He teaches at the College of Medicine and Dentistry, Univ. Ulster, N. Ireland. Dr. Caetano is team leader for scientific advice and submissions worldwide for novel biologicals. He was EU Sr. reg. manager at Allergan, Latin America reg. manager at Genzyme-Sanofi, and US reg. Manager at P&G. Caetano liaises with FDA, EMA, ANVISA, etc. bringing medicines to market. Peter authors BDs, INDs, CTAs, CTDs, BLAs, MAAs. He masters CMC, preclinical and clinical reg. strategy, with technical expertise in drug development ranging from pharmaceutical biotechnology to clinical endpoint validation. Peter holds a PhD in Pharmaceutics from Michigan, MPH from Harvard, PharmD from Ohio State, PgDip from Oxford, and MBA from ESSEC-Mannheim. He was a Professor of Pharmacology & Epidemiology at Nova Medical School, and of reg. clinical research at Northeastern University.