Peter Caetano
Senior Director, Global Regulatory Affairs
Ipsen
Peter Caetano is a Senior Director, Global Regulatory Affairs, and Global Regulatory Lead for multiple indications of novel biologicals at Ipsen in Cambridge, MA, US. He had previous regulatory roles at Allergan-AbbVie in the UK, Genzyme-Sanofi in Cambridge, MA, and Procter & Gamble in Cincinnati, Ohio. Peter’s 16-years of regulatory expertise ranges from first in human clinical trials to submissions, with many novel drugs approved thereafter, and post-market compliance. Peter successfully leads interactions with health authorities such as US FDA, EU EMA, Japan PMDA, China NMPA, or Brazil's ANVISA. This in therapeutic areas as diverse as neurology, rare diseases, endocrinology, oncology, rheumatology, or reproductive health. He leads and has led teams performing regulatory activities such as CTAs/INDs, PIP/PSP, parallel advice, BLAs/MAAs, variations, advisory committees, commercial regulatory compliance, inspections, etc. Additionally, he is a trusted regulatory advisor for external innovation and due diligence, quickly devising, challenging, or improving clinical and regulatory development plans in a variety of indications, including those yet without regulatory precedent. Outside of regulatory, he was in pharmaceutical sales and was a professor in a medical school. Dr. Caetano has a solid academic background focused on pharmaceutical development and regulatory. He has a PhD in Pharmaceutics, where at the University of Michigan he collaborated with FDA, USP (United States Pharmacopeia) and Viatris (formerly Mylan, UpJohn), with internships at BMS and Merck. Moreover, Peter completed a PharmD at Ohio State, an MPH at Harvard, an MBA at ESSEC-Mannheim, and postgraduate diplomas at the universities of Oxford, Hertfordshire, and London.