Dr. Gillian Woollett joined Samsung Bioepis in November 2021 as VP, Head Regulatory Strategy and Policy, US (SBUS), to stand up a US presence for science-based regulatory strategy and policy in the leading global market for biologics, including but not limited to biosimilars.

She CoChairs the Biosimilars Committee of the International Generics and Biosimilars Association (IGBA) and is their Topic Leader for ICH M18 – the ICH new guideline defining the role of clinical studies in biosimilars development.

Prior she was SVP and Principal Regulatory Scientist at Avalere Health where she led the FDA Policy and Regulatory Strategy Practice, providing the “prequel” of scientific and technical expertise to support drugs, biologics and devices gaining approval at the FDA in a manner that allows them to be commercially successful.

Previously, Dr. Woollett was Chief Scientist at the law firm of Engel & Novitt, LLP. She was VP, Science and Regulatory Affairs at BIO; after PhRMA, where her group led on the negotiation and creation with FDA of the comparability protocol in support of manufacturing changes to already licensed biologics (that became the conceptual basis of biosimilarity).

In her PhRMA capacity, she testified before Congress and represented the biopharma industry in the media as the industries’ voice on international, as well as US, regulatory and scientific issues. She has served on Federal Advisory Committees; such as the industry representative on CDC’s Board of Scientific Counsellors to the National Center for Infectious Disease. She was an appointee to the Nomenclature and Labelling Expert Committee of the United States Pharmacopeia (USP), was on the Board for the Foundation for The Accreditation of Cellular Therapy (FACT), and served on the Science Board of the Pharmaceutical Education Research Institute (PERI).

Dr. Woollett earned her B.A., M.A. in Biochemistry from the University of Cambridge, and her D.Phil. in Immunology from the University of Oxford in the UK.