Gillian Woollett


Gillian Woollett, M.A., D.Phil.
Chair, IGBA Biosimilars Committee

VP, Head Regulatory Strategy and Policy
Samsung Bioepis US (SBUS)

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.

Prior to this recent move, she was SVP and Principal Regulatory Scientist at Avalere Health where she created and led the FDA Policy and Regulatory Strategy Practice. Avalere, an advisory services firm of ~250 people, supported clients across the healthcare spectrum, from patients to biopharma companies and payers/providers. She provided 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. She led on peer reviewed publications supporting regulatory reliance globally, including harmonization (US)/ convergence (EU) to facilitate access and affordability. She created the Avalere FDA Fellows Program to enable scientists to transition effectively into the policy environment with >40 having used this steppingstone to transition their careers.

Previously, Dr. Woollett was Chief Scientist, and Administrator, at the law firm of Engel & Novitt, LLP – a boutique food and drug law firm that fully integrates sound science into all its services, and notably won an unreasonable delay suit against FDA during her tenure. Prior to that, she was VP, Science and Regulatory Affairs at BIO, where she established a new Department to support BIO companies’ interactions with regulatory agencies in all aspects of the discovery, development, and manufacture of biologic medicines from a scientific, technical and policy perspectives. She joined BIO after serving as AVP at 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). At both trade associations, Dr. Woollett managed the interface between bio/pharma companies and the US Government in a manner that enabled their collective ability to expedite product development. In her PhRMA capacity, she testified before Congress on human cloning, and with four Ambassadors on biothreat issues.

Dr. Woollett has represented the biopharma industry in the media as the industries’ voice on international, as well as US, regulatory and scientific issues. She has been appointed to Federal Advisory Committees; for example, she represented industry on CDC’s Board of Scientific Counsellors to the National Center for Infectious Disease. She currently represents biotechnology on the Material and Engineering Technical Advisory Committee (METAC) at the Department of Commerce and chairs the Biotech Work Group. She also provides a point of scientific interface with academic and professional organizations. She is an appointee to the Nomenclature and Labeling Expert Committee of the United States Pharmacopeia (USP), was on the Board for the Foundation for The Accreditation of Cellular Therapy (FACT) for almost a decade, 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. She was a post-doc in the Department of Molecular Biology at the University of Edinburgh, and at the Biomedical Research Institute, Rockville, MD funded by USAID. She is well published in the peer reviewed literature.

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