Senior Vice President and Head FDA Policy and Regulatory Strategy Practice - Avalere Health
Gillian Woollett, M.A., D.Phil., SVP at Avalere, leads the FDA Policy and Regulatory Strategy Practice at Avalere, an advisory services firm of over 250 people that supports clients throughout the healthcare
system, from patients to biopharma companies and payers/providers. At Avalere she provides the “prequel” of scientific and technical expertise that supports drugs, biologics and devices gaining approval at the FDA in a manner that allows them to be commercially successful in the public and private reimbursement world. She launched the FDA Practice in 2012. Dr. Woollett and her Team translate into practical action all aspects of regulatory engagement strategy and policy development relevant to commercial success for multiple multi-national clients. Concurrently, she created the Avalere FDA Fellows Program to enable scientists to transition effectively into the policy environment with over 20 now having used this stepping stone to transition 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, for example, 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 but without invoking any concerns of anticompetitive activity. In her PhRMA capacity, she testified before Congress on human cloning, and with four Ambassadors on biological weapons issues.
Dr. Woollett has represented the biopharma industry in the media as the industries’ voice on international, as well as domestic, regulatory and scientific issues. She has been an appointee on Federal Advisory
Committees; for example, she represented industry on CDC’s Board of Scientific Counsellors to the National Center for Infectious Disease. She is currently represents biotechnology on the Material Technical Advisory Committee (MTAC) at the Department of Commerce (requiring a Secret Security clearance), and chairs the Biotech Work Group that addresses export controls and the Biological Weapons Convention, among other issues. 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), on the Board for the Foundation for The Accreditation of Cellular Therapy (FACT), and on the Board of the Pharmaceutical Education Research Institute (PERI).
Gillian earned her B.A., M.A. in the 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.