Gillian Woollett MA, DPhil

VP, FDA Regulatory Strategy and Policy

Avalere Health, LLC

Gillian Woollett, MA, DPhil, Vice President, leads the FDA Practice within Avalere's Center on Evidence-Based Medicine. She provides the “prequel” of scientific and regulatory strategic policy expertise that supports medicinal products gaining approval at the FDA in a manner that allows them to be successful in the public and private reimbursement world. She is building a bridge for Avalere clients from the FDA space into the traditionally separate CMS and health care policy/business world. This connection must increasingly be considered from much earlier in product development that has historically been the case.

Trained as a molecular biologist/immunologist before coming to Washington, Gillian still publishes in the peer reviewed literature on biotechnology topics, and is also a frequent speaker educating on the core prospects and promises of the emerging biosciences and their ability to support better and more focused therapies. A true believer in the power of these technologies to change lives, she is also aware of the challenges for access and affordability as a public policy health objective, and sees opportunities for all stakeholders in a greater understanding of how thoughtful policy can stimulate practical solutions.

Immediately prior to joining Avalere, Gillian was Chief Scientist at the boutique food and drug law firm of Engel & Novitt, LLP. Prior to that, she was Vice President, Science and Regulatory Affairs at the Biotechnology Industry Organization (BIO), where she established and led a new Department to support BIO companies’ interactions with regulatory agencies in all aspects of the discovery, development, and manufacture of biotechnology-based medicines. She joined BIO after being Associate VP at PhRMA. Throughout, Gillian has represented the biopharma industry with the media, and she served as the industries’ voice on international, as well as domestic, regulatory and science issues. She has been an appointee on Federal Advisory Committees to CDC and the Department of Commerce, and provided a point of scientific interface with academic and professional organizations.

Gillian earned her B.A., M.A. in the Natural Sciences Tripos (Biochemistry) from the University of Cambridge, and her D.Phil in Immunology from the University of Oxford in the United Kingdom.
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