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Law and Policy Related Career Paths for Biologists

Law and Policy Related Career Paths for Biologists

Location: Online
Cost: Free and Open to the Public
Presented by: AIBS

Event Cosponsors
Burke and Associates

As part of the American Institute of Biological Sciences (AIBS) on-going Careers In Biology webinar series, we are pleased to offer this program exploring different career paths scientists can pursue in the legal and policy space.

This one-hour program was held on Thursday, May 11, 2017, at 1:00 p.m. eastern time. During this program, panelists shared experiences and insights about their career paths in the pharmaceutical/biotechnology industry and at law and healthcare consulting firms. Panelists provided practical tips helpful to those interested in potentially working in these exciting and rapidly growing arenas. Following presentations from the panelists, there was an opportunity for participants to ask questions of the speakers.

Dr. Ryann Muir, JD, organized this program. In addition to being an AIBS member, Dr. Muir is a patent holding scientist and an attorney with the firm of Steptoe & Johnson, LLP. Other panelists include:

  • Lisa Geller: Head of Intellectual Property at Seres Therapeutics, Inc. (formerly Seres Health, Inc.)
  • Jeffrey R. Luber: President & CEO at Good Start Genetics, Inc.
  • Gillian Woollett: Senior Vice President at Avalere Health

Lisa Geller
Coming soon.

Jeffrey R. Luber, JDJeffrey R. Luber, JD
President and CEO
Good Start Genetics, Inc.

Mr. Luber is President & CEO of Good Start Genetics, Inc., a national provider of high quality, affordable genetic sequencing for families from preconception through early childhood. With more than twenty years of experience bringing new healthcare products to market, Mr. Luber has served in leadership roles at the nexus of discovery and commercial rollout. In 2009, Mr. Luber co-founded SynapDx Corp, focused on the development of the first blood-based test for the early detection of autism. Prior to SynapDx, Mr. Luber served as CEO of EXACT Sciences Corp (NASDAQ: EXAS), where he orchestrated several foundational partnerships, helped win inclusion in the medical screening guidelines of the American Cancer Society and America College of Gastroenterology, and restored the company to long-term health through a strategic transaction with Genzyme Corp. He received his BS in Business Administration from Southern Connecticut State University and his Juris Doctor and MBA from Suffolk University.

Gillian Wollett Gillian Woollett
Senior Vice President
Avalere Health

Gillian Woollett, M.A., D.Phil., is Senior Vice President at Avalere, where she leads the FDA Policy and Regulatory Strategy Practice. Avalere is 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 Biochemistry from the University of Cambridge, and her D.Phil. in Immunology from the University of Oxford in the UK.

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