The Food and Drug Law Institute To Honor Axelrad, Gibbs, Holcombe, Kingham

Honorees Will Receive Distinguished Service and Leadership Awards at Holiday Reception December 10

WASHINGTON, Dec. 5, 2013 /PRNewswire-USNewswire/ -- The Food and Drug Law Institute will honor four outstanding food and drug law professionals with its annual Distinguished Service and Leadership Award: Jane Axelrad, Jeffrey Gibbs, Kay Holcombe and Richard Kingham.

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The honorees will receive their awards at FDLI's Holiday and Leadership Awards Reception December 10 at the Westin Georgetown Hotel in Washington, D.C., which will also be the site of the Institute's Enforcement, Litigation and Compliance Conference December 10-11.

The award, established in 1993, is given to individuals who have a record of sustained service, leadership and contribution to the food and drug law community and/or FDLI or provided an exceptional contribution to FDLI and/or the food and drug law community.

The Food and Drug Law Institute, founded in 1949, is a non-profit organization that provides a marketplace for discussing food and drug law issues through conferences, publications and member interaction. The scope of FDLI includes food, drugs, animal drugs, biologics, cosmetics, diagnostics, dietary supplements, medical devices and tobacco. FDLI is a not-for-profit 501(c)(3) organization. FDLI does not engage in advocacy activities. www.fdli.org

The 2013 FDLI Distinguished Service and Leadership Award Recipients:

JANE A. AXELRAD is the Associate Director for Policy in FDA's Center for Drug Evaluation and Research (CDER).  As the FDA lead on pharmacy compounding, Ms. Axelrad manages the legislative, policy, surveillance and enforcement issues related to compounding.  From 1995 to 2012, she served as the Director, Office of Regulatory Policy, CDER, where she was responsible for managing the development of new regulations and policies applicable to the FDA's regulation of human pharmaceuticals. Ms. Axelrad was instrumental in negotiating and implementing a number of key pieces of legislation including the FDA Modernization Act of 1997 and the FDA Amendments Act of 2007.   She was also a member of the FDA negotiating team on four reauthorizations of the Prescription Drug User Fee Act.  Before Ms. Axelrad joined FDA in 1991, she held a series of legal and policy positions at the Nuclear Regulatory Commission and the Environmental Protection Agency.  In 1997, she received the HHS Secretary's Award for Distinguished Service and was named a Presidential Rank Meritorious Executive in 1998 and again in 2007. Ms. Axelrad received her BA in mathematics and sociology from the University of Michigan and her JD from the Columbus School of Law, Catholic University of America.

JEFFREY N. GIBBS is a Director in the law firm of Hyman, Phelps & McNamara, P.C. in Washington, DC. In this role, he advises companies on a wide range of issues, including product approvals, marketing, clinical studies, and enforcement. Prior to entering private practice, he was Associate Chief Counsel for Enforcement at the Food and Drug Administration (FDA). He has written extensively on FDA regulatory topics, and was previously Chair of the Editorial Advisory Board of the Food and Drug Law Journal. He is currently General Counsel of The Food and Drug Law Institute (FDLI) and a member of FDLI's Board of Directors. He is also on the editorial advisory board of IVD Technology, and was a member of the Human Subjects Research Board for George Mason University. Mr. Gibbs is a graduate of Princeton University and New York University School of Law.

KAY HOLCOMBE is Vice President of Government Relations and Senior Health Policy Advisor at Genzyme- a Sanofi Company.  In this role, she works with government relations and regulatory affairs staff and principals in Genzyme and Sanofi business units and corporate offices to develop and implement corporate policies and appropriate responses to government initiatives. She also works with members of Congress and their staffs and with officials in the FDA and other agencies whose actions directly affect the corporation. Prior to this, Ms. Holcombe served as Executive Vice President of Policy Directions Inc., a government relations consulting firm, where she provided strategic planning, legislative, and policy advice to a variety of clients in the health care industry and academia. Ms. Holcombe was professional health legislative staff and senior health policy advisor to the House Commerce and Senate Labor and Human Resources Committees and FDA Deputy Associate Commissioner for Legislative Affairs, and held several other government positions. In these positions, she has engaged in every reauthorization cycle of the Prescription Drug User Fee Act. She currently serves as a Director on the FDLI Board. She received her BS in chemistry education from the University of Illinois and her MS in chemistry from the University of Virginia.

RICHARD KINGHAM is a partner at Covington & Burling LLP who concentrates on food and drug law.  He has advised most of the major pharmaceutical and biotechnology companies in the United States and Europe, as well as trade associations such as the Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Industry Organization (BIO), the Consumer Healthcare Products Association (CHPA), the Personal Care Products Council and the European Federation of Pharmaceutical Industries and Associations (EFPIA).  He has served on committees of the Institute of Medicine, the National Institutes of Health and the World Health Organization and has taught food and drug law at the University of Virginia, Georgetown University, Cardiff University and King's College London.  He was formerly the coordinator of the firm's Food and Drug Practice Group, Managing Partner of the London Office and a member of the firm-wide Management Committee.  He founded the firm's Life Sciences Industry Group, which consists of 250 senior lawyers who concentrate on representation of pharmaceutical and biotechnology companies, and is the co-head of the Industry, Regulatory and Legislative Umbrella Group, which includes the regulatory and public policy practices in the firm. 

SOURCE Food and Drug Law Institute

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