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FDLI to honor food & drug law professionals

WASHINGTON — Top officials at Johnson & Johnson and the Food and Drug Administration are among those to receive service and leadership awards from the Food and Drug Law Institute. The honorees include Minnie Baylor-Henry, worldwide VP for regulatory affairs at Johnson & Johnson Medical Devices & Diagnostics; John M. Taylor III, counselor to the commissioner, Office of the Commissioner, FDA; Alan Bennett, managing partner of the Ropes & Gray DC office and Thomas O. Henteleff, managing partner of Kleinfeld, Kaplan and Becker.

The four will receive their awards at FDLI's Holiday and Leadership Awards Reception December 12 at the Westin Georgetown in Washington, D.C.

FDLI, founded in 1949, is a nonprofit 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.

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, for example, through outstanding writing or scholarship, by developing new legal theories and precedents or engaging in significant activities on behalf of the public interest.

Baylor-Henry is the worldwide VP for regulatory affairs at Johnson & Johnson Medical Devices & Diagnostics. As a former FDA regulator, pharmacist and regulatory leader, she has extensive leadership, regulatory and policy experience from her careers in government, as well as the pharmaceutical and consumer industries. Prior to returning to J&J, she was a national director for regulatory & capital markets consulting at Deloitte & Touche, with a practice focus on regulatory life sciences. Prior to Deloitte & Touche, Baylor-Henry worked in several roles at J&J in the pharmaceutical and consumer sectors: senior director for regulatory affairs; VP, U.S. medical & regulatory affairs; and global VP for OTC regulatory affairs for McNeil Consumer Healthcare. During her career at FDA, she had many roles, most notably FDA's national health fraud coordinator and the director of the division of drug marketing, advertising, and communications from 1995-1999. As the director of DDMAC, Baylor-Henry was responsible for the regulatory oversight of all prescription drug advertising and marketing. She currently serves as immediate past chair of the Food and Drug Law Institute and president-elect of the Drug Information Association. Baylor-Henry received her pharmacy degree from Howard University's College of Pharmacy and her law degree from Catholic University's Columbus School of Law.

John M. Taylor III is counselor to the commissioner, Office of the Commissioner, FDA. In this role, he advises the commissioner on a broad range of policy and regulatory issues. He advocates for and advances the commissioner's priorities related to agency policies and programs. Taylor leads the development and management of FDA's emergency and crisis management policies and programs. He oversees FDA's participation in counterterrorism and emergency exercises and the coordination of the agency's emergency and crisis situations. Taylor began his FDA career in 1991 in the Office of the Chief Counsel. While at FDA, he has held several management positions such as: senior advisor for regulatory policy in the Office of the Commissioner, the acting director of the Office of Compliance in the Center for Drug Evaluation and Research, the director of the Office of Enforcement and associate commissioner for Regulatory Affairs. Outside of his FDA career, Mr. Taylor served as the EVP of health for the Biotechnology Industry Organization. Until this appointment, he served as divisional VP of government affairs, with Abbott Laboratories. Taylor received his law degree from the College of William and Mary.

Alan Bennett, managing partner of the Ropes & Gray DC office, has advised clients on issues involving pharmaceutical marketing and promotion for more than 25 years. Bennett counsels clients and represents them at FDA and in Congress on many of the critical issues that affect the pharmaceutical industry. He is a recognized expert on the Hatch-Waxman Act and lifecycle management. Bennett also has extensive experience in biological products, including the new biosimilars legislation, in food additive approvals, orphan drugs and in over-the-counter drugs and the procedures used to switch them from prescription to non-prescription status. He began his legal career in the Office of the General Counsel of the Food and Drug Administration, where he was a trial and appellate lawyer and legal advisor to several FDA bureaus. Subsequently he was legislative assistant to the late Senator Jacob Javits and special counsel to the Senate Governmental Affairs Committee, where he played a major role in one of the first medical records privacy initiatives. After leaving the Hill, Bennett co-founded a food and drug boutique firm that was ultimately known as Bennett, Turner and Coleman, which merged into Ropes & Gray in 2002. He received his law degree from Columbia University School of Law (Harlan Fiske Stone Scholar) and BA, with honors, from the University of Connecticut.

Thomas O. Henteleff joined Kleinfeld, Kaplan and Becker in 1969 after spending a year clerking for the honorable David T. Lewis of the United Court of Appeals for the 10th circuit. Henteleff became a partner of the firm 4.5 years after joining the firm and became the firm's managing partner in the 1990s. Since joining KK&B, Henteleff has been engaged in all aspects of food and drug law. He represents companies, trade associations, investors and individuals that manufacture, market, invest in or otherwise have a keen interest with respect to the legal and regulatory requirements pertaining to drugs, medical devices, foods, dietary supplements, cosmetics, pesticides and other consumer products. His practice covers the administration and enforcement of the Federal Food, Drug and Cosmetic Act, the Controlled Substances Act, the Federal Trade Commission Act, the Lanham Act and other related laws. He has been honored by FDA and numerous national and international lawyer rating organizations. Henteleff has served on FDA's Grassroots Task Force, FDLI's advisory board and editorial board and the advisory board of World Pharmaceutical Report. Henteleff received his law degree from the University of California at Berkeley (Boalt Hall) and BS, certificate in internal relations, from the University of Utah (magna cum laude).

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