Speaker biographies

John E. Calfee is a resident scholar at AEI. From 1980 to 1986, he served in the Bureau of Economics at the Federal Trade Commission. Mr. Calfee has taught marketing and consumer behavior in the business schools of the University of Maryland–College Park and Boston University, and was a visiting senior fellow at the Brookings Institution. Mr. Calfee’s research has focused on FDA regulation, health care, advertising and information, tort liability, and other related areas. He is the author of Prices, Markets, and the Pharmaceutical Revolution (AEI Press, 2000) and Fear of Persuasion: A New Perspective on Advertising and Regulation (AEI Press, 1997).

Bruce L. Downey is chairman of the board and chief executive officer of Barr Laboratories. Mr. Downey has also been chief executive officer and chairman of the board of Barr Pharmaceuticals Inc., a parent company of Duramed Pharmaceuticals Inc., since February 1994. From January 1993 to December 1999, Mr. Downey was president of Barr Laboratories. From 1981 to 1993, Mr. Downey was a partner in the law firm Winston & Strawn and a predecessor firm, Bishop, Cook, Purcell, and Reynolds. Mr. Downey has been a member of the board of directors of Barr Pharmaceuticals Inc. since January 1993. He has been a director of Warner Chilcott PLC since 1997.

Scott Gottlieb, M.D., is a resident fellow in health policy at AEI. Prior to returning to AEI, he was the deputy commissioner for medical and scientific affairs at the U.S. Food and Drug Administration (FDA) and a former senior official at the Centers for Medicare and Medicaid Services. While a practicing physician from 2003–04, Dr. Gottlieb served as a senior advisor to the FDA commissioner and as the agency’s director of medical policy development, leaving in the spring of 2004 to work on implementation of the new Medicare drug benefit as a senior adviser to the administrator of Medicare and Medicaid Services. Before re-joining the FDA, Dr. Gottlieb worked as a resident fellow at AEI, an American medical correspondent for the British Medical Journal, and a writer for Forbes magazine. The author of more than 300 policy and medical articles, Dr. Gottlieb is a noted authority on issues pertaining to health policy and medical technology, and on seeking improvements in public health through innovation in technology, medical practice, and health care delivery. Dr. Gottlieb practiced medicine as an attending physician at Stamford Hospital in Connecticut, where he was an internist on the hospital’s inpatient medical wards.

Henry Grabowski has been at Duke University since 1972, where he is a professor of economics and the director of the Program in Pharmaceuticals and Health Economics. He has also served on the faculty of Yale University and held visiting appointments at the Health Care Financing Administration in Washington, D.C., and the International Institute of Management in Berlin, Germany. Grabowski has published numerous studies on the pharmaceutical industry, with his principal research involving the economics of the innovation process, business regulation, and industrial organization. He has investigated the economics of pharmaceutical research and been an adviser and consultant to several organizations, including the National Academy of Sciences, the Institute of Medicine, the Federal Trade Commission, the General Accounting Office, and the Office of Technology Assessment.

Ajaz Hussain joined Sandoz Inc., the generic member of the Novartis group of companies, in November 2005 as vice president and global head of biopharmaceutical development, with responsibilities including the development and registration of the biosimilars and follow-on-protein portfolio. Immediately prior to Sandoz, he was deputy director of the Office of Pharmaceutical Science in the Center for Drug Evaluation and Research at the Food and Drug Administration (FDA), where he was the senior scientific leader, with oversight responsibilities for the development of science-based regulatory policies and the management of both review and research activities in the offices of new drug chemistry, generic drugs, biotechnology products, and test and Research. Prior to joining the FDA in 1995, he was a tenured associate professor of pharmaceutics at the University of Cincinnati.

Richard F. Kingham is a Covington & Burling LLP partner assigned to the Washington and London offices who concentrates on food and drug law, European community law, product liability, and product safety. He has acted for most of the major pharmaceutical manufacturers and biotechnology companies in the United States and Europe, as well as trade associations such as the Pharmaceutical Research and Manufacturers of America, the Consumer Healthcare Products Association, and the National Pharmaceutical Council

Jeffrey Kushan is a partner with Sidley Austin LLP in Washington, DC. He is practice group chair for the patent group in the firm’s DC office. Mr. Kushan focuses on Hatch-Waxman patent litigation, patent appeals, and complex patent administrative proceedings. He conducts patent portfolio reviews for clients, both for pre-litigation purposes and incidental to licensing or acquisitions. He also represents clients, including trade associations, on domestic and international patent policy matters. In 2003, he was named one of the top forty-five lawyers in the United States under the age of forty-five by American Lawyer magazine, and in 2006, was listed in the 2006–07 edition of “Best Lawyers in America” for the Washington, DC, region. Mr. Kushan has testified numerous times before Congress on patent law reform, and is a frequent lecturer on domestic and international patent issues. He is a member of the George Washington University Intellectual Property Advisory Board and serves on the executive committee of AIPPI-US and the Industry Functional Advisory Committee of the Department of Commerce.

Dan Mendelson is president and founder of Avalere Health, a leading strategic advisory company based in Washington, DC. Formerly known as the Health Strategies Consultancy, Avalere Health provides strategic consulting, policy development, and analytic research to a diverse client base including Fortune 500 health-care technology companies, federal government agencies, and major medical foundations. A primary focus of Avalere Health is Medicare and Medicaid policy, including the implementation of the Medicare Modernization Act. Mr. Mendelson previously served as associate director for health at the Office of Management and Budget (OMB), the White House office responsible for budget development and policy coordination across the administration. In his role with the OMB, Mr. Mendelson was responsible for Medicare, Medicaid, the National Institutes of Health, the Centers for Disease Control, and the Food and  Drug Administration. His work included development of presidential initiatives in pharmaceutical benefits, health information technology, medical error prevention, electronic disease surveillance, and other federal policies in reimbursement and technology assessment.

Audrey Phillips is an executive director of biopharmaceutical public policy and advocacy with more than thirty years of experience in the pharmaceutical sector at Johnson & Johnson. Her focus is to provide education with regard to health policies that affect patients and impact the innovation of biopharmaceutical medicine. Ms. Phillips has held various leadership positions over the years throughout all areas of drug discovery and development. These positions have included discovery team leader, reproductive medicine franchise team leader, various global product leader positions, and head of strategic life cycle management. She was an adjunct associate professor in the OB-GYN department at the University of Medicine and Dentistry of New Jersey, a recipient of the TWIN (Tribute to Women in Industry) Award, and the author of more than sixty publications.

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