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Business Roundtable

From the Hill to the Street - Examining Policy Issues in Biotech

Monday, February 11, 2008
9:30 AM
Park Avenue Suite Center/North

Tracking and predicting how policy changes will affect the marketplace is a crucial task for biotech companies. Public perception of drug safety, the lack of a regulatory pathway for follow-on biologics and recent legistlation to reauthorize PDUFA and reform the FDA are all transformative issues. How does policy affect the marketplace? What kind of action can we expect to see from Washington this year? This roundtable will review current regulatory issues in Congress and discuss how a wise policy agenda can ensure Street support for biotech.

Moderators

Panelists

Who's Who

Alan F. Eisenberg serves as Executive Vice President for Emerging Companies and Business Development at the Biotechnology Industry Organization (BIO). In this role, Eisenberg manages both advocacy and service operations for BIO?s 600 emerging companies. Specifically, he directs advocacy matters such as capital formation policy and human health policy relating to emerging companies as well as BIO?s business development and investor relations meetings and other member services. Previously at BIO, Eisenberg served as Executive Vice President for Advocacy and Operations. From March 2001 through October 2004, Eisenberg served as Health and Economics Policy Advisor to Congressman Jim Greenwood (PA-8). In this role, Eisenberg was extensively involved in the enactment of several public laws including the Medical Device User Fee and Modernization Act (P.L. 107-250), the Best Pharmaceuticals for Children Act (P.L. 107-109), and the Medicare Prescription Drug, Improvement, and Modernization Act (P.L. 108-173). Prior to that, Eisenberg served on the staff of the Senate Health, Education, Labor and Pensions Public Health Subcommittee as Health Policy Advisor and also was a legislative assistant for Congressman John Shadegg (AZ-4). Before coming to Washington, Eisenberg spent four years with Ford Motor Company in Dearborn, MI, as a research economist and finance manager in manufacturing. . Eisenberg holds a Master in Public Policy degree from Harvard University (Kennedy School of Government), a Master of Science in Finance degree from George Washington University, and a Bachelor of Science degree from Union College. He is married to Shalla Ross, and they have a daughter, Michayla.

John Swen is executive director, U.S. Science Policy and Public Affairs at Pfizer. He co-chairs Pfizer's Research, Science Policy, and Regulatory team and also represents the R&D organization on the U.S. and Global Policy Coordinating Committees. Prior to joining Pfizer in 2001, John held a series of senior posts in the biotechnology industry, as chief operating officer for Modex Therapeutiques, in the computer industry, and in government, where he served for three years in Governor Lincoln Almond's cabinet as director of economic development. John received his B.A. in English from Columbia College, and his M.S. in Management of Information and Technology and Strategy from MIT?s Sloan School of Management.

Nick Littlefield concentrates his practice in the areas of biotechnology, biomedical research and health care technology. He specializes in regulatory, administrative and legislative issues for large and small companies, non profit organizations and trade associations. Nick and his colleagues in the Foley Hoag Life Sciences Group work from offices in Boston and Washington. For nine years until 1998, Nick served as Staff Director and Chief Counsel for Massachusetts Senator Edward M.Kennedy on the United States Senate Health, Education, Labor and Pensions Committee, where he worked extensively on biomedical research, health policy, and life sciences regulatory and legislative initiatives. Previously, he taught at Harvard Law School and was an Assistant United States Attorney in the Southern District of New York. He is a graduate of Harvard College and the University of Pennsylvania Law School.

J. Donald deBethizy, Ph.D., is a co-founder of Targacept, Inc. and has served as President and Chief Executive Officer since its spinout from R. J. Reynolds Tobacco Company in August 2000; he has also served as Targacept's President since its inception in 1997. Previously, Dr. deBethizy held positions of increasing responsibility at RJR, including Vice President of Product Evaluation, Research and Development, where he was responsible for development, regulatory affairs and market introduction of reduced risk products. At Targacept, Dr. deBethizy continues to play a key role in development of a portfolio of clinical stage novel small molecules targeting central nervous system diseases, and in developing business relationships with AstraZeneca, Aventis, Dr. Falk Pharma and GlaxoSmithKline. Dr. deBethizy led Targacept?s Initial Public Offering (IPO) in April, 2006, raising $45 million; during Targacept's years as a private company, he was instrumental in raising $123 million in venture capital. Dr. deBethizy co-authored Innovation That Fits: Moving Beyond the Fads to Choose the Right Innovation Strategy for Your Business published by Prentice Hall. He is also the author of numerous peer-reviewed scientific articles and book chapters. Dr. deBethizy was recognized by Ernst & Young as Emerging Company Entrepreneur of the Year in 2002 for his leadership in founding Targacept. In June of that year, Targacept was also the subject of a Best Practice case study article in the Harvard Business Review entitled Spinning Out a Star. Within the Winston-Salem community, he is currently on the board of directors of the Piedmont Triad Research Park, United Way of Forsyth County, and Winston Salem Chamber of Commerce, and on the Board of Visitors of Winston-Salem State University. He has also served on the boards of Forsyth Technical Community College Foundation and Piedmont Triad Entrepreneurs Network (PTEN). Dr. deBethizy was recently elected to the Emerging Companies Se

Mr. Awadalla founded and developed Wells Fargo Securities' life sciences team, which handled corporate finance, mergers and acquisitions and private capital. In addition, he oversaw the firm's successful life sciences conferences. He brought a number of clients - including Arthrocare, Rita Medical, Insmed, InVivo and Cubist - to Wells Fargo Securities from Robertson Stephens, where he was a managing director and head of life sciences mergers and acquisitions from 1997 to 2002. He had held the same position at UBS. He was previously at Merrill Lynch & Co. and L.F. Rothschild, Unterberg, Towbin. He holds a BA from Columbia University and an MBA and an MA from The Wharton School.