Speaker
Frank M. Torti, MD, MPH, Principal Deputy Commissioner and Chief Scientist, FDA

Moderator
Erika Lietzan, Partner, Covington & Burling LLP

Panel Members
Craig W. Henry, PhD, Senior Vice President of Scientific & Regulatory Affairs,
and Chief Operating Officer, Grocery Manufacturers Association
Beverly H. Lorell, MD, Senior Medical and Policy Advisor, FDA/Healthcare Team,
King & Spalding, LLP

Program Description
This audio conference will focus on the critical role of science at the Food and Drug Administration (FDA).  The program features Frank Torti, MD, MPH, FDA’s Principal Deputy Commissioner and Chief Scientist, who will outline his agenda for science at FDA, including the categories of FDA science and its underlying principles. Dr. Torti will also discuss the FDA Commissioner’s Fellowship Program and the role of the newly expanded FDA Science Board.  Don’t miss this opportunity to hear Dr. Torti and the distinguished panelists discuss the role of science at FDA.

Registration Fees
$349 FDLI Members, Academics, 501(c)(3) Nonprofit, Government
$549 Non-members

Special CD Price!
Purchase the CD set for just $75 with your registration. To receive the special price, CDs must be purchased at the time of registration. Offer limited to one CD set per registrant. In order to use this CD, your portable CD player or computer player must be able to support the MP3 format. Shipping & handling charges will apply.

Tax: CD orders shipped to Washington, D.C. addresses will be charged 5.75% sales tax. Orders to Maryland addresses will be charged 6% sales tax.

Please contact FDLI at (800) 956-6293 or (202) 371-1420, or e-mail comments@fdli.org.

Conference Registration Policy

FRANK M. TORTI, M.D., M.P.H. serves as Principal Deputy Commissioner and Chief Scientist at the Food and Drug Administration (FDA).  The newly created Chief Scientist position stems from the Food and Drug Administration Amendments Act of 2007.  In this role, Dr. Torti will support the launch of the FDA Fellowship Program, a two year training program for professionals of varying disciplines.  Additionally, he will work to ensure the quality and regulatory focus of the intramural research programs of the agency, and place special emphasis on the importance of clinical research trials that are a part of the foundation of FDA’s regulatory structure.  Prior to joining FDA, Dr. Torti served as Charles L. Spurr Professor of Medicine, Chair of the Department of Cancer Biology, and Director of the Comprehensive Cancer Center at Wake Forest University School of Medicine in Winston-Salem, North Carolina.  Dr. Torti currently serves on the National Institutes of Health’s National Advisory Council for Complementary and Alternative Medicine.  He also founded and serves as President of the Cancer Biology Training Consortium, a national society of cancer biology department chairs and program directors.  Dr.  Torti is the recipient of a National Institutes of Health MERIT Award.  He served as an intern and resident at Beth Israel Hospital in Boston, and a fellow of medical oncology at Stanford University, where he subsequently joined the faculty and was tenured.  Dr. Torti received his Bachelor’s and Master’s degrees from the Johns Hopkins University, his M.D. from Harvard Medical School, and his M.P.H. from Harvard School of Public Health.

ERIKA LIETZAN is a Partner in the law firm of Covington & Burling LLP in Washington, D.C. She primarily advises clients in the drug, biotechnology, and medical device industries in their dealings with FDA, other regulatory agencies, Congress, the states, and the courts. She has particular expertise in issues relating to follow-on biologics, the Hatch-Waxman amendments to the FDCA, FDA protection of trade secrets and confidential commercial information, regulation of and constitutional protections for advertising and labeling, recalls, regulation of clinical trials, and drug safety issues. She has also advised clients in the food, dietary supplement, and cosmetic industries. She is on the Council for the American Bar Association's Section of Science and Technology, and she serves as chair of the section's Biotechnology Law Committee. Ms. Lietzan is also on the Editorial Advisory Board of the Food and Drug Law Journal (published by FDLI). From 2002 to 2005, she was Assistant General Counsel for the Pharmaceutical Research and Manufacturers of America (PhRMA). Ms. Lietzan received her B.A. from the University of North Carolina, with honors, her M.A. in intellectual history from UCLA, and her J.D., with high honors, from Duke Law School.

CRAIG W. HENRY, Ph.D. is Senior Vice President and Chief Operating Officer for Scientific and Regulatory Affairs, Grocery Manufacturers Association (GMA) in Washington, D.C. He is responsible for setting strategy and providing senior leadership, staff management, program direction, and financial control to the scientific and regulatory activities of the Association. This includes oversight of the Center for Technical and Laboratory Services and the Center for Northwest Seafood, the Office of Food Safety programs, regulatory affairs, and the Food Products Association Research and Education Foundation. Prior to joining FPA, he was Vice President of Quality and Food Safety with Koch Foods of Mississippi, LLC. Dr. Henry has published numerous articles in scientific journals. He is a member of the American Association of Avian Pathologists and the U.S. Poultry Science Association, where he has served as a member of the Committee on Drugs and Chemicals and he served a term as Chairman. Dr. Henry received his M.S. in Poultry Science from Clemson University, his B.Sc. in Agriculture from the University of Delaware, and his Ph.D. in Animal Science from Auburn University.

BEVERLY H. LORELL, M.D. (Bev) is the Senior Medical and Policy Advisor with the law firm of King & Spalding’s Food and Drug Administration (FDA)/Healthcare Practice Group in Washington, D.C. She specializes in the areas of clinical trial design of studies for drugs, devices and biologics; review of pre-market submissions; recalls; and assessment of matters involving a risk to health. She also specializes in the area of physician and industry relations and the development of independent scientific panels to advise health industries. Dr. Lorell is an internationally recognized clinical and basic science investigator with experience in multi-center clinical trials and preclinical proof-of-concept translational science. Prior to joining King & Spalding, she served as Vice President and global Chief Medical and Technology Officer at Guidant Corporation. Her responsibilities included evaluating emerging technologies and attendant regulatory challenges, determining product development priorities, and influencing clinical research strategies. She participated in the firm’s board for business development. Previously, Dr. Lorell was Professor of Medicine at Harvard University where she served the federal government in multiple roles. She has served in national leadership positions in professional societies. She continues to be an active invited lecturer at national professional meetings, as well as Harvard Law School and Harvard Medical School and is the author of numerous publications. Dr. Lorell graduated from Stanford University and received her M.D. and Residency in Internal Medicine from Stanford University Medical School. She received her advanced training as a Fellow in Cardiovascular Medicine at Harvard University.