A National Consumers League Stakeholder Forum

Biologics: The Pathway to Biosimilar Products?

September 18, 2007

AFL-CIO Building

Presidents Room, First Floor 

815 16th Street, NW

Washington, DC

 

Speaker Biographies

Legislative Update:

Nick Shipley

Nick Shipley has worked for Congressman Jay Inslee (D-WA) for six years and currently serves as his legislative director. He has handled a variety of issues during his time with Mr. Inslee, notably working on health care legislation for the last five years. During the past year, he has worked extensively on the issue of biosimilar biologics, including the development and introduction of HR 1956, the Patient Protection and Innovative Biologic Medicines Act of 2007, legislation that establishes a pathway for FDA approval of biosimilar biologics.

Ann Witt

Ann Witt, J.D., serves as Health Counsel to Congressman Henry Waxman (D-CA), Chairman, House Committee on Oversight and Government Committee.  Previous experience includes working at the FDA’s Office of the General Counsel focusing on counseling on new drug and device issues from 1980-1991.  She served as the Acting Director of the Division of Drug Marketing and Advertising in the Center for Drug Evaluation and Research (CDER) in 1992, and then joined the Office of the Commissioner in 1992, where she worked on a variety of issues including tobacco and pediatric labeling for new drugs.   Prior to working for Congressman Waxman, Ms. Witt served as the Staff Director of an investigation in 2000 for the World Health Organization (WHO) into covert attempts by the tobacco industry to influence WHO

 

Panel 1 :

Erika Lietzan

Erika Lietzan, J.D., partner at Covington & Burling, LLP, focuses on FDA regulation of prescription and OTC drugs, biologics, and medical devices. Her work includes advocacy at FDA, advisory work and strategic advice relating to FDA matters, and assistance with related legislative strategies on the Hill and in the states. Ms. Lietzan has particular expertise in issues relating to biosimilar biologics; the Hatch-Waxman amendments to the Food Drug and Cosmetic Act; FDA protection of trade secrets and confidential commercial information; regulation of and constitutional protections for advertising and labeling of drugs and devices; importation, counterfeiting, and Internet pharmacy; regulation of clinical trials; drug safety; and good manufacturing practices (GMPs).  Before joining Covington & Burling, she served as the Assistant General Counsel for PhRMA.

Roger L. Williams                        

Roger Williams, M.D., has been the Executive Vice President and Chief Executive Officer of the United States Pharmacopeia (USP) since April 2000. Dr. Williams provides strategic leadership for USP at the direction of USP's Board of Trustees and serves as chair of the Council of Experts, USP's scientific body. Since joining USP, Dr. Williams has reorganized the structure of the Council of Experts, brought focus to its science-based decisions, and has aligned USP's efforts with other pharmacopeias throughout the world.  He has established stakeholder forums that promote communication with and input from pharmaceutical and dietary supplement manufacturers, compounding professionals, patient safety advocates, and USP's membership. Before joining USP he worked at the FDA for 10 years. He has authored or co-authored approximately 200 reports in the areas of clinical pharmacology, patient safety, biopharmaceutics, and pharmaceutical chemistry, and has published books on clinical pharmacology and regulatory science. He retains an adjunct appointment at UCSF and is a board-certified internist and clinical pharmacologist.   

William B. Schultz

William Schultz, J.D., partner at Zuckerman Spaeder LLP, focuses on food and drug law, civil litigation, administrative law, and public interest law. Drawing from his vast experience in these areas, he represents individuals (including those who have been injured by foods, drugs, and other products), generic and small biotechnology drug companies, state and local governments, associations, and advocacy organizations before the courts, federal government agencies, and Congress.  Before joining Zuckerman Spaeder, Mr. Schultz held the position of Deputy Assistant Attorney General.  He also served as the Food and Drug Administration's Deputy Commissioner for Policy, and was Counsel to Representative Henry A. Waxman, Chairman of the House Subcommittee on Health and the Environment. At Public Citizen Litigation Group, where he began his legal career, Mr. Schultz tried and argued cases in federal and state trial and appellate courts, including several cases in the U.S. Supreme Court.  

Panel 2 :

David Borenstein

David Borenstein, M.D., F.A.C.P., F.A.C.R., is a Clinical Professor of Medicine, Division of Rheumatology at The George Washington University Medical Center and a partner at Arthritis and Rheumatism Associates, P.C.  He is board-certified in internal medicine and in rheumatology, and is author or co-author of more than 100 journal articles and books, including three medical textbooks. He is a Fellow of the American College of Rheumatology.  His research interests include development of new medications for pain and inflammation and appropriate use of magnetic resonance imaging.  Over the years, Dr. Borenstein has participated in numerous FDA Advisory Boards, and the FDA has invited him to review current low back pain medications.  He is a popular lecturer for the Arthritis Foundation and other patient education groups, and does public service spots about proper back health. He has appeared on national news programs including CBS National News.  He is listed in the Best Doctors in America, Year 2005, named a "top doctor" by Washingtonian Magazine multiple times, and was in Who's Who in America in 2004.

Michael T. Brodeur

Michael Brodeur, R.Ph., M.B.A., is the Head of the Formulary Development & Pharmacy Clinical Policies Unit for Aetna Pharmacy Management (APM).  His primary responsibilities include oversight of the drug class reviews for development of the Aetna National Formulary, and oversight of the Aetna National Pharmacy & Therapeutics Committee (P&T).  He has worked in managed care for over 13 years, and has 20 years of experience as a practicing pharmacist in clinical pharmacy and in pharmacy health care management roles.   Mr. Brodeur is also involved with the University of Georgia, College of Pharmacy as a preceptor in the PharmD program.  He is a licensed pharmacist in the states of Georgia, Massachusetts, and Florida. 

Henry G. Grabowski

Henry Grabowski, Ph.D., has been at Duke since 1972, where he is Professor of Economics and Director of the Program in Pharmaceuticals and Health Economics.  Professor 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 been an advisor 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. 

Steven B. Miller

Steven Miller, M.D., is Chief Medical Officer for both Express Scripts and CuraScript.  He has years of experience as a medical researcher, clinician and administrator.  Dr. Miller joined Express Scripts in April 2005 as vice president of Research and Product Development. He has made substantial contributions to reinforcing the model of generic and low-cost brand promotion.  As Chief Medical Officer he focuses much of his efforts on the integration of pharmacy into the total care of patients and to the rapidly growing field of specialty pharmacy.  Recognized for research in the areas of acute renal failure, hypertension and healthcare economics, Dr. Miller has been invited to speak in Europe, Asia, Africa, and North America, and has published over 75 scientific articles.

Respondents:
Ruth Hoffman

Ruth Hoffman, M.P.H., serves as the Executive Director of the national office of Candlelighters Childhood Cancer Foundation, a nonprofit organization dedicated to providing information and awareness for children and adolescents with cancer and their families, advocating for their needs, and supporting cancer research.  She is a patient consultant for the FDA and is a rotating member of the FDA's Pediatric Subcommittee of the Oncology Drug Advisory Committee.  Ms. Hoffman’s leadership has resulted in the publication of numerous books for families of children with cancer.  She also provides a patient navigation program and personally responds to thousands of requests for childhood cancer treatment information annually.  She is co-founder and organizer of Candlelighters National Childhood Cancer Awareness Tree.

Shawn O’Neail

Shawn O'Neail, M.P.A., is the Associate Vice President of Federal Government Relations at the National Multiple Sclerosis Society’s Public Policy Office in Washington DC.  Prior to joining the National MS Society, Mr. O’Neail worked for the Social Security Administration (SSA) as a District Manager in a St. Louis metropolitan office.  Other positions he held while working for SSA included Policy Analyst for the Deputy Commissioner in Washington, DC and Executive Officer for the Regional Commissioner in Kansas City, MO.  He also has experience working in Congressional offices, political campaigns and previously taught Political Science at Jefferson Community College.  

Lunch Speaker:

Susan Dentzer

Susan Dentzer is a career journalist and on-air correspondent for The NewsHour with Jim Lehrer on PBS, where she leads a unit that specializes in coverage of health care and health policy.  Ms. Dentzer’s work has received numerous awards, including a 2006 first place award for excellence from the Association of Health Care Journalists for a two-part series on one of the most severely wounded veterans of the Iraq war. Ms. Dentzer’s expertise and journalistic abilities have led to frequent appearances on other nationally televised news programs as well, including The McLaughlin Group and CNN.  She is also host of a weekly health segment on Discovery.com.  A graduate of Dartmouth, Ms. Dentzer holds an honorary Master of Arts degree from Dartmouth and an honorary doctorate of humane letters from Muskingum College, New Concord, Ohio.