Faculty

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Speakers

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Thomas W. Abrams, RPh, MBA, Director, Division of Drug Marketing, Advertising, and Communications, Office of Medical Policy, CDER, FDA

Jann T. Balmer, PhD, RN, Associate Professor, Director of Continuing Medical Education, University of Virginia School of Medicine, and, President, Alliance for CME

Minnie V. Baylor-Henry, JD, Regulatory & Capital Markets Consulting,
Deloitte & Touche LLP

Thomas Casola, Vice President, Regulatory Affairs, Advertising and Promotion, Shire Specialty Pharmaceuticals

David E. Chadwick, PhD, Regulatory Scientist, Regulatory Affairs, Cook Group Inc.

Barbara S. Chong, PharmD, Team Leader, DDMAC, OMP, CDER, FDA

Louis E. Cobuzzi, Associate Chief Consultant of Pharmacy Benefits Management Services, Policy Development & Program Analysis, Veterans Health Administration

Richard M. Cooper, Partner, Williams & Connolly LLP

James N. Czaban, Partner, Wiley Rein LLP

Diane E. Dorman, Vice President of Public Policy, National Organization for Rare Disorders (NORD)

Norman A. Drezin, RPh, JD, President, Drezin Consultants, LLC

Sue E. Duvall, Director, Global Regulatory and Safety, Amgen Inc.

Maryann R. Gallagher, Regulatory Reviewer, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality, CBER, FDA

Terri T. Garvin, JD, Regulatory Counsel, Office of Compliance, CDRH, FDA

Jonathan I. Gurland, Attorney, Office of the General Counsel, U.S. Department of Veterans Affairs

Ralph F. Hall, Distinguished Professor and Practitioner,
University of Minnesota Law School

Michele M. Hardy, Executive Director, Regulatory Advertising and Promotion Policy, GlaxoSmithKline

Sheila M. Hemeon-Heyer, JD, RAC, Vice President, Global Regulatory Affairs, Boston Scientific Corporation Inc.

Jennifer A. Henderson, MPH, Attorney, Hogan Lovells LLP

Steven E. Irizarry, Senior Vice President, Capitol Hill Consulting Group

Karen Jagielski, Senior Attorney, Division of Advertising Practices, Federal Trade Commission

David P. Jones, Legal Director, Intervet/Schering-Plough Animal Health

Geoffrey M. Levitt, Senior Vice President & Associate General Counsel, Regulatory & Policy, Pfizer, Inc.

Tammara M. Lewis, Director, Regulatory Affairs, Advertising and Promotional Labeling Group, Genzyme Corporation

Freda C. Lewis-Hall, MD, Chief Medical Officer, Senior Vice President,
Pfizer, Inc.

Michael K. Loucks, Partner, Skadden, Arps, Slate, Meagher & Flom

Dorothy R. McAdams, VMD, Team Leader, Post-Approval Review Team, Division of Surveillance, Office of Surveillance and Compliance, CVM, FDA

Daniel Meron, Partner, Latham & Watkins LLP

Lewis A. Miller, Principal, WentzMiller & Associates, LLC

Jeannie M. Perron, JD, DVM, Of Counsel, Covington & Burling LLP

Wayne L. Pines, President, Regulatory Services and Healthcare,
APCO Worldwide

Ann M. Ravel, Deputy Assistant Attorney General, Torts Branch and Office of Consumer Litigation, Civil Division, U.S. Department of Justice

Martin H. Redish, Professor of Law and Public Policy, Northwestern University School of Law, and, Senior Counsel, Sidley Austin LLP

Mary E. Riordan, Senior Counsel, Administrative & Civil Remedies Branch, Office of the Inspector General, U.S. Department of Health & Human Services

Janet Lucy Rose, President, Lucy Rose & Associates, LLC

Sheila K. Ryan, PharmD, Group Leader, Professional Review Group IV, DDMAC, OMP, CDER, FDA

Michael A. Sauers, Group Leader, Direct-to-Consumer Review Group I, DDMAC, OMP, CDER, FDA

Mark S. Senak, JD, Senior Vice President and Partner, Fleishman-Hillard, and, Editor, Eye on FDA blog

Jeffrey M. Senger, Partner, Sidley Austin LLP

James G. Sheehan, Inspector General, Office of Medicaid Inspector General, New York State

James C. Shehan, Vice President and General Counsel, Legal, Government and Quality Affairs, Novo Nordisk Inc.

Toni M. Stifano, Consumer Safety Officer, Office of Compliance, CDRH, FDA

Lisa L. Stockbridge, PhD, Acting Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality, CBER, FDA

Helen W. Sullivan, PhD, MPH, Social Science Analyst, Direct-to-Consumer Review Group, Research Team, DDMAC, OMP, CDER, FDA

Ladd A. Wiley, JD, Consultant, Akin Gump Strauss Hauer & Feld LLP

Susan C. Winckler, RPh, Esq, President & CEO, FDLI

Deborah A. Wolf, JD, Regulatory Counsel, Office of Compliance, CDRH, FDA

Allison M. Zieve, JD, Director, Public Citizen Litigation Group

Planning Committee

Thomas W. Abrams, RPh, MBA, Director, Division of Drug Marketing, Advertising, and Communications, Office of Medical Policy, CDER, FDA
Minnie V. Baylor-Henry, JD, Regulatory & Capital Markets Consulting,
Deloitte & Touche LLP
Geoffrey M. Levitt, Senior Vice President & Associate General Counsel, Regulatory & Policy, Pfizer, Inc.
Dorothy R. McAdams, VMD, Team Leader, Post-Approval Review Team, Division of Surveillance, Office of Surveillance and Compliance, CVM, FDA
Wayne L. Pines, President, Regulatory Services and Healthcare,
APCO Worldwide
Lisa L. Stockbridge, PhD, Acting Branch Chief, Advertising and Promotional Labeling Branch, Division of Case Management, Office of Compliance and Biologics Quality, CBER, FDA
Julia C. Tierney, General Attorney, Office of the Chief Counsel, FDA
Deborah A. Wolf, JD, Supervisory Regulatory Counsel, Regulations Staff, Office of Communications, Education, and Radiation Programs, CDRH, FDA

Speaker Biographies

THOMAS W. ABRAMS, RPh, MBA is Director of the Division of Drug Marketing, Advertising, and Communications (DDMAC), Office of Medical Policy, CDER, FDA. He has held the positions of Acting Director, Acting Deputy Director and Branch Chief in DDMAC. Mr. Abrams joined FDA as a reviewer in DDMAC where he was primarily responsible for reviewing promotional material for cardiovascular products. Prior to joining FDA, he worked in pharmaceutical sales and marketing for Merck and Company. Mr. Abrams received his BS in Pharmacy from the College of Pharmacy, Rutgers University and his MBA from Rutgers Graduate School of Management.

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JANN T. BALMER, PhD, RN is an Associate Professor and Director of Continuing Medical Education at the University of Virginia School of Medicine and is also President of the Alliance for Continuing Medical Education (CME). Previously, she served as Nurse Clinician, Division of Pediatric Cardiology, University of Virginia Department of Pediatrics from 1985 to 1990, as Staff Nurse, Pediatric Unit, University of Virginia Medical Center from 1984 to 1985 and as Assistant Professor of the Nursing Undergraduate Program at the University of Pittsburgh School of Nursing from 1980 to 1983. Dr. Balmer received a BS in nursing from the University of Pittsburgh, a MS in child health nursing from the State University of New York at Buffalo and a PhD in higher education administration from the University of Pittsburgh.

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MINNIE V. BAYLOR-HENRY is the Director for Regulatory & Capital Markets Consulting at Deloitte & Touche. 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 joining Deloitte & Touche, LLP, she worked for Johnson & Johnson (J&J). While at J&J, Ms. Baylor-Henry worked in several roles in the Pharmaceutical and Consumer Sectors. In pharmaceuticals, she began her J&J career at J&J Pharmaceutical Research & Development as the Senior Director for Regulatory Affairs. In this capacity, she had direct responsibility for the regulatory oversight of all advertising & promotional materials for Ortho-McNeil, Ortho-Biotech, and Janssen. She was promoted to Vice President, U.S. Medical & Regulatory Affairs for McNeil Pediatrics, where she had responsibility for Medical Science Liaisons (MSL), Continuing Medical Education (CME), IIS, Medical Communications (including the call center) and many other medical, as well as regulatory, functions. Within the Consumer sector, Ms. Baylor-Henry was the Global Vice President for OTC Regulatory Affairs for McNeil Consumer Healthcare. Before joining J&J, she worked for FDA from 1991-1999. 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 (DDMAC) from 1995-1999. As the Director of DDMAC, Ms. Baylor-Henry was responsible for the regulatory oversight of all prescription drug advertising and marketing. In addition, she was responsible for many policy initiatives, including the issuance of the draft Guidance on DTC Broadcast Advertising. She received her Pharmacy degree from Howard University's College of Pharmacy and her law degree from Catholic University's Columbus School of Law.

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THOMAS CASOLA is Vice President, Regulatory Affairs, Advertising and Promotion at Shire Specialty Pharmaceuticals. Previously, he served as a Senior Consultant at Schering-Plough Corporation, and prior to that as Executive Director of the Office of Medical/Legal at Merck & Co., Inc. He is a liaison with FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) and Advertising and Promotional Labeling Branch (APLB). He has over twenty-five years of experience in the pharmaceutical industry, including positions in market research, advertising, pricing, brand management, business development, and regulatory affairs. Most of his career has been spent working on various product lines within Merck's U.S. prescription pharmaceutical and vaccine businesses, but he has also worked in the international prescription markets and the over-the-counter pharmaceutical market in the U.S. and abroad. Mr. Casola received his BA in psychology from the University of Connecticut and his MBA in Marketing and Market Research from the Wharton School of the University of Pennsylvania.

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DAVID E. CHADWICK, PhD, RAC is a Regulatory Scientist in the Regulatory Affairs Department of Cook, Inc., a healthcare device development company. He focuses on regulatory strategy for emerging and marketed products within the company as well as regulatory submissions/compliance. Dr. Chadwick has over 25 years of experience in the medical device industry in various areas, such as basic research and development, clinical research and regulatory affairs/quality assurance. He also has experience in the product areas of dermatology, in vitro diagnostics, urology, cardiology, drug delivery and electrosurgery. Prior to his work in regulatory affairs, he spent a number of years in research and development functions as well as the management of clinical trials. Dr. Chadwick received a BS in biology from Albright College and a PhD in anatomy and cell biology from the School of Medicine, University of Pittsburgh.

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BARBARA S. CHONG, PharmD is a Team Leader in the Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA. In her current position (Training & Support), she is primarily responsible for providing training and working on policy development and special projects. Prior to this position, she was a Team Leader covering various therapeutic areas including Cardiovascular & Renal, Reproductive & Urology, Dermatology & Dental, Metabolic & Endocrinology, Special Pathogens & Transplant and Anti-Infectives & Ophthalmology. Dr. Chong joined FDA as a reviewer in DDMAC where she was primarily responsible for reviewing both the professional and consumer-directed promotional materials for the diabetes and urologic drug products. Prior to joining FDA, she was an Assistant Professor at the Medical University of South Carolina, College of Pharmacy in adult internal medicine. Dr. Chong received her PharmD from the University of Maryland, School of Pharmacy in Baltimore and her BS in Chemistry from the University of Maryland in College Park. She also completed a Geriatric Pharmacy Practice Residency at the Veterans Administration Medical Center in Gainesville, Florida.

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LOUIS E. COBUZZI is the Associate Chief Consultant of Pharmacy Benefits Management Services, Policy Development & Program Analysis, Veterans Health Administration. He is responsible for the development and maintenance of policy guidance for the Pharmacy Benefits Management, Strategic Healthcare Group. He also has oversight and operational responsibilities for EDMS activities, responding to Congressional inquiries and assisting the Deputy Chief Consultant on committees and task forces. Mr. Cobuzzi has worked for the Department of Veterans Affairs for over twenty-five years, all for the Veterans Health Administration. He started at the Bronx Veterans Affairs Medical Center in 1978, where he was appointed Chief of Pharmacy Services in 1987. In 1997, he was promoted to the Lead Chief of Pharmacy Services at the VA Maryland Health Care System where he was responsible for overall direction and supervision of VA pharmacy programs throughout the state of Maryland. Mr. Cobuzzi is a graduate of the College of Pharmaceutical Sciences at Columbia University and the New York Medical College, where he received his Masters Degree in Pharmacology.

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RICHARD M. COOPER is a Partner in the Washington, DC law firm of Williams & Connolly LLP. He specializes in medical products, including advising and enforcement (with regard to inspections, warning letters, administrative sanctions, injunction proceedings, and criminal proceedings). He has contributed articles to professional journals, has taught food and drug law at Georgetown University Law Center, and has served on advisory committees of the Institute of Medicine, the National Research Council and the Congressional Office of Technology Assessment. Mr. Cooper also served as Chairman of the Editorial Board of the Food and Drug Law Journal and has been a member of the American Law Institute. He edited the Food and Drug Law Institute (FDLI) book Food and Drug Law (1991) and co-edited the FDLI books Fundamentals of Law and Regulation (1997) and Food and Drug Law and Regulation (2008). Previously, Mr. Cooper was Chief Counsel of FDA from late 1977 through 1979. In 1977, he was a special assistant to James R. Schlesinger and a senior member of the Office of Energy Policy and Planning, Executive Office of the President, where he helped to develop the National Energy Plan. In 1970-71, he also did legal work for the Government of Uganda. He was a Rhodes Scholar, President of the Harvard Law Review and a law clerk to Justice William J. Brennan, Jr. of the U.S. Supreme Court. Mr. Cooper received a BA, summa cum laude, from Haverford College, a BA, First Class with Congratulations from Oxford University and a JD, summa cum laude, from Harvard Law School.

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JAMES N. CZABAN is a Partner in the law firm of Wiley Rein LLP in Washington, DC and is Chair of the firm's Food & Drug and Product Safety Practice Area. He focuses on serving pharmaceutical, biotechnology, food, medical device and other healthcare-related clients in all aspects of pharmaceutical regulation, including FDA approvals, Hatch-Waxman and lifecycle management strategies, FDA compliance and federal and state enforcement matters. He also advises pharmaceutical companies on prescription drug advertising matters, legislative strategies and advocacy, administrative litigation, Securities Exchange Commission (SEC)-regulated corporate disclosure issues and regulatory due diligence. Named a "Top Lawyer" in Food and Drug Law by Washingtonian magazine, Mr. Czaban has lectured widely on topics of FDA regulation of pharmaceuticals. He is a frequent author on Food and Drug Law topics and serves on the Editorial Advisory Boards of BNA's Pharmaceutical Law and Industry Report and the journals Specialty Pharma and Drug Delivery Technology. Mr. Czaban received his BA from the University of California, Berkeley and his JD from the University of Virginia School of Law.

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DIANE E. DORMAN is Vice President for Public Policy for the National Organization for Rare Disorders (NORD). She leads NORD efforts in its relationship with the federal government and Congress. Since joining NORD in October 2000, Ms. Dorman has been instrumental in the passage of the Rare Diseases Act (P.L. 107-281), and the Rare Diseases Orphan Product Development Act (P.L. 107-281). She was also influential in the introduction of House Concurrent Resolution 147, commemorating the 20th Anniversary of the Orphan Drug Act. In addition of these activities, she is responsible for ensuring that patients continue to have access to life-saving orphan therapies through Medicare, Medicaid and private insurance. Ms. Dorman serves as NORD's primary liaison to FDA, the National Institutes of Health, and the Center for Medicare and Medicare Services, as well as the pharmaceutical and biotechnology industry. On behalf of NORD and Coalitions in which NORD participates, Ms. Dorman leads education and outreach programs to gain policymaker support for increased research into rare diseases and greater development of orphan products. She develops and maintains relationships with other healthcare voluntary agencies and patient groups. Ms. Dorman provides technical assistance and legislative analysis to NORD's member agencies on government-related matters, as well as the training of staff and volunteers of member organizations. She serves on the Board of Directors of the FDA Alliance, and was recently elected Vice President. She is one of the founding members of the Alliance for Drug Safety and Access, and was also appointed to the Membership Committee of the U.S. Pharmacopeia.

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NORMAN A. DREZIN is President of Drezin Consultants, LLC. He specializes in corporate communications including professional and consumer advertising, promotion, and labeling matters, press releases and Internet sites. He was previously Executive Director of PharmaNet Consulting. Before his consulting practice, Mr. Drezin was the Acting Director and Supervisory Regulatory Counsel for the Division of Drug Marketing, Advertising and Communications (DDMAC), CDER, FDA. Prior to joining FDA in 1991, he served as an attorney with the Federal Trade Commission (FTC), Bureau of Competition, where he was involved in a variety of antitrust cases concerning the pharmaceutical industry and the regulation of pharmacy. Before his service with the FTC, Mr. Drezin was a Primary Examiner with the U.S. Patent and Trademark Office, where he specialized in the examination of patent applications for pharmaceutical products. Mr. Drezin received his BS in Pharmacy from Columbia University College of Pharmaceutical Sciences and his JD from the University of Baltimore School of Law.

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SUE E. DUVALL is Director of Regulatory Promotional Review for Oncology at Amgen. Her responsibilities include managing the regulatory reviewers for marketed products and providing guidance on labeling and draft promotional messaging on pipeline products. Ms. Duvall also provides guidance on promotional claims for Amgen devices. She has worked in the medical field for nearly 30 years, the past 14 in the pharmaceutical industry in clinical development, pharmaceutical sciences and regulatory. Ms. Duvall received her nursing degree from Kalamazoo Valley Community College, a BS and MPA from Western Michigan University, Kalamazoo, MI and completed post-graduate studies at Drew University in Madison, NJ.

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MARYANN R. GALLAGHER is a Regulatory Reviewer in the Advertising and Promotional Labeling Branch (APLB), Division of Case Management, Office of Compliance and Biologics Quality (OCBQ) in the Center for Biologics Evaluation and Research (CBER), FDA. She is responsible for regulatory review of advertising and promotional labeling activities for biologic drugs and medical devices and the review of proprietary names for biologic drugs. Ms. Gallagher began her FDA career in CBER's Control Test Laboratory. She transitioned from the laboratory to compliance working in the Licensing Branch, Bioresearch Monitoring Branch, and then to APLB in 1993. Ms. Gallagher has a Bachelors degree in Biology and has taken graduate courses at Catholic University of America.

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TERRI T. GARVIN, JD recently returned to the promotion and advertising program in the Office of Compliance, Center for Devices and Radiological Health (CDRH) at the Food and Drug Administration (FDA) where she serves as Regulatory Counsel. She is responsible for developing and enforcing Center regulations and policies on device promotion. Prior to her current position she worked as Regulatory Counsel on CDRH's Regulations Staff, and was a Regulatory Counsel in the Center's Promotion and Advertising Policy Staff from 1999-2001. She began her legal career with the U.S. Department of Justice's National Church Arson Task Force and then worked for the Drug Enforcement Administration Asset Forfeiture Division. Ms. Garvin received her BS from Howard University and her JD from Catholic University.

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RALPH F. HALL is a Distinguished Professor and Practitioner at the University of Minnesota Law School and is also of Counsel in the law firm of Baker & Daniels in Indianapolis, Indiana. He has experience in the areas of FDA and healthcare law and applying those regulatory systems to the medical device industry, the design and implementation of regulatory compliance programs, with FDA enforcement actions, in managing complex patent litigation and licensing matters and in general corporate counseling. Prior to rejoining Baker & Daniels, Mr. Hall was with Guidant Corporation where he served as Senior Vice President and Deputy General Counsel – Litigation and Compliance. He also served as Special Counsel to Guidant's Board of Director's Compliance Committee and to Guidant's Compliance Office. Earlier, he was General Counsel of Guidant's Cardiac Rhythm Management group. Prior to joining Guidant, Mr. Hall was with Eli Lilly and Company where he served in a number of legal roles, including chief environmental counsel. He speaks frequently at legal seminars on a variety of subjects. He also serves as the CEO of MR3 Medical, LLC. Mr. Hall received his AB, magna cum laude, from Indiana University and his JD, cum laude, from the University of Michigan Law School.

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SHEILA M. HEMEON-HEYER, JD, RAC is Vice President, Global Regulatory Affairs with Boston Scientific Corporation (BSC). She provides leadership to the global regulatory affairs function with responsibility for compliance with worldwide product approval and recertification regulations. She sits on the BSC Operating Committee, as well as the management boards for the Clinical and Quality functions. Ms. Hemeon-Heyer began her regulatory career at the Food and Drug Administration (FDA), where she was a Scientific Reviewer in the Division of General Neurological and Restorative Devices, Center for Devices and Radiological Health (CDRH), and was responsible for reviewing 510(k), premarket approval application (PMA) and investigational device exemption (IDE) applications. After leaving FDA, Ms. Hemeon-Heyer provided regulatory, clinical and quality consulting services to the medical device industry, specializing in developing regulatory strategies, interacting with FDA, securing domestic and international product approvals, and managing complex projects across the medical product lifecycle. Ms. Hemeon-Heyer received her BS in Biomedical Engineering from Boston University, her MS in Biomechanics from the University of Massachusetts at Amherst, and her JD from Western New England College School of Law. She is Regulatory Affairs Certified (RAC).

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JENNIFER A. HENDERSON is an Associate at the law firm of Hogan Lovells LLP in Washington, DC. Her practice focuses primarily on assisting medical device companies in addressing FDA regulatory issues, with an emphasis on premarket clearance and approval. Prior to joining Hogan Lovells, she held positions in the Regulatory Affairs Program for the Center for Integration of Medicine and Innovative Technology (CIMIT), where she directed systemic regulatory support and analysis and also oversaw legal and regulatory research and a number of program projects. Ms. Henderson has published articles on issues surrounding medical device regulation in both medical and legal literature. She also held several academic positions including Research Fellow and Research Associate at Massachusetts General Hospital and Instructor in Dermatology at Harvard Medical School. Ms. Henderson received her BA from Middlebury College, her JD from Boston University School of Law, and her MPH from Boston University School of Public Health.

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STEVEN E. IRIZARRY is Senior Vice President of the Capitol Hill Consulting Group. He specializes in federal healthcare programs and legislation with particular emphasis on pharmaceutical, medical device and life science issues. Previously, he served as Vice President of Government Relations for ML Strategies, LLC, where he represented an array of health care companies. Mr. Irizarry gained expertise through his service as Health Counsel in the Senate and the House of Representatives, including service on the Senate Health, Education, Labor and Pensions (HELP) Committee, where he advised Chairman Judd Gregg (R-NH) on a wide range of bioterrorism, food, drug, and medical device issues, including follow-on biologics and Hatch-Waxman reform. He helped craft a bipartisan agreement on the Greater Access to Affordable Pharmaceuticals Act (Gregg-Schumer), which was later included and signed into law as part of the Medicare Prescription Drug and Modernization Act of 2003. Mr. Irizarry has also worked on such legislation as the Prescription Drug User Fee Act, Medical Device User Fee and Modernization Act, the Bioterrorism Preparedeness Act and the Smallpox Emergency Personnel Protection Act. Prior to working with Senator Gregg, he served for two years as Health Counsel to then-HELP Committee member Senator Chuck Hagel (R-NE). He also advised Senator Hagel on Medicare issues and was instrumental in the development of the Medicare Prescription Drug Discount and Security Act of 2000, which included a prescription drug card proposal that was later adopted by the Bush Administration and passed as part of the Medicare bill. Mr. Irizarry also served as Health Counsel to then-House Commerce Committee Chairman Tom Blilely (R-VA) and, in private practice, as counsel to a number of national healthcare service providers. Mr. Irizarry is a graduate of Georgetown University.

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KAREN JAGIELSKI is a Senior Attorney with the Federal Trade Commission's Division of Advertising Practices, where she primarily focuses on advertising for health-related products. Before joining the FTC in 1998, Ms. Jagielski was an attorney with the Defender Association of Philadelphia. Ms. Jagielski received her BA from Bates College in Lewiston, Maine, and her JD magna cum laude from Cornell Law School.

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DAVID P. JONES is Legal Director of Intervet/Schering-Plough Animal Health, a supplier of pharmaceuticals and biologicals for the animal health sector. His responsibilities include advising Intervet on all legal matters before the company, including regulatory, commercial, and transactional issues. He specializes in commercial transactions, licensing, technology transfer, compliance, regulatory and quality affairs and general business advice. Previously, Mr. Jones served Intervet Inc. as General Counsel, where he supported the company's U.S. and Canadian operations. Prior to this, he practiced law at a number of private firms, including the PPL Corporation, CR Bard, Gerber Alley and Associates, Fieldcrest Cannon, Inc. and Thompson & Knight LLP. Mr. Jones received his BA from Louisiana State University and Agricultural and Mechanical College and his JD from Duke University School of Law.

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GEOFFREY M. LEVITT is Senior Vice President and Associate General Counsel, Regulatory & Policy, Pfizer, Inc. Previously, he served as Associate General Counsel and Chief Regulatory Counsel at Wyeth where he was responsible for a wide range of legal/regulatory issues related to Board of Health regulation and compliance worldwide. Prior to joining Wyeth, Mr. Levitt was a Partner and Co-chair of the food and drug law group at Venable, Baetjer, Howard & Civiletti in Washington, DC. He has published and lectured extensively on food and drug law, and is a past member of the editorial board of the Food and Drug Law Journal and a current member of the editorial board of the FDA Advertising and Promotion Manual. Mr. Levitt is a recipient of the Food and Drug Law Institute's 2009 Distinguished Service and Leadership Award and serves on the Board of Directors at the Institute. His most recent publications include the book Competitive Challenges in the Drug Approval Process: Generics, Hybrids and Follow-on Biologics (2005) and the chapter "The Drugs/Biologics Approval Process" in A Practical Guide to Food and Drug Law and Regulation (Food and Drug Law Institute, 3d ed. 2008). Mr. Levitt received his BA from Columbia University and his JD from Harvard Law School.

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TAMMARA M. LEWIS is the Director of Advertising Promotion and Labeling at Genzyme Corporation. She is responsible for U.S. promotion and labeling compliance of Genzyme drugs, biologics and medical devices. In this role, she oversees the regulatory team and promotion review processes. Before joining Genzyme in 2008, Ms. Lewis served in a number of positions of increasing responsibility in regulatory affairs at Wyeth Pharmaceuticals, Bayer Healthcare Pharmaceuticals and Warner Lambert. She has extensive experience in promotion compliance having supported brands such as Effexor, Protonix, Levitra and presently a portfolio of over 16 marketed products including Cerezyme. Ms. Lewis has worked across several therapeutic areas including: infectious disease, neuroscience, oncology and personalized genetics. Prior to her contributions in the pharmaceutical/biotechnology industry, she worked in the food industry as a food product developer for Kraft General Foods and Pepsi-Cola Company. Ms. Lewis received a BS in Biology from Savannah State University, a MS in Food Science from LSU and a JD from Pace University Law School.

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FREDA C. LEWIS-HALL, MD is Senior Vice President and Chief Medical Officer of Pfizer, Inc. In this role, she leads medical, patient safety, regulatory affairs and quality assurance efforts throughout the company, as well as outreach to doctors and other medical professionals. Before joining Pfizer, she worked for Vertex Pharmaceuticals where she was responsible for clinical and nonclinical development as well as both medical and regulatory affairs. Dr. Lewis-Hall managed a number of important functions, including regulatory affairs, clinical and nonclinical development, medical affairs and commercial development. Previously, she has served as the Senior Vice President, U.S. Pharmaceuticals, Medical Affairs at Bristol-Myers Squibb. Prior to this, she held leadership positions at Pharmacia Corporation, Eli Lilly and Company, the National Institute of Mental Health and at the Howard University College of Medicine Department of Psychiatry. Dr. Lewis-Hall received a Bachelor of Arts and Sciences in Natural Sciences from The Johns Hopkins University and her Medical Doctorate from Howard University Hospital and College of Medicine.

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MICHAEL K. LOUCKS is a Partner at the law firm of Skadden, Arps, Slate, Meagher & Flom in their Boston office. Prior to this, he served as the Acting U.S. Attorney in the U.S. Attorney's Office, District of Massachusetts, where he was responsible for all federal criminal law enforcement in Massachusetts and for handling defensive and affirmative civil matters on behalf of the U.S. Government. He was directly responsible for the management of attorneys and staff in the Terrorism and National Security Section; the White Collar Crime Section, consisting of the Health Care Fraud Unit, the Public Corruption Unit, the Economic Crimes Unit and the Internet Crimes Unit; the Organized and Violent Crime Section; the Springfield and Worcester Branch Offices; the Civil Division and the Administrative Division. Previous to this, Mr. Loucks held various other positions in the U.S. Attorney's office including First Assistant U.S. Attorney, the White Collar Crime Section Chief, the Health Care Fraud Unit Chief, and the Health Care Fraud Coordinator. Prosecutions included United States v. TAP Pharmaceutical Products Inc., United States v. C.R. Bard, Inc., United States v. Damon Clinical Laboratories, Inc., United States v. Copley Pharmaceutical, Inc. and many others. He is a frequent speaker on healthcare prosecutions, prosecutions of corporations, and corporate compliance programs. He was previously in private practice as an Associate Attorney at Choate, Hall & Stewart. Mr. Loucks received his BA in Economics, magna cum laude, from Harvard University and his JD from the University of Virginia.

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DOROTHY R. McADAMS, VMD is the Team Leader for the Post-Approval Review Team in the Division of Surveillance, Office of Surveillance and Compliance, Center for Veterinary Medicine (CVM) at FDA. She joined FDA in 1998 as an adverse event reviewer and joined the Post-Approval Review Team in 2007. Before joining CVM, she was the sole proprietor of an equine practice in Frederick County, MD. Dr. McAdams received her Veterinary Medical degree from the University of Pennsylvania School of Veterinary Medicine.

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DANIEL MERON is a Partner in the law firm of Latham & Watkins LLP in Washington, DC and serves as Global Co-Chair of the firm's Healthcare & Life Sciences Practice Group. He is in the Litigation Department and is also a member of the appellate practice group. He specializes in providing counseling and advocacy (regulatory, investigative and litigation) to members of the pharmaceutical, biotech and medical device industries and also represents providers. Previously, Mr. Meron served as General Counsel at the Department of Health and Human Services (HHS). Prior to joining HHS, he was the Principal Deputy Assistant Attorney General for the Civil Division of the U.S. Department of Justice (DOJ). He assisted in overseeing the work the work of over 700 lawyers, litigating thousands of cases, and in particular, providing counsel and legal representation to HHS on a broad array of legal issues. Previously, Mr. Meron was a partner at the law firm of Sidley Austin where he specialized in appellate, regulatory and commercial litigation, with a particular focus on regulated industries. He has argued numerous cases in the federal courts of appeals, as well as dispositive motions in the federal district courts. Following graduation from law school, he clerked for the Hon. Laurence H. Silberman of the U.S. Court of Appeals for the District of Columbia Circuit and for the Hon. Anthony M. Kennedy of the U.S. Supreme Court. Mr. Meron graduated magna cum laude from Harvard College with a major in government and received his JD, magna cum laude from Harvard Law School. He served as co-chair of the articles office of the Harvard Law Review and was a winner and oralist of the Ames moot court competition. He received his PhD, a.b.d. in Social Thought from the University of Chicago.

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LEWIS A. MILLER is a Principal in the firm of WentzMiller & Associates, LLC. In this role, he has assisted in the development of the concept for Project Globe Consortium for CPD, a nonprofit organization designed to bring CME to front-line doctors in developing countries, helped clients in accreditation processes in the U.S. and Europe, advised on e-CME projects in the U.S. and Europe, created a strategic report on health information directions in the U.S., and worked with CME and medical publishing groups on achieving competitive advantages in their marketplaces. Mr. Miller is the founder of both the Alliance for Continuing Medical Education in 1975, and the Global Alliance for Medical Education in 1995. He was also a founding director of the National Commission for Certification of CME Professionals (2006), and is co-founder and chairman of U Penn BestPractice CPD, a web-based educational resource for primary care physicians, their staff and their patients. In addition, he co-founded two major medical publishing education companies, Miller & Fink Corporation (1966) and Dowden Health Media (1988). He is also co-founder and past chairman of Intermedica, Inc., an international medical education company that exports U.S. CME to other countries, particularly to Latin America and Spain. Mr. Miller has also worked with a number of domestic and international medical organizations, including the American College of Physicians, the European Society of Cardiology and the Mexican National Academy of Medicine, among others. In addition, he has brought global CME programs to pharmaceutical companies such as Bristol Myers Squibb, Pfizer and Wyeth. Mr. Miller is a frequent speaker on trends in global CME at meetings in the U.S., Europe and Latin America and has received both the Founders Award and the Distinguished Service Award from the Alliance for CME, the Hippocrates Award from the Global Alliance for Medical Education (GAME), of which he is a director, and the Lifetime Award for Editorial Achievement from American Business Media. In 2007, he was inducted into the Medical Advertising Hall of Fame. Mr. Miller is a graduate of Princeton University and the Columbia University Graduate School of Business.

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JEANNIE M. PERRON, DVM is Of Counsel at Covington & Burling LLP in Washington, DC, where she is a member of the firm's Food and Drug Practice Group. Her practice emphasis is food and drug law, particularly animal food and drug law, and animal welfare cases. In this capacity, she represents companies that manufacture feed, feed ingredients, drugs, biologics and medical devices for animals, in addition to clients in related industries. Dr. Perron also specializes in the importation of animal-derived ingredients and products and advises clients on USDA regulations and procedures in this area and aids clients in securing the required permits and certifications. In addition, she advises clients in the regulation of dietary supplements, over-the-counter drugs, and cosmetics for humans. Dr. Perron has authored or co-authored numerous articles and chapters in various publications. She is a member of a number of state and federal bars and the U.S. Patent and Trademark Office. Dr. Perron received a BS from Purdue University, her JD from George Washington University Law School and her DVM from Texas A&M University College of Veterinary Medicine.

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WAYNE L. PINES is President of Regulatory Services and Healthcare at APCO Worldwide, Inc. He is also President of the Alliance for a Stronger FDA, a coalition interested in increasing FDA's budget through appropriated funds. Mr. Pines provides strategic counsel to clients facing media, legislative, regulatory or marketing problems. He served for ten years at FDA as Chief of Consumer Education and Information, Chief of Press Relations and Associate Commissioner for Public Affairs. He speaks and publishes frequently on FDA-related issues. He also conducts seminars for companies interested in training their employees. Mr. Pines is the author or editor of ten books about FDA and crisis management, including the FDA Advertising and Promotion Manual, a legal/regulatory manual published by Thompson Publishing Group; Communicating in a Healthcare Crisis, published by FDANews.com; How to Work With the FDA, A Practical Guide to Food and Drug Law and Regulation, A Framework for Pharmaceutical Risk Management, and FDA: A Century Of Consumer Protection, all published by FDLI. Mr. Pines is a graduate of Rutgers University.

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ANN M. RAVEL is the Deputy Assistant Attorney General, Torts Branch and Office of Consumer Litigation, Civil Division, U.S. Department of Justice. She previously served as the County Counsel of Santa Clara County, CA. Ms. Ravel has practiced civil law in various areas of the law, with an emphasis in political law and ethics, labor and employment, and civil rights litigation. Under her direction, Santa Clara County was the first public entity to bring a case to remedy the affects of lead paint poisoning in the community. Ms. Ravel also represented the county on the statewide steering committee for tobacco litigation, which won a large settlement that benefits health needs in Santa Clara County. She has received numerous awards and honors, including Woman of Influence in the Silicon Valley in 2008, the 2007 Public Lawyer of the Year award from the California State Bar, the Circle of Service Achievement Award by the California State Association of Counties in 2004, the Unsung Hero Award by the Santa Clara County Bar Association, the American Bar Association Award for State and Local Government Law Advocacy, the 2001 Professional Lawyer of the Year Award presented by the Santa Clara County Bar Association and the Elizabeth Ent award for contributions to law and justice. Ms. Ravel is a graduate of Hastings Law School.

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MARTIN H. REDISH is a Professor of Law and Public Policy at Northwestern University School of Law and Senior Counsel at the law firm of Sidley Austin LLP in Chicago. At Northwestern, he teaches and writes on federal jurisdiction, civil procedure, freedom of expression and constitutional law. He is the author or co-author of numerous articles and books, including The Logic of Persecution: Free Expression and the McCarthy Era and Wholesale Justice: Constitutional Democracy and the Problem of the Class Action Lawsuit. Professor Redish is also the recipient of a number of academic awards, including the L. Hart Wright Outstanding Teacher Award, which he received as a visiting professor at the University of Michigan Law School, and both the Robert Childress Memorial Award for Teaching Excellence and the Dean's Teaching Award from Northwestern. He has frequently appeared as an expert witness before congressional committees, and has also regularly appeared on media outlets such as the Today Show, ABC and NBC News, CNN and NPR. Professor Redish received his AB in political science from the University of Pennsylvania and his JD, magna cum laude, from Harvard Law School.

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MARY E. RIORDAN is a Senior Counsel, Administrative & Civil Remedies Branch in the Office Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS). She focuses primarily on cases brought under the federal False Claims Act involving alleged fraud against the Medicare and Medicaid programs. Ms. Riordan works closely with attorneys from the U.S. Department of Justice and, in certain cases, attorneys from the State Medicaid Fraud Control Units to negotiate settlements with defendant providers. In addition, she drafts and negotiates corporate integrity agreements (CIAs) entered into between the OIG and settling defendants. She has focused on matters involving pharmaceutical manufacturers and has represented the OIG in the negotiation of several significant settlements and CIAs with pharmaceutical manufacturers. Ms. Riordan is also a co-author of the OIG's 2003 Compliance Program Guidance for Pharmaceutical Manufacturers. In addition, she handles prescription drug issues relating to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) and the Deficit Reduction Act of 2005. Prior to joining the OIG, she practiced law at the firm of Reed Smith in Washington, DC. Ms. Riordan graduated from Cornell University and received her JD from the George Mason University School of Law.

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JANET L. (LUCY) ROSE is President of Lucy Rose & Associates, LLC (LRA), a pharmaceutical consulting firm providing prescription drug promotion regulatory training and consulting to the pharmaceutical industry and its support providers. From 1995 to 1997, she served as the Director of the Office of Training and Communications for the Center for Drug Evaluation (CDER) and Research at FDA. She designed and implemented programs to improve external communications with healthcare professionals, consumers and industry, and programs to improve employee performance, including leadership and management development. Ms. Rose led CDER's Division of Drug Marketing, Advertising, and Communications from 1993 to 1995 where she was responsible for the regulatory oversight of all prescription drug advertising and marketing to U.S. healthcare professionals and consumers. Prior to joining FDA, Ms. Rose was associated for seven years with Mead Johnson Pharmaceuticals, a division of Bristol-Myers Squibb Pharmaceuticals, where she began her career as a sales representative, served as a regional sales trainer, and for four years was the district sales manager of the Washington, DC district. Ms. Rose received her BS from Salem College in Winston-Salem, NC and her MBA from Averett College. She also graduated as a Physician Assistant from the Wake Forest University School of Medicine.

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SHEILA K. RYAN, PharmD is Group Leader, Division of Drug Marketing, Advertising, and Communications (DDMAC), OMP, CDER, FDA. She joined FDA in 2003 as a regulatory project manager in the Division of Drug Oncology Products after having held a variety of pharmacy positions in the private sector. She came to DDMAC in 2005 as a professional regulatory reviewer and has been a professional group leader since November 2007. Presently, Dr. Ryan oversees the promotion of anti-infective, anti-viral, ophthalmology, dermatology, dental, cardiology and nephrology. In addition, she is a Commander in the U.S. Public Health Service. Dr. Ryan obtained pharmacy degrees from the University of Pittsburgh and the University of Maryland.

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MICHAEL A. SAUERS is the Group Leader of Direct-to-Consumer (DTC) Review Group 1 in the Division of Drug Marketing, Advertising, and Communications (DDMAC), FDA. His group is responsible for the review of Reproductive, Psychiatric, Antiviral, Osteoporosis, Dermatology and Dental DTC promotional materials. Mr. Sauers has also served as Group Leader of Professional Review Group 1, as well as a reviewer on a number of professional and DTC dockets in DDMAC. He joined HHS through the Presidential Management Fellowship program, working as a Program Analyst in the HHS Office of the Secretary on FDA budget and policy issues, and subsequently in the FDA Office of the Commissioner. Prior to his time in the federal government, Mr. Sauers worked as a Healthcare Representative for Pfizer, Inc. He received his Bachelor's Degree in Neuroscience from the University of Delaware and a Master's of Public Policy with a concentration in Health Policy from Georgetown University.

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MARK S. SENAK is Senior Vice President and Partner at Fleishman-Hillard, an international communications firm. Prior to this, he served as National Director of Health Policy at Manning, Selvage & Lee where he was responsible for providing strategic communications counsel on an array of public health and health policy issues and community relations. Mr. Senak has over twenty years of experience in law, communications, public health and public relations, and has particular expertise in public health and medical product development, with an emphasis on regulatory approval and reimbursement strategies. He has served as a senior strategist for pharmaceutical companies and brought new products to market to align pre-approval communications with post-launch messaging, reinforce regulatory compliance and maximize the reimbursement environment. Mr. Senak also has experience in several therapeutic areas, including diabetes, HIV/AIDS, osteoporosis, allergy/asthma, oncology and gastroenterology as well as consumer and public health work in HIV/AIDS. In the public health arena, he has experience in designing global communications plans for clients such as the World Health Organization, the World Bank, the National Institutes of Health and the Bill & Melinda Gates Foundation, as well as public health communications plans in the U.S. for organizations such as the American Academy of Pediatrics. He is also the publisher of a blog about the current FDA landscape entitled "Eye on FDA." Mr. Senak received his Bachelor of Arts degree from the University of Illinois and his JD from Brooklyn Law School.

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JEFFREY M. SENGER is a Partner in the law firm of Sidley Austin LLP in Washington, DC, where he serves in the firm's Food, Drug and Medical Device Regulatory and Enforcement practices. Prior to this, he served as Acting Chief Counsel and Deputy Chief Counsel of FDA, where he reviewed regulations, guidance documents, and warning letters issued by FDA, worked on the most complex and sensitive FDA-related litigation and provided legal advice to the FDA Commissioner and senior staff. He is a member of the editorial board for the Food and Drug Law Journal, has published multiple law review articles and has spoken on FDA issues for numerous organizations around the country. He previously served as Senior Counsel in the Office of the Associate Attorney General at the United States Department of Justice, where he assisted in overseeing the work of more than 2,000 lawyers, including specific responsibility for the office that provides counsel and legal representation to FDA. In 17 years at the Justice Department, including appointment as a Special Assistant United States Attorney, he served as lead counsel in many civil and criminal trials before juries and judges in federal and state courts, and he argued cases in the United States Circuit Courts of Appeals. He has served as a federal mediator for the United States District Court and began his career as a law clerk for a United States District Court judge. An award-winning author, he wrote a book entitled Federal Dispute Resolution (Wiley 2003). He has taught trial advocacy, mediation, and negotiation at Harvard Law School, and he is an elected member of the American Law Institute. He is a member of the D.C. Circuit Judicial Conference, has testified as an expert witness before the United States Congress, and has spoken on behalf of the United States government on five continents. He is an honors graduate of Harvard College and Harvard Law School.

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JAMES G. SHEEHAN is the Inspector General, Office of Medicaid Inspector General, New York State. Previously, he served as the Associate U.S. Attorney for Civil Programs in the Eastern District of Pennsylvania (Philadelphia). He has also served as the Chief of the Civil Division of the United States Attorney's Office, Eastern District of Pennsylvania, where his practice emphasized healthcare fraud and abuse enforcement. Mr. Sheehan has represented the government in over 500 healthcare fraud cases and investigations. He has made numerous presentations on healthcare fraud to state and national programs and has had several articles published. Mr. Sheehan has served as a member of the board of the National Health Lawyer's Association and as a past board member of the National Health Care Anti-Fraud Association. He has received two Attorney General's Distinguished Service Awards, as well as the First Annual Distinguished Service Award of the National Association of Former United States Attorneys. Prior to his government service, he was an associate attorney at the Philadelphia law firm of Montgomery, McCracken, Walker & Rhoads. Mr. Sheehan received his BA in economics from Swarthmore College and his JD from Harvard Law School.

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JAMES C. SHEHAN is Vice President and General Counsel, Legal, Government and Quality Affairs at Novo Nordisk Inc. He is responsible for Novo Nordisk's legal, compliance, government affairs, grant administration and quality matters in North America. He also serves as a board member and corporate secretary for all of United States affiliates and as principal of the Global Legal Board. Before joining Novo Nordisk in 1993, Mr. Shehan held various positions in the legal department of Pfizer Inc. and was an Associate at the corporate law firm of Sutherland, Asbill & Brennan in Washington, DC. He has also worked in the Office of the Associate Commissioner for Health Affairs at FDA and was a recipient of FDA's "Award of Merit." Mr. Shehan received a BA from Columbia University with a major in biology and a concentration in French and his law degree from Georgetown University.

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TONI M. STIFANO recently joined the promotion and advertising policy group in the Office of Compliance in the Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA). Prior to joining CDRH she was a Science Policy Analyst with the Center for Drug Evaluation and Education's (CDER) Safety Policy and Communications Drug Safety Board Staff, and spent a year in the Office of the Commissioner working with the Senior Risk Communication Advisor on various risk communication initiatives and Healthy People 2010. Ms. Stifano came to the Center for Biologics Evaluation and Research (CBER) in 1991 after spending 14 years in private industry and worked as a reviewer in the Division of Product Certification and later in establishing CBER's Advertising and Promotional Labeling group in 1993. Ms. Stifano is a Medical Technologist and Electron Microscopist and recently received a Certificate in Public Health from Georgetown University.

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LISA L. STOCKBRIDGE, PhD is the Acting Branch Chief in the Advertising and Promotional Labeling Branch (APLB) of the Division of Case Management, Office of Compliance and Biologics Quality, Center for Biologics Evaluation and Research (CBER), FDA. She previously served as a Consumer Safety Officer, where her responsibilities included reviewing promotional advertising and labeling and participating on the product office review teams reviewing proposed proprietary names, product labeling and risk management programs. She has also served on CBER's Labeling Subcommittee and has been involved in the implementation of the Physician's Labeling Rule and Structured Product Labeling in the Center for Drug Evaluation and Research (CDER) and CBER. She was formerly the Business Program Manager for the FACTS@FDA Program in its first phase. Dr. Stockbridge has spent a number of years in advertising and promotional labeling review, both in CDER's Division of Drug Marketing, Advertising and Communications (DDMAC) and CBER's APLB. She is a recognized subject matter expert within FDA and continues to serve on taskforces and special projects. Dr. Stockbridge received her BA in Biology and Psychology from Manhattanville College and her PhD in Medical Physiology from New York Medical College. Her postdoctoral experience, in Cellular Neurophysiology and Biophysics, includes a Research Associateship at the University of Alberta, Edmonton and a Senior Staff Fellowship at the National Institutes of Health.

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HELEN W. SULLIVAN, PhD, MPH is a Social Science Analyst at the Division of Drug Marketing, Advertising and Communications (DDMAC), CDER, FDA. Prior to joining FDA, she was a Cancer Prevention Fellow at the National Cancer Institute (NCI), National Institutes of Health. In this role, she worked to develop original research projects in cancer prevention and control and collaborated with NCI staff on research proposals, presentations and publications. Before joining NCI, Dr. Sullivan performed research in the field of psychology and health behavior while completing her PhD. Her research centered on understanding the effects of pursuing different types of personal goals, and the way in which people's attitudes affect outcomes such as smoking cessation, dietary changes, and well-being. Dr. Sullivan received her BA in psychology from Yale University, her PhD in social psychology from the University of Minnesota and her MPH from Johns Hopkins Bloomberg School of Public Health.

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LADD A. WILEY is a Consultant at the law firm of Akin Gump Strauss Hauer & Feld LLP in Washington, DC. He specializes in healthcare policy and regulatory issues and gives legal and policy advice and advocacy on matters having to do with life sciences and healthcare financing and costs. Previously, Mr. Wiley served as counselor to Department of Health and Human Services Secretary Tommy G. Thompson, and was also principal deputy general counsel at HHS. While at the Department, he focused on a wide range of issues, including food and drug, Medicare and life sciences issues. He frequently interacted with the leadership at FDA, the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the National Institutes of Health. Before his federal government service, Mr. Wiley served as chief legal counsel to then-Governor of Wisconsin Tommy G. Thompson. He received his BA from Cornell College of Iowa and his JD from the University of Wisconsin Law School.

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SUSAN C. WINCKLER, RPh, Esq is the President and Chief Executive Officer of the Food and Drug Law Institute (FDLI). FDLI is nonprofit 501(c)(3) organization committed to providing high-quality education and a neutral forum for the generation of ideas and discussion of food and drug law and public policy. Immediately prior to joining FDLI, Ms. Winckler served as Managing Director, Medical Products Practice, at Leavitt Partners. Founded by former U.S. Health and Human Services (HHS) Secretary and EPA Administrator Michael O. Leavitt, the partnership advises senior executive teams in the practice areas of health, environment and trade. Ms. Winckler retains a limited affiliation with Leavitt Partners as a Senior Advisor. From January 2007 to June 2009, she served as the Chief of the Staff for the U.S. Food and Drug Administration (FDA) within HHS. In that capacity, she provided integrated policy analysis and strategic consultation to the Commissioner and senior FDA officials on significant agency issues and programs. Ms. Winckler also led the operations of the Office of Legislation (until April 2009), the Office of External Relations, Office of Public Affairs, and Office of the Executive Secretariat. Prior to joining FDA, Ms. Winckler was the Vice President for Policy and Communications and Staff Counsel for the American Pharmacists Association (APhA). Ms. Winckler served as the primary spokesperson for APhA during media interviews, and was APhA's senior lobbyist. Previous positions with the Association include Group Director of Policy and Advocacy, Director of Policy and Legislation, Director of Practice Affairs, and Manager of Special Projects. Prior to joining APhA, Ms. Winckler directed the implementation of the Iowa Medicaid Drug Prior Authorization Program for the Unisys Company, and worked for the Iowa Pharmacists Association (now the Iowa Pharmacy Association) and a community pharmacy in Iowa. Ms. Winckler is a graduate of the University of Iowa College of Pharmacy and the Georgetown University Law Center, magna cum laude. She is a licensed pharmacist in Iowa and admitted to the bar in the Commonwealth of Virginia.

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DEBORAH A. WOLF is Regulatory Counsel for the Promotion and Advertising Policy Staff, Office of Compliance, Center for Devices and Radiological Health (CDRH), FDA. Prior to assuming this position in 1995, she was Regulatory Counsel in the Regulatory Policy Staff in the Center for Drug Evaluation and Research at FDA. From 1988-1991 she was Attorney Advisor in the Office of the General Counsel in the Office of the Secretary, U.S. Department of Health and Human Services, where she advised components of the Social Security Administration. Ms. Wolf received her BA from Indiana University and her JD from the University of Virginia.

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ALLISON M. ZIEVE, JD is Director for Public Citizen Litigation Group, a not-for-profit membership organization devoted to research, advocacy, and education on a wide range of public health and consumer safety issues. Among other areas, her practice areas include food and drug law, open government, and federal preemption. Ms. Zieve has represented plaintiffs in numerous cases involving the question of whether regulation by FDA preempts product liability claims seeking damages for injuries caused by FDA-regulated products. She has also published articles on preemption of state-law damages actions, tobacco regulation, and the Freedom of Information Act for publications such as Internal Medicine News, Regulatory Affairs Journal (UK), TRIAL Magazine, and various BNA legal publications. Since its beginning, she has judged the American Constitution Society's Richard D. Cudahy Writing Competition on Regulatory and Administrative Law. In addition, Ms. Zieve has taught appellate advocacy as an adjunct professor at the American University's Washington College of Law. She also teaches a course on dietary supplement and food regulation at Georgetown University Law School, and serves as a trustee of the Client Security Fund of the District of Columbia Bar. Ms. Zieve received her AB, magna cum laude, from Brown University and graduated from Yale Law School.

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