ALLISON M. ZIEVE is Director of Public Citizen Litigation Group and general counsel of Public Citizen, a non-profit membership organization devoted to research, advocacy, and education on a wide range of public health and consumer safety issues. Among other areas, her litigation practice includes food and drug law, open government, and access to courts issues. She has published articles on federal preemption of state law, 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. In addition, Ms. Zieve teaches a course on dietary supplement and food regulation at Georgetown University Law School. She also serves as a public member of the Administrative Conference of the United States, a trustee of the Client Security Fund of the District of Columbia Bar, and as a judge of the American Constitution Society’s Richard D. Cudahy Writing Competition on Regulatory and Administrative Law. In addition, she serves on the Board of The Food and Drug Law Institute. Ms. Zieve graduated from Brown University and Yale Law School.
JEFFREY N. GIBBS is a Director in the law firm of Hyman, Phelps & McNamara, P.C. in Washington, DC. In this role, he advises companies on a wide range of issues, including product approvals, marketing, clinical studies, and enforcement. Prior to entering private practice, he was Associate Chief Counsel for Enforcement at the Food and Drug Administration (FDA). He has written extensively on FDA regulatory topics, and was previously Chair of the Editorial Advisory Board of the Food and Drug Law Journal. He is currently General Counsel of The Food and Drug Law Institute (FDLI) and a member of FDLI’s Board of Directors. He is also on the editorial advisory board of IVD Technology, and was a member of the Human Subjects Research Board for George Mason University. Mr. Gibbs is a graduate of Princeton University and New York University School of Law.
Immediate Past Chair
SHEILA M. HEMEON-HEYER, RAC is the Founder and President of Heyer Regulatory Solutions LLC, providing global regulatory submission and compliance consulting services to the medical device industry. Ms. Heyer has 25 years of experience in Regulatory Affairs, beginning at FDA where she was a Scientific Reviewer in the CDRH Office of Device Evaluation and was responsible for reviewing 510(k), IDE and PMA applications for orthopedic, physical medicine and surgical devices. After leaving FDA, Ms. Heyer was Director of Regulatory Services for Medical Device Consultants, Inc. (MDCI), providing regulatory, clinical and quality consulting services to the medical device industry and managing complex projects across the medical product lifecyle. She joined Boston Scientific Corporation (BSC) in April, 2005 as Vice President, Global Regulatory Affairs, where she was responsible for worldwide regulatory strategies and execution. Ms. Heyer holds a BS in Biomedical Engineering from Boston University, an MS in Biomechanics from the University of Massachusetts at Amherst and a JD from Western New England College School of Law. She is Regulatory Affairs Certified, a Fellow of the Regulatory Affairs Professional Society and serves on the Board of Directors for The Food and Drug Law Institute (FDLI).
FREDERICK R. BALL is a Partner at the law firm of Duane Morris LLP in Chicago, IL. He is vice-chair of Duane Morris’s White-Collar Government Regulatory Division of the Trial Practice Group and heads its Pharmaceutical, Pharmacy and Food Group. He focuses his practice on assisting companies or individuals when they are adverse to state or federal governments, including administrative, civil and criminal matters with the FDA, DEA, CMS and other federal and state regulatory agencies. Mr. Ball helps generic pharmaceutical companies, biologics manufacturers, food companies (including supplement manufacturers), pharmacies, long-term care providers and other health care providers navigate the complex challenges faced by state and federal regulation of their industries, including complying with current Good Manufacturing Practices, price reporting (AMP, AWP, ASP, etc.), the Foreign Corrupt Practices Act, fraud and abuse laws including and labeling and advertising requirements. Mr. Ball also assists generic manufacturers bring products to market through patent analysis and Hatch-Waxman litigation. He is experienced in conducting internal investigations and advising companies on actions following the investigation. Finally, he helps companies maintain their trade secrets and competitive advantage through trade secrets litigation and enforcement of restrictive covenants. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financially and legally. In his spare time, he is an adjunct professor of law at DePaul University School of Law and serves on the FDLI Board. He is admitted to the Illinois State Bar, the Trial Bar of the U.S. District Court for the Northern District of Illinois, the Seventh Circuit and the U.S. Supreme Court. A member of the American and Illinois State bar associations, Mr. Ball is a 1996 cum laude graduate of Cornell Law School and a graduate of the University of Colorado at Boulder.
Secretary and General Counsel
JOY LIU is Vice President of Commercial and Regulatory Legal and Vertex Pharmaceuticals. Previously Ms. Liu was a Partner at the law firm of Ropes & Gray LLP in Washington, DC. In this role, she represented large pharmaceutical, biotechnology, and medical device companies on a broad range of FDA regulatory issues. She counseled clients on promotional compliance matters, Hatch-Waxman exclusivity strategies, and government investigations, among other issues. Ms. Liu also provided FDA regulatory due diligence support for corporate transactional matters (e.g., licensing deals and M&A) and for securities filings for publicly traded life sciences companies. She has significant experience with the advertising and promotion of pharmaceuticals and medical devices. While on a seven-month secondment to a major pharmaceutical company, Ms. Liu served as the sole product attorney for a $3 billion product, sitting on the promotional review committee and also advising the client on issues arising under the Anti-Kickback Statute and the False Claims Act. She has also served as the legal representative on review committees of emerging companies with single products. Ms. Liu received an AB from Harvard College and a JD from Columbia Law School.
President & CEO
AMY COMSTOCK RICK, J.D., is the President and Chief Executive Officer of the Food and Drug Law Institute, having joined in August, 2014. Prior to joining FDLI, Ms. Rick was the Chief Executive Officer of the Parkinson’s Action Network (PAN) from 2003-2014. PAN is a Washington D.C.-based national nonprofit focused on educating the public and government leaders on better policies for research and therapy development and an improved quality of life for people living with Parkinson’s disease. Ms. Rick has also served as the President of the Coalition for the Advancement of Medical Research, on the Boards of Directors of Research!America, the National Health Council, and the American Brain Coalition. Before joining PAN, she was the Senate-confirmed Director of the U.S. Office of Government Ethics from 2000-2003 and the Associate Counsel to the President in the White House Counsel’s Office from 1998-2000. Ms. Rick began her federal service as a career attorney at the U.S. Department of Education in 1989 and became the Assistant General Counsel for Ethics in 1993. Prior to her government service, Ms. Rick was an associate attorney at the law firm of Beveridge & Diamond. She received a Bachelor of Arts degree from Bard College and a Juris Doctor degree from the University of Michigan.
STEVE H. ARMSTRONG is the Senior Food Law Counsel at Campbell Soup Company. He is responsible for counseling Campbell’s businesses around the world on food safety, labeling compliance and food policy. He advises Campbell’s U.S. businesses on compliance and policy matters involving the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA), as well as food agencies in Europe and Asia. Mr. Armstrong came to Campbell in January 2007 from Energizer’s Schick-Wilkinson Sword Division, where he served as Senior Marketing Counsel. He has had over 18 years of experience in advising companies on marketing and regulatory matters, having previously worked as an Assistant General Counsel at Unilever United States, and Division Counsel at Colgate-Palmolive Company. Before beginning his in-house practice, Mr. Armstrong advised clients on commercial litigation and regulatory matters at the law firm of Townley & Updike in New York City. Prior to entering law school, he had over twelve years’ experience as a journalist, including a five-year stint as an editor at The Miami Herald. Mr. Armstrong received his Bachelor’s degree in history and literature from Harvard College and earned his JD from Columbia University.
JENNIFER L. BRAGG is a Partner at the law firm of Skadden, Arps, Slate, Meagher & Flom LLP in Washington, DC. Ms. Bragg is an experienced regulatory and litigation attorney, advising FDA-regulated companies, as well as hospitals and health care systems, facing government investigations and U.S. FDA enforcement challenges. Previously, Ms. Bragg served in FDA’s Office of Chief Counsel as associate chief counsel for enforcement, where she provided advice to FDA’s Office of Criminal Investigations. In addition to her thriving practice, Ms. Bragg is a member of the firm’s Women’s Initiatives Committee, which is designed to promote the retention and advancement of women in the firm.
STACY L. EHRLICH is a Partner at the law firm of Kleinfeld, Kaplan & Becker, LLP in Washington, DC.
In her 20th year with the firm, Ms. Ehrlich’s practice focuses on counseling and advocating on behalf of pharmaceutical, food, dietary supplement, tobacco, cosmetic, and medical device companies on a variety of matters involving FDA, USDA, and FTC, as well as state agencies. Ms. Ehrlich is currently outside counsel for the Coalition of Independent Tobacco Manufacturers of America and has been involved in FDA’s regulation of tobacco products since early in the legislative process of the Family Smoking Prevention and Tobacco Control Act.
LEWIS A. GROSSMAN, PhD, is Professor of Law at the American University Washington College of Law (WCL). He is also Of Counsel with the food and drug group at Covington & Burling LLP. He joined the faculty of Washington College of Law in 1997 and became Professor of Law in 2003 and was previously Associate Dean for Scholarship. He teaches, writes, and lectures in the areas of food and drug law, civil procedure and American legal history. Prior to joining the faculty of WCL, he was an Associate at Covington & Burling, and before that was clerk for Chief Judge Abner Mikva, U.S. Court of Appeals, DC Circuit. Dr. Grossman is coauthor (with Peter Barton Hutt and Richard A. Merrill) of Food and Drug Law: Cases and Materials 3d ed. (Foundation Press, 2007). He is a member of the National Academies’ Institute of Medicine (IOM) Committee for Review of FDA’s Role in Ensuring Safe Food and was a legal consultant for the IOM Committee on the Framework for Evaluating the Safety of Dietary Supplements. He earned his BA, summa cum laude, from Yale University and his JD, magna cum laude, from Harvard Law School. Dr. Grossman received his PhD in History from Yale University, where he earned the George Washington Egleston Prize for Best Dissertation in American History.
FREDDY A. JIMENEZ is Vice-President, Law and Compliance at Celldex Therapeutics. In this role he is responsible for the development and execution of comprehensive legal and compliance strategies as well as coordination of legal services to support the R&D and commercial efforts of Celldex as it creates novel, disease-specific therapies that induce, enhance or suppress the body’s immune response to fight cancer.
Previously he served as Assistant General Counsel for Johnson & Johnson in New Brunswick, NJ. There, Mr. Jimenez was Regulatory Counsel for several pharmaceutical and device companies within J&J. In his more than 20 years in the industry, his practice has focused on the regulation of pharmaceutical and biotechnology products and health care compliance.
SCOTT M. MELVILLE is the president and chief executive officer of the Consumer Healthcare Products Association (CHPA) and leads the organization’s efforts to promote empowerment of consumer healthcare through advocacy, science, and education. With a diverse background in pharmaceuticals, association management, public policy and law, Melville has advocated before Congress, the U.S. Food and Drug Administration, state legislative and regulatory bodies, and the media. Prior to joining CHPA, Melville served as senior vice president for government affairs and general counsel for the Healthcare Distribution Management Association, the national association representing pharmaceutical wholesale distributors, where he was responsible for federal and state legislative, regulatory, legal, and political affairs. Before joining HDMA, Melville served as an attorney and head of government relations for Cephalon, Inc., an international biopharmaceutical company, since acquired by TEVA Pharmaceuticals, and previously served in public policy and government affairs positions at Hoffmann-La Roche and Sterling Winthrop, Inc. He is a former chair of the Pennsylvania Biotechnology Association. Prior to joining the pharmaceutical industry, Melville served as legislative counsel and Appropriations Committee associate on the staff of former U.S. Congressman Jerry Lewis (R-Calif.). Melville earned his bachelor’s degree from Bucknell University, and his juris doctorate from George Mason University School of Law. He is a member of the Virginia and Pennsylvania bars and the U.S. Chamber of Commerce Association Committee of 100. He serves on the boards of the World Self-Medication Industry, the CHPA Educational Foundation, and the Food & Drug Law Institute.
FRANCIS B. PALUMBO, PhD, is Professor and Executive Director, University of Maryland School of Pharmacy Center on Drugs and Public Policy in Baltimore, MD. He is a licensed pharmacist and a member of the Maryland Bar. He has practiced both pharmacy and law. Dr. Palumbo and his colleagues at the University of Maryland conducted much of the early work on drug use review, a subject on which they have published widely. He has been the principal investigator on major federal research grants examining the use of drugs in long term care patients. Dr. Palumbo has many journal articles and presentations to his credit and co-authored a book on containing costs in third party drug programs. He maintains an interest in pharmacoeconomics, pharmacoepidemiology and health services research as well as healthcare and food and drug law. He has also been very active in several national professional organizations, including the American Pharmacists Association, where he served as President of the Academy of Pharmaceutical Research and Science, and the American Society for Pharmacy Law, where he is a past president. He received his BS in pharmacy from the Medical University of South Carolina, MS and PhD in health care administration from the University of Mississippi, and JD from the University of Baltimore School of Law. He served in the US Army from 1969-1971.
ROBERT A. RHOADES is Vice President, Quality & Compliance at Quintiles. Within his thirty-seven year career, Mr. Rhoades has been a preferred advisor to senior pharmaceutical and medical device executives regarding compliance and its impact on corporate direction and strategy. A skilled practitioner of both the Quality System Regulation (QSR) and the pharmaceutical cGMPs, he has designed and implemented compliance improvement initiatives for major manufacturers in the U.S., Europe, China and India. Mr. Rhoades is often engaged to provide post-Warning-Letter guidance and remediation project management to re-establish client credibility with the FDA, as well as assisting manufacturers in proactively designing quality systems to assure successful inspections. Mr. Rhoades has also worked in concert with client counsel on a wide variety of legal cases. He was selected by client counsel to advise in the contaminated heparin crisis that reached world-wide proportions in 2008. Mr. Rhoades’ skills as a public speaker/instructor and project manager have often combined for successful outcomes. He has designed and executed quality systems programs and remediation efforts for client companies in China, Europe and India. He is frequently an invited speaker at pharmaceutical and medical device conferences in the U.S., Europe and Asia, and has authored several articles on quality-related topics. His first book, Risky Business: Managing The Quality of America’s Medicines, was released in February 2004 by FDANews, and is now in its second edition. Mr. Rhoades holds a BS in Microbiology from Purdue University and a MBA in Strategic Planning and Operations Management from Lake Forest (IL) Graduate School of Management.
CARMEN M. SHEPARD is the Senior Vice President, Global Policy and Legal Regulatory Counsel at Mylan. She is responsible for handling legal regulatory issues arising from the company’s generic drug business in over 140 countries. She is also responsible for the company’s Policy efforts globally. Prior to working at Mylan, she was a partner at Zuckerman, Spaeder and at Buc & Beardsley, specializing in Food and Drug Law. Ms. Shepard began her career as a trial attorney for the U.S. Department of Justice. Later, she embarked on a career with the Maryland Attorney General’s Office, where she served as Deputy Attorney General. Ms. Shepard is a graduate of the Yale Law School and Yale University.
PETER E. TAMBORSKI is General Counsel for the Sugar Creek Packing Company, a food company based in Washington Court House, OH that has operations in Ohio, Kansas, Illinois and Missouri. His responsibilities include management of all legal issues for the company, including corporate, employment, safety, litigation and regulatory matters. Mr. Tamborski practiced for 20 years as an associate and then partner at Smith & Schnacke LLP and Thompson Hine LLP in Ohio before assuming his current position in 2002. For the past eight years, he has interacted with a wide variety of food companies, food safety professionals and regulatory agencies in the management of Sugar Creek’s business, which focuses on both raw and RTE proteins (bacon, turkey and chicken products) and sandwich products. His experience includes management of co-packing, private label and food service matters. Mr. Tamborski received his BA in government from Centre College and his JD from Chase Law School at Northern Kentucky University. He is admitted to practice before the Ohio Supreme Court, the United States Court of Appeals for the Sixth Circuit and the Supreme Court of the United States.