Board of Directors
Jeffrey N. Gibbs | Read Bio
Director, Hyman, Phelps & McNamara, PC
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.
Allison Zieve | Read Bio
Director, Public Citizen Litigation Group
Immediate Past Chair
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.
Joy Liu | Read Bio
Vice President, Commercial and Regulatory Legal, Vertex Pharmaceuticals
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.
Frederick R. Ball | Read Bio
Partner, Duane Morris LLP
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.
Amy Comstock Rick | Read Bio
Food and Drug Law Institute
President and CEO
AMY COMSTOCK RICK, JD, 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.
Steven H. Armstrong | Read Bio
EAS Consulting Group, LLC
STEVE ARMSTRONG has had over 20 years of experience advising leading consumer products companies on marketing and regulatory issues. Mr. Armstrong currently serves as an Independent Advisor on Food Laws and Regulation for EAS Consulting Group, a firm specializing in FDA regulatory matters. Most recently, Mr. Armstrong served as the Chief Food Law Counsel at Campbell Soup Company, where he counseled Campbell businesses on food safety, food policy, labeling and regulatory compliance, including matters involving the Food and Drug Administration, the U.S. Department of Agriculture and food agencies around the world. Before coming to Campbell, Mr. Armstrong served as the Senior Marketing Counsel at Energizer’s Schick-Wilkinson Sword Division and as the Assistant General Counsel for Marketing at Unilever United States. He also served as a regulatory and division counsel at Colgate-Palmolive Company. Mr. Armstrong is on the Board of Directors of the Food and Drug Law Institute in Washington, D.C., and is a frequent speaker on food law issues. Prior to beginning his in-house practice, Mr. Armstrong worked as an associate in commercial litigation and regulatory matters at Townley & Updike in New York City. Before law school, he had over 12 years’ experience as a journalist, including five years as an editor at The Miami Herald. Mr. Armstrong earned his bachelor’s degree from Harvard College and his law degree from Columbia University.
Jennifer L. Bragg | Read Bio
Partner, Skadden, Arps, Slate, Meagher & Flom LLP
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 | Read Bio
Partner, Kleinfeld, Kaplan & Becker, LLP
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.
Miriam Guggenheim | Read Bio
Partner, Covington & Burling, LLP
MIRIAM GUGGENHEIM is a Partner and Co-Chair of the Food, Drug and Device practice at Covington & Burling LLP. Her practice focuses primarily on the food and dietary supplement industries. Ms. Guggenheim counsels clients in all aspects of food and dietary supplement development and marketing, from product formulation, manufacturing, and safety considerations to labeling and advertising. Her work for a broad range of leading global food and dietary supplement companies and major trade associations includes regulatory advice, advocacy before regulators, courts and legislative bodies, and strategic counseling in light of overarching public health and nutrition policy considerations. Ms. Guggenheim is ranked as one of America’s Leading Business Lawyers, Food & Beverages: Regulatory & Litigation by Chambers USA. Ms. Guggenheim received her BA, magna cum laude, from the University of Pennsylvania and her JD, with honors, from Columbia University School of Law.
Freddy A. Jimenez | Read Bio
Vice President, Law and Compliance, Celldex Therapeutics
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.
Sandra Cohen Kalter | Read Bio
Vice President and Chief Regulatory Counsel, Medtronic
SANDRA COHEN KALTER is Vice President and Chief Regulatory Counsel at Medtronic, where she leads a team of legal regulatory experts in various areas of government regulation, including FDA law, import and export trade laws, environmental health and safety, advertising, promotion and social media. Ms. Kalter serves as Co-Chair of AdvaMed’s Advertising and Promotion Working Group and is a member of AdvaMed’s Legal Committee and AdvaMed’s Case for Quality Working Group. Prior to joining Medtronic, she practiced FDA law with King & Spalding for 13 years, with an emphasis on medical devices. Before joining King & Spalding, Ms. Kalter practiced law at Weil, Gotshal & Manges in Washington, DC, specializing in food and drug law, advertising and consumer product safety. She received her BS in journalism from Northwestern University’s Medill School and her JD from The National Law Center of George Washington University. Ms. Kalter is a member of the District of Columbia Bar and the American Bar Association.
Daniel Kracov | Read Bio
Partner, Arnold & Porter Kaye Scholer, LLP
DANIEL KRACOV is a partner in Arnold & Porter Kaye Scholer’s Washington, DC office, where he co-chairs the firm’s Life Sciences & Healthcare practice. He helps life sciences manufacturers, trade associations and early-stage ventures negotiate challenges relating to the development, manufacturing, approval and promotion of drugs, biologics, medical devices and diagnostics. In addition to day-to-day regulatory counseling, he regularly handles high stakes investigations and enforcement proceedings, the development of global compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely recognized expertise in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislation.
Scott M. Melville | Read Bio
President and CEO, Consumer Healthcare Products Association (CHPA)
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 | Read Bio
Professor & Executive Director, University of Maryland School of Pharmacy, Center on Drugs & Public Policy
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 | Read Bio
Senior Vice President, Quality & Compliance Services, QuintilesIMS
ROBERT A. RHOADES is Vice President, Quality & Compliance at QuintilesIMS. 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 Shepard | Read Bio
Senior Vice President, Global Policy & Regulatory Counsel, Mylan Pharmaceuticals, Inc.
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.