Board of Directors
Jeffrey N. Gibbs | Read Bio
Director, Hyman, Phelps & McNamara, PC
Chair
Biography
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 Chair and member of the Food and Drug Law Institute (FDLI) 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.
Jennifer L. Bragg | Read Bio
Partner, Skadden, Arps, Slate,
Meagher & Flom LLP
Vice Chair
Biography
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.
Joy Liu | Read Bio
Vice President, Commercial and Regulatory Legal, Vertex Pharmaceuticals
Secretary and General Counsel
Biography
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
Treasurer
Biography
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
Biography
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.At-Large Directors
Stacy L. Ehrlich | Read Bio
Partner, Kleinfeld, Kaplan & Becker, LLP
Biography
STACY L. EHRLICH is a Partner at the law firm of Kleinfeld, Kaplan & Becker, LLP in Washington, DC. Her practice focuses on counseling and advocating on behalf of pharmaceutical, food, dietary supplement, tobacco, cosmetic, and medical device companies on a variety of regulatory matters. Ms. Ehrlich currently serves on the Board of Directors of FDLI and has authored chapters in the FDLI publications, Food and Drug Law & Regulation, How to Work with the FDA, and multiple editions of Top 20 Food and Drug Cases & Cases to Watch. She received her JD from Harvard Law School and her BA in English from Emory University.
Jeffrey Francer | Read Bio
Senior Vice President and General Counsel, Association for Accessible Medicines
Biography
JEFFREY FRANCER is Senior Vice President and General Counsel of the Association for Accessible Medicines, where he leads legal and international trade advocacy. Jeff served as Associate Chief Counsel of the Food and Drug Administration from 2003 to 2005, where he advised agency leaders on issues involving the regulation of drugs and biologics including clinical investigation, manufacturing, promotion, enforcement and legislative matters. After leaving the FDA, Jeff served as Associate General Counsel, U.S. Compliance Officer, and Chief Privacy Officer of Biogen Idec, Inc. At Biogen Idec, he was the primary in-house counsel on FDA issues, fraud and abuse prevention and patient privacy. Jeff was also responsible for overseeing the U.S. corporate compliance program. Immediately prior to joining AAM, Jeff served as Vice President and Senior Counsel of the Pharmaceutical Research and Manufacturers of America (PhRMA) where he was the principal counsel to the association on issues relating to the research, development and regulation of medicines in the U.S. and globally. Mr. Francer received his A.B. in Public Policy and Economics from Brown University, his M.P.P. from Harvard University, and his J.D. from the University of Virginia.
Miriam Guggenheim | Read Bio
Partner, Covington & Burling, LLP
Biography
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
Biography
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.
Elizabeth Jungman | Read Bio
Director, Public Health Programs, The Pew Charitable Trusts
Biography
ELIZABETH JUNGMAN directs Pew’s work on public health, overseeing initiatives related to antibiotics and innovation and the safety of prescription drugs, over-the-counter medicines, and other consumer health care products .Before joining Pew, she served as a senior health policy adviser with the U.S. Senate Committee on Health, Education, Labor, and Pensions, where she played a key role in drafting and negotiating the Food and Drug Administration Safety and Innovation Act of 2012, the FDA provisions in the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013, and the Drug Quality and Security Act of 2013, which included drug compounding and supply chain security measures. Before moving to the Hill, Jungman was in private legal practice, counseling clients on a broad range of FDA regulatory matters and other health care issues related to the human pharmaceutical industry. She serves on FDA’s Pharmacy Compounding Advisory Committee. She has an undergraduate biology degree from Harvard College, a Juris Doctor from Georgetown University, and a master’s degree in public health from Johns Hopkins University.
Sandra Cohen Kalter | Read Bio
Vice President and Chief Regulatory Counsel, Medtronic
Biography
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 LLP
Biography
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)
Biography
SCOTT M. MELVILLE is the president and chief executive officer of CHPA and leads the organization’s efforts to empower consumer self-care by preserving and expanding choice and availability of consumer healthcare products. Prior to joining CHPA, Melville served as senior vice president of government affairs and general counsel for the Healthcare Distribution Management Association (now the Healthcare Distribution Alliance), representing pharmaceutical wholesale distributors. Prior to that role, Melville served in various public affairs and legal roles for the pharmaceutical and biotechnology companies Sterling-Winthrop, Hoffmann- LaRoche, and Cephalon. Melville began his professional career as a legislative assistant and appropriations committee associate on the staff of retired U.S. Congressman Jerry Lewis (R-Calif.). He earned his bachelor’s degree from Bucknell University, and his juris doctorate from George Mason University School of Law. 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
Biography
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.
Margaret (Mimi) Foster Riley | Read Bio
Professor, University of Virginia, Schools of Law and Medicine
Biography
MARGARET (MIMI) FOSTER RILEY teaches food and drug law, health law, animal law, bioethics, regulation of clinical research and public health law at University of Virginia’ Schools of Law and Medicine. Riley has written and presented extensively about health care law, biomedical research, genetics, reproductive technologies, stem cell research, animal biotechnology, health disparities and chronic disease. She serves as chair of UVA’s Embryonic Stem Cell Research Oversight Committee and as legal advisor to the Health Sciences Institutional Review Board, which is responsible for reviewing all human subject research at UVA involving medically invasive procedures. She served on the National Research Council Committee on Revisions to the Common Rule for the Protection of Human Subjects and has advised numerous committees of the Institute of Medicine and the Virginia Bar. Riley was previously an associate with Pepper Hamilton & Scheetz in Philadelphia, where she worked primarily in complex securities, commercial and mass tort litigation. Prior to that position, she was a litigation associate with Rogers & Wells in New York. Riley received her law degree from Columbia University and her bachelor of arts from Duke University.
Bob Rhoades | Read Bio
Managing Partner, Validant
Biography
Bob Rhoades is Managing Partner at Validant. Throughout his 38-year career, Mr. Rhoades has been a preferred advisor to senior pharmaceutical and medical device executives seeking counsel on compliance and its impact on corporate direction and business strategy. A skilled practitioner of both the Quality System Regulation (QSR) and the pharmaceutical cGMPs, he has designed and implemented compliance improvement initiatives for manufacturers in the US, Europe, India and China. He frequently provides post-Warning-Letter guidance and remediation project management to re-establish client credibility with the FDA. In addition, he assists manufacturers in proactively designing and optimizing quality systems. Mr. Rhoades often works 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 global proportions in 2008, and has provided third-party expert services in several Consent Decree cases. Prior to joining Validant, he led the Quality & Compliance Consulting Practice at Quintiles for more than 7 years. Prior to Quintiles, Bob held various Quality leadership roles for Solvay Pharmaceuticals, Bausch & Lomb and Baxter Healthcare. He holds a Masters of Business Administration in Operations Management and Strategic Planning from Lake Forest Graduate School of Management and a Bachelor of Science degree in Microbiology from Purdue University.