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 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
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
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
Amy Comstock Rick | Read Bio
Food and Drug Law Institute
President and CEO
Stacy L. Ehrlich | Read Bio
Partner, Kleinfeld, Kaplan & Becker, LLP
Jeffrey Francer | Read Bio
Senior Vice President and General Counsel, Association for Accessible Medicines
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
Freddy A. Jimenez | Read Bio
Vice President, Law and Compliance, Celldex Therapeutics
Elizabeth Jungman | Read Bio
Director, Public Health Programs, The Pew Charitable Trusts
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
Daniel Kracov | Read Bio
Partner, Arnold & Porter LLP
Scott M. Melville | Read Bio
President and CEO, Consumer Healthcare Products Association (CHPA)
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
Margaret (Mimi) Foster Riley | Read Bio
Professor, University of Virginia, Schools of Law and Medicine
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
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.