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.
Jeffrey N. Gibbs | Read Bio
Director, Hyman, Phelps & McNamara, PC
Immediate Past Chair
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.
Daniel Kracov | Read Bio
Partner, Arnold & Porter LLP
Secretary and General Counsel
Frederick R. Ball | Read Bio
Partner, Duane Morris LLP
FREDERICK (RICK) R. BALL is located in the Boston office of Duane Morris LLP. Mr. Ball 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, FTC, DEA, CMS, OIG and other federal and state regulatory agencies. He serves as a team lead for the Duane Morris Life Sciences/Biotech industry group. Mr. Ball helps pharmaceutical companies, biologics manufacturers, medical device manufacturers, contract service providers, 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, False Claims Act, and Anti-Kickback Statute, as well as meeting labeling and advertising requirements. Mr. Ball assists companies bring product to market through patent analysis, identifying marketing and approval pathways, and, when necessary litigation. Mr. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. Mr. Ball emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal.
Amy Comstock Rick | Read Bio
Food and Drug Law Institute
President and CEO
Cathy L. Burgess | Read Bio
Partner, Alston & Bird LLP
CATHY L. BURGESS is a Partner at the law firm of Alston & Bird, LLP in Washington, DC, and serves as the co-chair of the firm’s FDA Practice. Her practice focuses primarily on regulatory compliance, product risk management, enforcement, and policy matters related to CGMP and QSR regulation of global manufacturers. Ms. Burgess provides strategic counseling, conducts internal investigations and special audits related to FDA compliance, and assists clients in designing compliance programs, internal audit programs, and other risk mitigation strategies. She is recognized as a leading practitioner for life sciences, food and beverage law, and in the area of pharmaceutical and medical products regulation.
Ms. Burgess previously served as associate general counsel for the American Red Cross, where she was responsible for regulatory matters; providing legal and strategic advice to Red Cross senior management and the board of governors’ Audit Committee on matters related to the Red Cross Amended Consent Decree. She also previously served as the defense team’s first chair for expert testimony on CGMPs and analytical method validation in United States v. Barr Laboratories, widely recognized as the leading case on CGMPs. Ms. Burgess earned her J.D. from The Catholic University of America and a B.S.F.S. from Georgetown University.
Carla Cartwright | Read Bio
Director, Global Regulatory Policy, Johnson & Johnson
CARLA CARTWRIGHT is a member of the Johnson & Johnson Government Affairs & Policy group where she manages a variety of global regulatory policy issues across the pharmaceutical, consumer and medical device sectors. Carla has served on the Federal Affairs team where she led on FDA matters and supported the oncology and immunology portfolios and was a part of the Global Regulatory Policy and Intelligence team where she was the US policy lead on topics including clinical trial innovation, patient engagement, expedited approval pathways, disease interception, and combination products. Prior to joining Johnson & Johnson, Carla was an attorney and team leader in FDA’s Office of the Chief Counsel where she advised the Center for Drug Evaluation and Research on legal and policy issues, working closely with the Offices of Policy and Legislation. Carla is a graduate of Washington University in St. Louis and has a JD from Yale Law School and an LLM from Georgetown University Law Center.
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. 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
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
Sandra Cohen Kalter | Read Bio
Vice President and Chief Regulatory Counsel, Medtronic
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.