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.
Daniel Kracov | Read Bio
Partner, Arnold & Porter LLP
Freddy A. Jimenez | Read Bio
Vice President, Law and Compliance, Celldex Therapeutics
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 and supply chain 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 JD from The Catholic University of America and a BSFS 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 (GA&P) policy team where she manages a variety of global regulatory policy issues across the pharmaceutical, consumer and medical device sectors including importation, harmonization, and biosimilars. Regularly convening and leading cross functional team on key issues, Carla works regularly with partners in legal, privacy, regulatory affairs, and supply chain. She leads on global policy issues related to digital and emerging technology for GA&P and is the co-lead of the Digital and Emerging Technology Platform Team. Carla was previously a part of the Federal Affairs team where she led on FDA matters and supported the oncology and immunology portfolios and worked for Janssen’s 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.
Dean R. Cirotta | Read Bio
President, EAS Consulting Group
DEAN R. CIROTTA is President of EAS Consulting Group where he is responsible for the day-to-day management of the company. Prior to being a partner at EAS, a firm that provides regulatory consulting to all the FDA regulated industries, Mr. Cirotta was the President and COO of UPM Pharmaceuticals and the Vice President of Global Regulatory Affairs for Pharmaceuticals at Bausch & Lomb. Mr. Cirotta has 30 years of experience in the pharmaceutical, dietary supplement, and tobacco industries, including executive management roles with responsibility for regulatory affairs, compliance, quality assurance, laboratory operations, overall corporate management, and the last 10 years in consulting. In addition, Mr. Cirotta regularly speaks on FDA compliance and initiatives and is a lead trainer for EAS. He often assists clients with GMP compliance, quality system implementation, and FDA remediation. He also assists the tobacco industry in complying with the Deeming Rule requirements and ensuring compliance with the Family Smoking Prevention and Tobacco Control Act. Mr. Cirotta holds a Bachelor of Science degree in chemistry from the University of North Carolina at Greensboro and an MBA from the University of North Carolina at Chapel Hill.
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
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 is on the Board of Directors of the Food and Drug Law Institute in Washington D.C. She also serves as 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. In 2010, Sandy was a recipient of Medtronic’s prestigious Wallin Leadership Award.
Amy Norris | Read Bio
Executive Counsel, Clif Bar & Company
AMY NORRIS is Executive Counsel and Senior Vice President, Legal for Clif Bar & Company, a leading maker of nutritious and organic foods and drinks. Amy advises the company on legal and operational matters, including regulatory compliance, food safety, food labeling, advertising, litigation, and domestic and international business issues. Amy oversees the operation of the legal department and actively manages the risk management and regulatory compliance groups. Amy has been with Clif Bar for eleven years. Prior to joining Clif Bar, Amy was in private practice for ten years. Amy has spoken on Proposition 65, food labeling, food advertising, and food law litigation. She co-authored an article entitled “When Regulation Can Lead to Litigation: Top Issues in Food & Dietary Supplements” and contributed a chapter of the American Health Lawyers Association’s Enterprise Risk Management Handbook for Healthcare Entities.
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.
Cynthia Schnedar | Read Bio
Executive Vice President, Greenleaf Health, Inc.
CYNTHIA SCHNEDAR is Executive Vice President of Regulatory Compliance at Greenleaf Health, where she provides strategic advice to clients in the life sciences industry. She was formerly Director of the Office of Compliance for FDA’s Center for Drug Evaluation and Research (CDER), where she spearheaded efforts to protect the American public from unsafe and ineffective drug products by ensuring that companies comply with federal standards for quality and safety. Cynthia previously served at the Department of Justice (DOJ) as Acting Inspector General and in other leadership positions focused on compliance and enforcement issues. Cynthia also served as a prosecutor and a civil trial attorney for DOJ. Cynthia clerked for a judge on the US Court of Appeals for the Ninth Circuit and worked as a television reporter for local stations in New Mexico and Texas. Cynthia earned a BA with Distinction from the University of New Mexico and a JD with Honors from the University of Texas School of Law.
Rachel Turow | Read Bio
Executive Counsel, Regulatory Law, TEVA Pharmaceuticals USA, Inc.
RACHEL TUROW is Executive Counsel, Regulatory Law at TEVA Pharmaceuticals USA, Inc. In this role, Rachel provides regulatory legal support to Teva’s specialty and generic pharmaceutical businesses and supports Teva’s drug-device combination products and digital health projects. Previously, Rachel was Director, Regulatory Policy, at Novo Nordisk Inc. Prior to joining Novo Nordisk, Rachel spent five years at FDA. She was a Regulatory Counsel in CDER’s Office of Regulatory Policy and she served as Special Assistant to Jeff Shuren, Director of CDRH. Rachel holds a JD and MPH from the University of Michigan and a BA in Biology from Stanford University.