Daniel Kracov | Read Bio
Partner, Arnold & Porter LLP Chair
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.
Jennifer L. Bragg | Read Bio
Partner, Skadden, Arps, Slate,
Meagher & Flom LLP Immediate Past Chair
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.
Freddy A. Jimenez | Read Bio
Senior Vice President and General Counsel, Celldex Therapeutics Secretary and General Counsel
FREDDY A. JIMENEZis Senior Vice-President and General Counsel at Celldex Therapeutics. Freddy brings over 25 years of experience in the biopharmaceutical industry. At Celldex he is chief lawyer and compliance officer 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. Significant contributions have included leading the legal team supporting the acquisition and integration of Kolltan Pharmaceuticals, designing and launching Celldex’s health care compliance program, and revamping the contracting process. Prior to Celldex, he was at Johnson & Johnson (J&J) for 23 years in various roles, including as head of the pharmaceutical regulatory legal group for J&J where he coordinated legal strategy, deployment, and provided advice and counsel regarding regulatory, compliance, and fraud and abuse matters to pharmaceutical and biopharmaceutical affiliates of J&J and to the North America Leadership Team. He is a recipient of six J&J Standards of Leadership Awards. He is on the Board of Directors and is General Counsel for the Food and Drug Law Institute and is a graduate of Brandeis University and the Rutgers School of Law – Newark.
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
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.
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.
Senior Director, Global Digital and 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.
Melanie Gross | Read Bio
Senior Director & Associate General Counsel, Genentech, Inc.
MELANIE GROSS is Senior Director & Associate General Counsel at Genentech, Inc. Melanie joined the Genentech Legal Department in 2008. Melanie leads a team of attorneys in the support of numerous global functions and initiatives in the areas of Research and Development, Manufacturing, Pharmacovigilance, Personalized Healthcare, Digital Health and Procurement. Prior to joining Genentech, Melanie was an Associate in the Washington, D.C. office of the law firm, King & Spalding in the FDA & Life Sciences Practice Group.
Melanie is passionate about the personal and professional development of others. Melanie motivates, inspires, challenges, and supports the people she leads and helps them grow, learn, and thrive. On her own initiative, Melanie has championed diversity and inclusion, sponsoring programs to increase awareness of unconscious bias and helped form and chaired the Legal Department’s diversity committee, IDEAL (Inclusion & Diversity: Excellence & Action in Legal). Melanie has been an active member of the Genentech Women Professionals organization. Her leadership was recognized in 2018 when she received the GWP Emerging Leader Award.
Prior to attending law school, Melanie worked in the non-profit sector where she led community development projects designed to address various public health issues in Houston, Texas including working with health care systems, patient advocacy groups and underserved communities to help raise awareness about the importance of breast cancer screening and treatment. Melanie also co-founded the former Houston-based non-profit breast health screening and resource organization called My Place, A Women’s Health Resource Center.
During her 13 years in the Bay Area, Melanie has been active in the Oakland and Global communities. Melanie has served as member of the Board of Directors for Black Women Lawyers of Northern CA, the Board of Directors for the North Oakland Community Charter School and Equal Rights Advocates, as well as a mentor for women residents at Oakland Elizabeth House. Through the Firelight Foundation Inc., based in Santa Cruz, she’s also served as a fundraiser for two CBOs (community based organizations) located in Lusaka, Zambia that provide HIV treatment and prevention services for women and their families. Currently, Melanie is involved in initiatives to raise funding and awareness of the issues supported by the national organization, Futures Without Violence and is an advisory board member for the Coalition of Black Excellence. Melanie is also a lifetime member of Delta Sigma Theta Sorority Inc.
Melanie received her J.D. from Howard University School of Law. She received her undergraduate degree in psychology from the University of Virginia, and a Masters in Public Health from the University of Texas Health Science Center at Houston.
Sonali P. Gunawardhana | Read Bio
Chief Counsel – FDA & Regulatory Law, McKesson Corporation
SONALI P. GUNAWARDHANA is Chief Counsel- FDA & Regulatory Law at McKesson Corporation. In this role, Sonali provides regulatory legal support to McKesson’s businesses, including pharmaceutical private label products, 3PL, REMS programs, clinical research programs, pharmaceutical and medical device distribution. Previously, Sonali served as outside counsel to a myriad of pharmaceutical and medical device companies while in private practice at Wiley Rein LLP and Shook, Hardy & Bacon LLP respectively. Prior to her tenure in private practice, Sonali served as Regulatory Counsel at the FDA for close to ten years. There she assisted on a variety of legal and policy issues in the following Centers: the Center for Devices and Radiological Health; the Center for Drug Evaluation and Research; and the Center for Food Safety and Applied Nutrition. Sonali received a BA from Syracuse University, a MA from Webster University, an MPH from Boston University, a JD from the University of New Hampshire School of Law and a LLM from Washington College of Law, American University.
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
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
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 Associate General Counsel, Regulatory Law & Policy and Head, U.S. Regulatory Policy, TEVA Pharmaceuticals USA, Inc.
RACHEL TUROW is Associate General Counsel, Regulatory Law & Policy and Head, U.S. Regulatory Policy 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. Rachel also serves as Head for U.S. Regulatory Policy where she leads policy advocacy on key areas for Teva’s R&D activities as well as Teva’s U.S. trade association interactions. 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.