Freddy A. Jimenez | Read Bio
Senior Vice President and General Counsel, Celldex Therapeutics Chair
FREDDY A. JIMENEZ is Senior Vice-President and General Counsel at Celldex Therapeutics. Jimenez brings over 25 years of experience in the biopharmaceutical industry. At Celldex, he is a 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. Jimenez is a recipient of six J&J Standards of Leadership Awards. He is Vice-Chair of the Board for the Food and Drug Law Institute and is a graduate of Brandeis University and the Rutgers School of Law – Newark.
Daniel Kracov | Read Bio
Partner, Arnold & Porter LLP Immediate Past 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.
Amy Norris | Read Bio Secretary and General Counsel
AMY NORRIS is Executive Counsel and Senior Vice President, Legal for Clif Bar & Company, a leading maker of nutritious and organic foods and drinks. She advises the company on legal and operational matters, including regulatory compliance, food safety, food labeling, advertising, litigation, and domestic and international business issues. Norris oversees the operation of the legal department and actively manages the risk management and regulatory compliance groups. She has been with Clif Bar for eleven years. Prior to joining Clif Bar, Norris was in private practice for ten years and 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.
Frederick R. Ball | Read Bio
Partner, Duane Morris LLP
FREDERICK (RICK) R. BALL is in the Boston office of Duane Morris LLP. 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. 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. He assists companies bring product to market through patent analysis, identifying marketing and approval pathways, and, when necessary litigation. Ball is experienced in conducting internal investigations and advising companies on actions following the investigation. He emphasizes a team approach to client problem solving and manages matters to achieve client goals both financial and legal.
Christine M. Simmon | Read Bio
Food and Drug Law Institute President and CEO
CHRISTINE M. SIMMON is the President & Chief Executive Officer of the Food and Drug Law Institute (FDLI), a nonprofit educational organization serving more than 30,000 food and drug law professionals working in pharmaceutical, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products, and providing them with a neutral venue to share perspectives and inform public policy, law, and regulation.
Before joining FDLI in 2022, Ms. Simmon had a 14-year career at the Association for Accessible Medicines, where she was the Executive Vice President and the Executive Director of its Biosimilars Council, a division which she co-founded. At AAM, which represents generic drug and biosimilars manufacturers, Ms. Simmon at various times led the policy, communications, international, strategic alliances, and legal functions and played a key role in the trade group’s growth into a top pharmaceutical organization. She also co-founded and served as executive sponsor of AAM’s Women in Health Policy (WiHP) networking group. She has testified before Congress, state legislatures, FDA, FTC, Wall Street investment firms, and the World Health Organization, and is a recognized thought leader in the generics and biosimilars space.
Ms. Simmon also has held senior policy positions at CVS Health, the Blue Cross and Blue Shield Association and as a managing editor at Thompson Publishing. She has served as a director on non-profit boards including Healthcare Ready, the Dispensary of Hope, and the National Coalition on Health Care.
Ms. Simmon earned her J.D. at Georgetown University Law Center and her B.A. at Georgetown University.
Ricardo Carvajal | Read Bio
Director, Hyman, Phelps & McNamara, PC
RICARDO CARVAJAL is a director at Hyman, Phelps & McNamara, PC, a law firm based in Washington, DC that specializes in FDA and related regulatory matters. From 2002 to 2007, he served as an associate chief counsel at FDA, where he counseled the agency on a variety of food-related enforcement and rulemaking activities. Drawing on that expertise, he counsels clients on a wide range of food regulatory issues. He advises clients on the regulatory status of ingredients and finished products and provides guidance on compliance with labeling and advertising requirements, as well as representation in advertising-related disputes. Carvajal also helps clients interpret and comment on the implementation of new requirements, such as those arising under the Food Safety Modernization Act. He applies his subject matter expertise to corporate transactions, issuing opinions and conducting due diligence for acquisitions and initial public offerings. Carvajal is a member of the Food and Drug Law Institute, the American Bar Association, and the European Food Law Association, and a professional member of the Institute of Food Technologists.
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, Cirotta was the President and COO of UPM Pharmaceuticals and the Vice President of Global Regulatory Affairs for Pharmaceuticals at Bausch & Lomb. He 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, 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. 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.
Melanie Gross | Read Bio
Senior Director & Associate General Counsel, Genentech, Inc.
MELANIE GROSS is Senior Director & Associate General Counsel at Genentech, Inc. She joined the Genentech Legal Department in 2008. Gross leads a team of attorneys in the support of Genentech’s Non-Oncology Business Portfolio, which includes but is not limited to, the therapeutic areas of Ophthalmology, Rare Disease, Multiple Sclerosis, Respiratory, Flu, Alzheimer’s, and Immunology. Prior to joining Genentech, she was an associate in the Washington, D.C. office of the law firm, King & Spalding in the FDA & Life Sciences Practice Group.
Gross is passionate about the personal and professional development of others. She motivates, inspires, challenges, and supports the people she leads and helps them grow, learn, and thrive. On her own initiative, Gross 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). She 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, she 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. She 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 14 plus years in the Bay Area, Gross has been active in the Oakland and Global communities. She served as a 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. Melanie is also a lifetime member of Delta Sigma Theta Sorority Inc.
Gross received her JD 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
Assistant General Counsel, Regulatory Law, Cardinal Health Inc.
SONALI P. GUNAWARDHANA is Assistant General Counsel-Regulatory Law at Cardinal Health. In this role, Sonali provides regulatory and legal support to Cardinal Health’s businesses including both pharmaceutical and medical device manufacturing and distribution. Previously, she served as Chief Counsel FDA and Regulatory Law at McKesson Corporation and 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, she 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. Gunawardhana 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.
Adora Ndu | Read Bio Chief Regulatory and interim Legal Officer, Bridgebio Pharma
Dr. Ndu is currently the Chief Regulatory and Interim Legal Officer for BridgeBio Pharma Inc. Prior to joining BridgeBio, Dr. Ndu served as Group Vice President, Worldwide Research & Development, Strategy, Scientific Collaborations and Policy at BioMarin Pharmaceutical, Inc. She brings over 15 years of complementary experience in drug development and regulatory affairs. Her expertise incorporates regulatory strategy, patient engagement, prescription drug promotion, and policy for U.S. and international markets. Prior to joining BioMarin, Dr. Ndu was Director and Head of the Division of Medical Policy Development at the U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research and also a Commander in the Commissioned Corps, U.S. Public Health Service. She has been involved in the registrations of multiple products globally and is a respected thought leader in regulatory science, having played a significant role in developing and evaluating guidance, as well as shaping regulatory policy. Dr. Ndu received her doctorate in pharmacy from Howard University’s College of Pharmacy and a law degree from the University of Maryland. Dr Ndu serves on the Board of Directors for Acadia Pharmaceuticals and DBV Technologies.
Vernessa Pollard | Read Bio Partner, McDermott Will & Emery LLP
Vernessa Pollard is Co-Chair of McDermott Will & Emery’s global Life Sciences practice and leads the FDA practice. A thought-leader on digital health and regulatory issues, Vernessa works alongside life sciences, medical device and technology companies, helping them navigate FDA regulatory complexities to bring novel technologies and cutting-edge products to market. She is a recognized leader, with numerous accolades, in the life sciences community. Vernessa is also a former Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel. She received her B.A. in Communications from Howard University and her Juris Doctor from Temple University School of Law.
ZACH ROTHSTEIN in is Executive Director for AdvaMedDx. In this role, Zach directs the policy, advocacy, communications, regulatory, payment and legislative strategy and operations of the association, which represents manufacturers of in vitro diagnostic (IVD) clinical tests in the U.S. and abroad. Prior to this position, Zach was AdvaMed’s Senior Vice President for Technology and Regulatory Affairs where he led the association’s efforts on digital health, software, cybersecurity and postmarket policy matters. Rothstein also participated in all aspects of the MDUFA V negotiation process, and served as AdvaMed’s lead coordinator for its COVID-19 Action team. Zach is also a member of the World Health Organization’s Digital Health Technical Advisory Group’s Roster of Experts.
Prior to joining AdvaMed, Zach was Deputy Senior Counsel for Public Policy at Samsung Electronics where he was responsible for the company’s medical device and healthcare regulatory and policy issues. In this position, Zach counseled Samsung’s global business units through all stages of product development on U.S. regulations affecting medical devices. Zach also planned and executed the company’s FDA and healthcare regulatory and legislative policy objectives. While at Samsung, Zach served on the Board of Directors for the Personal Connected Health Alliance (formerly Continua) and the Consumer Electronics Association’s Health and Fitness Technology Division.
Prior to joining Samsung, Zach was an Attorney in the FDA and Healthcare practice at the law firm of Morgan, Lewis & Bockius LLP. In this role, Zach served as outside counsel to various healthcare companies on FDA and HHS regulatory, compliance, and enforcement matters.
Zach earned his J.D. from The Catholic University of America, where he was a Notes and Comments Editor of the Law Review, President of the Moot Court Board, and won first place and best brief awards at the 2009 National Telecommunications Moot Court Competition. Zach received his B.A. in political science and criminal justice from Indiana University, Bloomington.
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. Schnedar previously served at the Department of Justice (DOJ) as Acting Inspector General and in other leadership positions focused on compliance and enforcement issues. She also served as a prosecutor and a civil trial attorney for DOJ. Schnedar 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. She earned a BA with Distinction from the University of New Mexico and a JD with Honors from the University of Texas School of Law.
David C. Spangler | Read Bio Senior Vice President, Legal, Government Affairs & Policy, Consumer Healthcare Products Association
DAVID C. SPANGLER is Senior Vice President, Legal, Government Affairs & Policy at CHPA where he leads the association’s team of eight across legal, government affairs, and policy functions. Spangler joined CHPA in 1984 as a legislative analyst. He subsequently served in a number of roles for the association in the president’s office, project management, international affairs, and, after completing law school in 1995, the association’s legal department. Spangler responsibilities were expanded to his current role in 2019. Spangler is a member of the DC Bar as well as the American Society of Association Executives. He authored the chapter on OTC medicines in “Modern Pharmaceutical Industry: A Primer” (Jacobsen and Wertheimer, eds., 2009) and has served on a range of committees and working groups for the Food and Drug Law Institute and the Global Self-Care Federation. Spangler earned his Certificate in Organization Management in 1991 from the US Chamber of Commerce’s Institute for Organization Management. He received his AB from Miami University (Ohio) and his JD from George Washington University National Law Center.
Rachel Turow | Read Bio Managing Counsel, FDA Regulated Products, Walmart
RACHEL TUROW is Lead Counsel, FDA Regulatory at Walmart. Turow has over 17 years of experience as an FDA regulatory lawyer, with expertise in healthcare and pharmaceutical industries. She also spent five years at the FDA. She and her team provide regulatory legal advice to Walmart’s business on OTC drugs, dietary supplements, medical devices, and food safety as well as counsel on other regulatory issues affecting these products as they arise. Prior to joining Walmart, Rachel was Associate General Counsel, Regulatory Law & Policy; and Head of U.S. Regulatory Policy at Teva Pharmaceuticals where she focused on legal and policy issues affecting the approval and uptake of innovative medicines, generic drugs, and biosimilars. She also served as Director of Regulatory Policy for Novo Nordisk, a leading global healthcare company, where she strategically responded to FDA policy and regulatory issues related to the company’s pipeline of products. During her five years at the FDA, Rachel focused on drug and medical device regulation. She served as Special Assistant to the Center Director at the Center for Devices and Radiological Health, and as Regulatory Counsel at the Office of Regulatory Policy in the Center for Drug Evaluation and Research. At the start of her career, Rachel was a corporate lawyer at United Therapeutics. She holds a degree in Human Biology from Stanford University and earned her Juris Doctor and a Master of Public Heath from the University of Michigan. She lives in McLean, Virginia, with her husband and three children.