FDLI - Key Persons
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- Executive Counsel and Senior Vice President, Legal for 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. 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.
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- Member of the Publications and Academic Programs Committee
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- Director, Membership and Stakeholder Engagement
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- Member of the Annual Conference Planning Committee
BETH G. OLIVA represents manufacturers, distributors, retailers, and trade associations in regulatory, litigation and legislative matters. She handles a wide range of regulatory issues before federal and state agencies, including the Food and Drug Administration, and routinely counsels tobacco industry clients regarding FDA compliance and premarket review requirements. Beth also has extensive experience with state and federal government affairs. In addition, Beth has significant experience working with scientific issues. She has worked with scientific and medical personnel in the U.S., Canada, Europe and the Middle East. She has worked to identify and review relevant literature within different fields of medicine and science to advise product manufacturers on regulatory and duty-of-care issues. Further, Beth has worked with scientific consultants, expert witnesses, and scientific literature both to support regulatory submissions and to prepare defenses in domestic and international product liability litigation.
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- Partner in the Washington
BRYANT M. GODFREY is a partner in the Washington, D.C. office of Foley Hoag and is Co-Chair of the firm's Healthcare Department and FDA Practice Group. He advises FDA-regulated companies on a broad range of FDA regulatory, policy, compliance, enforcement, and strategic matters. His experience encompasses a wide range of issues relating to advertising and promotion, labeling, scientific exchange, investigations of off-label marketing, product jurisdiction, medical product development and approval/clearance, post-marketing commitments and requirements, Current Good Manufacturing Practices (CGMPs), drug supply chain issues, medical device reporting, FDA warning letters and responses, dispute resolution, FDA inspections, recalls, administrative detention, import alerts and refusals, combination products, digital health, food and dietary supplements, tobacco products, and cannabis-derived products. During his nearly 10-year tenure at FDA, Mr. Godfrey served in several senior regulatory and policy positions, including as Senior Lead Regulatory Counsel for FDA's Office of Prescription Drug Promotion, Senior Regulatory Counsel in the Office of Regulations in the Center for Tobacco Products, and Senior Counsel/Special Assistant to the Principal Deputy Commissioner.
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- Senior Director, Meetings and Partnerships
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- Member of the Finance Committee
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- CEO
- President
- President & Chief Executive Officer of the Food and Drug Law Institute
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.
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- Member of the Publications and Academic Programs Committee
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- Member of the Advertising and Promotion Conference Planning Committee
- Co - Chair ), PhillyCooke Consulting
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- Senior Vice President, Legal, Government Affairs
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.
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- Member of the Annual Conference Planning Committee
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- Member of the Medical Products Committee
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- Member of the Annual Conference Planning Committee
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- Senior Vice - President and General Counsel at Celldex Therapeutics
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.
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- Member of the Finance Committee
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- Toscano Consulting Group ( TCG )
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- Member of the Advertising and Promotion Conference Planning Committee
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- Chief Operating Officer
- Member of the Finance Committee
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- Member of the Advertising and Promotion Conference Planning Committee
- Co - Chair ), DLA Piper LLP ( US )
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- Member of the Finance Committee
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- Member of the Update Magazine Peer Review Committee
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- Assistant Director, Marketing
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- Member of the Annual Conference Planning Committee
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- Member of the Annual Conference Planning Committee
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- Member of the Publications and Academic Programs Committee
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- Managing Partner of Saul Ewing LLP 's Baltimore
JONATHAN A. HAVENS is the Managing Partner of Saul Ewing LLP's Baltimore office, and serves as co-chair of both the firm's Cannabis Law and Food, Beverage & Agribusiness Practices. Companies in the cannabis (both hemp and marijuana), life sciences, food and beverage, and cosmetics industries turn to Jonathan for advice on how to get and keep their products on the market. Since 2019, Chambers USA has recognized Jonathan as one of America's leading lawyers in cannabis law. In 2021, Law360 selected Jonathan as a cannabis law rising star, making him one of only five attorneys nationwide to receive the honor that year. He is regularly interviewed by mainstream and trade press outlets, alike, and has been quoted by or authored pieces for The New York Times, The Los Angeles Times, Reuters, CNBC, WIRED, MarketWatch, Engadget, Law360, High Times Magazine, and Marijuana Business Daily, among others. Jonathan began his legal career as a regulatory counsel with the U.S. Food and Drug Administration, and prior to law school, he served as a legislative aide in both the U.S. Senate and U.S. House of Representatives.
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- Member of the Annual Conference Planning Committee
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- Member of the Advertising and Promotion Conference Planning Committee
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- Member of the Annual Conference Planning Committee
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- Assistant Director, Training Programs
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- Member of the Medical Products Committee
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- Member of the Annual Conference Planning Committee
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- Member of the Advertising and Promotion Conference Planning Committee
- Member of the Medical Products Committee
- Assistant Director, Educational Programs
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- Member of the Update Magazine Peer Review Committee
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- Member of the Annual Conference Planning Committee
- Member of the Publications and Academic Programs Committee
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- Administrative Coordinator, Membership and Stakeholder Engagement
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- Member of the Medical Products Committee
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- Member of the Medical Products Committee
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- Member of the Annual Conference Planning Committee
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- Member of the Annual Conference Planning Committee
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- Principal in Biomedical Engineering
MARTA L. VILLARRAGA is a Principal in Biomedical Engineering & Sciences at Exponent, based in Philadelphia, PA. Her expertise focuses on the evaluation of medical device performance during the premarketing and postmarketing stages. Dr. Villarraga has evaluated orthopedic, spinal, plastic and reconstructive surgery, urology, urogynecology, general surgery, women's health, wearables and diagnostic medical devices. Dr. Villarraga has provided technical support for due diligence, regulatory submissions, regulatory compliance, risk management, postmarketing surveillance, product development, product liability, and intellectual property matters. As a Regulatory Affairs Certified (RAC-US) professional, Dr. Villarraga uses her knowledge of the US FDA regulations to develop regulatory strategies for novel products, contribute to or prepare regulatory submissions, and to support identifying and justifying technical evaluations for pre-market assessments and postmarket compliance matters. Dr. Villarraga has experience in identifying scientifically justifiable methodologies for assessment of medical device performance, evaluating quality control issues as applied to medical devices and pharmaceuticals, medical device quality systems compliance (gap analysis), contamination, manufacturing compliance, and finished device evaluations. Dr. Villarraga has also conducted failure analyses, root cause analyses, and compliance evaluations related to medical device recalls. She has served as an expert witness in product liability and intellectual property cases involving medical devices. Dr. Villarraga has a PhD in Biomedical Engineering from Tulane University.
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- Member of the Annual Conference Planning Committee
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- Chairman of the Finance Committee
- Senior Director & Associate General Counsel at 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.
Job Titles:
- Administrative Coordinator, Operations
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- Director of the Institute for Food Laws
NEAL FORTIN is the Director of the Institute for Food Laws & Regulations at Michigan State University, and Professor in the Department of Food Science and Human Nutrition. He is also an Adjunct Professor at the Michigan State University College of Law. Neal teaches the courses "United States Food Law," "International Food Law," and is the author of Food Regulation: Law, Science, Policy, and Practice, 2nd ed. Neal was the 2009 recipient of a Michigan State University Distinguished Faculty Award for his teaching in food safety. He served as a Commissioner for the Michigan Local Public Health Accreditation Program, the Advisory Council of the Michigan Community Health Leadership Institute, and the NSF Council of Public Health Consultants. Neal has been a curriculum advisor to the International Food Protection Training Institute and the University of Catalonia. He is an emeritus member of the Association of Food and Drug Officials, a member of the Institute of Food Technologists, and the State Bar of Michigan.
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- Toscano Consulting Group ( TCG )
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- Member of the Publications and Academic Programs Committee
- Member of the Update Magazine Peer Review Committee
- Director, Innovative Programs and Publications
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- Member of the Medical Products Committee
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- Chairman of the Audit Committee
- Director at Hyman, Phelps & Mc
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.
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- Member of the Update Magazine Peer Review Committee
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- Administrative Coordinator
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- Member of the Update Magazine Peer Review Committee
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- Member of the Medical Products Committee
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- Member of the Annual Conference Planning Committee
- Co - Chair ), Johnson & Johnson
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- Member of the Annual Conference Planning Committee
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- Member of the Annual Conference Planning Committee
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- Professor at Catholic University of America
SONALI P. GUNAWARDHANA is a professor at Catholic University of America. Previously, she served as Assistant General Counsel-Regulatory Law at Cardinal Health. In this role, Sonali provided regulatory and legal support to Cardinal Health's businesses including both pharmaceutical and medical device manufacturing and distribution. 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.
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- Member of the Annual Conference Planning Committee
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- Member of the Update Magazine Peer Review Committee
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- Member of the Annual Conference Planning Committee
- Director, Educational Programs
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- Deputy Director, Operations
Vernessa Pollard is a Partner at DLA Piper and Co-Chair of the FDA practice in Washington, D.C. 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.
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- Member of the Annual Conference Planning Committee
- Co - Chair ), BakerHostetler
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.