Vernessa Pollard | Read Bio
Partner, DLA Piper LLP (US)
Chair
Biography
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.
Scott D. Danzis | Read Bio
Partner, Covington & Burling, LLP
Vice Chair
Biography
SCOTT DANZIS is a partner at Covington & Burling LLP’s Food & Drug and Health Care practice groups. His practice focuses on the regulation of medical devices and diagnostics. Mr. Danzis regularly works with companies in developing strategies for interacting with the U.S. Food and Drug Administration (FDA), including strategies for clinical development and premarket review (including appeals and dispute resolution, when needed). He also advises on compliance with postmarket requirements, including advertising and promotion restrictions, quality system and manufacturing requirements, postmarket reporting, recalls, and enforcement actions.
Amy Norris | Read Bio
Vice President and General Counsel at Nordic Naturals
Secretary and General Counsel
Biography
AMY NORRIS is Vice President and General Counsel at Nordic Naturals. Prior to her current role, Norris was Executive Counsel and Senior Vice President, Legal for Clif Bar & Company. 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.
Melanie Katrice Gross | Read Bio
Senior Director & Associate General Counsel, Genentech, Inc.
Treasurer
Biography
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.
Christine M. Simmon | Read Bio
Food and Drug Law Institute
President and CEO
Biography
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.
At-Large Directors
Stacy Amin | Read Bio
Vice President and Chief Counsel for Global Health Regulatory and Policy, Oracle
Biography
STACY AMIN is Vice President and Chief Counsel for Global Health Regulatory and Policy at Oracle, where she leads the Oracle Health & Life Sciences legal, regulatory and policy teams. Previously, she served as Chief Counsel of the U.S. Food and Drug Administration, as Senior Counsel to the President in the White House Counsel’s Office, and as Chief Counsel of the Senate HELP Committee. Immediately before joining Oracle, she chaired Morrison Foerster’s global Health and Life Sciences Regulatory & Compliance practice, advising pharma, biotech and medtech clients on their most complex challenges and strategic priorities. She has a J.D. from Harvard Law School and B.A. from George Washington University and clerked on the US Court of Appeals for the 8th Circuit.
Neal Fortin | Read Bio
Director & Professor, Michigan State University
Biography
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.
Bryant M. Godfrey | Read Bio
Partner, Foley Hoag LLP
Biography
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.
Jonathan A. Havens | Read Bio
Partner, Saul Ewing LLP
Biography
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.
Winston S. Kirton | Read Bio
Partner, BakerHostetler
Biography
WINSTON S. KIRTON co-leads the firm’s FDA Practice, as well as the Life Sciences Industry team. He advises both domestic and international companies that are facing regulatory challenges involving products and services regulated by the FDA, including biopharmaceuticals, medical devices, foods, dietary supplements, cosmetics and enabling technologies. His practice focuses on corporate transactions, research and development, manufacturing and supply chain and commercial regulatory and compliance matters. He also advises clients on business and legal strategies and disputes related to third-party contract manufacturing relationships, third-party supplier relationships and alliance-partner relationships. Due to his significant experience with the complex FDA requirements, Winston is able to guide clients and their most significant transactions with all aspects of FDA regulatory due diligence. He provides comprehensive advice to clients facing legal and regulatory challenges with products and services regulated by the FDA, including on how to address the FDA regulatory process.
Winston accumulated in-depth international legal and business life sciences experience through a variety of in-house positions at several large multinational biopharmaceutical companies, particularly in the areas of quality and compliance, regulatory affairs, compliance and ethics, and legal affairs. This allows him to provide clients with a holistic view of their regulatory matters and strategies when combined with his knowledge of the regulatory process for pharmaceuticals, medical devices, foods, dietary supplements and cosmetics.Winston previously served as the head of compliance and ethics, while based in London, for a multinational U.S. pharmaceutical company, and was responsible for business units comprised of Latin America, Central and Eastern Europe, Middle East-Asia-India, China and the Pacific Rim regions.
Anne K. Miller | Read Bio
Senior Strategic Legal Counsel, Medtronic
Biography
ANNE K. MILLER is a Senior Strategic Legal Counsel at Medtronic, focuses on FDA regulatory requirements for medical devices, and provides expert advice on quality system issues, FDA inspections, and responses to 483s and Warning Letters. She also specializes in post-market regulatory requirements, including complaint handling, Medical Device Reporting, risk assessments, and recall strategy and execution. Anne’s expertise extends to post-market issues related to combination products, including GMP and post-market safety reporting. She also offers guidance on global quality system issues, such as Notified Body audits and the European Union Medical Device Regulation. Before joining Medtronic in 2007, Anne spent four years in the FDA’s Office of the Chief Counsel, where she counseled FDA clients and handled enforcement matters and defensive litigation. She has served on the FDLI Enforcement, Litigation, and Compliance Conference Planning Committee and has been a speaker on several panels. Anne holds a BA in English from Gustavus Adolphus College and a JD from Mitchell Hamline School of Law.
Adora Ndu | Read Bio
Chief Regulatory and interim Legal Officer, Bridgebio Pharma
Biography
ADORA 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.
Liz Oestreich | Read Bio
Senior Vice President, Regulatory Compliance, ELIQUENT Life Sciences
Biography
ELIZABETH OESTREICH is Senior Vice President, Regulatory Compliance at ELIQUENT Life Sciences, where she brings a diverse background of legal, public policy, and non-profit sector knowledge to her position. Liz provides strategic guidance on premarket and postmarket issues, specifically related to regulatory compliance. She works with pharmaceutical and medical device clients to prepare for FDA inspection and to address and remediate compliance matters. She advises clients on FDA communication, including 483 and warning letter responses, and offers guidance on agency expectations and regulatory policy.
Liz also leads the Advisory Services practice area, working with life science investors and industry to evaluate the potential regulatory risks during the due diligence stage of transactions.
Liz has particular expertise in two of the FDA’s newest regulated product categories, tobacco and cannabis-derived products. Liz advises clients navigating the regulatory landscape for tobacco products and assists with content and format of applications, interpretation of FDA regulation, engagement with the FDA and stakeholders, and policy development. Liz also offers strategic guidance and risk-based strategies to stakeholders in the cannabis industry.
Prior to joining ELIQUENT (formerly Greenleaf Health), Liz served as Director of Educational Programming for the Food and Drug Law Institute (FDLI). Before earning her law degree, Liz worked as a government relations professional for the Society of Chemical Manufacturers and Affiliates (SOCMA). She earned a BS in Political Science from the University of Arizona and a JD from the University of the District of Columbia’s David A. Clarke School of Law.
Beth G. Oliva | Read Bio
Partner, Fox Rothschild LLP
Biography
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.
Zach Rothstein | Read Bio
Executive Director, AdvamedDx
Biography
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.
Marta L. Villarraga | Read Bio
Principal, Exponent, Inc.
Biography
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.
