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This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness Food and Drug Law Journal 2020 Symposium November 12–13 | Virtual Event This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness Food and Drug Law Journal 2020 Symposium November 12–13 | Virtual Event

TABLE OF CONTENTS AGENDA

SPEAKER BIOGRAPHIES

ATTENDEE LIST Food and Drug Law Journal 2020 Symposium This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness November 12–13, 2020 Virtual Event Agenda

THURSDAY, NOVEMBER 12, 2020

12:00–12:15 PM Welcome Announcements

Amy Comstock Rick, President & CEO, FDLI Paige Samson, Director, Innovative Programs and Publications, FDLI

12:15–12:45 PM Keynote Address

Dr. Anand Shah, Deputy Commissioner for Medical and Scientific Affairs, Office of the Commissioner, FDA Lowell Zeta, Senior Counselor to the Commissioner, Office of the Commissioner, FDA

12:45–12:50 PM Break

12:50–2:20 PM Paper Presentations

Topic: “History, Legislative Innovation, and Future Pandemics” Daniel A. Kracov, Arnold & Porter and Vice Chair, FDLI Board of Directors

Topic: “Agencies Unbound: How COVID-19 Prompted Regulatory Flexibility and How to Build on it for the Future” Brian D. Eyink, Elizabeth B. Fawell, Steven B. Steinborn, and Anneke Baran Altieri, Hogan Lovells US LLP

Moderator: Laurie Beyranevand, Vermont Law School Discussant: Kalah Auchincloss, Greenleaf Health, Inc.

2:20–2:30 PM Break

2:30–3:15 PM Paper Presentation

Topic: “The American Pharmaceutical Supply Chain: Will COVID-19 Drive Manufacturing Back Home?” Gregory H. Levine, Jenna McCarthy*, and Beth P. Weinman, Ropes & Gray LLP and Grant Sims*, NYU Stern School of Business

Moderator: Marian J. Lee, Gibson, Dunn & Crutcher LLP

Food and Drug Law Journal 2020 Symposium This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness November 12–13, 2020 Virtual Event Agenda

Discussant: Ralph F. Hall, University of Minnesota Law School and Leavitt Partners, LLC

3:15–3:30 PM Break

3:30–5:00 PM Paper Presentations

Topic: “Vaccine-Related Liability: Past Approaches, Current Challenges, and Proposals for Encouraging Future Innovation and More Widespread Vaccine Use” Camille L. Fletcher, Greg Margolis*, and John D. Winter, Patterson, Belknap, Webb & Tyler LLP

Topic: “A Test of the Emergency (Use Authorization) System: Challenges in FDA Regulation of COVID-19 Diagnostics” Jeffrey N. Gibbs, and Gail H. Javitt*, Hyman, Phelps & McNamara, P.C.

Moderator: James T. O’Reilly, University of Cincinnati, and Chair, Food and Drug Law Journal Editorial Advisory Board Discussant: J.R. McNair, Winston & Strawn LLP

5:00–5:30 PM Networking Event

FRIDAY, NOVEMBER 13, 2020

12:00 PM Welcome Remarks

Sonia L. Canzater, Senior Associate, Hepatitis Policy Project, O’Neill Institute for National and Global Health Law, Georgetown University Law Center Paige Samson, Director, Innovative Programs and Publications, FDLI

12:00–1:30 PM Paper Presentations

Topic: “How We Got Here: FDA Emergency Use Authorization from 9/11 to COVID-19” Jonathan Iwry, Harvard Law School

Topic: “Assessing COVID-19 Emergency Use Authorizations” Efthimios Parasidis, Patricia J. Zettler*, and Micah Berman*, The Ohio State University

Moderator: Joseph Page, Georgetown University Discussant: Nathan A. Brown, Akin Gump Strauss Hauer & Feld LLP

1:30–1:45 PM Break

1:45–2:30 PM Paper Presentation

Topic: “One Health Pandemic Prevention and Mitigation: The Role of FDA” Margaret Foster Riley, University of Virginia, and Member, FDLI Board of Directors

Discussants: Bernadette Dunham, Milken Institute School of Public Health, George Washington University and Advisor to the FDA One Health Initiative, Center for Veterinary Medicine, FDA Capt. Brianna Skinner, Office of the Commissioner, Office of Counterterrorism and Emerging Threats, FDA

2:30–2:45 PM Break

2:45–4:15 PM Paper Presentations

Topic: “Federal Law’s Protective Quilt: Understanding the Statutory Regimes for Personal Protective Equipment (PPE) and Recommending an Additional Piece” John F. Johnson III, Shook, Hardy & Bacon LLP

Topic: “Regulatory Reactivity: FDA and the Response to COVID-19” Yaniv Heled, Georgia State College of Law Ana Santos Rutschman, St. Louis University School of Law Liza Vertinsky, Emory University School of Law

Discussants: Lewis Grossman, American University Alan G. Minsk, Arnall Golden Gregory LLP Carolina M. Wirth, Arnall Golden Gregory LLP

Food and Drug Law Journal 2020 Symposium November 12-13, 2020

ANNEKE BARAN ALTIERI is an associate at Hogan Lovells US LLP where she provides practical legal and policy solutions to clients at all levels of the food supply chain. She is committed to helping clients navigate the complex state and federal regulatory landscape, without sacrificing business innovation. Anneke advises clients on US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) labeling and advertising requirements, food safety issues, and enforcement actions. Anneke also has experience counseling clients in the consumer product, pharmaceutical, and health care industries and maintains an active pro bono practice. Drawing on previous regulatory experience with the Department of Homeland Security, Anneke understands the nuanced intersection of government and industry. Before arriving at Hogan Lovells, Anneke graduated from the University of Virginia School of Law, where she was a Fellow for the Legal Research and Writing Program and served on the editorial board of the Virginia Law and Business Review.

KALAH AUCHINCLOSS is Senior Vice President, Regulatory Compliance and Deputy General Counsel at Greenleaf Health, LLC. She has more than a decade of food and drug legal, policy, and regulatory experience at FDA, on Capitol Hill, and in the private sector. Ms. Auchincloss spent six years at FDA, most recently as Deputy Chief of Staff for two FDA Commissioners: Dr. Robert Califf and Dr. Scott Gottlieb. As Deputy Chief of Staff, she worked with senior FDA leadership to manage crises, develop policy decisions, implement communications strategies, and liaise with the Department of Health and Human Services, the White House, and other agencies. Ms. Auchincloss was also a primary point of contact in the immediate Office of the Commissioner for the six FDA Centers and other components of the Commissioner’s Office. She has also served in FDA’s Center for Drug Evaluation and Research (CDER) as a regulatory counsel in the Office of Regulatory Policy, and as Director of CDER’s Office of Unapproved Drugs and Labeling Compliance in the Office of Compliance, leading a team of more than 50 staff working on pharmacy compounding, unapproved drugs, over-the- counter drugs, and other enforcement issues. Before joining FDA, Ms. Auchincloss was an associate at the law firm Foley Hoag LLP, in the firm’s health care practice group. She holds a BA with honors from Williams College, a JD with honors from Georgetown University Law Center, and an MPH from Harvard University.

MICAH BERMAN is an associate professor of public health and law at The Ohio State University’s College of Public Health and Michael E. Moritz College of Law. He teaches courses on public health law, health care law, and tobacco regulation, and he is a co-author of a The New Public Health Law: A Transdisciplinary Approach to Practice and Advocacy (Oxford University Press & APHA Press, 2018). His current research, funded by the National Cancer Institute, seeks to inform the FDA’s regulation of tobacco products. Before joining Ohio State’s faculty in 2013, Professor Berman directed policy centers that provided legal and policy support to state and local health departments in Ohio, New York, and Vermont. He has also served as a senior advisor to the FDA’s Center for Tobacco Products and as a trial attorney with the US Department of Justice. He received his JD with distinction from Stanford Law School and his BA in Public Policy from Brandeis University.

LAURIE BEYRANEVAND is Senior Faculty Fellow of Food Law and Policy at the Center for Agriculture and Food Systems, and a professor of law at Vermont Law School. Prior to joining the faculty at Vermont Law School, Laurie was a Staff Attorney at Vermont Legal Aid where she represented adults and children in individual cases and class action litigation advocating for access to health care, education equality, and civil rights. Laurie has published a number of scholarly articles and book chapters that focused on the connections between human health and food systems. Her work has been cited in petitions to major federal agencies, books, blogs, and articles, and she has been quoted in Politico, Mother Jones, the Christian Science Monitor, Climate Wire, the Washington Post, and E & E Greenwire, among others. She is an appointed member of the Food and Drug Law Institute and Georgetown Law School’s Food and Drug Law Journal Editorial Advisory Board, a founding member of the Academy of Food Law and Policy, and the Chair of the Agriculture and Food Law Section of the American Association of Law Schools.

NATHAN A. BROWN is a partner in the Health Care and Life Sciences practice at Akin Gump. He has worked extensively in the FDA regulatory and compliance field and is sought after for his understanding and insights into the regulation and marketing of innovative medical technologies. He previously served in prominent roles at the Food and Drug Administration and as an FDA advisor to the Senate HELP Committee. He currently serves on the Food and Drug Law Journal Editorial Advisory Board.

BERNADETTE DUNHAM is with the Milken Institute School of Public Health at George Washington University (2016 to present) where her focus is on One Health issues. In October 2019, Dr. Dunham was appointed as a member of the National Academies of Sciences, Engineering and Medicine's Board on Agriculture and Natural Resources for a three-year term thru December 2022. Dr. Dunham returned to FDA in August 2019 to serve as an Advisor to the FDA One Health Initiative. Dr. Dunham has served FDA as Director of the Center for Veterinary Medicine (CVM) from 2008-2016, Deputy Director of CVM and Director of the Office of Minor Use and Minor Species from 2006-2008, and Deputy Director of the Office of New Animal Drug Evaluation from 2002-2006. Before beginning her government career, she was an Assistant Director with American Veterinary Medical Association’s Governmental Relations Division in Washington, DC from 1995-2002. Dr. Dunham served as Director of Laboratory Medicine and Adjunct Professor of Pharmacology at the State University of New York Health Science Center, Syracuse, NY from 1987-1995. Before returning to academy in 1979 to pursue her PhD and Post-Doctoral research in cardiovascular pathophysiology at Boston University, Dr. Dunham was in private veterinary practice for four years in Oshawa, Ontario, Canada. Dr. Dunham received her DVM degree from the Ontario College of Veterinary Medicine, University of Guelph, Canada and her PhD from Boston University, MA. BRIAN D. EYINK is counsel in the Washington, DC office of Hogan Lovells LLP where he helps clients find practical solutions to regulatory problems. Brian is particularly sensitive to risk management issues as companies adapt to a regulatory and political environment increasingly focused on inspections, enforcement, and investigations. Drawing on his experience throughout the supply chain, from animal production to food processing to distribution and retail sale, Brian helps companies navigate increasingly complex and high-stakes federal and state regulatory issues. He benefits from a deep experience with both the United States Department of Agriculture (USDA) and Food and Drug Administration (FDA), as well as the Federal Trade Commission (FTC). His knowledge working with state, local, and self-regulatory bodies, litigation, and acquisitions will help to solve clients' regulatory and business problems. Brian advises on the full scope of regulatory issues facing the food and agriculture sectors, ranging from USDA and FDA enforcement actions and federal investigations to regulatory compliance, import and export issues, litigation support, comment preparation, legislative drafting, policy development, trade association governance, advertising disputes, and labeling issues. He also represents food and agriculture trade associations, advising on issues such as general counseling and governance, influencing policy and public perspective, and implementation of industry initiatives. Before joining Hogan Lovells, Brian served as a judicial law clerk to the Honorable Gerald Bard Tjoflat of the United States Court of Appeals for the Eleventh Circuit. While in law school, he served as an executive editor of the Duke Law Journal.

ELIZABETH BARR FAWELL is a partner at Hogan Lovells LLP. Successfully navigating the detailed and often complex regulatory issues confronting the food industry, she helps companies understand both the rules and various risks involved to make the most informed and strategic decisions. Elizabeth has worked with every segment of the food industry, including manufacturers, distributors, retailers, restaurants, and food service operators, as well as their trade associations. Her work on behalf of food industry clients with the Food Safety Modernization Act (FSMA) since its inception and her understanding of Hazard Analysis Critical Control Point (HACCP) systems provides her with the experience and perspective needed to counsel clients on how to comply with new requirements under the law. Elizabeth is also a Preventive Controls Qualified Individual (PCQI) and has completed the FSPCA PCQI training. Elizabeth provides real-time advice during factory inspections, helps clients prepare 483 responses, and drafts inspection manuals. She assists clients in lawfully and creatively promoting their products; such as the development of labels, claims, and website and promotional campaigns. Elizabeth also supports clients in advertising disputes and with responses to FTC and Attorney General investigations. She also counsels clients on compliance with Consumer Product Safety Commission (CPSC) safety standards, testing and certification requirements, and reporting obligations.

CAMILLE L. FLETCHER is an associate in Patterson Belknap’s Litigation department, where her practice focuses on complex commercial litigation and internal and government investigations. She also maintains an active pro bono practice. From 2016 to 2017, Ms. Fletcher served as a law clerk to the Hon. Kiyo A. Matsumoto and the Hon. Pamela K. Chen of the United States District Court for the Eastern District of New York. She is a graduate of Stanford Law School.

JEFFREY N. GIBBS is a director in the Washington, DC law firm of Hyman, Phelps & McNamara, P.C. Before entering private practice, he was an Associate Chief Counsel for Enforcement at the Food and Drug Administration. He previously served as General Counsel and then as Chairman of FDLI’s Board of Directors. Jeff assists in vitro diagnostic and medical device companies with a variety of regulatory issues, including FDA product clearance and approval, product labeling, clinical studies, promotional and marketing programs, appeals, regulatory strategy, FDA enforcement actions, emergency use authorizations, citizen petitions, and laboratory developed tests. He has written extensively on FDA issues, including those involving diagnostic products, and has advised IVD companies on a wide range of FDA regulatory and strategic issues. He received FDLI’s Distinguished Service and Leadership Award in 2013, the LMG Life Sciences FDA Medical Device Attorney of the Year Award in 2013, and was inducted to LMG Life Sciences Hall of Fame Award in 2018. Jeff previously served on the Human Subjects Review Board of George Mason University, and is currently teaching medical device law at George Washington University. Jeff graduated from Princeton University and New York University School of Law.

LEWIS GROSSMAN, a former member of the FDLI Board of Directors, is a professor of law at American University’s Washington College of Law, where he has taught since 1997. During academic year 2017-18, he was a Law and Public Affairs (LAPA) Fellow at Princeton University. He was a visiting professor at Cornell Law School in 2015. He is also of counsel with the Food and Drug Practice Group at Covington & Burling LLP in Washington, DC. Prior to joining the American University faculty, he was an associate at Covington & Burling, and before that he clerked for Chief Judge Abner Mikva of the US Court of Appeals for the DC Circuit. Professor Grossman’s scholarship has appeared in the Cornell Law Review; Law and History Review; Yale Journal of Health Policy, Law & Ethics; Administrative Law Review; American Journal of Law & Medicine; and Food and Drug Law Journal, among others. He is the co-author of Food and Drug Law: Cases and Materials (with Peter Barton Hutt and Richard A. Merrill) and of a widely used supplement to the first-year civil procedure course titled A Documentary Companion to A Civil Action (with Robert G. Vaughn). He has been a legal advisor or member of three committees of the Health and Medicine Division (formerly the Institute of Medicine) of the National Academies of Sciences, Engineering, and Medicine. He earned his PhD in History from Yale University, where he was awarded the George Washington Egleston Prize for Best Dissertation in the Field of American History. He received a JD, magna cum laude, from Harvard Law School and a BA summa cum laude from Yale University.

RALPH F. HALL is a principal and works in association with the Washington, DC, office of Leavitt Partners. In this role, Ralph provides consulting services to clients in the areas of FDA statutes and regulations, regulatory compliance, as well as health care policy and legislation, and particularly the application of those regulatory systems to the medical device industry. Ralph’s rich background with drug and medical device regulation and corporate compliance matters makes him one of the nation’s foremost experts. Ralph previously served as counsel at Faegre Baker Daniels where he provided legal services, including FDA-related matters, corporate compliance, the design and implementation of multiple cross- disciplinary, corporate legal strategies, corporate law department organization and management, and general corporate counseling. Ralph has also served as General Counsel for Guidant CRM and Chief Compliance Officer for Guidant. Ralph furthermore serves as a Professor of Practice at the University of Minnesota Law School. He received his BA from Indiana University and his juris doctorate from the University of Michigan where he was a Weymouth Kirkland Scholar.

YANIV HELED is an associate professor of law and Co-Director of the Center for Intellectual Property at Georgia State College of Law. Mr. Heled’s research focuses on the legal and ethical aspects of biomedical technologies. He has written on such topics as the regulation of biologics and biosimilars, stem cells, human reproductive tissue, DNA sequencing and testing, and more. His recent notable scholarship includes the article, “Follow-On Biologics Are Set Up to Fail,” which explains why there is not going to be meaningful competition in biologics under current market and regulatory conditions. In another article, “Why Healthcare Companies Should (Be)come Benefit Corporations,” Heled and co-authors, Liza Vertinsky and Cass Brewer, make the case for requiring companies involved in the provision of healthcare products and services to incorporate (or re-incorporate) as benefit corporations, a relatively new type of business entity which is required to consider not only corporate profits but also public health. Heled earned a JSD from Columbia University School of Law. His doctoral dissertation focused on the regulation of novel biomedical technologies. In addition, Heled holds an LLM from Columbia, where he was a Harlan Fiske Stone Scholar, and an LLB and undergraduate Diploma in Biology, magna cum laude, from Tel Aviv University.

JONATHAN IWRY is an incoming associate at Ropes & Gray LLP and a recent graduate of Harvard Law School, where he received his JD in May 2020. He received his BA from the University of Pennsylvania in 2014 with a double major in philosophy and history. He is currently serving as a Teaching Fellow for "Justice," a Harvard College course on ethics and political philosophy taught by Professor Michael Sandel. View his TEDx talk on the science of improvisation here.

GAIL H. JAVITT is a director at Hyman, Phelps & McNamara, P.C. where she provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage. She also has significant experience advising clinical laboratories on FDA and CLIA requirements for laboratory developed tests. Ms. Javitt’s experience prior to joining Hyman, Phelps & McNamara includes serving as a partner in a leading Washington, DC health law practice and as a law and policy director at the Genetics and Public Policy Center, part of Johns Hopkins University. At the Center, she was responsible for developing policy options to guide the development and use of reproductive and other genetic technologies. Earlier in her legal career, Ms. Javitt clerked for the Honorable Gary Taylor of the US District Court for the Central District of California. In addition, Ms. Javitt has published and spoken widely on issues at the intersection of law, science, ethics and policy, including FDA regulation of genetic testing, precision medicine, and next-generation sequencing. Her academic experience has included serving as a faculty member at the Berman Institute of Bioethics at Johns Hopkins University and as an adjunct professor at the Georgetown University Law Center, American University’s Washington College of Law, and the University of Maryland School of Law. She was previously a Greenwall Fellow in Bioethics and Health Policy, a collaborative effort between Johns Hopkins University and Georgetown University

JOHN F. JOHNSON III is counsel at Shook, Hardy & Bacon LLP where he works with companies to develop and implement solutions for complying with the laws administered by Food and Drug Administration (FDA), US Department of Agriculture (USDA), Customs and Border Protection (CBP) and other federal and state agencies. He works with manufacturers, distributors, brand owners, importers and retailers of food, drugs, medical devices, cosmetics and animal products to satisfy their regulatory obligations. John represents companies before FDA and other government agencies subject to inspections or compliance activities, including a judicial action, Warning Letter, Untitled Letter, regulatory meeting, administrative detention, import detention and import alert, and FDA Form 483. Additionally, he helps companies evaluate complaints to determine if a recall is necessary, and if so, he works with clients to manage the product recall to remove the product from market. John counsels clients throughout the product life cycle, including product development and specifications, marketing and labeling, and manufacturing, importation, distribution and sales. This includes determining the possible registrations, permits, licenses and pre-market submissions. Also, he works with clients to create, implement and maintain internal programs to help foster smooth compliance.

DANIEL A. KRACOV is co-chair of Arnold & Porter LLP’s global Life Sciences and Healthcare Regulatory practice. For decades, he has been one of the foremost Food and Drug Administration lawyers in the country, and his expertise in critical regulatory matters has been widely recognized by Chambers, the Legal Times, The Legal 500, Best Lawyers in America, and other publications. Mostly recently, Mr. Kracov was named “Regulatory Attorney of the Year” by LMG Life Sciences and a “Trailblazer” by The National Law Journal. A particular focus of his practice is assisting pharmaceutical, biotechnology, medical device and diagnostic companies, including emerging companies, trade associations, and large manufacturers, negotiate challenges relating to the development, manufacturing, approval and promotion of FDA-regulated products. Mostly recently, he has advised a wide array of companies on COVID-19 countermeasures and pandemic response issues. In addition to day-to-day counseling on regulatory strategies and concerns, Mr. Kracov regularly handles product and compliance-related government and internal investigations, the development of global corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely recognized experience in biomedical public policy matters, including Congressional investigations and advising on FDA-related legislation.

MARIAN J. LEE is a partner and the co-chair of the FDA and Health Care practice at Gibson, Dunn & Crutcher LLP. She advises clients on strategic FDA regulatory and compliance matters, risk management, and enforcement actions. She is a frequent speaker and author on emerging developments in FDA law, including the regulation of digital health, hemp- based products, and commercial speech. The Best Lawyers in America® recognizes Ms. Lee in FDA law. Law360 selected her as a “Rising Star,” one of four attorneys chosen in her field nationwide. She is a member of the Food and Drug Law Journal’s Editorial Advisory Board and the Law360 Life Sciences Editorial Advisory Board. Ms. Lee is a graduate of Harvard Law School and Harvard College, magna cum laude and Phi Beta Kappa.

GREGORY LEVINE is chair of the FDA Regulatory practice group at Ropes & Gray LLP. He focuses his practice on FDA regulation of pharmaceuticals, biotechnology and medical devices, regularly representing such clients before state and federal regulators on all phases of the product lifecycle, and assisting with both internal and government compliance investigations and enforcement actions. Greg also advises manufacturers of other FDA-regulated products, including cosmetics and dietary supplements, on a broad range of issues under the Food, Drug, and Cosmetic Act and related laws. Prior to joining Ropes & Gray, Greg was a partner at an international law firm in Washington, DC. He is also a former legislative staff member in the US House of Representatives, where he worked on FDA-related legislation, policy, and appropriations.

GREG MARGOLIS is an associate in the Litigation department of Belknap, Webb & Tyler LLP. From 2018 to 2019, Mr. Margolis served as a Law Clerk to the Hon. Richard M. Berman of the United States District Court for the Southern District of New York.

JENNA McCARTHY is an associate at Ropes & Gray LLP and a member of the life sciences regulatory and compliance group. She received her JD from Vanderbilt University Law School.

J.R. McNAIR is a partner in Winston & Strawn LLP’s Chicago office who concentrates his practice in patent litigation and counseling. J.R.’s patent litigation practice covers a broad range of technologies, including pharmaceuticals, medical devices, veterinary products, chemicals, electronics, and computer software. He has extensive experience litigating pharmaceutical patent cases arising under the Hatch-Waxman Act, including particular specialty in cases involving New Chemical Entities. As part of his patent litigation practice in the area of pharmaceuticals and medical devices, he is familiar with the FDA regulatory issues his clients face. J.R. has a strong background in technology, which includes a degree in chemical engineering.

ALAN G. MINSK is a partner and leader of the Food and Drug Practice Team at Arnall Golden Gregory LLP. Alan is licensed to practice in Georgia and Washington, DC. He works out of AGG’s Atlanta and Washington offices. Alan is recognized by Chambers USA America’s Leading Lawyers for Life Sciences, Regulatory/Compliance and has been selected for inclusion in the International Who’s Who of Life Sciences Lawyers from 2013 – 2020. Nominees are selected based upon comprehensive, independent survey work with both General Counsel and private practice lawyers worldwide. He serves as general counsel of The Sharing Alliance Inc., a pharmaceutical trade organization focused on compliance with the Prescription Drug Marketing Act and sample accountability. Alan focuses his practice on advising pharmaceutical, biologic, medical device, cosmetic, food (including dietary supplements and medical foods) companies, on all legal and regulatory matters relating to the US Food and Drug Administration. For companies in the pre-approval phase, he counsels on the following areas: clinical trial issues, communications with the FDA during the review process, imports and exports, regulatory strategy including 505(b)(2) new drug applications, orphan drug designation, Fast Track and Breakthrough Therapy designations, combination product determinations, market exclusivity, premarket notification (510(k)) submissions, premarket approval applications, and pre-approval discussions. In addition, Alan works with life science companies and venture capital firms on regulatory diligence matters involving acquisitions, divestitures, regulatory opinion letters, co-promotions and licensing agreements. He also drafts and reviews agreements relating to clinical trials, quality, and contract manufacturing. He conducts in-house training on FDA and fraud and abuse topics. Alan’s client base is primarily focused on early-stage to mid-sized life science companies, where he must clearly articulate the legal and regulatory issues for consideration while also recognizing the client’s business realities and needs. He currently serves on a number of editorial boards for professional publications, including the RAPS Focus magazine and the Food and Law Drug Institute’s Food and Drug Law Journal.

JAMES O'REILLY teaches in the College of Medicine, University of Cincinnati, and authored the 3-volume West text "Food & Drug Administration" which the US Supreme Court has quoted as "The expert" in the FDA field. He chairs the ABA's FDA committee, formerly chaired the FDLI Programs Committee and is currently serving on the Food and Drug Law Journal advisory board. He has published 56 textbooks and 229 articles and has lectured internationally since retiring as Associate General Counsel for Product Safety for Procter & Gamble.

JOSEPH PAGE is a professor emeritus at Georgetown University Law Center, where he taught torts, products liability, and food and drug regulation. He has contributed chapters on the regulation of tobacco products for the third edition of Food and Drug Law and Regulation and for the sixth edition of A Practical Guide to FDA’s Food and Drug Law and Regulation and has published articles and reviews on the topics of cosmetics, over-the-counter drugs, and food. He is currently the faculty advisor for the Georgetown Law student editors of the Food and Drug Law Journal.

EFTHIMIOS PARASIDIS is Professor of Law and Public Health at Ohio State University. He has published dozens of articles, is co-author of a book on the ethics and regulation of human subjects research, and has a book on military medical ethics under contract with Oxford University Press. He has received grants from the Greenwall Foundation and Robert B. Silvers Foundation, serves as a law and bioethics consultant to the U.S. Air Force, and is a member of an NIH clinical data science research ethics committee. He practiced law in two New York firms and was an Assistant Attorney General in New York under Eliot Spitzer and Andrew Cuomo.

MARGARET FOSTER RILEY teaches food and drug law, health law, animal law, bioethics, regulation of clinical research, and public health law at the University of Virginia’ Schools of Law and Medicine. Ms. 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. Ms. 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. Ms. Riley received her law degree from Columbia University and her bachelor of arts from Duke University. She is a member of FDLI’s Board of Directors.

ANA SANTOS RUTSCHMAN has been assistant professor at Saint Louis University School of Law since 2018. She focuses on topics related to health law, intellectual property, innovation in the life sciences, and law and technology. Her legal scholarship has appeared or is forthcoming in UCLA Law Review, Emory Law Journal, Arizona Law Review, Yale Law Journal Forum, Michigan Law Review Online, Duke Law and Technology Review, Vanderbilt Journal of Transnational Law, Northwestern University Law Review of Note and the Georgetown Journal of International Affairs, among others. Her commentary pieces have been published by the Saint Louis Post- Dispatch, Health Affairs Blog, the Huffington Post and The Conversation, and republished in Scientific American, Newsweek Japan and newspapers around the U.S., including the Chicago Tribune. Her ongoing book, Vaccines as Technology: Innovation, Barriers and the Public Interest, is under contract with Cambridge University Press and is scheduled to be published in 2022. In spring 2020, Rutschman received a Beaumont Scholarship Research Award from Saint Louis University, as well as a Junior Faculty Non-Traditional Scholarly Work Award and a Spark Microgrant by Saint Louis University. In 2019, she was named a visiting fellow by the Centre for Intellectual Property Policy & Management Fellowship at the University of Bournemouth in the United Kingdom. In 2018, she was named a Health Law Scholar by the American Society of Law, Medicine & Ethics and a Wiet Life Sciences Law Scholar by the Beazley Institute for Health Law and Policy at Loyola University Chicago. And in 2017 she was named a Bio Intellectual Property Scholar by the American Society of Law, Medicine & Ethics. Previously, Professor Rutschman taught at DePaul University College of Law as the inaugural Jaharis Fellow in Health Law and Intellectual Property (2016-2018). She also worked as a consultant to the World Health Organization in 2015-2016 during the Ebola and Zika outbreaks, and was a visiting guest lecturer in intellectual property at Uppsala Law School (Sweden) in Fall 2015. She received her first law degree from the Catholic University School of Law in Portugal, followed by a master’s degree (LLM, 2008) and doctoral degree (SJD, 2016) from Duke University Law School.

ANAND SHAH is the Deputy Commissioner for Medical and Scientific Affairs. Dr. Shah leads the agency’s operations as it relates to medical and scientific affairs. He is responsible for developing and leading high- priority FDA policy initiatives and oversees cross-agency teams in support of the FDA’s public health mission. Dr. Shah’s efforts have focused on improving medical outcomes and lowering costs, redesigning health care delivery, and expanding competition and consumer choice. Previously at FDA, he provided guidance to industry and academia on medical product development, clinical trial design, and regulatory pathways to accelerate public access to safe and effective therapies. He co-led and scaled Information Exchange and Data Transformation (INFORMED), a science and technology incubator designed to harness the power of real-world evidence and advanced analytics to improve disease outcomes. He recently served in two senior leadership roles at the Centers for Medicare & Medicaid Services (CMS). As Senior Medical Advisor, he was the primary counselor to the Administrator for agency-wide policy related to medical and scientific innovation. Dr. Shah established consensus on several critical policy initiatives including aligning payment and prevention to increase Medicare beneficiaries’ access to novel antimicrobials, expanding patients’ access to new cell and gene therapies, and streamlining Medicare access to breakthrough technologies. He led a significant cross-agency effort to bridge gaps in access that patients often encounter between FDA approval and CMS coverage of medical products. As the Chief Medical Officer of the Center for Medicare & Medicaid Innovation (CMMI), Dr. Shah led the clinical design of novel value-based payment and service delivery models including those for advanced primary care, specialty care, and prescription drugs. Dr. Shah is an attending radiation oncologist at the National Institutes of Health (NIH) where he specializes in the early detection, surveillance, and treatment of prostate cancer. He developed and leads an NIH survivorship clinic in the care of patients on cancer clinical trials. He concurrently earned his MD from the University of Pennsylvania and an MPH in health care management and policy from the Harvard School of Public Health. Dr. Shah graduated with honors from Duke University with a degree in economics.

BRIANNA SKINNER is a Commissioned Corps officer in the US Public Health Service who has also served in the US Army Veterinary Corps. As a uniformed service officer, she has proudly served her country for the past 22 years within the continental United States and abroad on several humanitarian and disaster response missions. She is currently assigned to the Office of Countermeasures and Emerging Threats (OCET) at the US Food and Drug Administration (FDA) where she currently serves as a Senior Regulatory Veterinarian and animal model expert for the administration of policies to facilitate the availability of safe and effective medical countermeasures against chemical, biological, radiological, nuclear agents and emerging threats. Prior to transferring to the FDA, she worked at the Centers for Disease Control and Prevention for over eleven years leading clinical operations within the vivarium, consulting with principal investigators on animal care and use with infectious disease research from biosafety levels 1 – 4, and training laboratory animal veterinarians. She earned her Doctor of Veterinary Medicine degree from Tuskegee University, her Masters in Public Health from Benedictine University, and is board certified in laboratory animal medicine with the American College of Laboratory Animal Medicine.

STEVEN B. STEINBORN is a partner at Hogan Lovells US LLP. He literally wrote the book on food labeling as a principal author of the US Department of Agriculture's (USDA) labeling guide. On top of that, he offers clients 28 years of experience in guiding informed business decisions, considering food laws and other regulations, as well as the environment in which companies operate. Representing food processors, restaurant chains, foodservice operators, ingredient suppliers, and trade associations, Steven focuses on advertising, labeling, and food safety. He is also a strong advocate in enforcement matters brought by the Federal Trade Commission, the Food and Drug Administration, the USDA, and state regulators as well. From small start-ups to established international brands, Steven understands the dynamics of the food industry. He brings this knowledge to bear on cutting-edge issues ranging from claim substantiation to potential food safety situations. He is also regularly consulted in bringing and defending competitor challenges and represents companies before the Better Business Bureau's National Advertising Division. Keenly aware of the current litigation climate, Steven works closely with marketers in exploring all avenues to reach important business objectives. Beyond the food industry, Steven routinely advises consumer product companies on reporting and potential recall situations arising under the jurisdiction of the Consumer Product Safety Commission. His practice covers a diverse range of industries, including children's toys, household appliances, infant products, gas grills, furnaces, consumer electronics, computers, printers, handheld devices, and child-resistant packaging. Steven is a frequent speaker on innovation and legal compliance and has authored numerous articles on a range of subjects, from the latest developments in the regulation of genetically engineered foods to important developments that impact food advertising.

LIZA VERTINSKY is an Associate Professor at Emory School of Law, an Emory Global Health Institute Faculty Fellow, and Project Leader for the Emory Global Health Law & Policy Project. She came to Emory in 2007 after a decade of legal practice focusing on intellectual property transactions in the biomedical industry and university technology transfer.Her areas of expertise include biomedical innovation, the intersection of IP and global health, public health law, law & economics, and the regulation of healthcare markets and technologies. Her research program is motivated by a deep interest in how legal rules influence the ways in which individuals and groups organize their economic activities. She is particularly interested in exploring the institutional environments within which alternative forms of intellectual production take place, with a focus on biomedical innovation, innovations in global health, and the intersection of artificial intelligence, innovation, and competition. Liza Vertinsky clerked for Judge Stanley Marcus, first for the US District Court in the Southern District of Florida and then for the Eleventh Circuit Court of Appeals. She received her BA from Oxford University, her JD from Harvard Law School, her MA in Economics from the University of British Columbia, and her PhD in Economics from Harvard University.

BETH P. WEINMAN is a member of Ropes & Gray’s life sciences regulatory and compliance practice group, and focuses her practice on FDA regulation and enforcement of laws governing pharmaceuticals, biologics, medical devices and foods, including dietary supplements. Beth represents clients in False Claims Act (FCA) and Federal Food, Drug, and Cosmetic Act (FDCA) investigations, and other enforcement actions before state and federal regulators, and also represents clients in administrative litigation matters. Beth also provides counseling on issues related to marketing practices, current good manufacturing practices, good clinical practices, compounding, medical product development and approval, and product recalls and withdrawals. Prior to joining Ropes & Gray, Beth spent nearly eight years as Associate Chief Counsel for Enforcement within FDA’s Office of Chief Counsel. In that role, she worked closely with FDA’s Office of Criminal Investigations, the Department of Justice and other government agencies to investigate and, when appropriate, prosecute alleged violations of the FDCA and related crimes under Title 18 (including, e.g., mail fraud, wire fraud, healthcare fraud, and conspiracies to defraud). She also worked on numerous parallel and independent FCA investigations involving FDA regulated drugs and devices, including biologics. Before starting at FDA, Beth spent more than seven years as an associate in the litigation department of a large New York law firm, where, among other matters, she represented a number of pharmaceutical companies in government investigations and securities class action lawsuits.

JOHN D. WINTER is a Partner at Patterson Belknap where he has focused his practice on the defense of pharmaceutical and medical device cases. A member of Patterson Belknap since 1990, Mr. Winter has tried or argued the appeal of more than 50 product liability cases in state and federal courts throughout the United States. He has also acted as national counsel for pharmaceutical, consumer product, and medical device manufacturers in consolidated proceedings in state and federal courts. Mr. Winter also has substantial experience litigating commercial matters for Patterson Belknap clients including organizations, governmental entities, privately held companies as well as pharmaceutical, cosmetic and medical device companies. Prior to joining Patterson Belknap, Mr. Winter served as Law Clerk to the Hon. John M. Cannella, US District Judge for the Southern District of New York.

CAROLINA M. WIRTH is of counsel in the Food and Drug practice and is a member of the Dietary Supplements and Pharmaceuticals & Biologics industry teams at Arnall Golden Gregory LLP. She provides clients with FDA regulatory guidance related to food, dietary supplements, drugs, cosmetics, and medical device products. Carolina’s prior experience as regulatory counsel in CDER’s Office of Regulatory Policy at the FDA and as an in-house lawyer at a biotechnology company has aided her work with domestic and international clients on regulatory issues associated with the marketing, labeling, packaging, and advertising of conventional foods, prescription and over-the- counter (OTC) drugs, medical devices, and dietary supplements. She also assists clients with Federal Trade Commission (FTC) and Better Business Bureau National Advertising Division inquiries. In addition, Carolina counsels clients on clinical trial issues, including reviewing informed consent documents and master clinical trial agreements.

LOWELL ZETA is Senior Counselor to the Commissioner in the Office of the Commissioner at the US Food and Drug Administration (FDA), and is advising and leading several of the FDA’s high-priority policy initiatives. In this position, Mr. Zeta serves as an advisor to the Commissioner and FDA leadership on development, interpretation, and integration of cross-cutting policy priorities, as well as regulations and guidance development in support of the FDA’s public health mission. Mr. Zeta’s legal and regulatory expertise includes advising life science and health care industries on the complexities of the FDCA and FDA regulation, emerging legal and policy issues, and enforcement priorities. He joined the FDA from Hogan Lovells US LLP, where he was a member of a leading pharmaceutical and biotechnology law practice, and a trusted advisor on critical issues to advance clinical development, regulatory approval, and commercialization of drugs and biological products. His practice focused on manufacturing and drug quality and safety matters, including current good manufacturing practice (GMP) requirements for human sterile and non-sterile finished dosage form and APIs worldwide, data integrity and security, import and supply chain controls, pharmacovigilance, and recall strategies. He has also worked with sponsors to develop and implement Risk Evaluation and Mitigation Strategies (REMS) and other market access controls for prescription opioids and other therapies. He has counseled on the promotion and marketing of prescription and OTC drugs, cosmetics, and dietary supplements. Mr. Zeta was a Health Law Fellow with the O’Neill Institute, and received law and undergraduate degrees from Georgetown Law, Creighton University, and the University of Iowa. He has earned several notable accolades for his practice in Food and Drug Law, was an Editorial committee member of the Food and Drug Law Journal and has authored several life sciences related articles and peer-reviewed publications.

PATRICIA J. ZETTLER is an Associate Professor of Law at The Ohio State University Moritz College of Law, a faculty member of the Drug Enforcement & Policy Center housed at the College of Law, and a Member of The Ohio State University Comprehensive Cancer Center. Professor Zettler’s teaching areas include Torts, Legislation and Regulation, Health Law, and Food and Drug Law. Professor Zettler’s research focuses on the regulation of medicine, drugs and other medical products, and tobacco products, with an emphasis on FDA. She also regularly writes about FDA-related issues at Objective Intent, the FDA law and policy blog that she co-founded, as well as at Stanford’s Law and the Biosciences Blog. Zettler’s work has earned her recognition, including being selected as a 2015 Health Law Scholar by the American Society of Law, Medicine & Ethics. She also advises various groups and organizations on FDA law and policy. Among other things, she served as a consultant to the National Academies of Sciences, Engineering, and Medicine’s Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse from 2016 to 2017, and has served on the editorial advisory board for the Food and Drug Law Journal since 2015. Before joining the Ohio State faculty in 2019, Professor Zettler was a faculty member of the Center for Law, Health & Society at Georgia State University College of Law. At Georgia State Law, she was selected as the 2018 winner of the Patricia T. Morgan Award for Outstanding Scholarship among the faculty. Prior to Georgia State, she was a fellow at the Center for Law and the Biosciences at Stanford Law School. In addition to Professor Zettler’s academic work, she served as an associate chief counsel in the FDA’s Office of the Chief Counsel. In that role, she advised the FDA and the Department of Health and Human Services on various issues including drug safety, human subjects protection, expanded access to investigational drugs, over-the-counter drugs, dietary supplements, prescription drug advertising and promotion, incentives for developing antibiotics, and advisory committees. Professor Zettler also has bioethics experience through work at the Program in Medical Ethics at the University of California San Francisco and at the Department of Bioethics at the National Institutes of Health. Professor Zettler graduated with distinction from Stanford Law School in 2009. She received a BA in psychology, with distinction and departmental honors, from Stanford University in 2002. Food and Drug Law Journal 2020 Symposium This Teachable Moment: How COVID-19 Provides Lessons from FDA’s Past and Present That Will Benefit Its Future Preparedness November 12-13, 2020 Attendee List (current as of 11.10.20) First Name Last Name Job Title Organization Name City and State Anneke Altieri Associate Hogan Lovells US LLP Washington, DC Kalah Auchincloss SVP and Deputy General Counsel Greenleaf Health, Inc. Washington, DC Jeannie Baumann Reporter Bloomberg News Washington, DC Mitchel Berger Exton, PA

Gary A. Bergman Practice Director of Oxford Life Sciences Oxford Global Resources Calabasas, CA

Harvey Alan Berman Associate Professor, Director of Curriculum State University of NY at Buffalo Buffalo, NY Laurie J. Beyranevand* Professor of Law and Director Vermont Law School South Royalton, VT Ivanna Bihun Law Student Georgetown University Nathan Brown* Partner Akin Gump Strauss Hauer & Feld LLP Washington, DC Matthew Burr Public Policy Specialist ICF Washington, DC O'Neill Institute for National and Global Sonia Canzater Senior Associate, Hepatitis Policy Project Health Law, Georgetown Law Charise Carlson Attorney KAI Health Law St. Louis, MO Coleen Carney Marketing Manager Food and Drug Law Institute (FDLI) Washington, DC Director, Regulatory Affairs/Regulatory David E. Chadwick Science Cook Medical, Inc. Bloomington, IN Andrea Chamblee Regulatory Counsel FDA - ORA Rockville, MD Mayank Choudhary Director, Regulatory Affairs BD Biosciences San Jose, CA Bowman Cox Executive Editor, Manufacturing The Pink Sheet Washington, DC

Walery Desmond Regulatory Liaison, Global Consumer Safety Michigan State University Los Angeles, CA Meng Ding Juris Doctor Candidate Georgetown University Arlington, VA Ashley Docherty Student University of Miami El Paso, TX Professor - Retired FDA Director, Center for Bernadette M. Dunham Veterinary Medicine Milken Institute Rockville, MD Jessica Dunn Lead Regulatory Review Officer FDA - CBER Haymarket, VA Samantha Christine Eakes Senior Manager, Regulatory Affairs Greenleaf Health, Inc. Washington, DC Marissa Espinoza Student Brian D. Eyink Counsel Hogan Lovells US LLP Washington, DC Anthony Fanucci PharmD, JD Candidate Penn State Dickinson School of Law Carlisle, PA Elizabeth Barr Fawell Partner Hogan Lovells US LLP Washington, DC Camille L. Fletcher Associate Patterson, Belknap, Webb & Tyler, LLP New York, NY S.J. Quinney College of Law, University of Leslie Francis Distinguished Professor Utah Salt Lake City, UT Joseph Gabris Law Student Northern Illinois University DeKalb, IL Jeffrey N. Gibbs Director Hyman, Phelps & McNamara, PC Washington, DC Jonathan Gil Corporate Counsel Pfizer, Inc. New York, NY Ari Gordin Student Brooklyn Law School & Pace University Franklin Lakes, NJ Health Policy Director, HELP Committee Grace Graham Majority Staff US Senate Washington, DC Lewis A. Grossman* Professor of Law American University Arlington, VA Shlomit Halachmi Medical Officer at FDA FDA - CDRH Vienna, VA Ralph F. Hall Professor of Practice University of Minnesota Minneapolis, MN Yaniv Heled Associate Professor of Law Georgia State University Atlanta, GA Texas Health and Human Services Cynthia Hernandez Attorney Commission Austin, TX Megan Elise Howard JD Candidate Georgetown University Washington, DC Cat Humphries Public Policy Specialist ICF Charlotte, NC Alexandra Hussey Incoming Associate Venetia, PA Peter Barton Hutt* Senior Counsel Covington & Burling LLP Washington, DC Sae Hwang student Massachusetts College of Pharmacy Easthampton, MA Jonathan Iwry J.D., 2020; Incoming Associate Ropes & Gray LLP Potomac, MD Alexandra Jabs Attorney FDA - OC Baltimore, MD Freddy A. Jimenez** Vice-President, Law and Compliance Celldex Therapeutics, Inc. Hampton, NJ John F. Johnson* Of Counsel Shook, Hardy & Bacon LLP Washington, DC Maria Kalousi-Tatum Associate Morgan, Lewis & Bockius LLP Washington, MD Sheila M Kaplan Correspondent New York Times Bethesda, MD

Philip Katz Partner, Head of Pharma/Biotech Practice Hogan Lovells US LLP Washington, DC Abigail Keller Research Assistant Georgetown University Washington, DC Julie Kim Student George Washington Univ. Law School Washington, DC Daniel A. Kracov** Partner Arnold & Porter LLP Washington, DC Partner, Co-chair of the FDA & Health Care Marian J. Lee* Practice Gibson Dunn & Crutcher LLP Washington, DC Laurie Lenkel Ombudsman FDA - OC Silver Spring, MD Anton Lesaca Associate Venable LLP Washington, DC Gregory H. Levine Partner Ropes & Gray LLP Washington, DC Jane Massey Licata Partner Licata & Tyrrell P.C. Marlton, NJ Daniel Lichtenauer Student Brooklyn Law School & Pace University Kelly Lienhard Associate Editor InSide Washington Publishers Washington, DC Rachael Vieder Linowes Regulatory Counsel FDA - OC Silver Spring, MD Jakub Madej Manager

Associate Director, Global Quality Systems - Justin M. Mann QMS Processes, Novartis Gene Therapies Novartis Pharmaceuticals Corporation Cary, NC Davina Rosen Marano Regulatory Counsel FDA - CDRH Gaithersburg, MD William Chanes Martinez JD Student Seton Hall University School of Law Jersey City, NJ

Ann T. Maxwell Regional Inspector General Department of Health and Human Services Washington, DC Dominique McCraney Student Southern University Law Center Greenville, MS J.R. McNair* Partner Winston & Strawn LLP Chicago, IL Janet McNicholas Of Counsel Jones Day Chicago, IL Karen Meister Senior Advisor FDA - OC Silver Spring, MD Ann M. Metayer Senior Regulatory Counsel FDA - ORA Silver Spring, MD Nory Dianne Miano Student Georgetown University Washington, DC Kai Mindick Student Cornell University Ithaca, NY Partner and Head, Food and Drug Practice Alan G. Minsk* Team Arnall Golden Gregory LLP Atlanta, GA Isaac Mohar Senior Toxicologist Gradient Consulting Seattle, WA Aliya Moman Student London, Essex Lisa Mueller Partner Casimir Jones, S.C. Buffalo Grove, IL Cara Musciano Student University of Georgia Atlanta, GA Kerrie Nagrod Director, Regulatory Affairs Bristol-Myers Squibb Company Lawrenceville, NJ Helena Normandie Student University of San Diego San Diego, CA Elizabeth Oestreich VP Regulatory Compliance Greenleaf Health, Inc. Washington, DC Noreen Onimus Attorney Troutman Pepper Hamilton Sanders LLP Washington, DC James T. O'Reilly* Professor University of Cincinnati Cincinnati, OH

Daniel Orr Senior Legal Editor (Life Sciences) / Partner Thomson Reuters Annapolis, MD Joseph A. Page* Professor Georgetown University Washington, DC Cindy Palomino CNA Insurance Corporation Leander, TX Vice President of Regulatory Affairs, Pharma Andy Papas Biotech NSF International Washington, DC Stuart M. Pape Chair, FDA Practice Polsinelli PC Washington, DC Efthimios Parasidis Professor of Law and Public Health The Ohio State University Columbus, OH Rachel Park Associate DLA Piper LLP (US) Arlington, VA Amy Comstock Rick** President and CEO Food and Drug Law Institute (FDLI) Washington, DC Margaret Foster Riley** Professor, School of Law University of Virginia Charlottesville, VA

Laura Rose Regulatory Affairs Activity Lead Centers for Disease Control and Prevention Atlanta, GA Betty Ross New York University New York, NY Diane Rothong CEO Sole Practitioner Lake George, NY Andrea L. Ruth Principal Consultant Pacifica, CA Elizabeth J. Sadove Sr. Regulatory Counsel FDA - OC Silver Spring, MD Paige Samson Director Food and Drug Law Institute (FDLI) Washington, DC Ana Santos Rutschman Assistant Professor of Law Saint Louis University St. Louis, MO Alessandra Schaszberger Student Georgetown University Washington, DC Juan Luis Serrano-Leets Partner Sanchez Devanny Ciudad de México, CDMX Deputy Commissioner for Medical and Anand Shah Scientific Affairs FDA - OC Silver Spring, MD Shy Shorer* Director, OSRO National Institutes of Health Rockville, MD Bruce A. Silverglade Principal Olsson Frank Weeda Terman Matz PC Princeville, HI Brianna Skinner Senior Regulatory Veterinarian FDA - OC Silver Spring, MD Timothy Solberg Senior Advisor FDA - OC Silver Spring, MD Steven B. Steinborn Partner Hogan Lovells US LLP Washington, DC Hebe Sun Sr. Regulatory Affairs Manager BD Biosciences San Jose, CA Katarina Thallner Student Brooklyn Law School & Pace University Franklin Lakes, NJ Kyle Thomson Senior Legislative Counsel American Medical Association Silver Spring, MD Director, Global Compliance and External Deborah E. Tolomeo Collaborations Genentech, Inc. South San Francisco, CA

Kimberly A. Trautman EVP, Medical Device International Services NSF International Washington, DC Cory Trio Associate Covington & Burling LLP Washington, DC Roselyn Tyson Regulatory Counsel FDA - ORA Washington, DC Liza Vertinsky Assistant Professor Emory University Atlanta, GA Beth Wang Reporter InSide Washington Publishers Arlington, VA Beth P. Weinman Counsel Ropes & Gray LLP Washington, DC Allison Whelan Associate Covington & Burling LLP Washington, DC Joi Wilson Paralegal FDA - CTP Silver Spring, MD John D. Winter Partner Patterson, Belknap, Webb & Tyler, LLP New York, NY Carolina Wirth Of Counsel Arnall Golden Gregory LLP Washington, DC Carl Wu Student Brooklyn Law School & Pace University Franklin Lakes, NJ Lauren Wustenberg Vermont Law School, Student Clinician Vermont Law School Farmington, MN Emily J. Yang JD Candidate University of La Verne Rancho Cucamonga, CA Krupa Zachariah JD Candidate American University Washington, DC Mintz, Levin, Cohn, Ferris, Glovsky and Benjamin M. Zegarelli Of Counsel Popeo, P.C. New York, NY Lowell M. Zeta Senior Advisor to the Commissioner FDA - OC Washington, DC Patti Zettler* Assistant Professor The Ohio State University Columbus, OH Jing Zhang VP, Regulatory Affairs BD Biosciences San Jose, CA *Member, Symposium Planning Committee ** Member, FDLI Board of Directors