AHLA Vaccine, Vaccination, and Immunization Law (Non-Members)

Brian Dean Abramson is an adjunct professor of Vaccine Law at the Florida International University College of Law and the University of Houston Law Center, a frequent author and speaker on vaccine law, and the principal of the consulting firm, Vaccination Program Counsel. He serves on the Board of Directors of the National Vaccine Law Association, and chaired the inaugural National Vaccine Law Conference in 2022. Professor Abramson was a legal editor for Bloomberg BNA from 2013 to 2016, during which he authored the Vaccine Injury Claims chapter for Matthew H. Solomson’s treatise, Court of Federal Claims: Jurisdiction, Practice, and Procedure; and has since continued this relationship as a contract author for Bloomberg. From 2010 to 2012, Professor Abramson was a law clerk for the Honorable Pauline Newman of the U.S. Court of Appeals for the Federal Circuit, where he took an exceptional interest in the court’s vaccine injury docket. Prior to his clerkship, Professor Abramson earned a J.D. summa cum laude from the Florida International University College of Law in 2005, practiced intellectual property law with what is now Lott & Fischer, P.L., from 2005 to 2007. He earned an LL.M. in intellectual property law with highest honors from the George Washington University Law School in 2009, and interned for the Honorable Susan G. Braden of the U.S. Court of Federal Claims in 2010. 

Dorit Rubinstein Reiss is a professor of law at the University of California San Francisco College of the Law. She earned an undergraduate degree in Law and Political Science from the Faculty of Law in the Hebrew University of Jerusalem where she served as Editor in Chief of the Law Review. Professor Reiss then clerked for a year and a half in the Israeli Ministry of Justice’s Department of Public Law, working on a variety of constitutional and administrative law issues. She earned a Ph.D. from the Jurisprudence and Social Policy program at U.C. Berkeley. Her initial research examined accountability of agencies at the state, national, and international level, with agencies studied including the CPUC, the FAA, and other agencies in the United States and Europe. Increasingly, however, her research and activities are focused on legal and policy issues related to vaccines. Professor Reiss writes about school mandates, policy responses to non-vaccinating, tort issues and administrative issues related to vaccines. 

Peter O. Safir is senior counsel to the firm of Covington & Burling. Mr. Safir has practiced in the food and drug field for over 30 years and is widely recognized in the pharmaceutical industry as one of the leading food and drug regulatory lawyers in the country. In recent years, he has worked primarily with the research-based pharmaceutical industry concentrating on marketing practices, life cycle management, and issues involving drug quality and manufacturing. Mr. Safir has conducted numerous internal investigations for pharmaceutical and medical device companies involving fraud and abuse, advertising, and promotional practices. He has defended enforcement actions in the marketing and manufacturing areas, representing both companies and corporate executives targeted by the FDA. He has published and spoken widely in the area of drug regulation and has been a professorial lecturer in food and drug law at the George Washington University Law School since 1991. Mr. Safir is a graduate of Princeton University and the Yale Law School.

John R. Thomas is a professor of law at Georgetown University in Washington, D.C. He has served as the inaugural Thomas Alva Edison Visiting Scholar at the U.S. Patent and Trademark Office; law clerk to Chief Judge Helen W. Nies of the U.S. Court of Appeals for the Federal Circuit; and visiting researcher for the Congressional Research Service of the Library of Congress. He has also served as a visiting researcher at the Institute of Intellectual Property in Tokyo, Japan, and at the Max Planck Institute in Munich, Germany. He has been a member of the visiting faculties of the law schools of Cornell University and the University of Tokyo. Professor Thomas holds a B.S. in computer engineering from Carnegie Mellon, a J.D. magna cum laude from the University of Michigan, and an LL.M. with highest honors from the George Washington University. Pharmaceutical Patent Law is one of his six books concerning intellectual property law.

Ana Santos Rutschman is a Professor of Law at the Villanova University Charles Widger School of Law, teaching and researching topics related to health law, intellectual property, innovation in the life sciences and law and technology. She is a nationally and internationally recognized expert on vaccine law and policy, the regulation of emerging health technologies and access to medicines. At Villanova, Ms. Rutschman is the founder and director of the Health Innovation Lab, an interdisciplinary platform that brings together academic researchers, students, policymakers, practitioners, industry and the Philadelphia and Northeast Corridor communities. Rutschman’s work has been recognized by numerous institutions, including the American Society of Law Medicine & Ethics, which named her a Health Law Scholar in 2018 and Bio Intellectual Property Scholar in 2017. Ms. Rutschman’s book, Vaccines as Technology: Innovation, Barriers and the Public Health, was published in 2022 by Cambridge University Press. Before joining Villanova Law in 2022, She taught in the health law program at Saint Louis University School of Law (2018-2022) and served as the inaugural Jaharis Fellow in Health Law and Intellectual Property at DePaul University College of Law in Chicago (2016-2018). Ms. Rutschman has also consulted for the World Health Organization in (2022 and 2015-2016) on matters related to the development of drugs and vaccines against COVID-19, Zika, and Ebola.

Denise M. Hill, JD, MPA, is an Associate Professor at Drake University, where she teaches in the Zimpleman Colleges of Business and Law School. She is also an Attorney/Mediator with the Whitfield & Eddy law firm. Prior to joining the Zimpleman College of Business MPA faculty, Professor Hill was an Associate Professor appointed to the Colleges of Health Sciences, Medicine, and Podiatric Medicine at Des Moines University, where she received multiple faculty awards, including MHA Professor of the Year. She previously practiced law at the Davis Brown Law firm, was an Attorney/Manager of Public and Regulatory Affairs at the Iowa Medical Society, and was a State Labor Relations Attorney. Professor Hill maintains an active presence in the health care, legal, nonprofit, and academic communities. She is the Chair of the Health Law Section of the Iowa State Bar Association and on the Board of Trustees of Waldorf University, the National Law Vaccine Association, and the American Academy of ADR Attorneys. A sought-after speaker, writer, and media commentator, she was selected as a national health law expert for the 30th-anniversary edition of the Health Law Handbook. The American Health Law Association published her work “Vaccine Mandates in the Health Law Workplace: A Primer for Employers” in 2021.

James M. Beck is Reed Smith’s Senior Life Sciences Policy Analyst and a member of the firm’s Life Sciences, Health Industries, Product Liability, and Appellate Groups. He litigates complex personal injury and product liability litigation and has been involved in numerous multidistrict litigation matters and other mass torts. On the appellate side, since 1992 he has drafted major appellate briefs in significant product liability and related matters, including well over 100 amicus curiae briefs, mostly on product liability and other tort questions. Mr. Beck is the senior author of the Law Journal Press treatise Drug and Medical Device Product Liability Deskbook. He is also the co-founder and lead blogger of the award-winning Drug & Medical Device Law Blog. He is a member of the Product Liability Advisory Committee (PLAC) and has sat on PLAC’s case selection committee since 1997. In 2011, Mr. Beck was awarded the PLAC’s highest honor, the John P. Raleigh Lifetime Achievement Award. He has written numerous law review and other articles, including Beck & Azari, FDA, Off-Label Use, and Informed Consent: Debunking Myths and Misconceptions, 53 Food & Drug L.J. 71 (1998), which was cited twice by the United States Supreme Court in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). Mr. Beck is a graduate of Princeton University and Penn Law School. 

 Sonali Gunawardhana is Assistant General Counsel, Regulatory, at Becton Dickinson (BD). In this role, Ms. Gunawardhana provides regulatory and legal support to BD’s businesses including both medical device and pharmaceutical manufacturing. She also currently serves as an adjunct professor at American University, Washington College of Law and The Catholic University of America. Previously, she served as Assistant General Counsel-Regulatory Law at Cardinal Health, 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, Ms. Gunawardhana served as Regulatory Counsel at the FDA for almost 10 years. There, she assisted on a variety of legal and policy issues in the Center for Devices and Radiological Health; the Center for Drug Evaluation and Research; and the Center for Food Safety and Applied Nutrition. Ms. Gunawardhana earned a B.A. from Syracuse University, an M.A. from Webster University, an M.P.H. from Boston University, a J.D. from the University of New Hampshire School of Law, and an LL.M. from American University, Washington College of Law.