Advancing the Vaccine Law Dialogue
Pre-conference: September 13
Washington, D.C.
Members of the 2023 National Vaccine Law Conference Committee are:
Co-Chair: Brian Dean Abramson, Esq., LL.M.
Brian Dean Abramson is the primary author of the legal treatise, Vaccine, Vaccination, and Immunization Law, the most comprehensive treatise written with respect to this field of law, published by Bloomberg Law in cooperation with the American Health Law Association in November 2018, and regularly updated thereafter. A second print edition was published by AHLA in February 2022. He teaches the subject as Adjunct Professor of Vaccine Law at the Florida International University College of Law.
Mr. Abramson previously worked for Bloomberg Law, for whom he authored the vaccine injury claims chapter of Matthew H. Solomson’s Court of Federal Claims: Jurisdiction, Practice, and Procedure, and for whom he wrote extensively in the fields of health and international privacy law. He 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 this, he interned with the Honorable Susan G. Braden of the U.S. Court of Federal Claims, and practiced intellectual property law with the firm of Lott & Friedland in Coral Gables, Florida.
Mr. Abramson received an MA in Comparative Sociology from Florida International University, followed by his JD, summa cum laude, from the Florida International University College of Law, and an LLM in intellectual property law with highest honors from the George Washington University Law School.
Co-Chair: Richard Hughes IV, Esq.
Mr. Hughes is a partner in the firm of Epstein Becker & Green, and a professorial Lecturer in Law at The George Washington University Law School. A nationally recognized vaccine thought leader, he has led many efforts to expand access to vaccines and preventive services and improve public health outcomes.
Mr. Hughes is the former Vice President of Public Policy at Moderna. Previously, he was Managing Director at Avalere Health, where Mr. Hughes founded and led the firm’s vaccines group. Prior to joining Avalere, he practiced health care law and served as a strategic adviser at Epstein, Becker & Green, to which he has since returned as a partner. Mr. Hughes previously held roles with Merck and the Association of State and Territorial Health Officials, and as a gubernatorial appointee to the Arkansas State Board of Health.
Prior to joining the GW Law faculty, he held an appointment as a Professorial Lecturer in Health Policy and Management at the GW Milken Institute School of Public Health. During law school, Mr. Hughes proudly served as a research assistant to renowned health law and vaccines scholar Professor Sara Rosenbaum. He is a member of the National Delta Omega Honorary Society in Public Health and the District of Columbia Bar.
Vice-Chair: Professor Denise M. Hill
Drake Associate Professor Denise Hill, JD, MPA brings 25-years of health care legal, policy, public administration, and ADR experience to the classroom, practice of law, and community. She continues to practice health and employment law and mediate with the Whitfield & Eddy law firm in Des Moines, Iowa.
Denise is a sought-after speaker, author, media commentator, and thought leader on a variety of contemporary health law and ethics topics. Most recently she authored Vaccine Mandates in the Health Care Workplace: A Legal Primer for Employers published by the American Health Law Association. For many years Denise has advised health care organizations, written, and presented on public health and vaccination law issues at the state and national levels. For example, two decades ago Denise helped to negotiate the Public Health Disaster Emergency provisions in the Iowa Code that were utilized during the COVID-19 global pandemic. Denise was recently named the Vice-Chair for the first National Vaccine Law Conference to be held at the Antonin Scalia Law School at George Mason University in September 2022.
In 2017, Denise was selected as one of 15 nationally known health law experts to contribute to the 30th anniversary addition of the highly regarded Health Law Handbook series published by WestGroup in spring 2018. Her article “Patient-Centered Compliance in a World of Pain” provides insights and guidance on legal and compliance issues related to pain management and opioids; an area that she has studied and presented on for many years. Denise is also a co-author of the forthcoming text Maximize Student Retention and Persistence to Graduation: Proven Strategies for Higher Education as well as the Powerful Learning Communities: A Guide to Developing Student, Faculty, and Professional Learning Communities to Improve Student Success and Organizational Effectiveness that was published by Stylus.
Previously, Denise was the Director of Health Law Programs at Drake Law School; practiced law and mediation with the Davis Brown Law Firm, was an Associate Professor in the Colleges of Medicine, Podiatry, and Health Sciences at Des Moines University; and taught for the University of Iowa’s Executive MHA program. Over the years she has won a number of awards that recognize the quality of her teaching and passion for individual student success. In addition to her work in private practice and academia, Denise was an Attorney/Manager of Public & Regulatory Affairs with the Iowa Medical Society and a State of Iowa labor relations attorney.
Denise was a 1990 Harry S. Truman Congressional Scholar who graduated with honors from Drake University (law and MPA), Wartburg College (BA), and Waldorf College (AA).
Alexandra Bhatti, Esq.
Ms. Bhatti is Director of U.S. Vaccine Policy at Merck & Co. Inc. She has been an honors faculty associate at ASU since Fall 2015. Presently Ms. Bhatti is the Director of US Vaccine Policy at Merck & Co. Inc., where she leads US vaccine research and policy development and federal vaccine policy.
Previously, she spent years at the Centers for Disease Control and Prevention, as a public health attorney leading vaccination and health insurance policy issues. During her tenure at CDC, she also worked in the Office of the Director at the Centers for Disease Control and Prevention supporting the launch of health system transformation initiatives.
Prior to her CDC work, she was an immunization program manager within the Arizona Department of Health Services in the Bureau of Epidemiology and Disease Control. She began her career with the Arizona Department of Health Services as a public health scientist performing research and clinical laboratory work.
Chief Judge Susan G. Braden (Ret.)
Judge Susan G. Braden was appointed in 2003, by President George W. Bush, to the United States Court of Federal Claims which has exclusive jurisdiction over cases against the federal government arising from a variety of areas, including vaccine injury claims. On March 13, 2017, she was designated as Chief Judge.
Since her retirement from the federal bench, she has been appointed as a Public Member of the Administrative Conference of the United States, a Fellow of the American Bar Association, and to the Board of Directors of privately- held companies in the software, artificial intelligence, and construction industries.
Judge Braden recently was designated as one of ten U.S. Arbitrators to resolve disputes arising under the USMCA (United States-Mexico-Canada-Agreement) Treaty and Jurist-In-Residence, Center For Intellectual Property and Policy, Antonin Scalia School of Law, George Mason University.
Nicholas J. Diamond, Esq.
Nicholas “Nick” Diamond is a Partner at Jackson Walker LLP, based in the firm’s Houston, Texas, office. He is a regulatory lawyer with extensive, international experience counseling clients across the food, healthcare, life sciences, medical device, and technology sectors.
While his practice primarily focuses on compliance counseling, he also has experience in global policy advocacy, commercial transactions, enforcement actions and investigations, and ethics and governance.
Nick established and leads the firm’s U.S. Food and Drug Administration (FDA) practice. He provides comprehensive compliance and corporate counsel for entities and products regulated by FDA. He has experience counseling clients on matters falling under FDA’s jurisdiction, such as: animal and veterinary products, including animal drugs and drug compounding; cosmetics; food (both human and animal), beverage, and dietary supplements; human pharmaceuticals and biotechnology products, spanning all therapeutic areas; medical devices (especially software-as-a-medical-device) and diagnostics; and vaccines.
Nick is also an Adjunct Professor of Law at the Georgetown University Law Center and University of Houston Law Center, among other academic affiliations.
Dr. Michelle Fiscus
Dr. Fiscus is the Chief Medical Officer of the Association of Immunization Managers, where she leads AIM’s CDC-funded project to improve COVID-19 vaccination rates in children under 5 years and helps inform AIM’s products, strategies, and policies. Dr. Fiscus is a board-certified pediatrician and former medical director of Tennessee’s Vaccine-Preventable Diseases and Immunization Program. Dr. Fiscus received her undergraduate and medical degrees from Indiana University and completed her residency in pediatrics at the James Whitcomb Riley Hospital for Children in Indianapolis. Dr. Fiscus is a member of American Academy of Pediatrics Board of Directors and has served on workgroups for the Advisory Committee on Immunization Practices.
Renée Gentry, Esq.
Ms. Gentry founded her own firm, the Law Office of Renée J. Gentry, Esq. in Washington DC, specializing in vaccine injury litigation in June 2019. She is one of the leading experts on vaccine injury litigation in the National Vaccine Injury Compensation Program (NVICP).
Ms. Gentry has advised numerous congressional members, staff, and committees on issues relevant to the NVICP, and she has also helped to draft proposed legislation. She is licensed to practice law in the District of Columbia and is admitted to the Federal Claims Court Bar. She is a member of the Vaccine Injured Petitioners Bar Association, a national bar representing the interests of claimants in the NVICP, where she served as President for four years. She is also a member of the US Court of Federal Claims Bar Association and the American Association for Justice (formerly ATLA).
Previously, she served as the Senior Analyst on the Defense and Aerospace Companies Briefing for Teal Group Corporation. Ms. Gentry consulted for the US Government, French Government, and major prime contractors on European defense industry consolidation, antitrust issues, specific defense market overviews for product development and profiles of companies designed to assist management in acquisition activities. After leaving Teal Group, she worked as principal liaison to corporate clients, as well as the Washington National Opera and Domingo-Cafritz Young Artists Program advising them on a range of immigration issues. She has practiced vaccine litigation since 2001.
In addition to Directing the Vaccine Injury Litigation Clinic, Ms. Gentry teaches Disability Rights Law. She received her BA from Drake University, and her JD from Washington University Law School.
Sonali Gunawardhana, Esq.
Ms. Gunawardhana has taught is multiple courses relating to the regulation of vaccines, including Vaccine Law, at the American University Washington College of Law.
She is Assistant General Counsel Regulatory Law at Cardinal Health Incorporated. In this role, Sonali provides regulatory and legal support to Cardinal Health’s businesses including both pharmaceutical and medical device manufacturing and distribution. Previously, she served as Chief Counsel FDA and Regulatory Law at McKesson Corporation and as outside counsel to a myriad of pharmaceutical and medical device companies while in private practice at Wiley Rein LLP and Shook, Hardy & Bacon LLP, respectively. Prior to her tenure in private practice, she served as Regulatory Counsel at the FDA for close to ten years. There she assisted on a variety of legal and policy issues in the following Centers: the Center for Devices and Radiological Health; the Center for Drug Evaluation and Research; and the Center for Food Safety and Applied Nutrition.
Ms. Gunawardhana received a BA from Syracuse University, a MA from Webster University, an MPH from Boston University, a JD from the University of New Hampshire School of Law and a LLM from Washington College of Law, American University.
Brian Malkin, Esq.
Mr. Malkin is a partner with the firm of McDermott Will & Emory, where he counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.
Brian’s regulatory experience includes all types of FDA-regulated products: drugs and biologics (including animal drugs and biologics), medical devices, cannabis, foods and dietary supplements, cosmetics and tobacco products. He is a key advisor to pharmaceutical and biologic clients in the premarket, regulatory review, and marketing, enforcement and lifecycle management phases of product development. Brian works alongside his clients on drug development strategies and patent strategies across a variety of areas.
Professor Peter Meyers
Peter H. Meyers joined the law faculty of the George Washington University Law School in 1994. He served as Director of the law school’s Federal and Appellate Clinic and Vaccine Injury Litigation Clinic.
Professor Meyers has published articles on the constitutionality of pretrial drug testing and reform of the flaws in the Federal Vaccine Injury Compensation Program. He also served as a Designated Reviewer of nine publications issued by the National Academy of Sciences Institute of Medicine.
Professor Meyers has argued cases before many appellate courts around the country, including a landmark standing case before the US Supreme Court that established the right of people to sue the government for injuries to the environment. He has obtained reversals of murder convictions in several cases because of Confrontation Clause violations. He also served as Director of the Center for the Study of Drug Policy, and as Chairman of the Advisory Commission on Childhood Vaccines Workgroup of the U.S. Department of Health and Human Services.
After taking emeritus status, he continues to teach a class on Drugs and the Law at the law school, as well as teach in the Forensic Psychiatry Fellowship Programs at Saint Elizabeths Hospital and the George Washington University School of Medicine and Health Sciences.
Kirk J. Nahra, Esq.
Mr. Nahra is a partner with WilmerHale in Washington, D.C., where he specializes in privacy and information security litigation and counseling, along with a variety of health care and compliance issues. He is Co-Chair of the firm’s Cybersecurity and Privacy Practice as well as Co-Chair of the Big Data Practice. He assists companies in a wide range of industries in analyzing and implementing the requirements of privacy and security laws across the country and internationally. He provides advice on data breaches, enforcement actions, contract negotiations, business strategy, research and de-identification issues and privacy, data security and cybersecurity compliance. He advises companies in virtually all industries, ranging from Fortune 500 companies to start-ups. He also works with insurers and health care industry participants in developing compliance programs and defending against government investigations into their practices.
He has taught privacy issues at several law schools. He teaches both Information Privacy Law and Health Care Privacy and Data Security Law as an adjunct professor at the Washington College of Law at American University. A long-time member of the Board of Directors of the International Association of Privacy Professionals, he was the editor of Privacy Advisor, the monthly newsletter of the International Association of Privacy Professionals for more than a decade and chairs IAPP’s Publications Committee. He is also a founding Board Member of the Privacy Bar Section of the IAPP and is a Certified Information Privacy Professional. He received the 2021 Privacy Vanguard Award from IAPP in recognition of his “exceptional leadership, knowledge and creativity in privacy and data protection.”
Dr. René Najera
Dr. René F. Najera is an epidemiologist and Director, Public Health and History of Vaccines, The Susan and Stanley Plotkin Chair in Public Health, College of Physicians of Philadelphia. He is the editor of the History of Vaccines project, with a focus on news and information on vaccines, vaccine science, vaccine research, and the public health implications of vaccine policy. He previously directed the Fairfax County Health Department in Fairfax, Virginia.
Dr. Najera has a doctorate in public health (DrPH) from the Johns Hopkins University Bloomberg School of Public Health, a Master of Public Health (MPH) degree from George Washington University, and a Bachelor of Science in Medical Technology degree from the University of Texas at El Paso. He is affiliated with the Department of Epidemiology of the Johns Hopkins Bloomberg School of Public Health, and with the George Mason University Department of Global and Community Health.
Dr. Richard Pan
Dr. Richard Pan is a pediatrician and former UC Davis professor who served in the California State Senate from 2014 to 2022, representing the 6th Senate district, which encompassed parts of Sacramento and Yolo counties. Prior to being elected to the State Senate, he was a member of the California State Assembly representing the 5th Assembly District, and after the 2010 redistricting, the 9th Assembly District. He served as Chair of the Assembly and Senate Committees on Health. Dr .Pan currently serves on the American Academy of Pediatrics Committee on State Government Affairs.
Following a measles outbreak that began in California and infected 131 people, Dr. Pan and Senator Ben Allen introduced California Senate Bill 277 in 2015, which eliminated non-medical exemptions to vaccine requirements for California school children. In 2019, he authored SB276 to provide public health oversight over medical exemptions to vaccination. TIME magazine called Dr. Pan a “hero” of vaccine history. Dr. Pan is a champion for public health authoring legislation to expand newborn screening, fund gun violence research, increase health care coverage and affordability, reduce sexually transmitted infection and increase state funding for public health. In 2021 he authored a law (SB 742) that makes illegal to “harass, intimidate, injure or obstruct” people who are on their way to get a vaccination. The law was inspired by an incident in January 2021 when protesters targeted and briefly shut down a mass vaccination site in Los Angeles.
Dr. Pan has a Medical Doctorate from the University of Pittsburgh, a Master of Public Health from Harvard University and a bachelor’s degree in biophysics from Johns Hopkins University.
Roger L. Price, Esq.
Roger L. Price was born and raised on the South Side of Chicago, in the Hyde Park neighborhood. The area was best known as the home of the University of Chicago and the Museum of Science and Industry, as well as for its political independence. Critical thinking was the order of the day, as both common definitions and core principles were all subject to question. Equally important was that the discourse be civil.
Public grammar and high schools led to the University of Michigan, after which Price returned to Hyde Park to attend the University of Chicago Law School. Over forty years of engagement with the law included analyzing circumstances and events, identify legal issues, framing solutions, and writing persuasively and productively. In 2010, he retired as a partner with the firm of Seyfarth Shaw, LLP. Writing on Judaism and science since retirement in 2010 was a natural outgrowth of his roots in Hyde Park: no cow was too sacred for examination, nor immune to the power of empirical evidence. His first book, When Judaism Meets Science, reflects a commitment to recognizing differing viewpoints, gathering evidence, understanding the strengths and weakness of arguments, and, where possible, offering constructive proposals. The Chapter, “A Nice Jewish Shot,” outlines the permissibility of vaccination under the religious laws of Judaism.
Montrece Ransom, JD, MPH
Montrece McNeill Ransom currently serves as the Director of the National Coordinating Center for Public Health Training for the National Network of Public Health Institutes.
Ms. Ransom was appointed as a Presidential Management Fellow and worked at CDC for almost 20 years. For the last 10 years of her service, Ms. Ransom led CDC’s public health law related training and workforce development efforts. She received her law degree from the University of Alabama, her MPH from Emory University’s Rollins School of Public Health, and her Executive Leadership Coaching Certification from Georgetown University. In addition, she has received a certificate in training and facilitation from the Association of Talent Development. Ms. Ransom is the ABA Health Law Section’s 2019 Champion of Diversity and Inclusion Awardee, and the 2017 recipient of the American Public Health Association Jennifer Robbins Award for the Practice of Public Health Law. She is the President-Elect of the American Society for Law, Medicine, and Ethics and serves on the Advisory Committee for the Georgia Campaign for Adolescent Power and Potential.
Devoted to helping people reach their human potential, Ms. Ransom also spends a lot of time working on career pathing and professional development with new public health practitioners and public health lawyers. She is also a well-known public speaker, peer-reviewed published author, the Co-Editor of the textbook, Public Health Law: Concepts and Case Studies.
Professor Dorit Rubinstein Reiss
Professor Reiss is a professor of law at the University of California, Hastings College of the Law in San Francisco. She received her 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. She 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 received her Ph.D. from the Jurisprudence and Social Policy program in UC Berkeley. Professor Reiss’ 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. She writes about school mandates, policy responses to non-vaccinating, tort issues and administrative issues related to vaccines.
Dr. Chizoba Wonodi
Dr. Wonodi is an epidemiologist, and leader of Johns Hopkins Bloomberg School of Public Health Vaccine Access Center’s immunization support efforts in Nigeria. A public health physician with over twenty-seven years’ research and program experience in Africa, Asia and America. She serves as the Nigeria Country Director at the International Vaccine Access Centre (IVAC). In this role, she leads an important portfolio of work on technical assistance, implementation research and policy advocacy to improve immunization service delivery and primary health care systems in the country. She is currently the principal investigator for a Gates Foundation-funded project to improve immunization uptake by sending SMS messages to inform, educate and remind caregivers of their child’s vaccinations. Implemented as a cluster randomized trial, this intervention – the Immunization Reminder and Information SMS System – is intentionally large in scope to demonstrate how innovations like SMS reminders can be taken to scale.
In keeping with her focus on public health practice, Dr. Wonodi founded the Women Advocates for Vaccine Access (WAVA), a coalition of Civil Society Organizations in Nigeria advocating for increased uptake of vaccines and for sustainable financing of immunization programs. WAVA serves as the secretariat for the national platform, the Expanded Civil Society Initiative for Immunization (ECSII) in Nigeria. At the global level, Dr. Wonodi holds the vice chair position of the Gavi CSO Platform Steering Committee, a body that coordinates Civil Societies active in immunization.