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Bioethical and Legal Issues in the Time of Covid-19 11th Annual Pegalis Law Group Health Law Colloquium THE VACCINE: BIOETHICAL AND LEGAL ISSUES IN THE TIME OF COVID-19 DATE Opening remarks will be made by Anthony W. Crowell, Thursday Dean and President; Professor of Law, New York Law School. November 19, 2020 CO-MODERATORS Adam Herbst, Adjunct Professor, NYLS; Co-Director, NYLS TIME Health Law and Patient Safety Project; Lecturer at Columbia 6:00 p.m.–7:30 p.m. EST University’s Mailman School of Public Health Steven E. Pegalis, Adjunct Professor, NYLS; Co-Director, COST NYLS Health Law and Patient Safety Project; Member, Free NYLS Board of Trustees CLE PANELISTS 1.5 credits in Ethics Alison Bateman-House, Assistant Professor, Division of Medical Ethics, Department of Population Health at and Professionalism Grossman School of Medicine, NYU Langone Health (NY transitional and Arthur Caplan, the Drs. William F. and Virginia Connolly nontransitional) Mitty Professor and Founding Head, Division of Medical Ethics at Grossman School of Medicine, NYU Langone New York Law School is Health certified by the New York State Continuing Legal Education Hon. Richard N. Gottfried, New York State Assembly Board as an Accredited Provider (District 75); Chair of the Assembly’s Committee on Health of Continuing Legal Education Alicia Ouellette, President and Dean; Professor of Law, in the State of New York. Albany Law School RSVP: www.nyls.edu/VaccineCLE Zoom link will be sent with written materials 24 hours in advance of the program. WE ARE NEW YORK’S LAW SCHOOL 1 Since 1891 AGENDA 6:00-6:05pm – Opening Remarks – Anthony W. Crowell, Dean and President, New York Law School 6:05-6:10pm – Welcome – Professor Steven E. Pegalis 6:10-6:15pm – Introduction of the Panel by Moderator Professor Adam Herbst (please see detailed bios included below) 6:15-7:05pm – Panel Discussion 1 Ethics and Professionalism CLE Credit, NY Transitional and Nontransitional 7:05-7:30pm – Substantive Question & Answer with Audience 0.5 Ethics and Professionalism CLE Credit, NY Transitional and Nontransitional REMINDERS Attorney Attendance Verification: For any attorneys seeking CLE credit, per our accreditation guidelines, please complete this form by reporting back to us the three codes that were announced during the program. Ideally, you can complete this form by Monday, Nov. 23rd. CLE Certificates will be emailed to the email you provide in this form within 30 days. LINK: https://nyls.wufoo.com/forms/111920-cle- program-attendance-verification/ Feedback on the Program: For all attendees - please let us know what you thought about the program. Please share your feedback here: https://nyls.wufoo.com/forms/cle-evaluation-form-111920/ 2 Table of Contents Starts on Page Presenter Bios Page 1 Ethical Considerations for Protecting the Options of Subjects in Primary Epidemic Vaccine Page 4 Trials Fair Compensation for Rare Vaccine Harms Page 5 “Hell Freezes Over!” The Pharmaceutical Industry Stands in for a Politically Impaired FDA Page 8 Make Pre-Approval Covid-19 Vaccines Available Through Expanded Access, Not an EUA Page 12 New York State Vaccine Program DOWNL VISIT LINK: OAD https://www.governor.ny.gov/sites/governor.ny.gov/files/atoms/files/NYS_COVID_Vac cination_Program_Book_10.16.20_FINAL.pdf 3 11th Annual Pegalis Law Group Health Law Colloquium THE VACCINE: BIOETHICAL AND LEGAL ISSUES IN THE TIME OF COVID-19 SPEAKER BIOS OPENING REMARKS CO-MODERATORS ANTHONY W. CROWELL ADAM S. HERBST Dean and President, New York Law School Adjunct Professor, NYLS; Co-Director, NYLS Health Law And Patient Safety Anthony W. Crowell is the 16th Dean and Project; Lecturer at Columbia University’s President of New York Law School (NYLS). He Mailman School of Public Health has served in the role since May 2012 and has taught state and local government law at NYLS A senior hospital administrator, Adam Herbst since 2003. has devoted his career to specializing at the intersection of where health care law meets A first-generation student and a long-time New York City public servant, with communications, technology, and employment issues. He is an Dean Crowell proudly reintroduced NYLS as “New York’s law school.” adjunct professor at NYLS and a frequent speaker on health care access The School’s new motto illustrates NYLS’s commitment to building a at New York Medical College, Columbia University’s Mailman School of legal profession that reflects the diverse populations it serves. It also Public Health. Professor Herbst co-directs the NYLS Heath Law and Patient underscores NYLS’s identity as the only law school in Lower Manhattan, Safety Project and teaches health policy, bioethics, and healthcare access. the epicenter of the world’s economy. Under Dean Crowell’s leadership, NYLS issued the School’s first comprehensive Strategic Plan, annual Professor Herbst has extensive experience in structuring agreements progress reports on that plan, and most recently, the 2020 Strategic while advising on risk mitigation, and in offering solutions on operations, Plan. NYLS also published an Institutional Diversity Plan, built an Office board governance, and regulatory matters. He has worked on issues of Diversity and Inclusion, and adopted a dynamic and successful new related to housing, education, public health, and economic development. curriculum, Think BIG. The School further strengthened academic and bar He also has trial experience in both federal and state courts, and in support programs and dramatically expanded clinical and experiential arbitrations throughout the country. learning programs to leverage New York City as the ultimate classroom. Prior to his appointment, Dean Crowell served as Counselor to New York City Mayor Bloomberg. For more than a decade in City Hall, he STEVEN E. PEGALIS successfully managed a broad portfolio of legal, regulatory, legislative, Adjunct Professor, NYLS; Co-Director, governance, administrative, and operational matters focused on NYLS Health Law and Patient Safety enhancing New York City’s performance, competitiveness, accountability, Project; Member, NYLS Board of Trustees and public integrity. He coordinated and oversaw the work of city Steven Pegalis is the founder of Pegalis agencies, boards, and commissions; spearheaded government reform Law Group, LLC. He represents plaintiffs in and business process initiatives; and negotiated and implemented catastrophic medical malpractice actions and landmark reforms to the city’s lobbying and campaign finance laws. Dean specializes in perinatal brain injury cases. Crowell earned a Bachelor of Arts from the University of Pennsylvania and a Juris Doctor from American University. He is a member of the Board of Trustees at NYLS, where he also teaches medical malpractice as an adjunct professor. Professor Pegalis moderates the Annual Pegalis Law Group Lectureship on the Intersection of Law and Medicine to promote patient safety at NYLS. He also co-directs the NYLS Health Law and Patient Safety Project. Professor Pegalis has authored, American Law of Medical Malpractice, volumes 1–3. He has written and lectured on the subjects of trial advocacy, technique, and patient safety. 4 THE VACCINE: BIOETHICAL AND LEGAL ISSUES IN THE TIME OF COVID-19 SPEAKER BIOS (continued) Professor Pegalis is admitted to practice in New York, the U.S. Court group of internationally recognized medical experts, bioethicists, and of Appeals, 2nd Circuit, and the U.S. District Courts for the Eastern patient representatives. CompAC advises Janssen Pharmaceutical and Southern Districts of New York. He holds both a Juris Doctor and Companies of Johnson & Johnson on requests for compassionate use Bachelor of Law from New York Law School. and off-label access to many of its medicines. Professor Caplan previously served as a member of the WHO Ebola Ethics Committee. He is now a member of the WHO’s Monitored Emergency Use of Unregistered and Experimental Interventions Advisory DISTINGUISHED PANELISTS Committee on COVID-19. He has helped set policy for WIRB-Copernicus Group for reviewing research studies and compassionate use. Professor ALISON BATEMAN - HOUSE Caplan has also been consulted by Moderna and other vaccine Assistant Professor, Division of Medical companies on seeking emergency use authorizations. Ethics, Department of Population Health, New York University School of Medicine Professor Caplan earned a Doctor of Philosophy from Columbia University. Alison Bateman-House is an assistant professor in the Division of Medical Ethics at New York University (NYU) Grossman School of Medicine. THE HONORABLE RICHARD N. GOTTFRIED She serves as Co-Chair of the Working Group Assembly Member, District 75, New York on Compassionate Use and Preapproval Access (CUPA). CUPA is an State Assembly; Chair, New York State academic group—composed of patient advocates, clinicians, members Assembly Committee on Health of industry, former FDA staffers, lawyers, and academics—that studies The Honorable Richard N. Gottfried is the Chair ethical issues concerning access to investigational medical procedures. of the New York State Assembly Committee on Professor Bateman-House also co-chairs the Pediatric Gene Therapy Health, and has served in this role since 1987. and Medical Ethics working group, which includes academics, patient He is a Democrat representing District 75, advocates, industry representatives, and a wide array of clinical and which is located in a Manhattan and includes Chelsea, Hell’s Kitchen, research professionals. Bateman-House serves as the non-voting, Midtown, and part of the Upper West Side. non-paid Chair
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