Reconciling Research and Treatment: Seeking Answers & Saving Lives

2020-21 Webinar Series
2020-22
October 16, 2020 - 11:30am to 1:00pm

The COVID-19 pandemic poses profound ethical, legal, and social challenges to researchers, clinicians, legal professionals, and communities. This webinar will focus on how to conduct research on the efficacy and safety of medical interventions while also meeting the pressing clinical needs of COVID patients.

Leading experts will tackle pressing controversies, such as how to reconcile the FDA’s Emergency Use Authorization (EUA) of convalescent plasma for COVID patients with the need for clinical trials. Past pandemics like the Ebola crisis have led to recommendations on how to balance the need for research with caring for affected patients. This webinar will analyze these issues in the context of COVID-19.

Panelists are:

Robert M. Califf, MD, MACC

Robert M. Califf, MD, MACC
Head of Clinical Policy and Strategy for Verily and Google Health
Adjunct Professor, Duke University and Stanford University

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Bio

Robert M. Califf, MD, MACC, is the Head of Clinical Policy and Strategy for Verily and Google Health for Verily and Google Health. Prior to this Dr. Califf was the vice chancellor for health data science for the Duke University School of Medicine; director of Duke Forge, Duke’s center for health data science; and the Donald F. Fortin, MD, Professor of Cardiology. He served as Deputy Commissioner for Medical Products and Tobacco in the U.S. Food and Drug Administration (FDA) from 2015-2016, and as Commissioner of Food and Drugs from 2016-2017. A nationally and internationally recognized leader in cardiovascular medicine, health outcomes research, healthcare quality, and clinical research, Dr. Califf is a graduate of Duke University School of Medicine. Dr. Califf was the founding director of the Duke Clinical Research Institute and is one of the most frequently cited authors in biomedical science.

Arturo Casadevall, MD, PhD

Arturo Casadevall
Chair, Molecular Microbiology and Immunology
Johns Hopkins University

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Bio

Dr. Casadevall is a professor of medicine at the Johns Hopkins School of Medicine. He holds a joint appointment in molecular microbiology and immunology at the Johns Hopkins Bloomberg School of Public Health. His research focuses on how microbes cause disease and how the immune system defends itself. Dr. Casadevall serves as chair of the W. Harry Feinstone Department of Molecular Microbiology and Immunology at the Johns Hopkins Bloomberg School of Public Health. Dr. Casadevall’s work has been recognized with numerous awards, including the American Society for Microbiology Founders Distinguished Service Award, the National Institutes of Health Merit Award, and the Rhoda Benham Award from Medical Mycology Society of America.

Holly Fernandez Lynch, JD, MBe

Holly Fernandez Lynch, JD, MBe
Assistant Professor of Medical Ethics and Health Policy
University of Pennsylvania

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Bio

Holly Fernandez Lynch, JD, MBE, is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine, University of Pennsylvania. Her scholarly work focuses on the ethics and regulation of research with human subjects. As founder and co-chair of the Consortium to Advance Effective Research Ethics Oversight (AEREO), she is leading a collaborative effort to understand, evaluate, and improve IRB quality and effectiveness. In the context of COVID-19, she has applied her expertise to the ethical conduct of research, drug and vaccine development, and allocation of scarce investigational products during a pandemic. She served as member of the U.S. Department of Health and Human Services Secretary’s Advisory Committee on Human Research Protections (SACHRP) from 2014-2019 and continues to serve on a SACHRP subcommittee.

Moderated by:

Michael T. Osterholm, PhD, MPH

Michael T. Osterholm
Director of the Center for Infectious Disease Research and Policy (CIDRAP)
Regents Professor, McKnight Presidential Endowed Chair in Public Health
Distinguished Teaching Professor in the Division of Environmental Health Sciences, School of Public Health
Professor in the Technological Leadership Institute, College of Science and Engineering
University of Minnesota

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Bio

Michael T. Osterholm, PhD, MPH, is Regents Professor; McKnight Presidential Endowed Chair in Public Health; the Director of the Center for Infectious Disease Research and Policy (CIDRAP); and Distinguished Teaching Professor in the Division of Environmental Health Sciences, School of Public Health at the University of Minnesota. He is also a Professor in the Technological Leadership Institute, College of Science and Engineering, and an Adjunct Professor in the Medical School. He is a member of the National Academy of Medicine (NAM) and the Council on Foreign Relations. He has served as a high-level advisor on issues related to bioterrorism, public health preparedness, and infectious diseases.

Susan M. Wolf, JD

Susan Wolf
Chair, Consortium on Law and Values in Health, Environment & the Life Sciences
Regents Professor
McKnight Presidential Professor of Law, Medicine & Public Policy
Faegre Baker Daniels Professor of Law
Professor of Medicine

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Bio

Professor Susan M. Wolf is a Regents Professor; McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Baker Daniels Professor of Law; and Professor of Medicine at the University of Minnesota. She is Chair of the University’s Consortium on Law and Values in Health, Environment & the Life Sciences. She is an elected member of the National Academy of Medicine (NAM) and a Fellow of the American Association for the Advancement of Science (AAAS). 

10/16/20