Director of Health Policy Studies, Cato Institute
Michael F. Cannon is the Cato Institute’s director of health policy studies. His scholarship spans public health; regulation of clinicians, medical facilities, pharmaceuticals, and medical devices; employer‐sponsored and other private health insurance; Medicare; Medicaid; CHIP; the Veterans Health Administration; medical malpractice litigation; administrative law; international health systems; political philosophy; and more. Cannon is “an influential health‐care wonk” (Washington Post) and “the most famous libertarian health care scholar” (Washington Examiner). Washingtonian magazine named Cannon one of Washington, DC’s “Most Influential People” in 2021, 2022, and 2023.
Cannon has appeared on ABC, Al Jazeera, BBC, CBS, CNN, CNBC, C‑SPAN, Fox News Channel, NPR, and other broadcast media. His articles have appeared in the Wall Street Journal; the New York Times; USA Today; the Washington Post; the Los Angeles Times; SCOTUSBlog; Forum for Health Economics and Policy; JAMA Internal Medicine; Health Matrix: Journal of Law‐Medicine; Harvard Health Policy Review; the Yale Journal of Health Policy, Law, and Ethics; the Journal of Health Politics, Policy and Law; and Quinnipiac Health Law Journal. His latest book is Recovery: A Guide to Reforming the U.S. Health Sector.
Cannon was previously a domestic policy analyst for the U.S. Senate Republican Policy Committee, where he advised the Senate leadership on health, education, labor, welfare, and the Second Amendment. He is a member of the Board of Advisers of Harvard Health Policy Review and the Federalist Society Regulatory Transparency Project’s FDA & Health Working Group.
Cannon holds an MA in economics and a JM in law and economics from George Mason University and a BA in American government from the University of Virginia.
Vice Dean for Public Health Practice and Community Engagement, Bloomberg School of Public Health, Johns Hopkins University
Dr. Joshua M. Sharfstein is Vice Dean for Public Health Practice and Community Engagement and Professor of the Practice in Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. He is also the Director of the Bloomberg American Health Initiative. He is the author of the Public Health Crisis Survival Guide: Leadership and Management in Trying Times, and the co-author of The Opioid Epidemic: What Everyone Needs to Know.
Previously, Dr. Sharfstein served as Secretary of the Maryland Department of Health and Mental Hygiene from January 2011 to December 2014. In this position, he led efforts to align Maryland’s health care system with improved health outcomes, culminating in the adoption of a revised payment model for all hospital care for Maryland residents. He also oversaw the development of a statewide health improvement process with 18 local public-private coalitions and the reshaping of state’s approach to health information exchange, long-term care, and behavioral health.
From March 2009 to January 2011, Dr. Sharfstein served as Principal Deputy Commissioner of the U.S. Food and Drug Administration, where he oversaw the agency’s successful performance management and transparency initiatives. From December 2005 to March 2009, as Commissioner of Health for Baltimore City, Dr. Sharfstein led innovative efforts that contributed to major declines in both overdose deaths and infant mortality rates. From July 2001 to December 2005, as minority professional staff and health policy advisor for Congressman Henry A. Waxman, Dr. Sharfstein was engaged in a wide range of oversight and legislative activities on health care topics, including emergency preparedness, HIV, and the politicization of science.
Dr. Sharfstein graduated summa cum laude with an A.B. in Social Studies from Harvard College in 1991. From August 1991 to August 1992, he worked on public health projects in Guatemala and Costa Rica with a Frederick Sheldon Prize Fellowship. He graduated from Harvard Medical School in 1996, from the Boston Combined Residency Program in Pediatrics at Boston Medical Center and Children’s Hospital in 1999, and from the fellowship in general academic pediatrics at the Boston University School of Medicine in 2001.
Dr. Sharfstein is an elected member of the Institute of Medicine (2014) and fellow of the National Academy of Public Administration (2013). He serves on the editorial board of the Journal of the American Medical Association. His awards have included the Jay S. Drotman Memorial Award from the American Public Health Association (1994), Public Official of the Year from Governing Magazine (2008) and the Circle of Commendation Award from the Consumer Product Safety Commission (2013).
Dr. Sharfstein lives with his family in Baltimore, Maryland.
Managing Director, Berkeley Research Group
Dan Troy is the Managing Director at Berkeley Research Group.
Prior to that, he was the Chief Business Officer, Chief Administrative Officer, and General Counsel of Valo in Boston, Massachusetts.
Prior to joining Valo, he served as the Senior Vice President & General Counsel of GlaxoSmithKline and was a member of its Corporate Executive Team. Dan joined GSK in September 2008 and was responsible for leading the company’s legal department in protecting GSK’s intellectual property; managing litigation; supporting business development transactions; and business compliance and risk management. In 2012, Dan led the integration team following the acquisition of Human Genome Sciences, which later resulted in the launch of Benlysta, the first lupus treatment in 50 years. Dan led GSK’s Contributions Committee in the US and also led the Government Affairs, Public Policy and Patient Advocacy team from 2012 until 2014.
Prior to joining GSK, he was a Partner at the Washington law firm Sidley Austin LLP, where he principally represented pharmaceutical companies and trade associations on matters related to the US Food and Drug Administration (FDA) and government regulations. Dan was formerly Chief Counsel for the FDA, where he served as a primary liaison to the White House and the US Department of Health and Human Services.
Dan has chaired the American Bar Association's Section of Administrative Law and is a member of the American Law Institute. He currently chairs the US Chamber of Commerce Litigation Center. He has also chaired the Civil Justice Reform Group, as well as the PhRMA Law Section Executive Committee. He was the 2012 CPR Corporate Leadership Award recipient and, in 2013, was named a 'Legend in the Law' at the Burton Awards.
Dan holds a B.S. in Industrial and Labor Relations from Cornell University and a J.D. from Columbia University School of Law, where he was a member of the Law Review and a Kent Scholar. After graduation from law school, he was a law clerk for the US Circuit Court of Appeals for the District of Columbia Circuit.
Director of Health Policy Studies, Cato Institute
Michael F. Cannon is the Cato Institute’s director of health policy studies. His scholarship spans public health; regulation of clinicians, medical facilities, pharmaceuticals, and medical devices; employer‐sponsored and other private health insurance; Medicare; Medicaid; CHIP; the Veterans Health Administration; medical malpractice litigation; administrative law; international health systems; political philosophy; and more. Cannon is “an influential health‐care wonk” (Washington Post) and “the most famous libertarian health care scholar” (Washington Examiner). Washingtonian magazine named Cannon one of Washington, DC’s “Most Influential People” in 2021, 2022, and 2023.
Cannon has appeared on ABC, Al Jazeera, BBC, CBS, CNN, CNBC, C‑SPAN, Fox News Channel, NPR, and other broadcast media. His articles have appeared in the Wall Street Journal; the New York Times; USA Today; the Washington Post; the Los Angeles Times; SCOTUSBlog; Forum for Health Economics and Policy; JAMA Internal Medicine; Health Matrix: Journal of Law‐Medicine; Harvard Health Policy Review; the Yale Journal of Health Policy, Law, and Ethics; the Journal of Health Politics, Policy and Law; and Quinnipiac Health Law Journal. His latest book is Recovery: A Guide to Reforming the U.S. Health Sector.
Cannon was previously a domestic policy analyst for the U.S. Senate Republican Policy Committee, where he advised the Senate leadership on health, education, labor, welfare, and the Second Amendment. He is a member of the Board of Advisers of Harvard Health Policy Review and the Federalist Society Regulatory Transparency Project’s FDA & Health Working Group.
Cannon holds an MA in economics and a JM in law and economics from George Mason University and a BA in American government from the University of Virginia.
Vice Dean for Public Health Practice and Community Engagement, Bloomberg School of Public Health, Johns Hopkins University
Dr. Joshua M. Sharfstein is Vice Dean for Public Health Practice and Community Engagement and Professor of the Practice in Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. He is also the Director of the Bloomberg American Health Initiative. He is the author of the Public Health Crisis Survival Guide: Leadership and Management in Trying Times, and the co-author of The Opioid Epidemic: What Everyone Needs to Know.
Previously, Dr. Sharfstein served as Secretary of the Maryland Department of Health and Mental Hygiene from January 2011 to December 2014. In this position, he led efforts to align Maryland’s health care system with improved health outcomes, culminating in the adoption of a revised payment model for all hospital care for Maryland residents. He also oversaw the development of a statewide health improvement process with 18 local public-private coalitions and the reshaping of state’s approach to health information exchange, long-term care, and behavioral health.
From March 2009 to January 2011, Dr. Sharfstein served as Principal Deputy Commissioner of the U.S. Food and Drug Administration, where he oversaw the agency’s successful performance management and transparency initiatives. From December 2005 to March 2009, as Commissioner of Health for Baltimore City, Dr. Sharfstein led innovative efforts that contributed to major declines in both overdose deaths and infant mortality rates. From July 2001 to December 2005, as minority professional staff and health policy advisor for Congressman Henry A. Waxman, Dr. Sharfstein was engaged in a wide range of oversight and legislative activities on health care topics, including emergency preparedness, HIV, and the politicization of science.
Dr. Sharfstein graduated summa cum laude with an A.B. in Social Studies from Harvard College in 1991. From August 1991 to August 1992, he worked on public health projects in Guatemala and Costa Rica with a Frederick Sheldon Prize Fellowship. He graduated from Harvard Medical School in 1996, from the Boston Combined Residency Program in Pediatrics at Boston Medical Center and Children’s Hospital in 1999, and from the fellowship in general academic pediatrics at the Boston University School of Medicine in 2001.
Dr. Sharfstein is an elected member of the Institute of Medicine (2014) and fellow of the National Academy of Public Administration (2013). He serves on the editorial board of the Journal of the American Medical Association. His awards have included the Jay S. Drotman Memorial Award from the American Public Health Association (1994), Public Official of the Year from Governing Magazine (2008) and the Circle of Commendation Award from the Consumer Product Safety Commission (2013).
Dr. Sharfstein lives with his family in Baltimore, Maryland.
Managing Director, Berkeley Research Group
Dan Troy is the Managing Director at Berkeley Research Group.
Prior to that, he was the Chief Business Officer, Chief Administrative Officer, and General Counsel of Valo in Boston, Massachusetts.
Prior to joining Valo, he served as the Senior Vice President & General Counsel of GlaxoSmithKline and was a member of its Corporate Executive Team. Dan joined GSK in September 2008 and was responsible for leading the company’s legal department in protecting GSK’s intellectual property; managing litigation; supporting business development transactions; and business compliance and risk management. In 2012, Dan led the integration team following the acquisition of Human Genome Sciences, which later resulted in the launch of Benlysta, the first lupus treatment in 50 years. Dan led GSK’s Contributions Committee in the US and also led the Government Affairs, Public Policy and Patient Advocacy team from 2012 until 2014.
Prior to joining GSK, he was a Partner at the Washington law firm Sidley Austin LLP, where he principally represented pharmaceutical companies and trade associations on matters related to the US Food and Drug Administration (FDA) and government regulations. Dan was formerly Chief Counsel for the FDA, where he served as a primary liaison to the White House and the US Department of Health and Human Services.
Dan has chaired the American Bar Association's Section of Administrative Law and is a member of the American Law Institute. He currently chairs the US Chamber of Commerce Litigation Center. He has also chaired the Civil Justice Reform Group, as well as the PhRMA Law Section Executive Committee. He was the 2012 CPR Corporate Leadership Award recipient and, in 2013, was named a 'Legend in the Law' at the Burton Awards.
Dan holds a B.S. in Industrial and Labor Relations from Cornell University and a J.D. from Columbia University School of Law, where he was a member of the Law Review and a Kent Scholar. After graduation from law school, he was a law clerk for the US Circuit Court of Appeals for the District of Columbia Circuit.
Partner, Balch & Bingham LLP
General Counsel to the Mississippi Manufacturers Association, Pepper Crutcher advises and advocates for a wide range of Southeast U.S., private sector employers. Pepper regularly defends employment litigation, including class and collective actions, and both defends and prosecutes unfair competition claims. Pepper’s labor law practice involves all types of NLRB proceedings, labor contract negotiation and arbitration. Pepper also helps employers, insurers, brokers, administrators and providers achieve Affordable Care Act compliance and appeal ACA tax assessments.
Mr. Crutcher has been rated "AV" by Martindale Hubbell and since 2004 has been selected to be included in Chambers USA America's Leading Lawyers for Business: The Client's Guide (Employment, Mississippi). He is also listed in The Best Lawyers in America for Intellectual Property Law and Labor & Employment Law.
Senior Legal Fellow, the Meese Institute for the Rule of Law, Advancing American Freedom
Paul J. Larkin is a Senior Legal Fellow in the Meese Institute for the Rule of Law at Advancing American Freedom. Paul has held various positions in the federal and state governments throughout his career, such as being an attorney in the Organized Crime and Racketeering Section of the Criminal Division at the U.S. Department of Justice, an Assistant to the Solicitor General in the Office of the Solicitor General at the U.S. Department of Justice, Special Agent-in-Charge and Acting Director of the Criminal Investigation Division at the Environmental Protection Agency, and a member of the Parole Abolition and Sentencing Reform Commission and of the Juvenile Justice Reform Commission in the Office of Virginia Governor George Allen.
He has also worked at Verizon Communications and two law firms in Washington, D.C. His current research is principally in the fields of drug policy, criminal justice policy, and administrative law and policy. He has published numerous articles in law and public policy journals, both in print and online.
J. Larry Stine, a Senior Principal in the Firm and an AV rated attorney, enjoys a diverse practice in which he covers a broad range of labor and employment matters. Larry is the former Region IV Counsel for OSHA in the Office of the Solicitor for the U.S. Department of Labor. He is nationally known for his expertise in Occupational Safety and Health (OSHA), wage and hour laws (including FLSA, DBRA, SCA, and state laws) and the Migrant and Seasonal Agricultural Worker Protection Act (MSPA.) He is co-author of Wage and Hour Law: Compliance and Practice (West Publishing 1995 to date) and Occupational Safety and Health Law: Practice & Compliance (West Publishing 2008 to date).
Providing clients with the information and guidance they need to avoid controversies is Larry’s first line of defense. This role starts with regulatory impact analysis and keeping clients abreast of developments. He also focuses on litigation prevention through counseling, compliance audits and training, and through assisting employers with developing workplace policies and procedures to comport with all State and Federal laws and regulations including those directed at government contractors by the Office of Federal Contract Compliance Programs (OFCCP.) Larry also provides executive leadership and management training, and helps clients design effective systems for personnel management and review.
Larry’s litigation experience includes defending employers against individual, class and collective actions in Federal and State court, before Administrative tribunals, as well as in arbitration and mediation. In OSHA matters, Larry focuses on ensuring that employers do not accept citation items and penalties that are not proper. These skills were on display in his negotiated settlement of the largest OSHA case in history which included approximately 5000 citations.
Larry graduated cum laude from both the University of Georgia and its law school where he was Senior Editor of the Georgia Law Review. He is admitted to practice in Georgia and in U.S. District Courts in Arkansas, Florida, Colorado, Texas and Tennessee, the U.S. Supreme Court, and the 4th, 5th, 6th, 10th, and 11th Circuit Court of Appeals. He is a regular speaker on OSHA and wage & hour issues and former Editor of several trade publications including: Safety & Health Newsletter for Associated Builders & Contractors of Georgia; OSHA Alert for American Furniture Manufacturers Association; OSHA Alert for Georgia Poultry Association; and, Employment and Labor Law Section Newsletter -- Georgia Bar Association.
Partner, Balch & Bingham LLP
General Counsel to the Mississippi Manufacturers Association, Pepper Crutcher advises and advocates for a wide range of Southeast U.S., private sector employers. Pepper regularly defends employment litigation, including class and collective actions, and both defends and prosecutes unfair competition claims. Pepper’s labor law practice involves all types of NLRB proceedings, labor contract negotiation and arbitration. Pepper also helps employers, insurers, brokers, administrators and providers achieve Affordable Care Act compliance and appeal ACA tax assessments.
Mr. Crutcher has been rated "AV" by Martindale Hubbell and since 2004 has been selected to be included in Chambers USA America's Leading Lawyers for Business: The Client's Guide (Employment, Mississippi). He is also listed in The Best Lawyers in America for Intellectual Property Law and Labor & Employment Law.
Senior Legal Fellow, the Meese Institute for the Rule of Law, Advancing American Freedom
Paul J. Larkin is a Senior Legal Fellow in the Meese Institute for the Rule of Law at Advancing American Freedom. Paul has held various positions in the federal and state governments throughout his career, such as being an attorney in the Organized Crime and Racketeering Section of the Criminal Division at the U.S. Department of Justice, an Assistant to the Solicitor General in the Office of the Solicitor General at the U.S. Department of Justice, Special Agent-in-Charge and Acting Director of the Criminal Investigation Division at the Environmental Protection Agency, and a member of the Parole Abolition and Sentencing Reform Commission and of the Juvenile Justice Reform Commission in the Office of Virginia Governor George Allen.
He has also worked at Verizon Communications and two law firms in Washington, D.C. His current research is principally in the fields of drug policy, criminal justice policy, and administrative law and policy. He has published numerous articles in law and public policy journals, both in print and online.
J. Larry Stine, a Senior Principal in the Firm and an AV rated attorney, enjoys a diverse practice in which he covers a broad range of labor and employment matters. Larry is the former Region IV Counsel for OSHA in the Office of the Solicitor for the U.S. Department of Labor. He is nationally known for his expertise in Occupational Safety and Health (OSHA), wage and hour laws (including FLSA, DBRA, SCA, and state laws) and the Migrant and Seasonal Agricultural Worker Protection Act (MSPA.) He is co-author of Wage and Hour Law: Compliance and Practice (West Publishing 1995 to date) and Occupational Safety and Health Law: Practice & Compliance (West Publishing 2008 to date).
Providing clients with the information and guidance they need to avoid controversies is Larry’s first line of defense. This role starts with regulatory impact analysis and keeping clients abreast of developments. He also focuses on litigation prevention through counseling, compliance audits and training, and through assisting employers with developing workplace policies and procedures to comport with all State and Federal laws and regulations including those directed at government contractors by the Office of Federal Contract Compliance Programs (OFCCP.) Larry also provides executive leadership and management training, and helps clients design effective systems for personnel management and review.
Larry’s litigation experience includes defending employers against individual, class and collective actions in Federal and State court, before Administrative tribunals, as well as in arbitration and mediation. In OSHA matters, Larry focuses on ensuring that employers do not accept citation items and penalties that are not proper. These skills were on display in his negotiated settlement of the largest OSHA case in history which included approximately 5000 citations.
Larry graduated cum laude from both the University of Georgia and its law school where he was Senior Editor of the Georgia Law Review. He is admitted to practice in Georgia and in U.S. District Courts in Arkansas, Florida, Colorado, Texas and Tennessee, the U.S. Supreme Court, and the 4th, 5th, 6th, 10th, and 11th Circuit Court of Appeals. He is a regular speaker on OSHA and wage & hour issues and former Editor of several trade publications including: Safety & Health Newsletter for Associated Builders & Contractors of Georgia; OSHA Alert for American Furniture Manufacturers Association; OSHA Alert for Georgia Poultry Association; and, Employment and Labor Law Section Newsletter -- Georgia Bar Association.
Distinguished Fellow, Foundation for Applied Molecular Evolution
Steven Benner heads the Foundation for Applied Molecular Evolution, which he founded after serving on the faculty at Harvard, ETH Zurich, and University of Florida. His research combines two traditions in science, one from natural history, the other from the physical sciences. In His laboratory has been a leader in the field of synthetic biology, where it has redesigned DNA to better understand how these molecules work, generate new classes of diagnostics tools, and to open new avenues to disease therapy. Separately, he also created the field of paleogenetics, where genes and proteins from now-extinct organisms are sesurrected to better understand how those proteins functioned in those organisms in changing environments. He has founded or contributed technology to a dozen different biotechnology companies, whose products include those that personalize the care of HIV, hepatitis B and hepatitis C patients, detect insect-borne pathogens, and monitor COVID. The work also guides NASA missions to see alien life and how life originated. His most recent book is: "Life, the Universe, and the Scientific Method."
James A. Attwood and Leslie Williams Professor of Law, Deputy Dean, and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School
Prof. Cohen is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Professor Cohen has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues.
He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34), though not the youngest in history.
Prof. Cohen's current projects relate to big data, medical AI, health information technologies, mobile health, reproduction/reproductive technology, research ethics, organ transplantation, rationing in law and medicine, health policy, FDA law, COVID-19, translational medicine, and to medical tourism – the travel of patients who are residents of one country, the "home country," to another country, the "destination country," for medical treatment.
He is the author of more than 200 articles and chapters and his award-winning work has appeared in leading legal (including the Stanford, Cornell, and Southern California Law Reviews), medical (including the New England Journal of Medicine, JAMA), bioethics (including the American Journal of Bioethics, the Hastings Center Report), scientific (Science, Cell, Nature Reviews Genetics) and public health (the American Journal of Public Health) journals, as well as Op-Eds in the New York Times, Washington Post, New Republic, Time Magazine, and other venues.
Cohen is the author, co-author, editor, or co-editor of more than 18 books. They include: Consumer Genetic Technologies: Ethical and Legal Considerations (Cambridge University Press, 2021); Reproductive Technologies and the Law (Caroline Academic Press, 2021); Readings in Comparative Health Law and Bioethics (Carolina Academic Press, 2020); Disability, Health, Law, and Bioethics (Cambridge University Press, 2020); Transparency in Health and Health Care in the United States (Cambridge University Press, 2019); Health Care Law and Ethics (Aspen, 2018); Big Data, Health Law, and Bioethics (Cambridge University Press, 2018); Law, Religion, and Health in the United States (Cambridge University Press, 2017); Specimen Science (MIT Press, 2017); Nudging Health: Health Law and Behavioral Economics (John Hopkins University Press, 2016) The Oxford Handbook of U.S. Health Care Law (Oxford University Press, 2016); FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015); Identified Versus Statistical Lives: An Interdisciplinary Perspective (Oxford University Press, 2015); Patients with Passports: Medical Tourism, Law, and Ethics (Oxford University Press, 2014); Human Subjects Research Regulation: Perspectives on the Future (MIT Press, 2014); The Globalization of Health Care: Legal and Ethical Issues (Oxford University Press, 2013).
For his law school teaching he was awarded the HLS Student Government Teaching and Advising Award in 2017. He also sometimes teaches courses at Harvard College and Harvard Medical School. For the public he created the free online Harvard X class Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics, which was nominated by Harvard for the Japan Prize. More than 97,000 students have taken the course so far. You can also watch his Tedx talk, Are There Non-Human Persons? Are There Non-Person Humans? He is also the faculty lead on Zero-L, an online course to help law students transition to law school that is now being used by more than half of all U.S. law schools.
Prior to becoming a professor he served as a law clerk to Judge Michael Boudin of the U.S. Court of Appeals for the First Circuit and as a lawyer for U.S. Department of Justice, Civil Division, Appellate Staff, where he handled litigation in the Courts of Appeals and (in conjunction with the Solicitor General’s Office) in the U.S. Supreme Court. In his spare time (where he can find any!) he still litigates, having authored an amicus brief in the U.S. Supreme Court for leading gene scientist Eric Lander in Association of Molecular Pathology v. Myriad, concerning whether human genes are patent eligible subject matter, a brief that was extensively discussed by the Justices at oral argument. Most recently he submitted an amicus brief to the U.S. Supreme Court in Whole Women's Health v. Hellerstedt (the Texas abortion case, on behalf of himself, Melissa Murray, and B. Jessie Hill).
Cohen was selected as a Radcliffe Institute Fellow for the 2012-2013 year and by the Greenwall Foundation to receive a Faculty Scholar Award in Bioethics. He is also a Fellow at the Hastings Center, the leading bioethics think tank in the United States as well as being a fellow of the Pierre Elliot Trudeau Foundation. He leads the Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL), which is part of the larger Centre for Advanced Studies in Biomedical Innovation Law (CeBIL). He co-leads the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center program. He is also the lead on the Project on Psychedelics Law and Regulation (POPLAR). He previously served as one of the key co-investigators on the multi-million dollar Football Players Health Study at Harvard which is committed to improving the health of NFL players (for more on this work click here). He is also one of three editors-in-chief of the Journal of Law and the Biosciences, a peer-reviewed journal published by Oxford University Press and serves on the editorial board for the American Journal of Bioethics. He served on the Steering Committee for Ethics for the Canadian Institutes of Health Research (CIHR), the Canadian counterpart to the NIH, and the Ethics Committee for the American College of Obstetricians and Gynecologists (ACOG). He currently serves on the Ethics Committee of the U.S. Organ Procurement and Transplantation Network (OPTN).
You can freely download his work here, and follow him on twitter @CohenProf.
Judge, United States Court of Appeals, Ninth Circuit
Kenneth Kiyul Lee is a judge on the U.S. Court of Appeals for the Ninth Circuit. He was appointed in June 2019 and is based in San Diego, California.
Prior to his appointment, he was a partner at the law firm of Jenner & Block in Los Angeles. Judge Lee previously served as an Associate Counsel to President George W. Bush and as Special Counsel to Senator Arlen Specter, then-chair of the Senate Judiciary Committee. He started his legal career at Wachtell, Lipton, Rosen & Katz in New York.
Judge Lee received his J.D. from Harvard Law School, magna cum laude, and his A.B. from Cornell University, summa cum laude. He clerked for Judge Emilio M. Garza of the U.S. Court of Appeals for the Fifth Circuit.
Executive Vice President, Goldwater Institute
Christina Sandefur is the Executive Vice President at the Goldwater Institute. She develops policies and litigates cases advancing healthcare freedom, free enterprise, private property rights, free speech, and taxpayer rights.
Christina is a co-drafter of the Right to Try initiative, now federal law, which protects terminally ill patients' right to try safe investigational treatments that have been prescribed by their physician but are not yet FDA-approved. She has won important victories for property rights in Arizona and works nationally to promote the Institute's Private Property Rights Protection Act, a state-level reform that requires government to pay owners when regulations destroy property rights and reduce property values.
Christina is the co-author of the book Cornerstone of Liberty: Private Property Rights in 21st Century America (2016). She is a frequent guest on national television and radio programs, has provided expert legal testimony to various legislative committees, and is a frequent speaker at conferences. She is the recipient of the 2018 Buckley Award in recognition of her leadership in the freedom movement, and she is an Advisory Board Member of the Network of enlightened Women. Christina serves on the board of the Phoenix Lawyers Chapter of the Federalist Society and is a member of the executive committee for the Federalist Society's Regulatory Transparency Project: FDA & Health.
Christina is a graduate of Michigan State University College of Law and Hillsdale College.
Distinguished Fellow, Foundation for Applied Molecular Evolution
Steven Benner heads the Foundation for Applied Molecular Evolution, which he founded after serving on the faculty at Harvard, ETH Zurich, and University of Florida. His research combines two traditions in science, one from natural history, the other from the physical sciences. In His laboratory has been a leader in the field of synthetic biology, where it has redesigned DNA to better understand how these molecules work, generate new classes of diagnostics tools, and to open new avenues to disease therapy. Separately, he also created the field of paleogenetics, where genes and proteins from now-extinct organisms are sesurrected to better understand how those proteins functioned in those organisms in changing environments. He has founded or contributed technology to a dozen different biotechnology companies, whose products include those that personalize the care of HIV, hepatitis B and hepatitis C patients, detect insect-borne pathogens, and monitor COVID. The work also guides NASA missions to see alien life and how life originated. His most recent book is: "Life, the Universe, and the Scientific Method."
James A. Attwood and Leslie Williams Professor of Law, Deputy Dean, and Faculty Director, Petrie-Flom Center for Health Law Policy, Biotechnology & Bioethics, Harvard Law School
Prof. Cohen is one of the world's leading experts on the intersection of bioethics (sometimes also called "medical ethics") and the law, as well as health law. He also teaches civil procedure. From Seoul to Krakow to Vancouver, Professor Cohen has spoken at legal, medical, and industry conferences around the world and his work has appeared in or been covered on PBS, NPR, ABC, CNN, MSNBC, Mother Jones, the New York Times, the New Republic, the Boston Globe, and several other media venues.
He was the youngest professor on the faculty at Harvard Law School (tenured or untenured) both when he joined the faculty in 2008 (at age 29) and when he was tenured as a full professor in 2013 (at age 34), though not the youngest in history.
Prof. Cohen's current projects relate to big data, medical AI, health information technologies, mobile health, reproduction/reproductive technology, research ethics, organ transplantation, rationing in law and medicine, health policy, FDA law, COVID-19, translational medicine, and to medical tourism – the travel of patients who are residents of one country, the "home country," to another country, the "destination country," for medical treatment.
He is the author of more than 200 articles and chapters and his award-winning work has appeared in leading legal (including the Stanford, Cornell, and Southern California Law Reviews), medical (including the New England Journal of Medicine, JAMA), bioethics (including the American Journal of Bioethics, the Hastings Center Report), scientific (Science, Cell, Nature Reviews Genetics) and public health (the American Journal of Public Health) journals, as well as Op-Eds in the New York Times, Washington Post, New Republic, Time Magazine, and other venues.
Cohen is the author, co-author, editor, or co-editor of more than 18 books. They include: Consumer Genetic Technologies: Ethical and Legal Considerations (Cambridge University Press, 2021); Reproductive Technologies and the Law (Caroline Academic Press, 2021); Readings in Comparative Health Law and Bioethics (Carolina Academic Press, 2020); Disability, Health, Law, and Bioethics (Cambridge University Press, 2020); Transparency in Health and Health Care in the United States (Cambridge University Press, 2019); Health Care Law and Ethics (Aspen, 2018); Big Data, Health Law, and Bioethics (Cambridge University Press, 2018); Law, Religion, and Health in the United States (Cambridge University Press, 2017); Specimen Science (MIT Press, 2017); Nudging Health: Health Law and Behavioral Economics (John Hopkins University Press, 2016) The Oxford Handbook of U.S. Health Care Law (Oxford University Press, 2016); FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies (Columbia University Press, 2015); Identified Versus Statistical Lives: An Interdisciplinary Perspective (Oxford University Press, 2015); Patients with Passports: Medical Tourism, Law, and Ethics (Oxford University Press, 2014); Human Subjects Research Regulation: Perspectives on the Future (MIT Press, 2014); The Globalization of Health Care: Legal and Ethical Issues (Oxford University Press, 2013).
For his law school teaching he was awarded the HLS Student Government Teaching and Advising Award in 2017. He also sometimes teaches courses at Harvard College and Harvard Medical School. For the public he created the free online Harvard X class Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics, which was nominated by Harvard for the Japan Prize. More than 97,000 students have taken the course so far. You can also watch his Tedx talk, Are There Non-Human Persons? Are There Non-Person Humans? He is also the faculty lead on Zero-L, an online course to help law students transition to law school that is now being used by more than half of all U.S. law schools.
Prior to becoming a professor he served as a law clerk to Judge Michael Boudin of the U.S. Court of Appeals for the First Circuit and as a lawyer for U.S. Department of Justice, Civil Division, Appellate Staff, where he handled litigation in the Courts of Appeals and (in conjunction with the Solicitor General’s Office) in the U.S. Supreme Court. In his spare time (where he can find any!) he still litigates, having authored an amicus brief in the U.S. Supreme Court for leading gene scientist Eric Lander in Association of Molecular Pathology v. Myriad, concerning whether human genes are patent eligible subject matter, a brief that was extensively discussed by the Justices at oral argument. Most recently he submitted an amicus brief to the U.S. Supreme Court in Whole Women's Health v. Hellerstedt (the Texas abortion case, on behalf of himself, Melissa Murray, and B. Jessie Hill).
Cohen was selected as a Radcliffe Institute Fellow for the 2012-2013 year and by the Greenwall Foundation to receive a Faculty Scholar Award in Bioethics. He is also a Fellow at the Hastings Center, the leading bioethics think tank in the United States as well as being a fellow of the Pierre Elliot Trudeau Foundation. He leads the Project on Precision Medicine, Artificial Intelligence, and the Law (PMAIL), which is part of the larger Centre for Advanced Studies in Biomedical Innovation Law (CeBIL). He co-leads the Regulatory Foundations, Ethics, and Law Program of Harvard Catalyst | The Harvard Clinical and Translational Science Center program. He is also the lead on the Project on Psychedelics Law and Regulation (POPLAR). He previously served as one of the key co-investigators on the multi-million dollar Football Players Health Study at Harvard which is committed to improving the health of NFL players (for more on this work click here). He is also one of three editors-in-chief of the Journal of Law and the Biosciences, a peer-reviewed journal published by Oxford University Press and serves on the editorial board for the American Journal of Bioethics. He served on the Steering Committee for Ethics for the Canadian Institutes of Health Research (CIHR), the Canadian counterpart to the NIH, and the Ethics Committee for the American College of Obstetricians and Gynecologists (ACOG). He currently serves on the Ethics Committee of the U.S. Organ Procurement and Transplantation Network (OPTN).
You can freely download his work here, and follow him on twitter @CohenProf.
Judge, United States Court of Appeals, Ninth Circuit
Kenneth Kiyul Lee is a judge on the U.S. Court of Appeals for the Ninth Circuit. He was appointed in June 2019 and is based in San Diego, California.
Prior to his appointment, he was a partner at the law firm of Jenner & Block in Los Angeles. Judge Lee previously served as an Associate Counsel to President George W. Bush and as Special Counsel to Senator Arlen Specter, then-chair of the Senate Judiciary Committee. He started his legal career at Wachtell, Lipton, Rosen & Katz in New York.
Judge Lee received his J.D. from Harvard Law School, magna cum laude, and his A.B. from Cornell University, summa cum laude. He clerked for Judge Emilio M. Garza of the U.S. Court of Appeals for the Fifth Circuit.
Executive Vice President, Goldwater Institute
Christina Sandefur is the Executive Vice President at the Goldwater Institute. She develops policies and litigates cases advancing healthcare freedom, free enterprise, private property rights, free speech, and taxpayer rights.
Christina is a co-drafter of the Right to Try initiative, now federal law, which protects terminally ill patients' right to try safe investigational treatments that have been prescribed by their physician but are not yet FDA-approved. She has won important victories for property rights in Arizona and works nationally to promote the Institute's Private Property Rights Protection Act, a state-level reform that requires government to pay owners when regulations destroy property rights and reduce property values.
Christina is the co-author of the book Cornerstone of Liberty: Private Property Rights in 21st Century America (2016). She is a frequent guest on national television and radio programs, has provided expert legal testimony to various legislative committees, and is a frequent speaker at conferences. She is the recipient of the 2018 Buckley Award in recognition of her leadership in the freedom movement, and she is an Advisory Board Member of the Network of enlightened Women. Christina serves on the board of the Phoenix Lawyers Chapter of the Federalist Society and is a member of the executive committee for the Federalist Society's Regulatory Transparency Project: FDA & Health.
Christina is a graduate of Michigan State University College of Law and Hillsdale College.
Director of Health Policy Studies, Cato Institute
Michael F. Cannon is the Cato Institute’s director of health policy studies. His scholarship spans public health; regulation of clinicians, medical facilities, pharmaceuticals, and medical devices; employer‐sponsored and other private health insurance; Medicare; Medicaid; CHIP; the Veterans Health Administration; medical malpractice litigation; administrative law; international health systems; political philosophy; and more. Cannon is “an influential health‐care wonk” (Washington Post) and “the most famous libertarian health care scholar” (Washington Examiner). Washingtonian magazine named Cannon one of Washington, DC’s “Most Influential People” in 2021, 2022, and 2023.
Cannon has appeared on ABC, Al Jazeera, BBC, CBS, CNN, CNBC, C‑SPAN, Fox News Channel, NPR, and other broadcast media. His articles have appeared in the Wall Street Journal; the New York Times; USA Today; the Washington Post; the Los Angeles Times; SCOTUSBlog; Forum for Health Economics and Policy; JAMA Internal Medicine; Health Matrix: Journal of Law‐Medicine; Harvard Health Policy Review; the Yale Journal of Health Policy, Law, and Ethics; the Journal of Health Politics, Policy and Law; and Quinnipiac Health Law Journal. His latest book is Recovery: A Guide to Reforming the U.S. Health Sector.
Cannon was previously a domestic policy analyst for the U.S. Senate Republican Policy Committee, where he advised the Senate leadership on health, education, labor, welfare, and the Second Amendment. He is a member of the Board of Advisers of Harvard Health Policy Review and the Federalist Society Regulatory Transparency Project’s FDA & Health Working Group.
Cannon holds an MA in economics and a JM in law and economics from George Mason University and a BA in American government from the University of Virginia.
Vice Dean for Public Health Practice and Community Engagement, Bloomberg School of Public Health, Johns Hopkins University
Dr. Joshua M. Sharfstein is Vice Dean for Public Health Practice and Community Engagement and Professor of the Practice in Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. He is also the Director of the Bloomberg American Health Initiative. He is the author of the Public Health Crisis Survival Guide: Leadership and Management in Trying Times, and the co-author of The Opioid Epidemic: What Everyone Needs to Know.
Previously, Dr. Sharfstein served as Secretary of the Maryland Department of Health and Mental Hygiene from January 2011 to December 2014. In this position, he led efforts to align Maryland’s health care system with improved health outcomes, culminating in the adoption of a revised payment model for all hospital care for Maryland residents. He also oversaw the development of a statewide health improvement process with 18 local public-private coalitions and the reshaping of state’s approach to health information exchange, long-term care, and behavioral health.
From March 2009 to January 2011, Dr. Sharfstein served as Principal Deputy Commissioner of the U.S. Food and Drug Administration, where he oversaw the agency’s successful performance management and transparency initiatives. From December 2005 to March 2009, as Commissioner of Health for Baltimore City, Dr. Sharfstein led innovative efforts that contributed to major declines in both overdose deaths and infant mortality rates. From July 2001 to December 2005, as minority professional staff and health policy advisor for Congressman Henry A. Waxman, Dr. Sharfstein was engaged in a wide range of oversight and legislative activities on health care topics, including emergency preparedness, HIV, and the politicization of science.
Dr. Sharfstein graduated summa cum laude with an A.B. in Social Studies from Harvard College in 1991. From August 1991 to August 1992, he worked on public health projects in Guatemala and Costa Rica with a Frederick Sheldon Prize Fellowship. He graduated from Harvard Medical School in 1996, from the Boston Combined Residency Program in Pediatrics at Boston Medical Center and Children’s Hospital in 1999, and from the fellowship in general academic pediatrics at the Boston University School of Medicine in 2001.
Dr. Sharfstein is an elected member of the Institute of Medicine (2014) and fellow of the National Academy of Public Administration (2013). He serves on the editorial board of the Journal of the American Medical Association. His awards have included the Jay S. Drotman Memorial Award from the American Public Health Association (1994), Public Official of the Year from Governing Magazine (2008) and the Circle of Commendation Award from the Consumer Product Safety Commission (2013).
Dr. Sharfstein lives with his family in Baltimore, Maryland.
Managing Director, Berkeley Research Group
Dan Troy is the Managing Director at Berkeley Research Group.
Prior to that, he was the Chief Business Officer, Chief Administrative Officer, and General Counsel of Valo in Boston, Massachusetts.
Prior to joining Valo, he served as the Senior Vice President & General Counsel of GlaxoSmithKline and was a member of its Corporate Executive Team. Dan joined GSK in September 2008 and was responsible for leading the company’s legal department in protecting GSK’s intellectual property; managing litigation; supporting business development transactions; and business compliance and risk management. In 2012, Dan led the integration team following the acquisition of Human Genome Sciences, which later resulted in the launch of Benlysta, the first lupus treatment in 50 years. Dan led GSK’s Contributions Committee in the US and also led the Government Affairs, Public Policy and Patient Advocacy team from 2012 until 2014.
Prior to joining GSK, he was a Partner at the Washington law firm Sidley Austin LLP, where he principally represented pharmaceutical companies and trade associations on matters related to the US Food and Drug Administration (FDA) and government regulations. Dan was formerly Chief Counsel for the FDA, where he served as a primary liaison to the White House and the US Department of Health and Human Services.
Dan has chaired the American Bar Association's Section of Administrative Law and is a member of the American Law Institute. He currently chairs the US Chamber of Commerce Litigation Center. He has also chaired the Civil Justice Reform Group, as well as the PhRMA Law Section Executive Committee. He was the 2012 CPR Corporate Leadership Award recipient and, in 2013, was named a 'Legend in the Law' at the Burton Awards.
Dan holds a B.S. in Industrial and Labor Relations from Cornell University and a J.D. from Columbia University School of Law, where he was a member of the Law Review and a Kent Scholar. After graduation from law school, he was a law clerk for the US Circuit Court of Appeals for the District of Columbia Circuit.
Partner, Balch & Bingham LLP
General Counsel to the Mississippi Manufacturers Association, Pepper Crutcher advises and advocates for a wide range of Southeast U.S., private sector employers. Pepper regularly defends employment litigation, including class and collective actions, and both defends and prosecutes unfair competition claims. Pepper’s labor law practice involves all types of NLRB proceedings, labor contract negotiation and arbitration. Pepper also helps employers, insurers, brokers, administrators and providers achieve Affordable Care Act compliance and appeal ACA tax assessments.
Mr. Crutcher has been rated "AV" by Martindale Hubbell and since 2004 has been selected to be included in Chambers USA America's Leading Lawyers for Business: The Client's Guide (Employment, Mississippi). He is also listed in The Best Lawyers in America for Intellectual Property Law and Labor & Employment Law.
Senior Legal Fellow, the Meese Institute for the Rule of Law, Advancing American Freedom
Paul J. Larkin is a Senior Legal Fellow in the Meese Institute for the Rule of Law at Advancing American Freedom. Paul has held various positions in the federal and state governments throughout his career, such as being an attorney in the Organized Crime and Racketeering Section of the Criminal Division at the U.S. Department of Justice, an Assistant to the Solicitor General in the Office of the Solicitor General at the U.S. Department of Justice, Special Agent-in-Charge and Acting Director of the Criminal Investigation Division at the Environmental Protection Agency, and a member of the Parole Abolition and Sentencing Reform Commission and of the Juvenile Justice Reform Commission in the Office of Virginia Governor George Allen.
He has also worked at Verizon Communications and two law firms in Washington, D.C. His current research is principally in the fields of drug policy, criminal justice policy, and administrative law and policy. He has published numerous articles in law and public policy journals, both in print and online.
J. Larry Stine, a Senior Principal in the Firm and an AV rated attorney, enjoys a diverse practice in which he covers a broad range of labor and employment matters. Larry is the former Region IV Counsel for OSHA in the Office of the Solicitor for the U.S. Department of Labor. He is nationally known for his expertise in Occupational Safety and Health (OSHA), wage and hour laws (including FLSA, DBRA, SCA, and state laws) and the Migrant and Seasonal Agricultural Worker Protection Act (MSPA.) He is co-author of Wage and Hour Law: Compliance and Practice (West Publishing 1995 to date) and Occupational Safety and Health Law: Practice & Compliance (West Publishing 2008 to date).
Providing clients with the information and guidance they need to avoid controversies is Larry’s first line of defense. This role starts with regulatory impact analysis and keeping clients abreast of developments. He also focuses on litigation prevention through counseling, compliance audits and training, and through assisting employers with developing workplace policies and procedures to comport with all State and Federal laws and regulations including those directed at government contractors by the Office of Federal Contract Compliance Programs (OFCCP.) Larry also provides executive leadership and management training, and helps clients design effective systems for personnel management and review.
Larry’s litigation experience includes defending employers against individual, class and collective actions in Federal and State court, before Administrative tribunals, as well as in arbitration and mediation. In OSHA matters, Larry focuses on ensuring that employers do not accept citation items and penalties that are not proper. These skills were on display in his negotiated settlement of the largest OSHA case in history which included approximately 5000 citations.
Larry graduated cum laude from both the University of Georgia and its law school where he was Senior Editor of the Georgia Law Review. He is admitted to practice in Georgia and in U.S. District Courts in Arkansas, Florida, Colorado, Texas and Tennessee, the U.S. Supreme Court, and the 4th, 5th, 6th, 10th, and 11th Circuit Court of Appeals. He is a regular speaker on OSHA and wage & hour issues and former Editor of several trade publications including: Safety & Health Newsletter for Associated Builders & Contractors of Georgia; OSHA Alert for American Furniture Manufacturers Association; OSHA Alert for Georgia Poultry Association; and, Employment and Labor Law Section Newsletter -- Georgia Bar Association.
Deep Dive Episode 209 – Who Should Decide Whether Drugs Are Available Over-The-Counter or by Prescription?
Michael F. Cannon, Joshua Sharfstein, Dan Troy
In October 2020, Michael Cannon and Jeffrey Singer proposed ending the U.S. Food and Drug...
Who Should Decide Whether Drugs Are Available Over-The-Counter or by Prescription?
Michael F. Cannon, Joshua Sharfstein, Dan Troy
In October 2020, Michael Cannon and Jeffrey Singer proposed ending the U.S. Food and Drug...
Who Should Decide Whether Drugs Are Available Over-The-Counter or by Prescription?
TeleforumBodily Autonomy and Individual Rights; Subtitle: Showcase Panel IV: Law, Science, and Public Policy
Last month, I spoke on a panel at the Federalist Society’s National Lawyers Conference about...
Topics
Jacobson v. Massachusetts Lends Questionable Support to Covid-19 Executive Orders Imposing Criminal Penalties for Non-Compliance
Across the nation, in response to the Covid-19 virus, state and local leaders have issued...
Litigation Update: the OSHA Vaccine Mandate
R. Pepper Crutcher, Paul James Larkin, Larry Stine
Late in 2020, several pharmaceutical companies developed vaccines for Covid-19 that received FDA approval, first...
Litigation Update: the OSHA Vaccine Mandate
R. Pepper Crutcher, Paul James Larkin, Larry Stine
Late in 2020, several pharmaceutical companies developed vaccines for Covid-19 that received FDA approval, first...
Litigation Update: the OSHA Vaccine Mandate
TeleforumShowcase Panel IV: Law, Science, and Public Policy
Steven A. Benner, I. Glenn Cohen, Kenneth Kiyul Lee, Christina Sandefur
The 2021 National Lawyers Convention took place November 11-13, 2021 at the Mayflower Hotel in...
Showcase Panel IV: Law, Science, and Public Policy
Steven A. Benner, I. Glenn Cohen, Kenneth Kiyul Lee, Christina Sandefur
The 2021 National Lawyers Convention took place November 11-13, 2021 at the Mayflower Hotel in...