Associate Professor of Law, Center for Intellectual Property and Entrepreneurship, University of Missouri School of Law
Professor Lietzan researches, writes, and teaches primarily in the areas of food and drug regulation, intellectual property, and administrative law. Some of her recent scholarship has focused on the nature and purpose of the new drug approval system, federal regulation of fecal microbiota transplantation, federal regulation of products derived from cannabis, the political economy of the Hatch-Waxman (generic drug) statute, and incentives to study already approved drugs for new uses. She is an award-winning teacher, and she has been an elected member of the American Law Institute since 2006.
Professor Lietzan brings to her scholarship and teaching eighteen years of private practice experience, eight of them as a partner in the food and drug group at Covington & Burling in Washington, DC. In practice, she handled a wide range of complex legal problems and broader legislative and regulatory policy questions affecting FDA-regulated companies. This work included lifecycle management and strategy issues, regulatory strategy and advocacy, white collar defense, congressional investigations, briefing in products liability cases, and international regulatory policy work. She was involved in every major amendment to the Federal Food, Drug, and Cosmetic Act (FDCA) between 1997 and 2014 and was deeply immersed for more than a decade in the development of the Biologics Price Competition and Innovation Act of 2010. She has been consistently identified by her peers in private practice as a “Best Lawyer in America” in the categories of FDA law (since 2013) and Biotechnology Law (since 2007).
Professor Lietzan has held one leadership position or another at the Food and Drug Law Institute (FDLI) since 2004, including a stint on its Board of Directors from 2008 to 2012. She also held leadership positions in the American Bar Association’s Section of Science and Technology Law for fourteen years.
Professor Lietzan received a bachelor’s degree from the University of North Carolina, where she graduated with honors in history. She holds a master’s degree in history from UCLA and a law degree with high honors from Duke Law School.
Vice President, Edwin Meese III Institute for the Rule of Law, Advancing American Freedom
John G. Malcolm oversees Advancing American Freedom’s work to increase understanding of the Constitution and the rule of law as Vice President of the organization’s Edwin Meese III Institute for the Rule of Law. Malcolm brings to the challenge a wealth of legal expertise and experience in both the public and private sectors.
Prior to joining Advancing American Freedom in 2025, Malcolm was the Vice President of the Institute for Constitutional Government and the Director of the Meese Center for Legal and Judicial Studies at the Heritage Foundation. Prior to joining Heritage in 2012, Malcolm was general counsel at the U.S. Commission on International Religious Freedom, as well as a distinguished practitioner in residence at Pepperdine Law School. From 2004 to 2009, Malcolm was executive vice president and director of worldwide anti-piracy operations for the Motion Picture Association.
Malcolm served as a deputy assistant attorney general in the Department of Justice’s Criminal Division from 2001 to 2004, where he oversaw sections on computer crime and intellectual property, domestic security, child exploitation and obscenity, and special investigations. Immediately prior to that, he was a founding partner in the Atlanta law firm of Malcolm & Schroeder, LLP.
From 1990 to 1997, Malcolm was an assistant U.S. attorney in Atlanta, assigned to the fraud and public corruption section, and also an associate independent counsel, investigating fraud and abuse in the Department of Housing and Urban Development. He was honored with the Director’s Award for Superior Performance for his work in connection with the successful prosecution of Walter Leroy Moody Jr., who assassinated an 11th Circuit judge and the head of the Savannah chapter of the NAACP.
A graduate of Harvard Law School and Columbia College, Malcolm began his career as a law clerk to a federal district court judge and a federal appellate court judge, and as an associate at the Atlanta-based law firm of Sutherland, Asbill & Brennan (new Eversheds Sutherland).
Malcolm, who resides in Washington, D.C., serves on the Board of Trustees of the Washington National Opera and is a Senate-confirmed member of the Board of Directors of the Legal Services Corporation, the largest funder of civil legal aid in the United States.
Attorney Specializing in Government Relations
Alec D. Rogers is an attorney specializing in government practice and policy in Washington, DC.
A graduate of James Madison College at Michigan State University and the University of Michigan Law School, he practiced law for several years before spending over a decade on Capitol Hill as a staffer to various Members and Committees.
He has reviewed books for the Washington Times, Hardball Times, The Journal of the American Revolution, and The Weekly Standard, and writes on legal matters in Engage, an online publication of the Federalist Society.
John W. Wade Professor of Law, Pepperdine University School of Law
Richard L. Cupp, Jr. serves as the John W. Wade Professor of Law at Pepperdine Law School. He loves teaching and working with students. He is widely recognized as a leading scholar and commentator in the fields of torts and products liability law. He has authored more than 20 significant scholarly articles and numerous shorter articles. Professor Cupp is an elected member of the American Law Institute, and he has served as chair of the Association of American Law Schools Section on Torts and Compensation Systems.
In addition to his work in torts and products liability, Professor Cupp writes and speaks extensively about the legal and moral status of animals. He has advised many organizations on these subjects, including the National Academy of Sciences Committee on Science, Technology and Law, the National Academy of Sciences Committee on Neuroscience, the American Veterinary Medical Association, the National Association for Biomedical Research, the Animal Health Institute, and the American Animal Hospital Association.
President and Founder, JKC Consulting LLC
John Kneuer is the President and Founder of JKC Consulting LLC. He sits on multiple public and private company boards.
Prior to starting Kneuer LLC, Mr. Kneuer served as the Assistant Secretary of Commerce for Communications and Information. In this capacity Mr. Kneuer was the principal advisor to the President of the United States on telecommunications policy and the Administrator of the National Telecommunications and Information Administration ("NTIA").In addition to representing the Executive Branch in domestic and international telecommunications and information policy activities, NTIA also manages the federal use of spectrum; performs cutting edge telecommunications research and engineering, including resolving technical telecommunications issues for the federal government and private sector; and administers infrastructure and public telecommunications facilities grants.
Prior to his service at NTIA, Mr. Kneuer served as a Senior Associate at the law firm of Piper Rudnick in Washington, D.C., providing regulatory and legislative representation to corporate clients in the telecommunications, defense, and transportation industries. Earlier in his career, Mr. Kneuer served as the Executive Director for Government Relations at the Industrial Telecommunications Association, and prior to that served as an Attorney-Advisor in the Commercial Wireless Division of the Federal Communications Commission's Wireless Bureau. Mr. Kneuer received B.A. and J.D. degrees from the Catholic University of America.
Senior Policy Director, Mobile Future
Rachael Bender is Senior Policy Director for Mobile Future, where she focuses on issues involving wireless technology, broadband, and spectrum. Prior to joining Mobile Future in 2011, Ms. Bender was a law clerk in the Department of Regulatory Affairs at CTIA – The Wireless Association. Ms. Bender graduated from the University of Maryland with a B.A. in Government & Politics, and from the Catholic University of America Columbus School of Law with a J.D. and certificate from the Institute for Communications Law Studies. During law school, she served as president of the Communications Law Student Association and competed in the National Telecommunications Moot Court Competition, for which she also served as Vice Chancellor during her third year. She is a member of the Pennsylvania and New Jersey Bars.
Legal Fellow, Center for the Separation of Powers, Pacific Legal Foundation
Alison Somin joined Pacific Legal Foundation in May 2020 as a legal fellow in the Center for the Separation of Powers and part of the equality before the law practice group.
Before joining the Pacific Legal Foundation team, Alison was a special assistant and counsel for over a decade to Gail Heriot, a member of the bipartisan United States Commission on Civil Rights. She also has deep roots in the liberty movement. Alison was a Koch Associate at the National Federation for Independent Business Legal Foundation and, during law school, completed summer clerkships at the Institute for Justice and the Charles G. Koch Charitable Foundation. She holds a J.D. from Emory University School of Law and an A.B. in history from Dartmouth College.
Her work has been published in the San Francisco Chronicle, the Daily Journal, Texas Journal of Law and Politics, and The Federalist Society’s Engage magazine and blog.
She lives in northern Virginia with her husband Ilya; two children; and golden retriever Willow. In her spare time, she enjoys reading, baking and cooking, children’s art projects, and training and exercising Willow.
Senior Policy Analyst, The George Washington University Regulatory Studies Center
Sofie Miller's regulatory research portfolio includes economic analysis of energy efficiency standards, analysis of regulatory benefits, use of cost benefit analysis by agencies, retrospective review of existing rules, regressive effects of regulations, and the efficacy of public participation within the rulemaking process. Sofie has submitted public comments on regulations establishing energy efficiency standards, airline passenger protections, consumer product safety, and standards to prevent foodborne illnesses. Sofie has published articles in Regulation Magazine and the journal Engage, and is the editor of the GW Regulatory Studies Center's weekly Regulation Digest, which tracks regulatory developments in federal agencies, think tanks, and the media.
Partner, Cooley
Rob McDowell advises telecommunications, media and technology clients on their most significant regulatory, legal and business matters. As a former commissioner of the Federal Communications Commission (FCC) and a highly regarded industry leader, Rob has been at the forefront of the most complex and groundbreaking issues facing telecommunications.
Mr. McDowell was first appointed to the FCC by President George W. Bush in 2006 and again by President Obama in 2009. He was unanimously confirmed both times by the US Senate. During his tenure, Mr. McDowell led efforts to expand consumer access to spectrum through his work on the two largest wireless auctions in US history at the time, played a key role in the 2009 digital television transition and led efforts to establish the first federal civil rights rule in a generation by creating a ban on racially discriminatory practices in broadcast advertising. He also worked extensively on several large and complex mergers, including Sirius/XM and Comcast/NBC-Universal.
He is an advocate for internet freedom, serving on the US delegation to the 2012 World Conference on International Telecommunications and exposing an international bid to regulate vital aspects of the Internet through multilateral treaty-based organizations. Mr. McDowell authored an op-ed in the Wall Street Journal opposing multilateral internet regulation that led to a resolution passed unanimously in the House and Senate, as well as the ultimate defeat of the international bid at a treaty negation in Dubai later that year.
Prior to the FCC, Mr. McDowell was senior vice president for CompTel, the Competitive Telecommunications Association, where he led advocacy efforts before several government agencies, the White House and Congress.
Mr. McDowell is often called upon for speaking engagements and frequently appears on TV and radio. He has written opinion pieces for many high-profile publications, including the Wall Street Journal and Washington Post.
Secretary, Galen Institute
John Hoff, founding board member of the Galen Institute, has a unique background that combines both health care policy and legal expertise. He served as the Health Attaché of the United States Mission to the United Nations Educational, Scientific and Cultural Organization (UNESCO) and the U.S. Mission to the Organization for Economic Cooperation and Development (OECD) from 2005-2009. While stationed in Paris, Mr. Hoff represented the U.S. Government on a broad range of issues of health and science policy on the international level, including intellectual property rights, health information technology, medical innovation, and comparative health systems data.
Prior to his work with UNESCO and the OECD, Mr. Hoff served as a Deputy Assistant Secretary for Planning and Evaluation at the U.S. Department of Health and Human Services. He was in charge of the Office of Disability, Aging, and Long Term Care Policy. He led the Office’s research on these issues, and also worked on additional policy initiatives such as reform of the medical malpractice litigation system, improvements in patient safety, and reform of the health care financing system.
Before joining the Government, Mr. Hoff practiced law for more than 30 years, specializing in health law and policy. He has published a number of articles and drafted legislation on health care issues, including the first bill introduced in Congress for market-based health care reform.
Mr. Hoff received his B.A. and LL.B. degrees from Harvard University. He is a member of the Bar of the District of Columbia and of the Supreme Court of the United States.
Scott K. Ginsburg Professor of Health Law & Policy, Georgetown University
David A. Hyman, M.D., J.D., is the Scott K. Ginsburg Professor of Health Law & Policy at Georgetown University. Professor Hyman focuses his research and writing on the regulation and financing of health care. He teaches or has taught health care regulation, civil procedure, insurance, medical malpractice, law & economics, professional responsibility, and tax policy.
While serving as Special Counsel to the Federal Trade Commission, Professor Hyman was principal author and project leader for the first joint report ever issued by the Federal Trade Commission and Department of Justice, “Improving Health Care: A Dose of Competition” (2004). He is also the author of Medicare Meets Mephistopheles, which was selected by the U.S. Chamber of Commerce/National Chamber Foundation as one of the top ten books of 2007, and the co-author (with Charles Silver) of Overcharged: Why Americans Pay Too Much for Health Care (2018). He has published widely in student-edited law reviews and peer-reviewed medical, health policy, law, and economics journals.
Robert L. Willett Family Professor of Law, Washington and Lee University School of Law
Timothy Stoltzfus Jost, J.D., holds the Robert L. Willett Family Professorship of Law at the Washington and Lee University School of Law. He is a coauthor of a casebook, Health Law, used widely throughout the United States in teaching health law and now in its sixth edition. He is also the author of Health Care at Risk, A Critique of the Consumer-Driven Movement, Health Care Coverage Determinations: An International Comparative Study, Readings in Comparative Health Law and Bioethics, and many articles and book chapters on health care regulation and comparative health law and policy. He has written numerous monographs on legal issues in health care reform for national organizations and blogs regularly for Health Affairs on regulatory issues. He is a consumer representative to the National Association of Insurance Commissioners and a member of the Institute of Medicine.
James R. Dougherty Chair for Faculty Excellence, University of Texas School of Law
Bill Sage, both a medical doctor and a lawyer, and a leading expert in health law and policy, joined the UT Law faculty at the beginning of the fall semester in 2006. Sage holds the James R. Dougherty Chair for Faculty Excellence and teaches courses in health law and in regulation and public policy. Sage is also the vice provost for health affairs at UT-Austin.
Sage has edited two books, including Medical Malpractice and the U.S. Health Care System (Cambridge University Press, 2006), and has written approximately 75 articles in legal, health policy, and medical publications. From 2002 through 2005, he was the principal investigator for the Project on Medical Liability in Pennsylvania funded by The Pew Charitable Trusts. In 2002, Sage served on the Institute of Medicine’s Committee on Rapid Advances in Health Care. In 1998, he received an Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation. In 1993, he headed four working groups for the White House Task Force on Health Care Reform. He is an elected fellow of the Hastings Center on bioethics, and is a member of the editorial board of Health Affairs.
In 2002, Sage served on the Institute of Medicine’s Committee on Rapid Advances in Health Care. In 1998, he received an Investigator Award in Health Policy Research from the Robert Wood Johnson Foundation. In 1993, he headed four working groups for the White House Task Force on Health Care Reform. He is an elected fellow of the Hastings Center on bioethics, and is a member of the editorial board of Health Affairs.
Paula Stannard is a former deputy general counsel and acting general counsel of the U.S. Department of Health and Human Services (HHS), where she oversaw the Food and Drug, Civil Rights and Legislation divisions of the 450-attorney HHS Office of the General Counsel and provided legal advice and counsel to senior HHS officials, including the Secretary of the department, on the issues arising in their respective areas.
At Alston & Bird, Paula advises clients on regulatory questions that arise out of the on-going health care reform effort and focuses her practice on HIPAA and health information technology (including certified EHR and meaningful use issues), food and drug and other regulatory issues in the health care sector. Her HHS experience provides clients substantive knowledge of, and experience in, FDA, HIPAA, e-health and health IT, federal health insurance regulation, patient safety, and public health preparedness and emergency response issues.
Paula received her J.D. from Stanford Law School in 1990, where she was an executive editor of the Stanford Law Review, and her B.A., magna cum laude, in political science and Latin from Amherst College, where she was elected to Phi Beta Kappa. She clerked for the Honorable J.L. Edmondson of the United States Court of Appeals for the Eleventh Circuit.
Stanford University
(J.D., 1990)
Amherst College
(B.A., 1987)
Managing Director, Alvarez & Marsal Healthcare Industry Group
With prior service as Deputy General Counsel of the U.S. Department of Health and Human Services and as Executive Vice President and General Counsel of Tenet Healthcare, he brings more than 20 years of experience in addressing challenging healthcare issues in government and private industry.
Mr. Urbanowicz regularly advises boards of directors, senior management, investors and lenders of health care organizations facing significant regulatory, compliance, financial or operating challenges. His clients include healthcare providers, payors and suppliers.
Recent engagements include: serving as a federally-appointed hospital restructuring and safety monitor; compliance and operational improvements for publicly-traded and not-for-profit Medicare Advantage plans, Medicare Prescription Drug Plans (PDP) and Medicaid managed care companies; renegotiating of government debt for a major hospital system; restructuring advisory services to the Medicaid program of a large state; numerous internal and government investigations involving healthcare providers including: academic health systems, medical device companies, pharmaceutical manufacturers, long term care hospital companies, hospice providers, dental services companies and disease management companies.
Mr. Urbanowicz also serves on the board of directors of Maxim Healthcare Services, one of the nation’s largest home health services companies, and chairs the company’s compliance committee.
As Deputy General Counsel of HHS, from 2001 to 2003, Mr. Urbanowicz served as the senior legal adviser to the Secretary of Health and Human Services on significant federal healthcare policy issues including Medicare and Medicaid provider payment and fraud and abuse enforcement policy. He was part of the team that drafted the historic Medicare Prescription Drug Act of 2003.
During his tenure at Tenet, Mr. Urbanowicz was responsible for successfully resolving several major federal criminal investigations and civil lawsuits facing Tenet by the U.S. Department of Justice, the Securities and Exchange Commission, and the HHS Office of Inspector General. Prior to his government service, he was a partner in the law firm of Locke, Liddell & Sapp.
Mr. Urbanowicz earned a bachelor of arts’ degree and a Juris Doctor degree from Tulane University. He is admitted to the bars of the District of Columbia, the U.S. Supreme Court and the Louisiana Supreme Court, and is a member of the American Law Institute.
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