Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
Professor of Practice and Distinguished Scholar in Residence; Co-Director of the Legislative and Regulatory Process Clinic, New York University School of Law
Sally Katzen served in the Clinton administration as administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB), as deputy assistant to the president for economic policy and deputy director of the National Economic Council in the White House, and then as the deputy director for management at OMB. She served as the head of the Agency Review Group for the Obama/Biden transition with responsibility for the Executive Office of the President and all government-wide agencies. She has taught both undergraduates and at various law schools. She is a member of the American Law Institute and the National Academy of Public Administration, has served on multiple panels for the National Academy of Sciences, testified frequently before Congress, and is on the board of several non-profit organizations. Before joining the Clinton administration, Katzen was a partner in the Washington, DC, law firm of Wilmer, Cutler & Pickering, specializing in regulatory and legislative matters, while serving in leadership roles in the American Bar Association (including chair of the Section on Administrative Law and Regulatory Practice and as DC delegate to the ABA’s House of Delegates), as president of the Federal Communications Bar Association and as president of the Women’s Legal Defense Fund. She graduated from Smith College and the University of Michigan Law School, where she was the first woman editor-in-chief of the Law Review. She clerked for Judge J. Skelly Wright of the United States Court of Appeals for the District of Columbia Circuit and served in the Carter administration as the general counsel of the Council on Wage and Price Stability in the Executive Office of the President.
Faculty Fellow, Center for Law, Science & Innovation, Sandra Day O'Connor College of Law, Arizona State University
Dr. Klein is a Faculty Fellow at the Center for Law, Science & Innovation at the Sandra Day O'Connor College of Law at Arizona State University. He is also Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A. He was formerly Chief Medical Officer at OmniSeq, an oncology focused genomic profiling company that was recently acquired by LabCorp. Previously, Roger was the Medical Director at the Molecular Oncology division at the Cleveland Clinic. He was also the Chair of the Professional Relations Committee at the Association for Molecular Pathology. Prior to joining the Cleveland Clinic, he served as Medical Director of Molecular Oncology at the BloodCenter of Wisconsin where he led the center’s Diagnostic Laboratories’ initiative focused on DNA- and RNA-based testing for evaluation of cancer patients.
Dr. Klein has been an advisor to the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). He has participated in and assumed leadership roles in many professional society committees and corporate advisory boards and is a policy advisor to the Heartland Institute.
Dr. Klein is licensed to practice medicine in Ohio, Florida, and Wisconsin. Additionally, he is licensed to practice law in the District of Columbia and Ohio. Roger obtained his Molecular Genetic Pathology certification at Mayo Medical School following completion of his M.D. Yale University School of Medicine. He obtained his J.D. from Yale Law School.
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.
David and Mary Harrison Distinguished Professor of Law, University of Virginia School of Law
Paul G. Mahoney is a David and Mary Harrison Distinguished Professor and served as dean of the Law School from 2008-16. Mahoney's teaching and research areas are securities regulation, law and economic development, corporate finance, financial derivatives and contracts. He has published widely in law reviews and peer-reviewed finance and law and economics journals. His book, “Wasting a Crisis: Why Securities Regulation Fails,” was published by the University of Chicago Press in 2015.
Mahoney joined the Law School faculty in 1990 after practicing law with the New York firm of Sullivan & Cromwell and clerking for Judge Ralph K. Winter, Jr. of the U.S. Court of Appeals for the Second Circuit and Justice Thurgood Marshall of the U.S. Supreme Court. He served as academic associate dean at the Law School from 1999 to 2004 and has held the Albert C. BeVier Research Chair and the Brokaw Chair in Corporate Law. He has been a visiting professor at the University of Chicago Law School, the University of Southern California Law School and the University of Toronto Faculty of Law. He has also worked on legal reform projects in Kazakhstan, Kyrgyzstan, Mongolia and Nepal.
Mahoney is a member of the Council on Foreign Relations and a fellow of the American Academy of Arts and Sciences. In 2018 he joined Securities and Exchange Commission’s Investor Advisory Committee. He served as an associate editor of the Journal of Economic Perspectives from 2004 to 2007 and as a director of the American Law and Economics Association from 2002 to 2004. He is a past recipient of the All-University Outstanding Teacher Award and the Law School's Traynor Award for excellence in faculty scholarship.
Robert Walmsley University Professor, Harvard Law School
Cass R. Sunstein is currently the Robert Walmsley University Professor at Harvard. He is the founder and director of the Program on Behavioral Economics and Public Policy at Harvard Law School. In 2018, he received the Holberg Prize from the government of Norway, sometimes described as the equivalent of the Nobel Prize for law and the humanities. From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs, and after that, he served on the President's Review Board on Intelligence and Communications Technologies and on the Pentagon's Defense Innovation Board. Mr. Sunstein has testified before congressional committees on many subjects, and he has advised officials at the United Nations, the European Commission, the World Bank, and many nations on issues of law and public policy. He serves as an adviser to the Behavioural Insights Team in the United Kingdom.
Mr. Sunstein is author of hundreds of articles and dozens of books, including Nudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008), Simpler: The Future of Government (2013), The Ethics of Influence (2015), #Republic (2017), Impeachment: A Citizen's Guide (2017), The Cost-Benefit Revolution (2018), On Freedom (2019), Conformity (2019), How Change Happens (2019), and Too Much Information (2020). He is now working on a variety of projects involving the regulatory state, "sludge" (defined to include paperwork and similar burdens), fake news, and freedom of speech.
Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
Professor of Practice and Distinguished Scholar in Residence; Co-Director of the Legislative and Regulatory Process Clinic, New York University School of Law
Sally Katzen served in the Clinton administration as administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB), as deputy assistant to the president for economic policy and deputy director of the National Economic Council in the White House, and then as the deputy director for management at OMB. She served as the head of the Agency Review Group for the Obama/Biden transition with responsibility for the Executive Office of the President and all government-wide agencies. She has taught both undergraduates and at various law schools. She is a member of the American Law Institute and the National Academy of Public Administration, has served on multiple panels for the National Academy of Sciences, testified frequently before Congress, and is on the board of several non-profit organizations. Before joining the Clinton administration, Katzen was a partner in the Washington, DC, law firm of Wilmer, Cutler & Pickering, specializing in regulatory and legislative matters, while serving in leadership roles in the American Bar Association (including chair of the Section on Administrative Law and Regulatory Practice and as DC delegate to the ABA’s House of Delegates), as president of the Federal Communications Bar Association and as president of the Women’s Legal Defense Fund. She graduated from Smith College and the University of Michigan Law School, where she was the first woman editor-in-chief of the Law Review. She clerked for Judge J. Skelly Wright of the United States Court of Appeals for the District of Columbia Circuit and served in the Carter administration as the general counsel of the Council on Wage and Price Stability in the Executive Office of the President.
Faculty Fellow, Center for Law, Science & Innovation, Sandra Day O'Connor College of Law, Arizona State University
Dr. Klein is a Faculty Fellow at the Center for Law, Science & Innovation at the Sandra Day O'Connor College of Law at Arizona State University. He is also Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A. He was formerly Chief Medical Officer at OmniSeq, an oncology focused genomic profiling company that was recently acquired by LabCorp. Previously, Roger was the Medical Director at the Molecular Oncology division at the Cleveland Clinic. He was also the Chair of the Professional Relations Committee at the Association for Molecular Pathology. Prior to joining the Cleveland Clinic, he served as Medical Director of Molecular Oncology at the BloodCenter of Wisconsin where he led the center’s Diagnostic Laboratories’ initiative focused on DNA- and RNA-based testing for evaluation of cancer patients.
Dr. Klein has been an advisor to the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). He has participated in and assumed leadership roles in many professional society committees and corporate advisory boards and is a policy advisor to the Heartland Institute.
Dr. Klein is licensed to practice medicine in Ohio, Florida, and Wisconsin. Additionally, he is licensed to practice law in the District of Columbia and Ohio. Roger obtained his Molecular Genetic Pathology certification at Mayo Medical School following completion of his M.D. Yale University School of Medicine. He obtained his J.D. from Yale Law School.
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.
David and Mary Harrison Distinguished Professor of Law, University of Virginia School of Law
Paul G. Mahoney is a David and Mary Harrison Distinguished Professor and served as dean of the Law School from 2008-16. Mahoney's teaching and research areas are securities regulation, law and economic development, corporate finance, financial derivatives and contracts. He has published widely in law reviews and peer-reviewed finance and law and economics journals. His book, “Wasting a Crisis: Why Securities Regulation Fails,” was published by the University of Chicago Press in 2015.
Mahoney joined the Law School faculty in 1990 after practicing law with the New York firm of Sullivan & Cromwell and clerking for Judge Ralph K. Winter, Jr. of the U.S. Court of Appeals for the Second Circuit and Justice Thurgood Marshall of the U.S. Supreme Court. He served as academic associate dean at the Law School from 1999 to 2004 and has held the Albert C. BeVier Research Chair and the Brokaw Chair in Corporate Law. He has been a visiting professor at the University of Chicago Law School, the University of Southern California Law School and the University of Toronto Faculty of Law. He has also worked on legal reform projects in Kazakhstan, Kyrgyzstan, Mongolia and Nepal.
Mahoney is a member of the Council on Foreign Relations and a fellow of the American Academy of Arts and Sciences. In 2018 he joined Securities and Exchange Commission’s Investor Advisory Committee. He served as an associate editor of the Journal of Economic Perspectives from 2004 to 2007 and as a director of the American Law and Economics Association from 2002 to 2004. He is a past recipient of the All-University Outstanding Teacher Award and the Law School's Traynor Award for excellence in faculty scholarship.
Robert Walmsley University Professor, Harvard Law School
Cass R. Sunstein is currently the Robert Walmsley University Professor at Harvard. He is the founder and director of the Program on Behavioral Economics and Public Policy at Harvard Law School. In 2018, he received the Holberg Prize from the government of Norway, sometimes described as the equivalent of the Nobel Prize for law and the humanities. From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs, and after that, he served on the President's Review Board on Intelligence and Communications Technologies and on the Pentagon's Defense Innovation Board. Mr. Sunstein has testified before congressional committees on many subjects, and he has advised officials at the United Nations, the European Commission, the World Bank, and many nations on issues of law and public policy. He serves as an adviser to the Behavioural Insights Team in the United Kingdom.
Mr. Sunstein is author of hundreds of articles and dozens of books, including Nudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008), Simpler: The Future of Government (2013), The Ethics of Influence (2015), #Republic (2017), Impeachment: A Citizen's Guide (2017), The Cost-Benefit Revolution (2018), On Freedom (2019), Conformity (2019), How Change Happens (2019), and Too Much Information (2020). He is now working on a variety of projects involving the regulatory state, "sludge" (defined to include paperwork and similar burdens), fake news, and freedom of speech.
Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
President, Harned Strategies LLC
Karen Harned is President at Harned Strategies LLC. Previously, she served as Executive Director of the National Federation of Independent Business Small Business Legal Center, a post she held from 2002-2022. Prior to joining the Legal Center, Ms. Harned was an attorney at a Washington, D.C. law firm specializing in food and drug law, where she represented several small and large businesses and their respective trade associations before Congress and federal agencies. She also served as Assistant Press Secretary to U.S. Senator Don Nickles of Oklahoma from August of 1989 to March of 1993. Ms. Harned received her B.A. from the University of Oklahoma in 1989 and her J.D. from The George Washington University National Law Center in 1995. She is admitted to practice in the District of Columbia.
As Executive Director of the NFIB Small Business Legal Center, Ms. Harned commented regularly on small business cases before federal and state courts, as well as the U.S. Supreme Court. She has appeared on Fox News, Fox Business, NBC Nightly News, CNN, CNBC and MSNBC, as well as National Public Radio, CBS Radio, and radio outlets across the country. Her opinion editorials and articles regarding healthcare, lawsuit abuse, regulation, and other issues important to small business have been published in newspapers and other publications nationwide.
Ms. Harned has testified before Congress on the small business impact of regulation and the civil justice system. Additionally, she has conducted numerous webinars and legal compliance seminars for small business owners across the country on issues relating to employment law, including unionization and immigration.
Research Professor, Regulatory Studies Center, The George Washington University
Brian Mannix is a Research Professor at George Washington University’s Regulatory Studies Center. From 2005 – 2009 he was the EPA’s Associate Administrator for Policy, Economics, and Innovation. Earlier he served as the Deputy Secretary of Natural Resources for the Commonwealth of Virginia. Brian was an economist at OIRA from 1981 – 1987, and then served as managing editor of Regulation magazine at the American Enterprise Institute.
Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
President, Harned Strategies LLC
Karen Harned is President at Harned Strategies LLC. Previously, she served as Executive Director of the National Federation of Independent Business Small Business Legal Center, a post she held from 2002-2022. Prior to joining the Legal Center, Ms. Harned was an attorney at a Washington, D.C. law firm specializing in food and drug law, where she represented several small and large businesses and their respective trade associations before Congress and federal agencies. She also served as Assistant Press Secretary to U.S. Senator Don Nickles of Oklahoma from August of 1989 to March of 1993. Ms. Harned received her B.A. from the University of Oklahoma in 1989 and her J.D. from The George Washington University National Law Center in 1995. She is admitted to practice in the District of Columbia.
As Executive Director of the NFIB Small Business Legal Center, Ms. Harned commented regularly on small business cases before federal and state courts, as well as the U.S. Supreme Court. She has appeared on Fox News, Fox Business, NBC Nightly News, CNN, CNBC and MSNBC, as well as National Public Radio, CBS Radio, and radio outlets across the country. Her opinion editorials and articles regarding healthcare, lawsuit abuse, regulation, and other issues important to small business have been published in newspapers and other publications nationwide.
Ms. Harned has testified before Congress on the small business impact of regulation and the civil justice system. Additionally, she has conducted numerous webinars and legal compliance seminars for small business owners across the country on issues relating to employment law, including unionization and immigration.
Research Professor, Regulatory Studies Center, The George Washington University
Brian Mannix is a Research Professor at George Washington University’s Regulatory Studies Center. From 2005 – 2009 he was the EPA’s Associate Administrator for Policy, Economics, and Innovation. Earlier he served as the Deputy Secretary of Natural Resources for the Commonwealth of Virginia. Brian was an economist at OIRA from 1981 – 1987, and then served as managing editor of Regulation magazine at the American Enterprise Institute.
Former Congressman, Vice-President, U.S. Association of Former Members of Congress
The Honorable Martin Frost served in the U.S. House of Representatives from 1979-2005.
With 26 years of legislative experience, he is regarded as a preeminent political analyst among his peers. He held numerous leadership positions in his party and is also considered to be one of its top strategists, an innovative lawmaker who is able to craft bipartisan legislation, and a strong fundraiser for fellow Democrats. He is also the co-author, with Congressman Tom Davis (V-RA) of The PARTISAN DIVIDE: Congress in Crisis, which looks at how to solve the gridlock in Washington. In his presentations, Martin Frost addresses our current political climate, what to expect from Congress after the election, and what it takes to achieve bi-partisan cooperation.n, and what it takes to achieve bi-partisan cooperation.
Early in his political career, Frost served six years on the House Budget Committee and was chairman of the Health Task Force from 1985–1988. During the 1996 and 1998 elections, Frost was the chair of the Democratic Congressional Campaign Committee, a position he utilized to help his party gain 14 seats in the House. In 1999, he earned the distinguished role of chairman of the House Democratic Caucus, the party’s third-highest leadership role. During his last term, Frost held noteworthy positions as the ranking member of the House Rules Committee and highest ranking Southerner in the House Democratic Leadership. He was also the senior southern democrat in the House and the dean of the Texas congressional delegation.
Frost earned his bachelor’s degree in journalism and history from the University of Missouri-Columbia. Following his graduation from Georgetown Law School, he practiced in Dallas until his election in 1978. In 2005, Frost was a fellow at the Institute of Politics at the John F. Kennedy School of Government at Harvard, and in 2006, the Woodrow Wilson International Center for Scholars named him a public policy scholar.
Professor of Law, Notre Dame Law School
Professor Derek Muller is a nationally-recognized scholar in the field of election law. His research focuses on the role of states in the administration of federal elections, the constitutional contours of voting rights and election administration, the limits of judicial power in the domain of elections, and the Electoral College.
He has published more than two dozen academic works, and his op-eds have appeared in the New York Times, the Los Angeles Times, and the Wall Street Journal. He has testified before Congress, and he is a contributor at the Election Law Blog. He is a co-author on a Federal Courts casebook published by Carolina Academic Press. He is also the co-reporter on a new Restatement of the Law, Election Litigation, an effort led by the American Law Institute.
Professor Muller teaches Election Law, Civil Procedure, and Evidence.
David Boies Professor of Law, Yale Law School
Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
Vice President for Public Policy, American Forest and Paper Association
Paul Noe serves as Vice President for Public Policy at the American Forest and Paper Association. Paul has extensive regulatory, legislative and technical experience, including in environmental regulation, regulatory reform, renewable energy, biomass carbon neutrality, chemicals and product stewardship, workplace health and safety, and sustainability. He previously served as the Vice President of Regulatory Affairs at the Grocery Manufacturers Association.
Paul also has broad experience in public service, including as Counselor to the Administrator in the Office of Information and Regulatory Affairs, Office of Management and Budget (2001-2006), where he helped to lead the development of regulatory policy and White House review of regulations in the Administration of George W. Bush. He previously served as Senior Counsel to the U.S. Senate Committee on Governmental Affairs under Chairmen Fred Thompson, Ted Stevens and Bill Roth (1995-2001), where his work focused on reforming the regulatory process. He also has been a lawyer in private practice, most recently as a partner with C&M Capitolink LLC, as well as counsel in Crowell & Moring’s Environment and Natural Resources Group.
Paul currently serves as the Co-Chair of the Legislation Committee in the American Bar Association’s Section of Administrative Law and Regulatory Practice, and recently coauthored a chapter, “Beyond Process Excellence: Enhancing Societal Well-Being,” published in a book by Brookings Institution Press entitled, “Achieving Regulatory Excellence.” In the spring of 2016, he also served as a Policy Fellow at the University of Pennsylvania Law School, where he offered lectures in environmental law, advanced regulatory policy, legislation, and administrative law.
Paul is a graduate of The Georgetown University Law Center, where he was a John M. Olin fellow in law and economics and an editor on the law journal, and Williams College, where he was a member of Phi Beta Kappa.
Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
Professor of Practice and Distinguished Scholar in Residence; Co-Director of the Legislative and Regulatory Process Clinic, New York University School of Law
Sally Katzen served in the Clinton administration as administrator of the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB), as deputy assistant to the president for economic policy and deputy director of the National Economic Council in the White House, and then as the deputy director for management at OMB. She served as the head of the Agency Review Group for the Obama/Biden transition with responsibility for the Executive Office of the President and all government-wide agencies. She has taught both undergraduates and at various law schools. She is a member of the American Law Institute and the National Academy of Public Administration, has served on multiple panels for the National Academy of Sciences, testified frequently before Congress, and is on the board of several non-profit organizations. Before joining the Clinton administration, Katzen was a partner in the Washington, DC, law firm of Wilmer, Cutler & Pickering, specializing in regulatory and legislative matters, while serving in leadership roles in the American Bar Association (including chair of the Section on Administrative Law and Regulatory Practice and as DC delegate to the ABA’s House of Delegates), as president of the Federal Communications Bar Association and as president of the Women’s Legal Defense Fund. She graduated from Smith College and the University of Michigan Law School, where she was the first woman editor-in-chief of the Law Review. She clerked for Judge J. Skelly Wright of the United States Court of Appeals for the District of Columbia Circuit and served in the Carter administration as the general counsel of the Council on Wage and Price Stability in the Executive Office of the President.
Faculty Fellow, Center for Law, Science & Innovation, Sandra Day O'Connor College of Law, Arizona State University
Dr. Klein is a Faculty Fellow at the Center for Law, Science & Innovation at the Sandra Day O'Connor College of Law at Arizona State University. He is also Principal at Roger D. Klein, MD JD Consulting and Klein & Klein Co., L.P.A. He was formerly Chief Medical Officer at OmniSeq, an oncology focused genomic profiling company that was recently acquired by LabCorp. Previously, Roger was the Medical Director at the Molecular Oncology division at the Cleveland Clinic. He was also the Chair of the Professional Relations Committee at the Association for Molecular Pathology. Prior to joining the Cleveland Clinic, he served as Medical Director of Molecular Oncology at the BloodCenter of Wisconsin where he led the center’s Diagnostic Laboratories’ initiative focused on DNA- and RNA-based testing for evaluation of cancer patients.
Dr. Klein has been an advisor to the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). He has participated in and assumed leadership roles in many professional society committees and corporate advisory boards and is a policy advisor to the Heartland Institute.
Dr. Klein is licensed to practice medicine in Ohio, Florida, and Wisconsin. Additionally, he is licensed to practice law in the District of Columbia and Ohio. Roger obtained his Molecular Genetic Pathology certification at Mayo Medical School following completion of his M.D. Yale University School of Medicine. He obtained his J.D. from Yale Law School.
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.
David and Mary Harrison Distinguished Professor of Law, University of Virginia School of Law
Paul G. Mahoney is a David and Mary Harrison Distinguished Professor and served as dean of the Law School from 2008-16. Mahoney's teaching and research areas are securities regulation, law and economic development, corporate finance, financial derivatives and contracts. He has published widely in law reviews and peer-reviewed finance and law and economics journals. His book, “Wasting a Crisis: Why Securities Regulation Fails,” was published by the University of Chicago Press in 2015.
Mahoney joined the Law School faculty in 1990 after practicing law with the New York firm of Sullivan & Cromwell and clerking for Judge Ralph K. Winter, Jr. of the U.S. Court of Appeals for the Second Circuit and Justice Thurgood Marshall of the U.S. Supreme Court. He served as academic associate dean at the Law School from 1999 to 2004 and has held the Albert C. BeVier Research Chair and the Brokaw Chair in Corporate Law. He has been a visiting professor at the University of Chicago Law School, the University of Southern California Law School and the University of Toronto Faculty of Law. He has also worked on legal reform projects in Kazakhstan, Kyrgyzstan, Mongolia and Nepal.
Mahoney is a member of the Council on Foreign Relations and a fellow of the American Academy of Arts and Sciences. In 2018 he joined Securities and Exchange Commission’s Investor Advisory Committee. He served as an associate editor of the Journal of Economic Perspectives from 2004 to 2007 and as a director of the American Law and Economics Association from 2002 to 2004. He is a past recipient of the All-University Outstanding Teacher Award and the Law School's Traynor Award for excellence in faculty scholarship.
Robert Walmsley University Professor, Harvard Law School
Cass R. Sunstein is currently the Robert Walmsley University Professor at Harvard. He is the founder and director of the Program on Behavioral Economics and Public Policy at Harvard Law School. In 2018, he received the Holberg Prize from the government of Norway, sometimes described as the equivalent of the Nobel Prize for law and the humanities. From 2009 to 2012, he was Administrator of the White House Office of Information and Regulatory Affairs, and after that, he served on the President's Review Board on Intelligence and Communications Technologies and on the Pentagon's Defense Innovation Board. Mr. Sunstein has testified before congressional committees on many subjects, and he has advised officials at the United Nations, the European Commission, the World Bank, and many nations on issues of law and public policy. He serves as an adviser to the Behavioural Insights Team in the United Kingdom.
Mr. Sunstein is author of hundreds of articles and dozens of books, including Nudge: Improving Decisions about Health, Wealth, and Happiness (with Richard H. Thaler, 2008), Simpler: The Future of Government (2013), The Ethics of Influence (2015), #Republic (2017), Impeachment: A Citizen's Guide (2017), The Cost-Benefit Revolution (2018), On Freedom (2019), Conformity (2019), How Change Happens (2019), and Too Much Information (2020). He is now working on a variety of projects involving the regulatory state, "sludge" (defined to include paperwork and similar burdens), fake news, and freedom of speech.
Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
President, Harned Strategies LLC
Karen Harned is President at Harned Strategies LLC. Previously, she served as Executive Director of the National Federation of Independent Business Small Business Legal Center, a post she held from 2002-2022. Prior to joining the Legal Center, Ms. Harned was an attorney at a Washington, D.C. law firm specializing in food and drug law, where she represented several small and large businesses and their respective trade associations before Congress and federal agencies. She also served as Assistant Press Secretary to U.S. Senator Don Nickles of Oklahoma from August of 1989 to March of 1993. Ms. Harned received her B.A. from the University of Oklahoma in 1989 and her J.D. from The George Washington University National Law Center in 1995. She is admitted to practice in the District of Columbia.
As Executive Director of the NFIB Small Business Legal Center, Ms. Harned commented regularly on small business cases before federal and state courts, as well as the U.S. Supreme Court. She has appeared on Fox News, Fox Business, NBC Nightly News, CNN, CNBC and MSNBC, as well as National Public Radio, CBS Radio, and radio outlets across the country. Her opinion editorials and articles regarding healthcare, lawsuit abuse, regulation, and other issues important to small business have been published in newspapers and other publications nationwide.
Ms. Harned has testified before Congress on the small business impact of regulation and the civil justice system. Additionally, she has conducted numerous webinars and legal compliance seminars for small business owners across the country on issues relating to employment law, including unionization and immigration.
Research Professor, Regulatory Studies Center, The George Washington University
Brian Mannix is a Research Professor at George Washington University’s Regulatory Studies Center. From 2005 – 2009 he was the EPA’s Associate Administrator for Policy, Economics, and Innovation. Earlier he served as the Deputy Secretary of Natural Resources for the Commonwealth of Virginia. Brian was an economist at OIRA from 1981 – 1987, and then served as managing editor of Regulation magazine at the American Enterprise Institute.
Director, GW Regulatory Studies Center & Distinguished Professor of Practice, Trachtenberg School of Public Policy & Public Administration, The George Washington University
Susan Dudley is the Founder and Director of the George Washington University Regulatory Studies Center, established in 2009 to raise awareness of regulations’ effects and improve regulatory policy through research, education, and outreach. She is also a distinguished professor of practice in the Trachtenberg School of Public Policy and Public Administration. She is past-president of the Society for Benefit Cost Analysis, a senior fellow of the Administrative Conference of the United States, and on the Regulatory Transparency Project Regulatory Practice Working Group. Her book, Regulation: A Primer, with Jerry Brito, is available on Amazon.com.
From April 2007 through January 2009, Professor Dudley served as the Presidentially-appointed Administrator of the Office of Information and Regulatory Affairs in the U.S. Office of Management and Budget and was responsible for the review of draft executive branch regulations under Executive Order 12866, the collection of federal-government-wide information under the Paperwork Reduction Act, the development and implementation of government-wide policies in the areas of information policy, privacy, and statistical policy, and international regulatory cooperation efforts.
Prior to OIRA, she directed the Regulatory Studies Program at the Mercatus Center at George Mason University, and taught courses on regulation at the George Mason University School of Law. Earlier in her career, Professor Dudley served as an economist at OIRA, as well as the Environmental Protection Agency and the Commodity Futures Trading Commission. She was also a consultant to government and private clients at Economists Incorporated. She holds a Master of Science degree from the Sloan School of Management at MIT and a Bachelor of Science degree (summa cum laude) in Resource Economics from the University of Massachusetts, Amherst.
Vice President for Public Policy, American Forest and Paper Association
Paul Noe serves as Vice President for Public Policy at the American Forest and Paper Association. Paul has extensive regulatory, legislative and technical experience, including in environmental regulation, regulatory reform, renewable energy, biomass carbon neutrality, chemicals and product stewardship, workplace health and safety, and sustainability. He previously served as the Vice President of Regulatory Affairs at the Grocery Manufacturers Association.
Paul also has broad experience in public service, including as Counselor to the Administrator in the Office of Information and Regulatory Affairs, Office of Management and Budget (2001-2006), where he helped to lead the development of regulatory policy and White House review of regulations in the Administration of George W. Bush. He previously served as Senior Counsel to the U.S. Senate Committee on Governmental Affairs under Chairmen Fred Thompson, Ted Stevens and Bill Roth (1995-2001), where his work focused on reforming the regulatory process. He also has been a lawyer in private practice, most recently as a partner with C&M Capitolink LLC, as well as counsel in Crowell & Moring’s Environment and Natural Resources Group.
Paul currently serves as the Co-Chair of the Legislation Committee in the American Bar Association’s Section of Administrative Law and Regulatory Practice, and recently coauthored a chapter, “Beyond Process Excellence: Enhancing Societal Well-Being,” published in a book by Brookings Institution Press entitled, “Achieving Regulatory Excellence.” In the spring of 2016, he also served as a Policy Fellow at the University of Pennsylvania Law School, where he offered lectures in environmental law, advanced regulatory policy, legislation, and administrative law.
Paul is a graduate of The Georgetown University Law Center, where he was a John M. Olin fellow in law and economics and an editor on the law journal, and Williams College, where he was a member of Phi Beta Kappa.
Regulation or “Don’t Let a Good Crisis Go to Waste”
Susan E. Dudley, Sally Katzen, Roger D. Klein, Erika Lietzan, Paul G. Mahoney, Cass Sunstein
The fifth panel of the Federalist Society's COVID-19 & the Law Conference discussed "Regulation or...
Regulation or “Don’t Let a Good Crisis Go to Waste”
Susan E. Dudley, Sally Katzen, Roger D. Klein, Erika Lietzan, Paul G. Mahoney, Cass Sunstein
The fifth panel of the Federalist Society's COVID-19 & the Law Conference discussed "Regulation or...
Regulation or “Don’t Let a Good Crisis Go to Waste”
COVID-19 & the Law Conference
Regulation or “Don’t Let a Good Crisis Go to Waste”
Deep Dive Episode 88 – The Whys and Hows of Commenting on Rules
Susan E. Dudley, Karen Harned, Brian F. Mannix
Public notice and comment on rulemaking is a core requirement of the Administrative Procedure...
The Whys and Hows of Commenting on Rules
Susan E. Dudley, Karen Harned, Brian F. Mannix
Public notice and comment on rulemaking is a core requirement of the Administrative Procedure Act,...
The Whys and Hows of Commenting on Rules
TeleforumShould We Change the Size of Congress? [Article I Initiative]
Martin Frost, Derek T. Muller, Keith E. Whittington
How are Congressional seats allotted to the various states? Why has the total number of...
Deep Dive 80 – New Executive Orders Directing Agency Guidance
Susan E. Dudley, Paul R. Noe
On October 9, President Trump signed two Executive Orders designed to restrict Executive Agencies’ use...
Deep Dive 80 – New Executive Orders Directing Agency Guidance
Regulatory Transparency Project Teleforum
Teleforum