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.
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.
David Scott has a Ph.D. in political science from Northwestern University and has taught American government courses at a number of Illinois colleges and universities. In retirement he was the president of the Illinois State Historical Society and attended Federalist Society meetings in St. Louis.
Senior Legal Counsel, Pacific Legal Foundation
Before becoming an attorney, James had been a productive member of society working as an exploration geologist in the late 1970s throughout the southwestern United States. However, after several years of dealing with irrational government bureaucrats and environmental policies untethered from reality, James decided that what the world needs is more lawyers — if they are willing to fight for rationality in regulatory regimes, property rights, and liberty.
James attended the University of Arizona College of Law in Tucson, where he served as an editor for the Law Review and received a J.D. degree in 1983. He had previously received a Masters degree in geological sciences from Brown University and an undergraduate degree from Hamilton College in New York. James received the Professional Achievement Award from the University of Arizona Alumni Association in 2018.
James has worked with Pacific Legal Foundation since 1983, litigating cases from Alaska to Florida. He is a member of the Federalist Society’s Environmental Law and Property Rights Practice Group’s Executive Committee, a member of the American College of Real Estate Lawyers, and an honorary member of Owners Counsel of America, an organization comprised of eminent domain attorneys who represent property owners. The Owners Counsel awarded James its Crystal Eagle award in 2013. In 2022, James was awarded the Brigham-Kanner Property Rights Prize at the William & Mary College of Law. The prize is awarded annually to an individual whose work has advanced the cause of property rights and has contributed to the overall awareness of the important role property rights occupy in the broader scheme of individual liberty.
In 2001, James successfully argued a major property rights case, Palazzolo v. Rhode Island, before the United States Supreme Court, a case which affirmed that rights in regulated property do not disappear when land is bought and sold. He has written extensively on all aspects of property rights and environmental law and frequently speaks on these subjects throughout the nation.
When James is not suing the government he enjoys skiing faster than he should, bicycling, hiking, swimming, and spending quality time with his wife, family, and grandchild.
Mr. Burling’s book Nowhere to Live: The Hidden Story of America’s Housing Crisis is available now on Amazon.
James is a member of the bar only in the states of Alaska and California.
Laurence H. Silberman Chair in Constitutional Governance and Senior Fellow, American Enterprise Institute; Co-Director, Antonin Scalia Law School’s C. Boyden Gray Center for the Study of the Administrative State
Adam J. White is the Laurence H. Silberman Chair in Constitutional Governance and senior fellow at the American Enterprise Institute, where he focuses on the Supreme Court and the administrative state. Concurrently, he codirects the Antonin Scalia Law School’s C. Boyden Gray Center for the Study of the Administrative State.
Mr. White practiced constitutional and administrative law, particularly in the regulation of energy and financial markets. He started his legal career as a law clerk for Judge David B. Sentelle at the US Court of Appeals for the DC Circuit.
Mr. White has written for the Wall Street Journal, the New York Times, the Washington Post, National Affairs, Commentary, Harvard Journal of Law & Public Policy, and Notre Dame Law Review, among other publications. He is a regular contributor to the Yale Journal on Regulation’s Notice and Comment blog, and for many years, he was one of the Weekly Standard’s lead writers on constitutional law and the Supreme Court.
Mr. White has testified often before Congress, including before the Senate’s Committees on the Judiciary; Commerce, Science, and Transportation; and Homeland Security and Governmental Affairs and before the House’s Judiciary and Financial Services Committees. In 2018, the Senate Committee on the Judiciary called him to testify in Brett Kavanaugh’s Supreme Court confirmation hearings to advise senators on Kavanaugh’s approach to administrative law.
In 2021, he served on the Presidential Commission on the Supreme Court of the United States, where he criticized “Court packing” and other efforts to restructure the Supreme Court. In 2017, he was appointed to serve on the Administrative Conference of the United States. He also serves on the leadership council for the American Bar Association’s Administrative Law and Regulatory Practice Section, which he will chair in 2023–24. Before joining AEI, he was a research fellow at Stanford University’s Hoover Institution and an adjunct fellow at the Manhattan Institute.
Mr. White has a JD from Harvard Law School and a bachelor of business administration from the College of Business at the University of Iowa.
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.
Partner, McCarter & English, LLP
Daniel Kelly brings over thirty years of experience to the firm’s government contracts group. His practice combines both counseling and acting as an advocate on behalf of clients doing business in the government marketplace. Dan has knowledge of the government contracting process both on a federal and state level, and the specific laws, regulations, contract clauses and dispute resolution mechanisms in this specialized area. He provides advice and guidance to clients who are in the government supply chain, either as prime contractors, subcontractors or vendors. He reviews government solicitations with clients, prepares proposals, and negotiates teaming arrangements and subcontracts with other suppliers. He helps clients build and enhance their compliance programs. He assists clients in protecting their intellectual property and proprietary information concerning their businesses when doing business with the government. He advocates for clients who wrongfully were passed over for a contract award. He prepares claims arising under government contracts as a result of change orders, delays, and terminations for default or convenience. Dan’s practice extends to a broad spectrum of industries and federal and state authorities for whom they supply research, products and services, including emerging and established biomedical, intelligence, pharma, security, and textile R&D, manufacturing and production houses working under prime and subcontracts, SBIRs, CRADAs, OTAs, and grants for DoD and civilian agencies; Medicare and Medicaid audit and investigation service providers; commercial software developers who modify their software for military applications; professional services providers; and raw materials and component suppliers to large military prime contractors.
Dan is the author of the August 2018 edition Thomson Reuters’ Briefing Papers, which provides a comprehensive review of patent rights under “Other Transaction Agreements” (OTAs) with DoD and NASA. Heavily promoted by Congress, and only partially understood by industry, OTAs are quickly becoming DoD’s and NASA’s contractual vehicle of choice to lure commercial companies to sell the Government their latest and greatest technologies. However, OTAs are not governed by standard government contracts laws and regulations, meaning there are significant changes to the common provisions of ownership and license rights incident to government contracts and grants. The Briefing Paper should be required reading before entities enter into an OTA as a vehicle for developing new technologies for NASA and DoD to ensure their company’s intellectual property efforts are properly protected
In the matters, AdvanceMed Corporation, B-415360,B-415360.2,B-415360.3 (Dec 19, 2017), and AdvanceMed Corporation, B-414373.3 (Jan 10, 2018) Dan and the Government Contracts team at McCarter successfully defended its client Health Integrity, LLC (now Qlarant) against protests launched at the Government Accountability Office challenging awards by the Centers for Medicare and Medicaid Services (CMS) for Medicare and Medicaid audit and program integrity services.
Dan serves on the Board of Directors for NCMA Boston (National Contract Management Association) and NDIA New England (National Defense Industrial Association), and is a frequent speaker at NCMA and NDIA events.
Dan serves as an adjunct member of the faculty at Suffolk University Law School where he has taught Government Contracts.
Dan receives Mentor of the Year Award in recognition of his contributions and support to NCMA Boston Chapter’s 2017-2018 Program Year.
Independent Analyst, None
Allison Hayward most recently served as the Head of Case Selection at the Oversight Board. Previously, she was a Commissioner at the California Fair Political Practices Commission, a Board Member at the Office of Congressional Ethics, and an Assistant Professor of Law at George Mason University School of Law. She also previously worked as Chief of Staff and Counsel in the office of Federal Election Commission Commissioner Bradley A. Smith and practiced election law in California and in Washington DC.
In 1994-1995, Professor Hayward was a judicial clerk for the Honorable Danny J. Boggs, United States Court of Appeal for the Sixth Circuit.
She is a member of the State Bar of California and the District of Columbia Bar.
Senior Writer, The Weekly Standard
Jonathan V. Last is a senior writer at The Weekly Standard inWashington. His writings have been featured in The Wall Street Journal, The Los Angeles Times, The Washington Post, The Philadelphia Inquirer, The New York Post, The Claremont Review of Books, First Things, The Week,Salon, Slate, TV Guide, and elsewhere. He writes the column “One Last Thing” for the iPad paper, The Daily.
Senior Writer, National Review
Ramesh Ponnuru is a senior editor for National Review, a columnist for Bloomberg View, and a visiting fellow at the American Enterprise Institute. Ponnuru grew up in Kansas City and graduated summa cum laude from Princeton’s history department. Ponnuru has published articles in numerous newspapers including the New York Times, the Washington Post, the Wall Street Journal, the Financial Times, Newsday, and the New York Post. He has also written for First Things, Policy Review, The Weekly Standard, The New Republic,Reason, and other publications. He has appeared on numerous television news programs. He is the author of The Party of Death: The Democrats, the Media, the Courts, and the Disregard for Human Life. He is also the author of the monograph The Mystery of Japanese Growth (American Enterprise Institute/Centre for Policy Studies).
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