Who Should Decide Whether Drugs Are Available Over-The-Counter or by Prescription?
In October 2020, Michael Cannon and Jeffrey Singer proposed ending the U.S. Food and Drug...
The Regulatory Transparency Project is a nonprofit, nonpartisan effort dedicated to fostering discussion and a better understanding of regulatory policies.
Michael F. Cannon, Joshua Sharfstein, Dan Troy
In October 2020, Michael Cannon and Jeffrey Singer proposed ending the U.S. Food and Drug...
Regulatory Transparency Project's Fourth Branch Podcast
Experts Marc Scribner and Adam Thierer join us to provide an update on autonomous vehicle...
Title IX of the Education Amendments of 1972 supplemented Title VI of the Civil Rights...
Karen Harned, Ilan Wurman, Luke A. Wake
Regulatory Transparency Project's Fourth Branch Podcast
On January 13, the Supreme Court stayed the Occupational Safety and Health Administration's (OSHA) COVID-19 vaccine-or-test...
Andrei Iancu, David J. Kappos, Arti K. Rai, Saurabh Vishnubhakat
Regulatory Transparency Project's Fourth Branch Podcast
In October 2020, India and South Africa filed a request at the World Trade Organization...
Assistant Attorney General, Office of Legal Policy, Department of Justice
Deputy Secretary of Energy
James P. Danly was sworn in as Deputy Secretary on June 9, 2025.
Before arriving at the Department, Deputy Secretary Danly was a partner and the Energy Regulatory Group leader at Skadden in Washington, D.C. This followed his service at the Federal Energy Regulatory Commission, first as the Commission’s general counsel then as the commissioner and chairman.
Deputy Secretary Danly was an officer in the United States Army. He served two tours in Iraq, receiving a Bronze Star and a Purple Heart.
A graduate of Yale University, Deputy Secretary Danly earned his J.D. from Vanderbilt University Law School. He clerked for Judge Danny J. Boggs of the Sixth Circuit.
Partner, Boies Schiller Flexner LLP
Jesse, the former third-ranking official at the U.S. Department of Justice, helps clients with their most difficult litigation and regulatory issues─whether that means defending against an enforcement action, pursuing high-stakes litigation and appeals, navigating regulatory thickets at federal and state agencies, or crafting a comprehensive strategy to manage a crisis. He approaches these problems with the knowledge gained both from his broad private-practice experience and from having served at the highest levels of federal and state government.
Jesse has experience across a range of substantive and regulatory areas. He has sued the federal government and has also been one of its top law-enforcement officials; he has represented states and has also navigated their regulatory agencies on behalf of clients; and he has represented companies in business disputes, both as defendants and plaintiffs.
Before joining the firm, Jesse was the Acting Associate Attorney General at the United States Department of Justice. In that role, he oversaw the civil and criminal work of the Antitrust, Civil, Civil Rights, Environment and Natural Resources, and Tax Divisions. During Jesse’s tenure, the Associate’s office closely managed the Department’s most significant litigation, including matters involving large financial institutions, healthcare companies, automakers, energy companies, and state and local governments. In addition, Jesse served as Chair of DOJ’s Regulatory Reform Task Force and Vice Chair of DOJ’s Task Force on Market Integrity and Consumer Fraud. Jesse regularly provided legal and strategic advice to the highest-level decision makers in the federal government, including the Attorney General and Deputy Attorney General, general counsels across the spectrum of federal agencies, and White House officials.
Jesse served for three years as the secretary of Florida’s labor, economic-development, and land-use agency, the Florida Department of Economic Opportunity. Before that, he served as Governor (now Senator) Rick Scott’s general counsel.
Jesse maintains offices in both Washington D.C. and Florida. From Washington, he focuses on federal litigation and crisis management. In Florida, in addition to federal litigation, Jesse employs his knowledge of state government and regulation to help clients in courts across the state, from trial through the Florida Supreme Court.
Jesse currently serves on the Florida Supreme Court Judicial Nominating Commission, the body that provides the governor with nominees for appointment to the Florida Supreme Court. Jesse is also a fellow at the Center for the Study of the Administrative State at the Scalia Law School at George Mason University, where he writes and speaks about administrative law.
Director of the Center for Energy and Environment and Senior Fellow, Competitive Enterprise Institute
Daren Bakst is Director of the Competitive Enterprise Institute’s Center for Energy and Environment and a Senior Fellow. In this role, he manages, develops, and leads the coalition, advocacy, and research activities of the Center, which is one of the most effective advocates for Free Market Environmentalism.
Before joining CEI as Deputy Director in March, 2023, Daren was a Senior Research Fellow in Environmental Policy and Regulation at the Heritage Foundation, where he played a leading role in the launch of the organization’s new energy and environment center, and created and hosted the Heritage Foundation’s energy and environment podcast the “PowerCast.” During his decade at Heritage, Daren wrote about energy and environmental policy, food and agricultural policy (including editing and co-authoring the book Farms and Free Enterprise), regulation, and trade among other topics.
Daren also worked on environmental policy and regulation at the U.S. Chamber of Commerce, where he was a policy counsel and served as the executive to the association’s Government Oversight, Operations & Consumer Affairs committee, which was responsible for issues such as regulatory process reform. Daren has significant state level experience, working for seven years at the Raleigh, N.C.-based John Locke Foundation, one of the largest state-based, free-market think tanks. As director of legal and regulatory studies, his broad portfolio included energy and environmental policy, regulatory reform, and property rights.
Daren has testified numerous times before Congress, regularly submits comments to federal agencies and has appeared in or been quoted by a wide range of media outlets such as The Wall Street Journal, USA Today, The Washington Times, CNN, Fox Business News, Al-Jazeera America, and U.S. News and World Report. He is a member of the Federalist Society’s Environmental Law and Property Rights Executive Committee and serves on the College Level Advisory Board for Constituting America, an organization that informs and educates about the importance of the U.S. Constitution.
Daren, who hails from Florida, received his bachelor’s and master’s degrees from George Washington University. A licensed attorney, he holds a law degree from the University of Miami and a master of laws degree from American University.
Professor of Law Emeritus; Senior Fellow for Climate Policy, Environmental Law Center, Vermont Law School
Patrick A. Parenteau is Emeritus Professor of Law and Senior Fellow for Climate Policy in the Environmental Law Center at Vermont Law School. He previously served as Director of the Environmental Law Center and was the founding director of the EAC (formerly the Environmental and Natural Resources Law Clinic) in 2004.
Professor Parenteau has an extensive background in environmental and natural resources law. His previous positions include Vice President for Conservation with the National Wildlife Federation in Washington, DC (1976-1984); Regional Counsel to the New England Regional Office of the EPA in Boston (1984-1987); Commissioner of the Vermont Department of Environmental Conservation (1987-1989); and Senior Counsel with the Perkins Coie law firm in Portland, Oregon (1989-1993).
Professor Parenteau has been involved in drafting, litigating, implementing, teaching, and writing about environmental law and policy for over three decades. His current focus is on confronting the profound challenges of climate change through his teaching, publishing, public speaking and litigation.
Professor Parenteau is a Fulbright US Scholar and a Fellow in the American College of Environmental Lawyers. In 2005 he received the National Wildlife Federation’s Conservation Achievement Award in recognition of his contributions to wildlife conservation and environmental education. In 2016 he received the Kerry Rydberg Award for excellence in public interest environmental law.
Professor Parenteau holds a B.S. from Regis University, a J.D. from Creighton University, and an LLM in Environmental Law from the George Washington U.
Senior Attorney, Pacific Legal Foundation
Damien Schiff is a senior attorney at Pacific Legal Foundation. He leads its environmental practice group, a unique initiative that draws broadly from PLF’s expertise and success in property rights and separation of powers litigation. Over the years, Damien has represented hundreds of landowners and property rights advocates to defend their liberties against heavy-handed and unwarranted environmental and land-use regulation. His litigation experience includes Sackett v. U.S. Environmental Protection Agency, a groundbreaking decision in which the U.S. Supreme Court upheld the right of landowners to challenge Clean Water Act compliance orders issued by EPA, and Contoski v. Norton, PLF’s successful effort to force the federal government to make good on its promise to delist the bald eagle from the Endangered Species Act.
Besides litigation, Damien has written academic articles on a variety of subjects, including the Endangered Species Act, the Clean Water Act, greenhouse gas torts, the duty to rescue, and international water law. He has appeared on a variety of television and radio programs and has been quoted in The New York Times, The Wall Street Journal, Harper’s Magazine, and The Economist, among other publications.
He obtained his law degree magna cum laude from the University of San Diego School of Law, and his undergraduate degree magna cum laude from Georgetown University. While at USD, he was a research assistant for Professor Bernard Siegan, a leading constitutional theorist and advocate for property rights and economic liberty. Immediately prior to joining PLF, Damien clerked for Judge (and former PLF attorney) Victor Wolski of the United States Court of Federal Claims. Damien credits the mentoring and examples of Professor Siegan and Judge Wolski for his decision to pursue a career in liberty-based public interest litigation.
Damien lives in Sacramento with his wife, two young sons, four chickens, and a cat named Princess. In his off hours he enjoys stamp collecting, Gregorian chant, and martinis—preferably at the same time.
Principal, Advantus Strategies, LLC
John Paul Woodley Jr. is currently the Principal of Environmental and Energy Practice Group for Advantus Strategies. From 2003 to 2009, Woodley served as Assistant Secretary of the Army for Civil Works, supervising the Army Corps of Engineers Civil Works Program. Under his leadership, the Corps Wetland Regulatory Program was strengthened. He also oversaw the restoration of the Florida Everglades and the reconstruction of the hurricane protection system for New Orleans following Hurricane Katrina.
Woodley also served as Assistant Deputy Under Secretary of Defense, Environment, where he was responsible for policy and oversight of the Defense Department’s environmental cleanup, compliance, pollution prevention and natural resource management.
He has also served as Secretary of Natural Resources for Virginia, where he was responsible for environmental protection and for permitting, outdoor recreation, open space management, inland and marine fisheries and historic resources in the Commonwealth.
Woodley served on active duty with the U.S. Army Judge Advocate General’s Corps from 1979 to 1985, and retired from the Army Reserve in August 2003 as a Lieutenant Colonel.
Woodley has been awarded the Legion of Merit, the Meritorious Service Medal (2nd Oak Leaf Cluster), the Army Commendation Medal (1st Oak Leaf Cluster), and the Army Achievement Medal. He has been honored with the U. S. Army Decoration for Distinguished Civilian Service, the Secretary of Defense Medal for Outstanding Public Service and the Silver de Fleury Medal from the Army Engineer Regiment.
Senior Fellow and Director of Finance Policy, Competitive Enterprise Institute
John Berlau is a senior fellow and Director of Finance Policy at the Competitive Enterprise Institute. His work focuses on how public policy affects access to capital, entrepreneurship, and investments made by the public and business community alike. In recent years, he has studied the consequences of financial reform efforts passed by Congress like the Sarbanes-Oxley Act, the government’s response to the 2008 financial crisis including the Dodd-Frank Act, the placement of Fannie Mae and Freddie Mac into conservatorship, and the rise of cryptocurrency.
He is also the author of the book George Washington: Entrepreneur: How Our Founding Father’s Private Business Pursuits Changed America and the World. The book received rave reviews in the Wall Street Journal and other forums, and was endorsed by eminent historians and scholars such as Richard Brookhiser, Amity Shlaes, and Craig Shirley.
Berlau is a contributing writer for Forbes. His work has been published and cited in The Wall Street Journal, The New York Times, The Washington Post, Financial Times, Bloomberg News, The Atlantic, Politico, Daily Caller, Washington Examiner, Investor’s Business Daily, National Journal, National Review, American Spectator, Reason Magazine, and more. He is a frequent guest on radio and television programs, including CNBC’s “The Call,” “Power Lunch” and “Closing Bell,” Fox News’ “Fox & Friends” and “Your World with Neil Cavuto,” and Fox Business’ “Cavuto.”
He has testified on the impact of financial regulation before the House Committee on Financial Services and the House Committee on Energy and Commerce. A recognized expert on the phenomenon of crowdfunding, Berlau has spoken at prominent conferences such as South by Southwest Interactive in Austin, Money 20/20 in Las Vegas, the FinTech Global Expo in San Diego, the CFGE Crowdfund Banking and Lending Summit in San Francisco and the Crowdfund Intermediary Regulatory Advocates (CFIRA) Summit in Washington, D.C. He is also author of the widely cited paper “Declaration of Crowdfunding Independence: Finance of the People, by the People, and for the People.”
Berlau is an award-winning financial and political journalist. He served as Washington correspondent for Investor’s Business Daily and as a staff writer for Insight magazine, published by The Washington Times. In 2002, he received the Sandy Hume Memorial Award for Excellence in Political Journalism from Washington’s National Press Club. He was a media fellow at the Hoover Institution in 2003. He graduated from the University of Missouri-Columbia in 1994 with degrees in journalism and economics.
Executive Vice President & Co-Head of Regulatory Affairs, Bank Policy Institute
Tabitha Edgens is Executive Vice President & Co-Head of Regulatory Affairs, for the Bank Policy Institute.
Ms. Edgens was previously Counselor to the Deputy Chief Counsels and Special Counsel at the Office of the Comptroller of the Currency. In that role, she advised OCC senior leadership on critical bank regulatory issues including national bank digital asset activities, licensing decisions and supervisory matters. She played a leading role in drafting OCC interpretations on the permissibility of national bank digital asset activities as well as the 2019 and 2020 interagency revisions to the Volcker rule. From 2020-2021, Tabitha was detailed to the U.S. Department of the Treasury’s Office of the General Counsel, Banking and Finance, where she advised policymakers on small business pandemic relief programs. Prior to the OCC, Ms. Edgens was an associate at Cleary Gottlieb Steen and Hamilton where she focused on bank regulatory matters. Before her legal career, Tabitha served as an aide to U.S. Senator Mary L. Landrieu.
Tabitha is a graduate of Yale Law School and Tulane University and is a member of the bar in New York and Washington D.C.
Washington Bureau Chief, American Banker
John Heltman is the Washington Bureau Chief for American Banker, leading coverage of federal bank regulators, monetary policy and Capitol Hill.
John, a Washington native living in Baltimore, joined American Banker as a Federal Reserve and Treasury reporter in 2014, launching longform narrative podcast Bankshot in 2019 and running American Banker Magazine from 2021 until 2022. He has received numerous professional awards from the Society for the Advancement of Business Editor and Writers, the American Society of Business Publication Editors and the Jesse H. Neal awards. John won the Grand Neal in 2019 for his podcast "Nobody's Home," which examined the causes and effects of concentrated vacant housing.
John joined American Banker from Argus Media, where he covered the Commodity Futures Trading Commission as the agency was implementing its Dodd-Frank reforms to the commodity and derivatives markets. Prior to that, John covered environmental policy for Inside Washington Publishers from 2008 until 2012.
Senior Counsel, Corporate Engagement Team, Alliance Defending Freedom
Brian Knight serves as senior counsel on the Corporate Engagement Team. His work focuses on issues of financial access, debanking, and preventing the power of the private sector from being weaponized against people of faith by both public and private actors.
Prior to joining ADF, Knight spent almost nine years at the Mercatus Center at George Mason University, as both a senior research fellow and as a program director. In addition to managing a team of scholars, Knight’s research focused on financial regulation and the politicization of financial services. His research helped inform legislation and regulation at the federal and state level. He was also the lead author for two amicus briefs submitted to the U.S. Supreme Court in the case of National Rifle Association v. Vullo.
Before joining Mercatus, Knight worked at the Milken Institute, where he focused on financial technology. He was also an entrepreneur, co-founding a firm focused on compliance for crowdfunding.
Knight earned a Juris Doctor from the University of Virginia School of Law and a Bachelor of Arts from the College of William and Mary.
Director of Health Policy Studies, Cato Institute
Michael F. Cannon is the Cato Institute’s director of health policy studies. His scholarship spans public health; regulation of clinicians, medical facilities, pharmaceuticals, and medical devices; employer‐sponsored and other private health insurance; Medicare; Medicaid; CHIP; the Veterans Health Administration; medical malpractice litigation; administrative law; international health systems; political philosophy; and more. Cannon is “an influential health‐care wonk” (Washington Post) and “the most famous libertarian health care scholar” (Washington Examiner). Washingtonian magazine named Cannon one of Washington, DC’s “Most Influential People” in 2021, 2022, and 2023.
Cannon has appeared on ABC, Al Jazeera, BBC, CBS, CNN, CNBC, C‑SPAN, Fox News Channel, NPR, and other broadcast media. His articles have appeared in the Wall Street Journal; the New York Times; USA Today; the Washington Post; the Los Angeles Times; SCOTUSBlog; Forum for Health Economics and Policy; JAMA Internal Medicine; Health Matrix: Journal of Law‐Medicine; Harvard Health Policy Review; the Yale Journal of Health Policy, Law, and Ethics; the Journal of Health Politics, Policy and Law; and Quinnipiac Health Law Journal. His latest book is Recovery: A Guide to Reforming the U.S. Health Sector.
Cannon was previously a domestic policy analyst for the U.S. Senate Republican Policy Committee, where he advised the Senate leadership on health, education, labor, welfare, and the Second Amendment. He is a member of the Board of Advisers of Harvard Health Policy Review and the Federalist Society Regulatory Transparency Project’s FDA & Health Working Group.
Cannon holds an MA in economics and a JM in law and economics from George Mason University and a BA in American government from the University of Virginia.
Vice Dean for Public Health Practice and Community Engagement, Bloomberg School of Public Health, Johns Hopkins University
Dr. Joshua M. Sharfstein is Vice Dean for Public Health Practice and Community Engagement and Professor of the Practice in Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health. He is also the Director of the Bloomberg American Health Initiative. He is the author of the Public Health Crisis Survival Guide: Leadership and Management in Trying Times, and the co-author of The Opioid Epidemic: What Everyone Needs to Know.
Previously, Dr. Sharfstein served as Secretary of the Maryland Department of Health and Mental Hygiene from January 2011 to December 2014. In this position, he led efforts to align Maryland’s health care system with improved health outcomes, culminating in the adoption of a revised payment model for all hospital care for Maryland residents. He also oversaw the development of a statewide health improvement process with 18 local public-private coalitions and the reshaping of state’s approach to health information exchange, long-term care, and behavioral health.
From March 2009 to January 2011, Dr. Sharfstein served as Principal Deputy Commissioner of the U.S. Food and Drug Administration, where he oversaw the agency’s successful performance management and transparency initiatives. From December 2005 to March 2009, as Commissioner of Health for Baltimore City, Dr. Sharfstein led innovative efforts that contributed to major declines in both overdose deaths and infant mortality rates. From July 2001 to December 2005, as minority professional staff and health policy advisor for Congressman Henry A. Waxman, Dr. Sharfstein was engaged in a wide range of oversight and legislative activities on health care topics, including emergency preparedness, HIV, and the politicization of science.
Dr. Sharfstein graduated summa cum laude with an A.B. in Social Studies from Harvard College in 1991. From August 1991 to August 1992, he worked on public health projects in Guatemala and Costa Rica with a Frederick Sheldon Prize Fellowship. He graduated from Harvard Medical School in 1996, from the Boston Combined Residency Program in Pediatrics at Boston Medical Center and Children’s Hospital in 1999, and from the fellowship in general academic pediatrics at the Boston University School of Medicine in 2001.
Dr. Sharfstein is an elected member of the Institute of Medicine (2014) and fellow of the National Academy of Public Administration (2013). He serves on the editorial board of the Journal of the American Medical Association. His awards have included the Jay S. Drotman Memorial Award from the American Public Health Association (1994), Public Official of the Year from Governing Magazine (2008) and the Circle of Commendation Award from the Consumer Product Safety Commission (2013).
Dr. Sharfstein lives with his family in Baltimore, Maryland.
Managing Director, Berkeley Research Group
Dan Troy is the Managing Director at Berkeley Research Group.
Prior to that, he was the Chief Business Officer, Chief Administrative Officer, and General Counsel of Valo in Boston, Massachusetts.
Prior to joining Valo, he served as the Senior Vice President & General Counsel of GlaxoSmithKline and was a member of its Corporate Executive Team. Dan joined GSK in September 2008 and was responsible for leading the company’s legal department in protecting GSK’s intellectual property; managing litigation; supporting business development transactions; and business compliance and risk management. In 2012, Dan led the integration team following the acquisition of Human Genome Sciences, which later resulted in the launch of Benlysta, the first lupus treatment in 50 years. Dan led GSK’s Contributions Committee in the US and also led the Government Affairs, Public Policy and Patient Advocacy team from 2012 until 2014.
Prior to joining GSK, he was a Partner at the Washington law firm Sidley Austin LLP, where he principally represented pharmaceutical companies and trade associations on matters related to the US Food and Drug Administration (FDA) and government regulations. Dan was formerly Chief Counsel for the FDA, where he served as a primary liaison to the White House and the US Department of Health and Human Services.
Dan has chaired the American Bar Association's Section of Administrative Law and is a member of the American Law Institute. He currently chairs the US Chamber of Commerce Litigation Center. He has also chaired the Civil Justice Reform Group, as well as the PhRMA Law Section Executive Committee. He was the 2012 CPR Corporate Leadership Award recipient and, in 2013, was named a 'Legend in the Law' at the Burton Awards.
Dan holds a B.S. in Industrial and Labor Relations from Cornell University and a J.D. from Columbia University School of Law, where he was a member of the Law Review and a Kent Scholar. After graduation from law school, he was a law clerk for the US Circuit Court of Appeals for the District of Columbia Circuit.
Senior Transportation Policy Analyst, Reason Foundation
Marc Scribner is a senior transportation policy analyst at Reason Foundation.
Scribner's work focuses on a variety of public policy issues related to transportation, land use, and urban growth, including infrastructure investment and operations, transportation safety and security, risk and regulation, privatization and public finance, urban redevelopment and property rights, and emerging transportation technologies such as automated road vehicles and unmanned aircraft systems. He frequently advises policymakers on these matters at the federal, state, and local levels.
Scribner has testified before Congress at the invitation of both Democrats and Republicans on issues including highway revenue collection, traffic congestion management, and airport financing. He is a member of the Transportation Research Board's Standing Committee on Emerging Technology Law.
He has appeared on television and radio programs in outlets such as Fox Business Network, National Public Radio, and the Canadian Broadcasting Corporation, and has also written for numerous publications, including USA Today, The Washington Post, Wired, CNN.com, MSNBC.com, Forbes, and National Review. And his work has been featured by The Wall Street Journal, New York Times, Washington Post, Los Angeles Times, Scientific American, Congressional Quarterly, Washington Monthly, POLITICO, CNN, Bloomberg, BBC, C-SPAN, and other print, television, and radio outlets.
Scribner joined Reason Foundation after more than a decade at the Competitive Enterprise Institute, where he was a senior fellow in transportation policy. He received his undergraduate degree in economics and philosophy from George Washington University.
Senior Fellow, R Street Institute
Prior to R Street, Adam spent 12 years as a senior fellow at the Mercatus Center at George Mason University. Before the Mercatus Center, he served as the president of the Progress and Freedom Foundation. Adam has also worked for the Adam Smith Institute, the Heritage Foundation and the Cato Institute.
Adam has published 10 books on a wide range of topics, including online child safety, internet governance, intellectual property, telecommunications policy, media regulation and federalism.
In 2008, Adam received the Family Online Safety Institute’s “Award for Outstanding Achievement.”
Senior Fellow, American Enterprise Institute
Mark J. Perry is concurrently a senior fellow at AEI and a professor emeritus of economics at the University of Michigan. He is best known as the creator and editor of the popular economics blog Carpe Diem. At AEI, Perry writes about economic and financial issues for American.com and the AEIdeas blog.
Devon Westhill is the Assistant Secretary for Civil Rights at the U.S. Department of Agriculture. The U.S. Senate confirmed President Donald Trump’s nomination of Westhill on October 7, 2025.
Westhill returns to the USDA where he previously headed the civil rights office as Deputy Assistant Secretary in President Trump’s first term. His previous government appointments also include service at the U.S. Department of Labor, liaison to the Administrative Conference of the U.S., and liaison to the White House Initiative on Historically Black Colleges and Universities. Prior to returning to government service, Westhill was President and General Counsel of a nonprofit civil rights organization.
Westhill has testified on civil rights matters before Congress, federal agencies, and as an expert witness in federal court. He has spoken hundreds of times at college campuses, conferences, and on radio and TV programs, and he is frequently quoted in print publications, and his writing has appeared in numerous national outlets. A U.S. Navy veteran, Westhill earned his BA from the University of North Carolina at Chapel Hill and his JD from the University of Florida.
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.
Professor, University of Minnesota Law School
Ilan Wurman is the Julius E. Davis Professor of Law at the University of Minnesota, where he teaches administrative law and constitutional law. He previously taught at Arizona State University. He writes primarily on the Fourteenth Amendment, administrative law, separation of powers, and constitutionalism. His academic writing has appeared in the Yale Law Journal, the Stanford Law Review, the University of Chicago Law Review, the University of Pennsylvania Law Review, the Virginia Law Review, the Duke Law Journal, the Minnesota Law Review, the Notre Dame Law Review, and the Texas Law Review among other journals.
Professor Wurman is the author of a casebook, Administrative Law Theory and Fundamentals: An Integrated Approach (Foundation Press 2d ed. 2024). He is also the author of A Debt Against the Living: An Introduction to Originalism (Cambridge 2017), and The Second Founding: An Introduction to the Fourteenth Amendment (Cambridge 2020). His next book, The Constitution of 1789: A New Introduction, is also forthcoming with Cambridge University Press.
Professor Wurman practices law with the firm Tully Bailey. He has litigated a variety of administrative law and constitutional law cases, including cases involving COVID-19 restrictions, transmission lines, and Appointments Clause challenges. He also devised winning public nuisance theories to force city governments to address the increasingly challenging public camping crises throughout the country.
Attorney, Pacific Legal Foundation
Luke A. Wake is an attorney at the Pacific Legal Foundation. Prior to joining PLF, he was a senior staff attorney at the NFIB Small Business Legal Center.
Wake has particular expertise on environmental and land use issues, and has worked on numerous other constitutional issues and matters of importance to small business owners. He is an ardent defender of private property rights, which he believes are essential to the free enterprise system and the foundation of American liberty. As a strong advocate of individual rights and economic liberties, he has built his career defending small business interests.
Wake has focused on a whole host of issues, from employment law matters to regulatory compliance. In addition to serving as a resource for small business owners, Wake is committed to ensuring that the voice of small business is heard in the nation’s courts. As an appellate practitioner, Wake has focused particularly on informing the courts on matters of administrative law and on issues under the Fifth Amendment’s Takings Clause. He is also working to advance small business interests in law review articles, and was recently published in the Berkeley Journal of Law & Ecology. See R.S. Radford & Luke A. Wake, Deciphering and Extrapolating: Searching for Sense in Penn Central, 38 Ecology L.Q. 731, 746-747 (2011).
Before joining the Legal Center’s team, Wake completed a prestigious two-year fellowship as an attorney in the Pacific Legal Foundation’s College of Public Interest Law. Wake is a graduate of Case Western Reserve University School of Law in Cleveland Ohio, and is a member of the California Bar. He completed his undergraduate studies at Elon University in North Carolina in 2006 where he focused on political theory and corporate communications.
Partner, Sullivan & Cromwell LLP
Andrei Iancu is a partner at Sullivan & Cromwell and one of the leading voices in intellectual property law and innovation policy. He is a former Undersecretary of Commerce for Intellectual Property and Director of the U.S. Patent and Trademark Office (USPTO), a position to which he was confirmed unanimously by the Senate. Andrei has decades of experience representing plaintiffs and defendants in IP matters across the technical and scientific spectra, including medical devices, genetic testing, therapeutics, the Internet, telephony, TV broadcasting, video game systems and computer peripherals. He represents clients in litigation and trials before the district courts, the U.S. International Trade Commission and the USPTO, the Federal Circuit and U.S. Supreme Court, and also counsels clients on obtaining, licensing, enforcing and defending against IP rights globally.
Partner, Cravath Swaine & Moore LLP
David J. Kappos is a partner at Cravath. He is widely recognized as one of the world’s foremost leaders in the field of intellectual property, including intellectual property management and strategy, the development of global intellectual property norms, laws and practices as well as commercialization and enforcement of innovation-based assets. Mr. Kappos supports the Firm’s clients with a wide range of their most complex intellectual property issues, including those pertaining to blockchain and financial technology (FinTech).
From August 2009 to January 2013, Mr. Kappos served as Under Secretary of Commerce and Director of the United States Patent and Trademark Office (USPTO). In that role, he advised the President, the Secretary of Commerce and the Administration on intellectual property policy matters. As Director of the USPTO, he led the Agency in dramatically re-engineering its entire management and operational systems as well as its engagement with the global innovation community. He was instrumental in achieving the greatest legislative reform of the U.S. patent system in generations through passage and implementation of the Leahy‑Smith America Invents Act, signed into law by President Obama in September 2011.
Prior to leading the USPTO, Mr. Kappos held several executive posts in the legal department of IBM, the world’s largest patent holder. From 2003 to 2009, he served as the company’s chief intellectual property lawyer. In that capacity, he managed global intellectual property activities for IBM, including all aspects of patent, trademark, copyright and trade secret protection. Mr. Kappos joined IBM as a development engineer. During his more than 25 years at IBM, he served in a variety of roles including litigation counsel and Asia Pacific IP counsel, based in Tokyo, Japan, where he led all aspects of intellectual property protection, including licensing, transactions support and mergers and acquisitions activity for the Asia/Pacific region.
Mr. Kappos has received numerous accolades for his contributions to the field of intellectual property, including, among others, the 2014 Global Agenda Council Vision Award for the Intellectual Property Council’s pro bono initiative from the World Economic Forum, the 2014 Jefferson Medal from the New Jersey Intellectual Property Law Association (NJIPLA), the 2013 Board of Director’s Excellence Award from the American Intellectual Property Law Association (AIPLA), the 2013 Champion of Intellectual Property Award from the District of Columbia Bar Association and the 2013 North America Government Leadership Award from Semiconductor Equipment and Materials International (SEMI). He was named one of the “Top 25 Icons of IP” by Law360, one of the “50 Most Influential People in Intellectual Property” and the “Outstanding Practitioner of the Year in IP Transactions” by Managing IP, one of the “Top 50 Intellectual Property Trailblazers & Pioneers” and one of the “100 Most Influential Lawyers in America” by The National Law Journal, “Intellectual Property Professional of the Year” by the Intellectual Property Owners Association and inducted into the Intellectual Property Hall of Fame by Intellectual Asset Management Magazine in 2012. Mr. Kappos was also recognized as a leading lawyer by IAM Strategy 300, IAM Patent 1000, World IP Review, The Legal 500 US, Who’s Who Legal: Patents, Lawdragon, Super Lawyers and The Best Lawyers in America. He is a frequent speaker and has authored many published articles on various intellectual property, innovation and leadership topics.
Mr. Kappos serves on the Boards of Directors of the Partnership for Public Service, the Center for Global Enterprise and the Intellectual Property Owners Education Foundation. He is the Chair of the Advisory Council of the Naples Roundtable, and the U.S. Chair of the U.S.-China IP Cooperation Dialogue. He is also an Adjunct Professor at Columbia Law School, where he teaches copyright litigation, and Cornell Law School, where he teaches legal advising for the start-up general counsel.
Mr. Kappos was born in Palos Verdes, California. He received a B.S. summa cum laude in Electrical and Computer Engineering from the University of California, Davis in 1983 and a J.D. from the University of California, Berkeley in 1990.
Elvin R. Latty Professor of Law, Duke University School of Law
Arti Rai, Elvin R. Latty Professor of Law and co-Director, Duke Law Center for Innovation Policy, is an internationally recognized expert in intellectual property (IP) law, administrative law, and health policy. Rai has also taught at Harvard, Yale, and the University of Pennsylvania law schools. Rai's research on IP law and policy in biotechnology, pharmaceuticals, and software has been funded by NIH, the Kauffman Foundation, and the Woodrow Wilson Center. She has published over 50 articles, essays, and book chapters on IP law, administrative law, and health policy. Her publications have appeared in both peer-reviewed journals and law reviews, including Science, the New England Journal of Medicine, the Journal of Legal Studies, Nature Biotechnology, and the Columbia, Georgetown, and Northwestern law reviews. She is the editor of Intellectual Property Law and Biotechnology: Critical Concepts (Edward Elgar, 2011) and the co-author of a 2012 Kauffman Foundation monograph on cost-effective health care innovation.
From 2009-2010, Rai served as the Administrator of the Office of External Affairs at the U.S. Patent and Trademark Office (USPTO). As External Affairs Administrator, Rai led policy analysis of the patent reform legislation that ultimately became the America Invents Act and worked to establish the USPTO’s Office of the Chief Economist. Prior to that time, she had served on President-Elect Obama’s transition team reviewing the USPTO. Prior to entering academia, Rai clerked for the Honorable Marilyn Hall Patel of the U.S. District Court for the Northern District of California; was a litigation associate at Jenner & Block (doing patent litigation as well as other litigation); and was a litigator at the Federal Programs Branch of the U.S. Department of Justice's Civil Division.
Rai regularly testifies before Congress and relevant administrative bodies on IP law and policy issues and regularly advises federal agencies on IP policy issues raised by the research that they fund. She is a member of the National Advisory Council for Human Genome Research and of an Expert Advisory Council to the Defense Advanced Projects Research Agency (DARPA). Rai is a public member of the Administrative Conference of the United States, a member of the American Law Institute, and co-chair of the IP Committee of the Administrative Law Section of the ABA. Rai is currently a member of the Institute of Medicine Committee on Strategies for Responsible Sharing of Clinical Trial Data and has served on, or as a reviewer for, numerous National Academies of Science committees. In 2011, Rai won the World Technology Network Award for Law.
Rai graduated from Harvard College, magna cum laude, with a degree in biochemistry and history (history and science), attended Harvard Medical School for the 1987-1988 academic year, and received her J.D., cum laude, from Harvard Law School in 1991. Rai's moot court team at Harvard Law School won Best Brief and Team honors at the school's prestigious Ames Moot Court Competition.
Professor of Law and Director, Intellectual Property and Information Law Program, Benjamin N. Cardozo School of Law, Yeshiva University
Saurabh Vishnubhakat is a Professor of Law and Director of the Intellectual Property and Information Law Program at Cardozo Law. He is also a Research Fellow at the Duke Law Center for Innovation Policy and a Senior Scholar at the George Mason University Center for IP and Innovation Policy. Previously, he held joint appointments as a Professor of Law and Professor of Engineering at Texas A&M University.
Professor Vishnubhakat’s expertise is in intellectual property, administrative law and federal litigation, especially from an empirical perspective. His legal writings have been cited in federal judicial opinions, agency regulations and over two dozen Supreme Court briefs. His latest work is published or forthcoming in the Indiana Law Journal, the Washington and Lee Law Review and the Iowa Law Review as well as the peer-reviewed Journal of the Copyright Society of the USA and the Journal of Economic Perspectives.
His research explores the interaction of the U.S. intellectual property system with federal courts and agencies, among other topics. With a background in the natural sciences, Professor Vishnubhakat brings a scientific mindset to legal thinking and is dedicated to teaching students how to build arguments with analytical rigor.
Prior to his appointment at Texas A&M, Professor Vishnubhakat served in the United States Patent and Trademark Office as principal legal advisor to that agency’s first two chief economists. He was also a faculty fellow at Duke Law School, where he co-taught patent law and was a postdoctoral associate at the Duke Center for Public Genomics, where he researched law and policy issues surrounding innovation in genetics and biomedicine.
Professor Vishnubhakat holds both a J.D. and LL.M. in intellectual property from the University of New Hampshire Franklin Pierce School of Law, where he was an editor of the Law Review. He also holds a B.S. in chemistry from the Georgia Institute of Technology. He is admitted to the bars of Texas, Illinois, the U.S. Court of Appeals for the Federal Circuit and the Supreme Court of the United States.