Managing Director, Berkeley Research Group
Dan Troy is Managing Director and an expert witness on FDA matters at Berkeley Research Group. Previously he served as Chief Counsel of the US Food and Drug Administration and General Counsel of GlaxoSmithKline PLC.
Publius comes from the pen name Alexander Hamilton, James Madison, and John Jay used when they wrote 85 publicly printed letters now known as the Federalist Papers. Hamilton chose “Publius” as a name that would represent friends of the newly proposed American republic - Publius Valeria Publicola was a Roman general who helped to found the Roman Republic. The Federalist Society continues the tradition of publishing things under the name Publius in celebration of our constitutional roots and recognition that author credit is not always necessary.
Managing Director, Berkeley Research Group
Dan Troy is Managing Director and an expert witness on FDA matters at Berkeley Research Group. Previously he served as Chief Counsel of the US Food and Drug Administration and General Counsel of GlaxoSmithKline PLC.
John S. Battle Professor of Law, University of Virginia School of Law
Julia D. Mahoney teaches courses in property, government finance, constitutional law and nonprofit organizations. A graduate of Yale Law School, she joined the University of Virginia faculty as an associate professor in 1999 and is now John S. Battle Professor of Law. She has also taught at the University of Southern California Law School and the University of Chicago Law School, and before entering the legal academy, practiced law at the New York firm Wachtell, Lipton, Rosen & Katz. Her scholarly articles include works on land preservation, eminent domain, health care reform and property rights in human biological materials.
Stevenson Bernard Professor, George Washington University Law School
The Honorable F. Scott Kieff is the Stevenson Bernard Professor at George Washington University Law School and a Visiting Fellow at Stanford University’s Hoover Institution.
He served as Commissioner of the U.S. International Trade Commission from 2013-2017. He also served during the Bush, Obama, and Trump Administrations in the part-time leadership of the national security defense-intelligence community.
He was previously a professor of law and medicine at Washington University in Saint Louis and a Senior Fellow at Hoover. A former law clerk to U.S. Circuit Judge Giles S. Rich, he is a graduate of Penn Law School and MIT, where he studied molecular biology and microeconomics. He was elected to the European Academy of Sciences and Arts in 2012 and the Academia Europaea in 2024.
His private sector work through Kieff Strategies LLC (www.kieffstrategies.com) provides neutral services including mediation and compliance, and expert services including crisis management, advising, and testimony.
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.
Managing Director, Berkeley Research Group
Dan Troy is Managing Director and an expert witness on FDA matters at Berkeley Research Group. Previously he served as Chief Counsel of the US Food and Drug Administration and General Counsel of GlaxoSmithKline PLC.
President, Cass & Associates, PC
Ronald A. Cass is Dean Emeritus of Boston University School of Law (where he was Dean from 1990-2004), President of Cass & Associates, PC, former Vice-Chairman and Commissioner of the U.S. International Trade Commission, former faculty member at Boston University School of Law and the University of Virginia Law School, and Distinguished Senior Fellow at the C. Boyden Gray Center for the Study of the Administrative State. Dean Cass also sits as an arbitrator for commercial, international, and intellectual property rights disputes, and is a former United States member of the Panel of Conciliators of the International Centre for Settlement of Investment Disputes. He is a member of the Council of the Administrative Conference of the United States and has received seven presidential appointments, spanning Presidents Ronald Reagan to Donald J. Trump.
As a law professor, lecturer, and scholar, Dean Cass has been teaching and writing about a wide array of legal issues on topics such as administrative law and regulation, antitrust, constitutional law, communications, intellectual property, international trade, separation of powers, and legal process. He has published more than 160 scholarly books, chapters, articles, and papers, including a leading casebook on administrative law. Dean Cass has taught judges as well as students in schools of law, economics, business, and public policy and has held academic appointments in the United States, Europe, and Latin America.
In addition to his academic work, Dean Cass has participated in numerous important legal cases as an amicus, consultant, or expert, and has advised businesses, law firms, investment funds, and government agencies on a range of trade, antitrust, intellectual property, and regulatory issues. He has a broad range of affiliations with professional groups, and has received numerous honors, fellowships and awards.
Dean Cass is a graduate of the University of Virginia and the University of Chicago Law School.
Managing Director, Berkeley Research Group
Dan Troy is Managing Director and an expert witness on FDA matters at Berkeley Research Group. Previously he served as Chief Counsel of the US Food and Drug Administration and General Counsel of GlaxoSmithKline PLC.
Partner, Willkie Farr & Gallagher LLP
Francis J. Menton, Jr. is a partner in the Litigation Department and Co-Chair of the Business Litigation Practice Group of Willkie Farr & Gallagher LLP in New York. Mr. Menton specializes in complex and technical commercial litigation, principally contract and securities claims. He has a nationwide trial practice, and has tried cases in state and federal courts including Colorado, Kansas, Massachusetts, Michigan, New York, Puerto Rico, Texas, Virginia, and Washington.
Mr. Menton is the author of "New Opportunities for Defendants in Securities Class Actions," Engage (Fall 2007), "Can You Protect Yourself Against Identity Theft?" New York Law Journal (April 29, 2002), and "Top Ten Federal Government Efforts to Suppress Free Speech," Federalist Society Free Speech and Election Law News (Summer 2000, 1999, 1998). He also authored "Evaluating Claims Under The Securities Litigation Reform Act of 1995," New York Law Journal (January 6, 1996).
Stevenson Bernard Professor, George Washington University Law School
The Honorable F. Scott Kieff is the Stevenson Bernard Professor at George Washington University Law School and a Visiting Fellow at Stanford University’s Hoover Institution.
He served as Commissioner of the U.S. International Trade Commission from 2013-2017. He also served during the Bush, Obama, and Trump Administrations in the part-time leadership of the national security defense-intelligence community.
He was previously a professor of law and medicine at Washington University in Saint Louis and a Senior Fellow at Hoover. A former law clerk to U.S. Circuit Judge Giles S. Rich, he is a graduate of Penn Law School and MIT, where he studied molecular biology and microeconomics. He was elected to the European Academy of Sciences and Arts in 2012 and the Academia Europaea in 2024.
His private sector work through Kieff Strategies LLC (www.kieffstrategies.com) provides neutral services including mediation and compliance, and expert services including crisis management, advising, and testimony.
John S. Battle Professor of Law, University of Virginia School of Law
Julia D. Mahoney teaches courses in property, government finance, constitutional law and nonprofit organizations. A graduate of Yale Law School, she joined the University of Virginia faculty as an associate professor in 1999 and is now John S. Battle Professor of Law. She has also taught at the University of Southern California Law School and the University of Chicago Law School, and before entering the legal academy, practiced law at the New York firm Wachtell, Lipton, Rosen & Katz. Her scholarly articles include works on land preservation, eminent domain, health care reform and property rights in human biological materials.
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.
Managing Director, Berkeley Research Group
Dan Troy is Managing Director and an expert witness on FDA matters at Berkeley Research Group. Previously he served as Chief Counsel of the US Food and Drug Administration and General Counsel of GlaxoSmithKline PLC.
State-Level Protection for Good-Faith Pharmaceutical Manufacturers
Daniel E. Troy
In 1996, the Michigan legislature enacted a common-sense proposition into law: drug-safety determinations should be...
Combating Bioterrorism: The Product Liability Threat
Bert W. Rein, Kristina Reynolds Osterhaus
By: Bert W. Rein and Kristina R. Osterhaus [1]The September 11 attack and recent anthrax...
Panel Analyzes First Amendment Concerns Raised in Pharmaceutical Regularion: Summary of "FDA and the First Amendment"-- October 21, 2002
Recent court decisions reflect increasing judicial interest in the constitutional rotections afforded to speech regarding...
Mass Tort (Mississippi)
Publius
In 2000, a group of 155 plaintiffs filed suit against the manufacturers of the prescription...
An Address by the Honorable Daniel Troy
Daniel E. Troy
MR. TROY: Thank you very much. It is always a pleasure to get outside the...
Intellectual Property: Intellectual Property Rights: Advancing or Hindering Medical Breakthroughs?
2001 National Lawyers Convention
Washington, DCIntellectual Property: Advancing or Hindering Medical Breakthroughs? - Transcript
Robert Oldham, Michael Werner, Julia D. Mahoney, F. Scott Kieff, Arti K. Rai, Daniel E. Troy
The Intellectual Property Practice Group sponsored this panel during the 2001 National Lawyers Convention on...
Domestic Regulation and International Trade: Where's the Race?
Ronald A. Cass
INTRODUCTION Critics claim that international trade undermines a nation's ability to maintain an independent national...
FDA Censorship Could Cost Lives
Daniel E. Troy
Last month brought news that an inexpensive generic drug is remarkably effective in reducing congestive...
Top Ten Federal Government Efforts to Suppress Free Speech 1998-99
Francis J. Menton
It's been another year of tireless struggle by the Government to suppress the free speech...