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.
Adjunct Professor, George Washington University
Howard W. Cox is a former federal prosecutor, criminal investigator and Senior Intelligence Service officer. After almost 40 years of federal service, he retired as the Assistant Inspector General for Investigations of the Central Intelligence Agency. In this capacity, Mr. Cox supervised criminal, civil and administrative investigations conducted by the Office of Inspector General (OIG). Prior to his employment with the CIA, Mr. Cox was the Assistant Deputy Chief of the Computer Crime and Intellectual Property Section of the Department of Justice, where he was responsible for supervising criminal prosecutions of federal hacking and identity theft cases. While at the Department of Justice, Mr. Cox received the Attorney General’s Distinguished Service Award.
Prior to his service with the Department of Justice, Mr. Cox served as a manager, attorney and criminal investigator at OIG offices at the US Postal Service, the Department of Defense, and the General Services Administration. He also served as Staff Counsel for the US Senate Permanent Subcommittee on Investigations. Prior to his federal civilian service, Mr. Cox was also a Captain and trial attorney in the US Army’s Judge Advocate General’s Corps. Mr. Cox also served as Law Secretary to the Hon. Sherwin D. Lester, NJ Superior Court.
Mr. Cox is an adjunct professor at George Washington University, where he teaches graduate level courses in computer forensics. He is also an instructor with the Graduate School USA, and the Federal Law Enforcement Training Center, where he teaches courses related to procurement fraud and electronic search and seizure. Mr. Cox received his AB degree from Seton Hall University, South Orange, NJ. He received his law degree from Georgetown University Law Center, Washington, DC.
Judge, United States Court of Appeals, Sixth Circuit
Judge Readler earned his undergraduate and law degrees from the University of Michigan. After graduating, he served as a law clerk to Judge Alan Norris of the United States Court of Appeals for the Sixth Circuit. Judge Readler then began practicing law in the Columbus office of the international law firm Jones Day, eventually spending ten years as a partner in the firm’s Issues and Appeals Practice Group. While at Jones Day, Judge Readler appeared in state and federal trial and appellate courts around the country, most frequently the Supreme Court of Ohio and the Sixth Circuit. Judge Readler also successfully argued before the United States Supreme Court in McQuiggin v. Perkins on behalf of an inmate claiming actual innocence. His other pro bono representations include representing capital defendants before the Tenth Circuit and the Supreme Court of Ohio, as well as representing defendants sentenced to life in prison before the Sixth Circuit. While at Jones Day, Judge Readler traveled to Nairobi with Lawyers Without Borders to train Kenyan lawyers in prosecuting domestic violence cases, and he was also a recipient of the American Marshall Memorial Fellowship awarded by the German Marshall Fund of the United States. Following his career in private practice, Judge Readler served as Acting Assistant Attorney General for the Civil Division of the United States Department of Justice from 2017 to 2019. In that role, Judge Readler led and supervised over 1,000 lawyers in the Department’s largest litigating division, briefing and arguing several cases on behalf of the United States in federal courts across the country, including high-profile cases significant to the Administration and the Department. In March 2019, Judge Readler was confirmed to serve as a Circuit Judge on the Sixth Circuit. He resides in Columbus.
Partner, Ashbrook Byrne Kresge Flowers LLC
Ben Flowers, a partner at Ashbrook Byrne Kresge Flowers LLC, is an accomplished litigator with experience briefing, arguing, and winning high-stakes cases in courts throughout the country.
Before joining the law firm, Ben served as Ohio's 10th Solicitor General. In that role he regularly represented the State of Ohio before the Supreme Court of the United States, the United States Court of Appeals for the Sixth Circuit, and the Supreme Court of Ohio. Most prominently, in National Federation of Independent Business v. Department of Labor, Ben led a multi-state challenge to OSHA's vaccine mandate, ultimately prevailing before the Supreme Court.
Ben is a graduate of The Ohio State University and the University of Chicago Law School. Following law school, Ben clerked for Judge Sandra Ikuta of the U.S. Court of Appeals for the Ninth Circuit and for Justice Antonin Scalia of the Supreme Court of this United States. Ben lives in Upper Arlington, Ohio with his wife Denise and their three very active children.
Executive in Residence, Wake Forest University School of Business
John Allison is an Executive in Residence at the Wake Forest School of Business. He is a member of the Cato Institute’s Board of Directors and Chairman of the Executive Advisory Council of the Cato Institute’s Center for Monetary and Financial Alternatives. Allison was president and CEO of the Cato Institute from October 2012 to April 2015. Prior to joining Cato, Allison was chairman and CEO of BB&T Corporation, the 10th-largest financial services holding company headquartered in the United States. During his tenure as CEO from 1989 to 2008, BB&T grew from $4.5 billion to $152 billion in assets. He was recognized by theHarvard Business Reviewas one of the top 100 most successful CEOs in the world over the last decade.
Allison has received the Corning Award for Distinguished Leadership, been inducted into the North Carolina Business Hall of Fame, and received the Lifetime Achievement Award from theAmerican Banker. He is the author of The Financial Crisis and the Free Market Cure: Why Pure Capitalism Is the World Economy’s Only Hope and The Leadership Crisis and the Free Market Cure: Why the Future of Business Depends on the Return to Life, Liberty, and the Pursuit of Happiness. In addition, he is a former Distinguished Professor of Practice at Wake Forest University School of Business, and serves on the Board of Visitors at the business schools at Wake Forest, Duke, and the University of North Carolina–Chapel Hill.
Allison is a Phi Beta Kappa graduate of the University of North Carolina–Chapel Hill. He received his master’s degree in management from Duke University and is also a graduate of the Stonier Graduate School of Banking. Allison is the recipient of six honorary doctorate degrees.
Wayne A. Abernathy, Wild Bells
Wayne A. Abernathy is a former U.S. Treasury Assistant Secretary for Financial Institutions under President George W. Bush, receiving the Alexander Hamilton Award in recognition of his service. In that office he was also a member of the Board of Directors of the Securities Investor Protection Corporation. Prior to his work at the Treasury, Mr. Abernathy served as Staff Director of the Senate Banking Committee, under Chairman Phil Gramm.
Following his service at the Treasury, Mr. Abernathy worked for 15 years on the staff of the American Bankers Association, as Executive Vice President for Financial Institutions Policy and Regulatory Affairs.
Previous experience with the Senate Banking Committee includes serving as Staff Director of the Subcommittee on Securities during 1995-1998. From 1989 until 1994, Mr. Abernathy was a Republican economist for the committee. He previously worked as a senior legislative assistant for Senator Gramm during 1987-1989 and as an economist for the Banking Committee’s Subcommittee on International Finance and Monetary Policy during 1981-1986, under Chairman Jake Garn.
Mr. Abernathy earned his bachelor’s degree in International Studies from The Johns Hopkins University in 1978. In 1980, he received a master’s degree in International Studies from the School of Advanced International Studies of The Johns Hopkins University.
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Note from the Editor: This article critically discusses the CREATES Act, which is currently pending...
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John A. Allison, Wayne A. Abernathy
Note from the Editor: The following is a transcript of a Federalist Society Practice Group...
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