News Archive
IU McKinney's Annual Fall CLE Event Features Experts on Regulation and Ethics in Health Law
10/12/2016
The Annual Fall Continuing Legal Education Program at IU McKinney considered the topic “Regulating Innovation: Best Practices and Ethics in Health Law” during the event on October 11 at Inlow Hall.
Alice Fisher from the Washington, D.C., firm Latham & Watkins began the event with a discussion of “The Foreign Corrupt Practices Act.” Fisher focuses her practice on global white collar criminal investigations, including a range of government enforcement matters.
Faegre Baker Daniels attorneys Jessica Cox from the Indianapolis office and Joe Price from the Minneapolis office discussed, “Biosimilars: Liability Issues.” Cox concentrates her practice on the defense of pharmaceutical companies, device manufacturers and other industry leaders involved in product liability litigation. Price focuses exclusively in the area of complex litigation, mass tort and class action products liability defense, especially litigation involving pharmaceuticals and medical devices.
Patrick Raulerson, Senior Regulatory Counsel in the FDA’s Center for Drug Evaluation and Research’s Office of Regulatory Policy; and Dave Ceryak, Senior Director – Assistant General Counsel, Regulatory Legal Team at Eli Lilly and Company talked about “Biosimilars: Regulatory Issues.” Raulerson works on a wide range of legal and policy matters related to biosimilars, abuse-deterrent opioids, combination products, and medical gasses. Ceryak leads the team that counsels on drug and device matters, including clinical development, registration, Hatch-Waxman, biosimilars, good manufacturing practices, diagnostics, and drug safety.
United States Attorney Josh Minkler of the Southern District of Indiana centered his discussion on the topic, “Issues Surrounding the DOJ’s ‘Yates Memo.’” He has been an assistant United States Attorney for the Southern District of Indiana since 1994. He was appointed by the U.S. District Court to serve as U.S. Attorney in 2015.
Professor James Dimitri of IU McKinney presented “Legal Writing in the Electronic Age.” He has written and spoken about teaching legal writing, appellate advocacy, and persuasion. He also has spoken on the topics of intergenerational theory and the use of technology in teaching.
Mike Witte, ’82, Executive Secretary of the Indiana Disciplinary Commission, provided the “Indiana Ethics Update.” Prior to joining the Commission, Witte served as a judge for 25 years, including as judge pro tem in Wayne Superior Court 1, Dearborn Superior Court 1, and Dearborn County Court. His teaching experience is primarily in legal ethics, impaired driving, and traffic court administration.
In the top photo from left are Jessica Cox, David Ceryak, IU McKinney Dean Andrew R. Klein, Patrick Raulerson, Joe Price, IU McKinney Professor James Dimitri, and Munjot Sahu of Faegre Baker Daniels (who co-authored an article on biosimilars with Cox and Price).
In the bottom photo is U.S. Attorney Josh Minkler.
