Overview
This panel of experts will discuss how the practice of FDA law has changed since they started their careers. They will compare how working in the industry has evolved and what can be expected in the future, as well as whether the FDCA can continue to address an ever-growing and changing industry. A reception will follow the panel presentation. This program is limited to FDLI members who are a part of NFDL, summer associates, and student members.
Speakers
Karen R. Gally, Vice President, and General Counsel, Otsuka America Pharmaceutical, Inc.
Lewis Grossman, Ph.D., JD, Professor of Law at American University
Sonali P. Gunawardhana, Chief Counsel, FDA & Regulatory Law, McKesson Corporation and Member, FDLI Board of Directors
Stuart Pape, Chair, FDA Practice, Polsinelli PC
Moderated by Jennifer L. Bragg, Partner, Life Sciences and Health Care; Litigation, Skadden, Arps, Slate, Meagher & Flom LLP
JENNIFER L. BRAGG is a partner at the law firm of Skadden, Arps, Slate, Meagher & Flom LLP in Washington, DC. She is head of the firm’s Washington, DC litigation practice and is a nationally recognized lawyer advising Food and Drug Administration (FDA)-regulated companies facing government investigations and related enforcement challenges. Since serving in the FDA’s Office of Chief Counsel as associate chief counsel for enforcement, Ms. Bragg has represented companies in criminal and civil litigation and strategic regulatory matters. She is frequently called upon to conduct due diligence and related counseling in connection with transactions in the life sciences and health care industries, and has extensive litigation and trial experience. Ms. Bragg’s primary practice involves advising pharmaceutical and medical device companies in connection with complex regulatory issues in an effort to minimize litigation and enforcement risks, as well as overcome transactional hurdles. She has been recognized in the highest band in Chambers USA for her work in the pharmaceutical and medical device space. In addition to her thriving practice, Ms. Bragg is a member of the firm’s Women’s Initiatives Committee, which is designed to promote the retention and advancement of women in the firm.
KAREN GALLY is Vice President and General Counsel at Otsuka America Pharmaceutical, Inc. Karen is passionate about using her legal acumen to positively contribute to Otsuka’s business, mission and employee culture. Her leadership style is firmly rooted in Otsuka’s purpose to defy limitation, so that others can too. Driven by the belief that people perform best when they are challenged, she actively seeks ways to continuously encourage those around her to reach their full potential and fulfilment. Karen focuses on legal issues related to clinical development, product commercialization, and corporate governance. Karen loves the diversity of the opportunities she has had in her Otsuka career, which has afforded her the ability to work on the legal issues for a compound from Phase I studies through its full lifecycle. In addition, Karen supports the Boards of Directors of Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC) and Otsuka America Pharmaceutical, Inc. (OAPI). Karen’s ability to evolve and learn has served her well throughout her career. Prior to joining Otsuka in 2003, Karen was an Associate with Epstein, Becker & Green in the Washington, D.C. office in the national health law practice group. From 1996 through 2003, she represented national healthcare companies in the areas of durable medical equipment, home healthcare, and pharmaceuticals in criminal and civil investigations. Before earning her J.D. from the University of Maryland Carey Law School in Baltimore, Karen worked in public relations and public policy in Albany. She also holds a Bachelor of Arts from Dartmouth College in Hanover, New Hampshire. Outside of Otsuka, Karen is on the Board of Directors of the Alliance of Aging Research and the Alumni Board of the University of Maryland Carey Law School.
LEWIS A. GROSSMAN is Professor of Law and Affiliate Professor of History at American University. He has also been a Law and Public Affairs Fellow at Princeton University and a Visiting Professor at Cornell Law School. He teaches and writes in the areas of food and drug law, health law, American legal history, and civil procedure. Prior to joining the American University faculty, Professor Grossman was an associate at Covington & Burling LLP (where he currently serves as Of Counsel), and before that he clerked for Chief Judge Abner Mikva of the US Court of Appeals for the DC Circuit. His scholarship has appeared in numerous academic journals and published volumes. In October 2021, Oxford University Press published Professor Grossman’s book, Choose Your Medicine: Freedom of Therapeutic Choice in America. He is also the co-author (with Peter Barton Hutt) of Food and Drug Law: Cases and Materials. He has served on four committees of the Health and Medicine Division (formerly the Institute of Medicine) of the National Academies of Sciences, Engineering, and Medicine. He is also a former member of the FDLI board of directors. Professor Grossman earned his PhD in History from Yale University, where he was awarded the George Washington Egleston Prize for Best Dissertation in the Field of American History. He received a JD from Harvard Law School and a BA from Yale University.
SONALI P. GUNAWARDHANA is Chief Counsel- FDA & Regulatory Law at McKesson Corporation. In this role, Sonali provides regulatory legal support to McKesson’s businesses, including pharmaceutical private label products, 3PL, REMS programs, clinical research programs, pharmaceutical and medical device distribution. Previously, Sonali served as outside counsel to a myriad of pharmaceutical and medical device companies while in private practice at Wiley Rein LLP and Shook, Hardy & Bacon LLP respectively. Prior to her tenure in private practice, Sonali served as Regulatory Counsel at the FDA for close to ten years. There she assisted on a variety of legal and policy issues in the following Centers: the Center for Devices and Radiological Health; the Center for Drug Evaluation and Research; and the Center for Food Safety and Applied Nutrition. Sonali received a BA from Syracuse University, a MA from Webster University, an MPH from Boston University, a JD from the University of New Hampshire School of Law and a LLM from Washington College of Law, American University.
STUART M. PAPE is senior partner and chair of the FDA practice at Polsinelli. He helps clients understand and face challenges presented by regulations imposed by the US Food and Drug Administration (FDA), US Department of Agriculture (USDA), and similar health and safety regulatory bodies worldwide. He focuses on assisting clients in obtaining approval of new food ingredients, pharmaceuticals, and medical devices; advising on labeling and advertising of regulated products; assisting in enforcement proceedings initiated by regulatory bodies; helping clients develop sound strategies in the face of challenges from NGOs; and lobbying in connection with legislative consideration of statutory changes to the laws governing FDA regulated products. Regularly appearing before the FDA, USDA, the Federal Trade Commission, Consumer Product Safety Commission, US Customs and Border Protection, numerous other federal and state regulatory bodies, and the Congress of the United States, Stuart serves clients across the US in many capacities. Previously, he served in various positions in the Office of the Chief of Counsel at the FDA, including as associate chief counsel for food. In 1978, he received the FDA Commendable Service Award. He also served as executive assistant to FDA Commissioner Donald Kennedy. Stuart is ranked in Chambers USA: America’s Leading Lawyers in Business, Food and Beverages: Regulatory and Litigation; Selected for in inclusion in Super Lawyers; included in The Best Lawyers in America, FDA and in Who’s Who in America and Who’s Who in the World. In 2012, he received the Judge Learned Hand Award from the American Jewish Committee. Stuart is a 1970 graduate of the University of Virginia and a 1973 graduate of its Law School.May 23, 2022
4:45–6:30 PM ET
Agenda
4:45-5:00 PM | Check-In
5:00-5:45 PM| Panel Discussion
5:45-6:30 PM | Reception
The Panel Discussion will be indoors. In the event of inclement weather, the Panel Discussion and Reception will be indoors.
This program is limited to FDLI members who are a part of NFDL, summer associates, and student members. This complimentary program includes a light reception. Please register by May 20 to reserve your spot.
New to Food and Drug Law Group
The New to Food and Drug Law Group (NFDL) offers young professionals with up to six years of experience an opportunity to connect, learn from their peers, and enhance their skills. Individuals affiliated with member organizations, those employed by the government, and law students are encouraged to participate.
For questions, please contact Bianca Cardona.
Location
Confirmed Location
Skadden, Arps, Slate, Meagher & Flom LLP
Rooftop
1440 New York Avenue, NW
Washington, DC 20005
Program Host
