It is more important than ever to connect and share ideas. The Law Over Lunch series offers FDLI members the exclusive opportunity to engage in facilitated virtual discussions over lunch on topics of interest to the food and drug law community. This event features unique and co-occurring discussion groups, limited to ten attendees per topic to encourage fruitful conversation. This member-only benefit is a chance to closely learn from, educate, and network with other professionals in the field on new and pertinent topics.
Please only sign up for one discussion as they will take place at the same time.
Table Topics and Facilitators
Biden Administration Priorities for FDA and the COVID-19 Pandemic
Vanessa K. Burrows, Counsel, Simpson Thacher & Bartlett LLP
Understanding How Absence of Federal Clarity on CBD Can Impact the Marketplace
Michelle Dimarob, Senior Director, Federal Government Relations, Altria Client Services
Challenges and Priorities for Compliance Programs in 2021
Hannah Bornstein, Partner, Nixon Peabody, Government Investigations & White Collar Defense
VANESSA BURROWS is Counsel in Simpson Thacher & Bartlett LLP’s Corporate Department and is based in the Washington, DC office. Vanessa has advised pharmaceutical and medical device manufacturers, healthcare and technology companies, hospitals and other providers in connection with regulatory and compliance needs, as well as in connection with M&A and capital-raising transactions. Vanessa has extensive experience counseling clients with respect to Health Insurance Portability and Accountability Act (HIPAA) compliance, health privacy, security and breach issues, fraud and abuse compliance, pharmacy law, cannabis and hemp laws, and public health matters, including medical countermeasures, emergency preparedness, and quarantine and isolation. Previously, Vanessa held several government positions focused on healthcare regulation. Her experience includes serving as HIPAA Privacy Officer and Attorney for the Department of Public Health for the City of Chicago. Vanessa also advised Members of Congress and their staff on FDA matters as a Legislative Attorney with the Congressional Research Service. She handled healthcare law, administrative law and constitutional law matters during the creation and passage of the Patient Protection and Affordable Care Act (ACA) and the 2009 H1N1 pandemic. Vanessa received her JD, cum laude, from American University, Washington College of Law, an MA, with honors, from Queen’s University Belfast, and a BA, magna cum laude, from Valparaiso University. Vanessa is a member of the Food and Drug Law Institute’s Webinar Committee and served as a Vice Chair of Member Engagement for the Women’s Leadership Council for the American Health Lawyers Association. She is admitted to practice in the District of Columbia and Illinois.
MICHELLE DIMAROB is a Sr. Director of Federal Government Affairs for Altria. Michelle has worked on and around Capitol Hill for more than 20 years – first as a Congressional staffer to Congressman George Radanovich (CA-19) and later for Congresswoman Jo Ann Emerson (MO-8) and Small Business Committee Chairman Jim Talent (MO-2). Active in both political campaigns and public policy, Michelle served as a spokesperson and lobbyist for the National Federation of Independent Business (NFIB) where she worked on improving access to and affordability of health care for small businesses owners and their employees. In 2011, Michelle returned to the Hill where she served as Sr. Advisor to Ways and Means Committee Chairman Dave Camp (MI-4). As the lead spokesperson for his communications team and chief coalition strategist, Michelle worked alongside the Ways and Means Committee team to advance trade, health care and tax policy. Michelle joined Altria’s Federal Government Affairs team in 2014 as the principal on corporate tax and wine policy. Currently, Michelle leads work on cannabis for the public policy team. Michelle is a graduate of Fresno State and the University of Oklahoma.
HANNAH R. BORNSTEIN is a partner and the deputy practice group leader of Nixon Peabody’s Government Investigations & White-Collar practice group and is also a member of the firm’s Life Sciences team. She represents individuals and multi-national companies in compliance matters, investigations and litigation. She is experienced in health care industry matters involving the False Claims Act; the Food, Drug and Cosmetic Act; and the Anti-Kickback Statute. Hannah represents life sciences companies, including pharmaceutical and medical device companies, in responding to governmental inquiries or investigations conducted by the United States Attorney’s Office and the Department of Justice, among others. She has advised companies in responding to grand jury subpoenas, HIPAA subpoenas and civil investigative demands (CIDs), as well as informal requests for information. She assists companies in conducting internal investigations into potentially problematic conduct within a company and provides pro-active compliance advice, including compliance with FDA regulations.Proposed Regulatory Framework for Modifications to Artificial Intelligence/ Machine Learning- Based Software as a Medical Device
Priya Mannan, Associate General Counsel, Novartis Pharmaceuticals
Regulatory and Legal Implications of Innovative Clinical Trial Designs and Tools in Biologics and Drugs
Jacqueline R. Berman, Partner, Morgan, Lewis & Bockius LLP
PRIYA MANNAN is a solution based business partner and lawyer who loves to listen and move the business forward in achieving its goals. As she has primarily been a pharmaceutical and medical device lawyer, patients come first to her. She graduated law at the top of her class at the age of 21. And started her career as a biochemist and lawyer. After a few years in the law firms practicing Healthcare and Intellectual property law she was hired by Pfizer where she developed business development, and licensing skills. She then gained medical device expertise on legal, regulatory and compliance matters. She was also instrumental in launching their first drug coated stent Endeavor. She was then recruited by Baxter as a senior FDA lawyer to support their Bioscience business. In 2009, she joined Novartis and has had the opportunity to build her team focused on corporate governance, clinical, research and licensing contracts, compliance and regulatory matters. She has been on leadership teams advising the business since 2005.
JACQUELINE R. BERMAN is a partner in Morgan Lewis’ FDA Practice. Jackie counsels pharmaceutical and biologic companies, manufacturers, investigators, contract research organizations, and investors, as well as pharmacies, distributors, and healthcare institutions on U.S. Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and U.S. Department of Health and Human Services (HHS) regulatory, transactional, compliance, and enforcement matters. She advises clients on product development strategies, clinical and pre-clinical trials, expanded access, marketing applications, recalls, labeling, and promotion and advertising. Jackie also works with companies on post-marketing obligations including adverse event reporting and compliance with current good manufacturing practices (cGMP). She is a frequent writer and lecturer on these issues. Jackie is a graduate of American University, Summa Cum Laude, and The George Washington University Law School with Highest Honors.February 18, 2021
12:00-1:00 PM
Registration is open to FDLI members only and is first come, first served.
This is a complimentary virtual event.
For questions, please contact Tess Garraty.