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 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
Promise to Pathway: Understanding Federal Cannabis Regulation and How to Communicate for Progress
Jessica Wasserman, Partner at WassermanRowe and Co-Chair of the CFCR Science and Regulatory Affairs Committee
Sarah A. Chase, Executive Director
Council for Federal Cannabis Regulation (CFCR)
Real-World Data to Support FDA Filings: Impact on Traditional Drug Development, Decentralized Trials and FDA Review
Rodney William Butt, Sr VP – Strategic Solutions
Nutrasource Pharmaceutical & Nutraceutical Services
The Importance of FDA/Health Authority Due Diligence for Life Sciences Transactions
Winston S. Kirton, Partner
Winston & Strawn LLP
JESSICA WASSERMAN is the founder of Washington-DC based law and regulatory policy firm WassermanRowe. She brings to decades of experience as a practitioner representing highly regulated industries before federal agencies, including at the Food and Drug Administration on behalf of food, beverage, wellness and medical device companies. Jessica gets into the nitty gritty of premarket approvals, withdrawals, recalls, labeling and claims for FDA-regulated food, drugs, dietary supplements, medical devices, cosmetics, petfood and tobacco/vape products. Most recently, Jessica is proud of her role in assisting Covid 19 test developers to receive FDA Emergency Use Authorizations, necessary to get these important tests on the market. Jessica has worked since 2018, when hemp was de-scheduled, assisting hemp and CBD companies to commercialize their products. She has also donated many hours working on behalf of the industry as a whole in advocacy efforts toward a regulatory pathway at FDA for the marketing of CBD products. With experience working on Capitol Hill and as a political appointee at the Departments of Agriculture and Commerce, Jessica has a 360-degree view of the legislative, regulatory, and political path toward cannabis legalization. Jessica is a graduate of St. John’s College and the University of Michigan Law School.
RODNEY WILLIAM BUTT is Senior Vice President of Strategic Solutions at Nutrasource Pharmaceutical & Nutraceutical Services. Over the last 30 years Rod has been involved in all aspects of prescription drug development clinical trials, and organizational design within the pharmaceutical and allied industries. Rod’s experience with pharmaceutical drug development includes a broad spectrum of related activities from participation and leading international drug development teams, acting as key consultant on product development strategies, leading medical / clinical research departments, building research physician networks and acting as key liaison between Pharma and Investigators. Rod is a frequent speaker at pharma Industry events and is a lecturer in drug development at the University of Guelph. Rod completed his MSc in Clinical Trial Methodology at McMaster University and his MBA at Queen’s University.
WINSTON S. KIRTON is a leader in Winston & Strawn LLP’s FDA practice providing advice and counsel to biopharmaceutical, medical device, and food companies on corporate transactions, research and development, manufacturing and supply chain, and commercial regulatory and compliance matters. He also advises clients on legal disputes related to third-party contract manufacturing relationships, third-party supplier relationships, and alliance-partner relationships, as well as global health authority, government agency engagement and communications. Winston has significant international legal and business life sciences experience developed over many years working in-house for multinational biopharmaceutical companies. He previously served as the executive legal counsel and trusted business advisor of a multinational U.S. pharmaceutical company, working closely with leadership to prevent and minimize global regulatory and legal manufacturing and supply risks. Winston leverages his international in-house experience in quality and compliance, regulatory affairs, compliance and ethics, and legal affairs to provide end-to-end advice and counsel to clients.January 13, 2022
12:00-1:00 PM ET
Registration is open to FDLI members only and is first come, first served.
This is a complimentary virtual event.
Please only sign up for one discussion as they will take place at the same time.
For questions, please contact Tess Garraty.
