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
Biden’s FDA: What’s Next for the Agency?
Kristin M. Kaplan, Of Counsel, Shook, Hardy & Bacon LLP
and Sonia Nath, Partner, Cooley LLP
How FDA Center for Tobacco Products Communicates Regulatory Decisions: “Technical Project Lead Reviews” and What They Tell Us
Jim Solyst, Principal
JMS Scientific Engagement
FDA and USDA Regulatory Compliance Challenges with Cell-Based Foods
Allen Sayler, Advisor and Independent Consultant
EAS Consulting Group
SONIA NATH is a partner in the litigation and healthcare, life science, and FDA regulatory groups at Cooley LLP. Before joining Cooley, Sonia served for nearly a dozen years in the FDA’s Office of the Chief Counsel (OCC), handling litigation matters for the agency across the gamut of FDA-regulated products, including pharmaceuticals, medical devices, conventional foods, dietary supplements, OTC drugs, animal drugs, tobacco, and biologics. Sonia handled civil enforcement actions and defensive matters for her first eight years in OCC. During her last four years in the office, she also handled criminal prosecutions involving a wide variety of FDA-regulated products in her appointed role as Special Assistant United States Attorney (SAUSA) with the US Attorney’s Office in the Central District of California. In 2018, Sonia received the Award of Merit, the agency’s highest award, for her dedication to the agency’s mission through enforcement activities.
KRISTIN M. KAPLAN is of counsel at Shook, Hardy & Bacon LLP. She is a recognized leader in FDA regulatory practice with extensive experience working in the tobacco, animal health, pharmaceutical and medical device and food industries. She provides critical leadership—legal insights, advice and recommendations—to clients on sensitive and controversial regulatory topics affecting their products. Kristin counsels on the approval, marketing and defense of FDA-regulated products and guides clients on their responses to actions taken by regulatory agencies. She also negotiates with regulatory agencies on behalf of clients, and assists clients in creating and implementing best practices. She advises her clients on proactive steps to avoid litigation and to implement risk mitigation recommendations. Before joining Shook, Kristin was the deputy general counsel in charge of global regulatory legal support and litigation at a global animal health company. She also worked for more than eight years as associate chief counsel for FDA, advising the agency on sensitive, controversial and precedent-setting matters, including the approval of novel drug applications. She also developed, reviewed and evaluated various legal and regulatory documents while at FDA. She uses her insider’s knowledge of the US government regulatory environment to clients’ advantage in their legal matters.
JAMES M. SOLYST is Vice President, Federal Regulatory Affairs with Swedish Match North America, where he coordinates the Company’s Modified Risk Tobacco Product (MRTP) process and related regulatory science engagements. He has held senior positions in Washington, DC-based companies and associations, including the National Governors’ Association, American Chemistry Council, and the consulting firm Ramboll-Environ. During his over 35 years in Washington, he has worked closely with federal agencies, including the US Environmental Protection Agency (EPA), US Food and Drug Administration (FDA), and the Office of Management and Budget (OMB). He has also worked with international organizations, including the United Nations (UN), World Health Organization (WHO), and Organisation for Economic Co-operation and Development (OECD). Mr. Solyst has served as a member of the Food and Drug Law Institute (FDLI) Tobacco Committee, on the American Chemical Society (ACS) Committee on Environmental Improvement, the National Academy of Sciences (NAS) Chemical Sciences Roundtable, and the NAS Committee on Promoting Safe and Secure Chemical Management in Developing Countries. He also served as an External Affiliate to the health technology, including clinical diagnostic tests, digital health, health IT, and combination products.
ALLEN SAYLER is the Senior Director for Food Consulting Services at EAS Consulting Group LLC., part of the Certified Laboratory family of companies. EAS is headquarter in the Alexandria, Virginia (across the Potomac from Washington, DC). His food-based career spans thirty-eight years, sixteen years as a state, FDA and USDA food regulator, with the last twenty-two years as a food processing industry regulatory advisor, specializing in evaluation, assessments and the trouble shooting of food plant processing operations and their food safety and quality programs, having attained ISO 22000, BRC auditor certifications. He is an FDA-recognized “Lead Instructor” for the US FDA FSMA regulations on Preventive Controls for Human Foods (PCHF) and the Foreign Supplier Verification Program (FSVP) and is familiar with the SQF, BRC, IFS, FSSC22000 and various ISO food safety standards. At EAS, he leads the food consulting services provided by almost 170 Independent Consultants, each with 20 or more years of experience in their area of expertise. Mr. Sayler has been active in the International Dairy Federation (IDF) since 1996 and has served in various leadership roles, including being elected to the IDF Scientific Program Coordination Committee (SPCC) in October. He has a working knowledge of USDA, FDA, EPA and US Customs & Border Protection requirements as they apply to foods imported into the US. He received Group Excellence Awards from both the US FDA and the US Department of Agriculture, the Harold Barnum and the Lifetime Membership Award from IAFP and the IDF Leadership and Prize of Excellence Award from IDF in 2020.September 23, 2021
12:00-1:00 PM EST
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.
