Agenda | Materials

subject to change

November 2, 2018

8:15 AM
Registration and Continental Breakfast

8:30 AM
Welcome and Announcements
Judy Rein
, Director, Publications, FDLI

8:40 – 9:30 AM
History and Overview of Cannabis Regulation

Presenters: Erika Lietzan, Associate Professor, University of Missouri School of Law
  Lewis A. Grossman, Professor of Law, Washington College of Law, American University

9:30 – 10:20 AM
Canadian Liberalization and the Global Market

Presenter: Patrick Moen, General Counsel, Privateer Holdings

10:20 – 10:30 AM
Networking and Coffee Break

10:30 – 11:45 AM
Edibles and Infused Products

Authors: Deborah Shelton, Practice Group Leader, Food & Drug Law Practices, McCarter & English, LLP
  Daniel L. Flint, Ph.D Associate, McCarter & English, LLP
  “Points to Consider When Seeking Approval of Cannabis Edibles as Botanical Drugs”
  Kellsi Booth, Attorney, Wake Law Group (Los Angeles, CA)
  “The Mysteries of Medibles: Exploring the Regulation of Marijuana-Infused Products Intended for Medical Use”
Discussant: James O’Reilly, University of Cincinnati
Moderator: Daniel Dwyer, Partner, Kleinfeld Kaplan & Becker LLP

11:45 – 1:15 PM
Luncheon Keynote
Aidan Hampson
, Program Officer, Clinical Research Grants Branch, Division of Therapeutics & Medical Consequences, Special Content Expert on Cannabis, National Institute on Drug Abuse, National Institutes of Health
Introduced by Joseph A. Page, Professor Emeritus, Georgetown University Law Center and Faculty Advisor, Food and Drug Law Journal

1:15 – 2:30 PM
Medical Product Pathways

Authors: Heike Newman, Senior Regulatory Manager, University of Colorado
  “Marijuana Research in Colorado 2018”
  Micha Mesure, Wake Law Group (Los Angeles, CA)
  “Using Foreign Data for Cannabis Derived Drug: Israel as a Guideline to Satisfy FDA Requirements and Comply with Federal Regulation”
Discussant: Linda Bentley, Member, Mintz, Levin LLP
Moderator: Sandra Retzky, Johns Hopkins University and FDA

2:30 – 2:45 PM
Networking and Coffee Break

2:45 – 4:15 PM
Strategies and Constraints for Moving Forward

Authors: Srikumaran Melethil, Professor Emeritus, Schools of Pharmacy and Medicine, University of Missouri-Kansas City
  “State Regulation of the Commerce and Uses of Marijuana, a Federal Schedule I Drug”
  Tami Wahl, Principal, Tami L. Wahl
  “A Modern, Forward-Thinking State-Federal Framework”
  Eric Lindblom, Director, Tobacco Control and Food & Drug Law, O’Neill Institute for National & Global Health Law, Georgetown University Law Center
  “How FDA Could Use Its Existing Authorities to Make State Legalization of Cannabis for Medical or Broader Purposes More Safe and Effective”
Discussant: Erica M. Jackson, Partner, K & L Gates LLP
Moderator: Robert Giddings, Attorney, Hutchison PLLC and Chair, FDLI Editorial Advisory Board, Food and Drug Law Journal


4:15 PM
FDLI Membership Discussion: Cannabis-Derived Products and Future Programming
FDLI invites Symposium participants to join FDLI members and staff in a brainstorming session led by FDLI President & CEO Amy Rick to share ideas for FDLI’s future engagement in this emerging area.

5:00 – 6:00 PM
Sponsored by Wake Law Group, APC