David will be joined by other experts in the field including Ed Sellers, Michael Klein (former Director of the Controlled Substance Staff [CSS] at the FDA) and Dominic Chiapperino (current Director of CSS).
Session Chairs: Reem Elbekai, Otsuka Pharmaceutical Development and Commercialization, Rockville, MD; and William Brock, Brock Scientific Consulting, LLC, Montgomery Village, MD.
Pharmacology and Molecular Mechanisms of Drugs of Abuse
Michael Klein, Controlled Substance Scientific Solutions, LLC, Chevy Chase, MD
Building the Nonclinical Study Package to Address Abuse Potential
David Heal, DevelRx Ltd, Nottingham and University of Bath, United Kingdom
Conducting a Successful Human Abuse Potential Study and Leveraging Data from Other Clinical Trials
Edward Sellers, University of Toronto and DL Global Partners Inc, Toronto, ON, Canada
The US FDA’s Role in Drug Scheduling and the Eight Factor Analysis
Dominic Chiapperino, U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD