Dr. Gannon will compare the process of conducting a product quality assessment for cannabis extracts and purified cannabinoid drugs, as well as discuss approaches to address quality issues that may result in clinical safety concerns. This insight will inform the attendees about the regulatory expectations for the quality of products and the challenges in the development of cannabinoid-containing products.

Dr. Winsauer will present data from monkeys administered cannabinoids to demonstrate that the disruptions in learning and antinociception are mediated by the cannabinoid type-1 receptors (CB1R), and to discuss potency ratios calculated for cannabinoids across the assays employed. These data from monkeys will provide attendees with a direct comparison of cannabinoid doses that produce therapeutic (i.e., antinociception) and adverse (i.e., disruptions in learning and/or memory) effects in the same species, findings that provide insight into the potential therapeutic index for these drugs .

Dr. Delatte will present hazard assessments for delta9-THC and cannabidiol (oral doses) based on published data and describe approaches for managing these hazards. Each assessment will identify the target organs of toxicity and discuss the clinical significance of toxicities produced by these cannabinoids. Insights on the assessment and management of hazards related to delta9-THC and cannabidiol will inform the attendees of approaches employed to determine the safety concerns related to cannabinoids and to leverage the findings obtained from nonclinical studies to inform clinical protocol design. Nonclinical data may be leveraged to help ensure the safety of humans by informing inclusion/exclusion criteria, dosing schedule, and safety monitoring in clinical protocols.

Dr. Cooper will present data from randomized clinical trials and human laboratory studies assessing the risk profile with attention to the abuse liability and the potential therapeutic effects of cannabinoids. Strategies for optimizing analgesic effects and mitigating adverse effects will be discussed. These data will inform the attendees of the risk/benefit profile of these products and the challenges related to developing these products for therapeutic uses such as pain management.