Development of Cannabinoids for Clinical Use - CNS Hazards and Therapeutic Effects

Tuesday April 27, 2021

4:00 pm - 5:30 pm Eastern Time (ET)

View session on the EB Virtual Platform (EB registration required)

BEH DDD MP NEU TOX TCP

Chair :

Ziva Cooper
UCLA Cannabis Research Initiative



The development of potential therapeutic products such as cannabinoids is a complex process that requires the integration of various types of data to understand the potential therapeutic and toxic effects of products in humans. This symposium will review the regulatory expectations of the FDA for the quality of cannabinoid-containing products that are either botanicals or highly purified drug products, discuss the antinociceptive and adverse effects of cannabinoids in animals and leverage these results to inform the design of clinical protocols, and review the analgesic and adverse effects of cannabinoids in humans.

Speakers

Brenda Gannon - Mercer University College of Pharmacy

Cannabinoids: Product Quality Information and Regulatory Expectations

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.

Peter Winsauer - Louisiana State University Health Sciences Center

Effects of Cannabinoids on Complex Behaviors and Antinociception in Animals

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 .

Marcus Delatte - Parexel International

Cannabinoids: Hazard Assessment and Management Based on Nonclinical Data

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.

Ziva Cooper - UCLA Cannabis Research Initiative

Cannabinoids in the Clinic: Considering Abuse Liability when Evaluating Analgesic Effects

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.

Last Updated: February 8, 2021
Key Dates
 
April 27 – 30, 2021

ASPET Annual Meeting at EB 2021

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