Drug Delivery, Bioavailability, Clinical Trial Design
Actions of Cannabinoids On & Via the Skin
8:00 am Skin as a Prototypic Translational Scientific Organ
Synopsis
- The Skin’s ECS: The skin as a translational organ in the context of classical translational scientific applications: diseases, models, and new trends
- Targeting the skin: application routes, efficacy challenges
- Discussing entourage to synergism, the ‘better than CBD’ story
8:30 am Delivering Therapeutic Cannabinoids Via Skin: Exploring Current State & Future Perspective to Achieve Low Psychotropic Side Effects
Synopsis
- Identifying how cannabinoid research is gaining renewed interest given favorable policy changes
- Exploring delivery via the transcutaneous route and understanding its promise for cannabinoids
- How is the potential of microneedles and other active strategies underutilized?
- Understanding the importance of academic collaborations with respect to cannabinoid R&D
9:00 am Complex Chemically Active Transdermal Emulsion System Systemically Delivering CBD for the Treatment of Dravet syndrome & Lennox-Gastaut syndrome Patients: A Clinical Perspective
Synopsis
- Novel chemically active transdermal system used for systemic delivery of therapeutic concentrations of CBD and THC
- Review of in vivo patient bioavailability data including blood concentrations curves for delivery of CBD and THC over a 12-hour period
- Review of in vivo patient response in CBD clinical trials to treat Dravet syndrome and Lennox-Gastaut syndrome patients
9:30 am Panel Discussion: Enhancing Bioavailability of CBD Molecules
Synopsis
- New CBD derivatives with higher bioavailability
- Discussing meaningful differences between topical, oral, and transdermal delivery
- Exploring formulations and penetration enhancers
9:50 am Morning Break & Poster Session
Synopsis
Submit, present and review data from across the CBD therapeutic field to get up to speed with pipeline progress beyond the presentations.
CBD in Pipelines: An update on MoA, Efficacy, & Research Direction of CBD Therapeutics
10:30 am A SPR Binding- & Proteomics-Based Platform for the Biological Evaluations of Cannabinoids’ Anti-Inflammasome Activity in Human Skin Cells
Synopsis
- Discussing CBD and minor cannabinoids
- Data from skin inflammation (acne, psoriasis, rosascea)
- Identifying targets
11:00 am Battle of Synthetic Cannabinoids vs Natural Cannabinoids: Discussing ‘The Entourage Effect’ Referring to The Synergistic Interaction Between Different Cannabinoids
Synopsis
- Review of cannabinoid subtypes; natural versus synthetic
- Entourage effects of natural cannabinoids in human therapies
- Potential advantages and disadvantages of analogous synthetic cannabinoids in human therapies
11:30 am A Novel Synthetic THC Analog That Diminishes Pain & Anxiety While Enhancing Cognition
Synopsis
- Understanding the process of development and testing of novel cannabinoid analogs that optimizes side effect properties
- Reviewing the strengths and vulnerabilities of THC as a therapeutic drug
- Sharing novel, dramatic cognitive enhancing potential of novel cannabinoids based on their pharmacodynamic properties
12:00 pm Making CBD Genuine Human Medicine
Synopsis
- The FDA-approval process framework is best for making CBD and other cannabinoids safe and effective medicine
- Novel delivery technologies may enhance the value of CBD and other cannabinoids as medicine.
- An evidence-based, pharmaceutical-centered mindset has led to the use of Ananda Scientific’s proprietary CBD investigational drug, Nantheia™, in Investigational New Drug (IND) application-approved, placebo-controlled human studies
12:30 pm Lunch & Networking
12:30 pm How Does the Price & Availability of Medical Cannabis Affect the Development of Phytocannabinoid Products for Widespread Use?
Synopsis
- Bringing cannabis-based medicinal products to market in compliance with the 1961 UN Single Convention on Narcotic Drugs: Where and how?
- Does R&D provide a competitive advantage for unauthorized medications?
- Market share: Illegal, medicinal, recreational
Clinical Decisions & Evidence-Based Retrospections to More Confidently Develop Cannabinoid-Derived Drugs
1:30 pm Mind Over Matter: Considerations for Cannabinoid Clinical Trials – Regulatory Considerations & Designs to Minimize Placebo Effects
Synopsis
- Discussing “The Sativex Experience” – Randomized double-blind placebo controlled trials versus enriched designs
- Variables effecting cannabinoid clinical trials: patient population, background medication, rescue medication and beyond
- The medical cannabis conundrum – life beyond THC and CBD
- What’s next?
2:00 pm Approval & Beyond: Risk Assessment in Selecting a Clinical Trial Outcome
Synopsis
- Review primary outcomes selected for existing examples of cannabinoid drug development: what worked, what didn’t, and why.
- Strengths and weaknesses in choosing patient-reported outcomes, clinician-reported outcomes, and objective outcomes.
- Agency guidance for specific therapeutic areas and agency partnership
2:30 pm Afternoon Break & Networking
3:00 pm Importance of Foundational Cannabinoid Science Education Throughout Development of Cannabinoid-Derived Drugs
Synopsis
- Discussing the uniqueness of misinformation for cannabinoids, the endocannabinoid system, and the complexity of their interactions
- Retrospective analysis of Jazz’s journey in medical education alongside product launch
- Sharing a blueprint for evidence-based information generation to support cannabinoidbased medicine development