2023 CONFERENCE DAY 2 | Wednesday, September 13

Drug Delivery, Bioavailability, Clinical Trial Design

Actions of Cannabinoids On & Via the Skin

8:00 am Skin as a Prototypic Translational Scientific Organ

  • Tamas Biro Principal Scientific Advisor, Alterola Biotech Inc.


  • 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


  • 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


  • 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


  • 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


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

  • Hang Ma Assistant Professor, University of Rhode Island


  • 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


  • 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

  • Adam Kaplin President & Chief Scientific Officer, Mira Pharmaceuticals, Inc


  • 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


  • 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?


  • 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


  • 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


  • 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


  • 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

3:30 pm Panel Discussion: A Translational Journey: What Does it All Mean for Regulatory Approval?

3:50 pm End of Conference