9.00AM - 5.00PM EDT | 6.00AM - 2.00PM PDT
9:00 am Preconference Virtual Networking
9:20 am Chair’s Opening Remarks
9:30 am Optimizing Method of Delivery to Maximize Efficiency of Administration
Synopsis
• Cover a wide array of methods of administration including, oral, topical,
nanotechnology-based and more
• Outline what formulation requirements apply to each method to ensure
effective drug delivery
• Discuss how to test these compounds in a preclinical and clinical setting
Sourcing, Extraction and Synthesis of Cannabinoid for Research
9:50 am Cannabinoid-Related IP: Novelty Amidst a Treasure Trove
10:10 am Live Presenter Q&A
10:20 am The Evolving Cannabinoid API Market: Disruption for Some, Normal Course for Most
Synopsis
10:40 am Advancements in Cannabinoid-Derived Active Pharmaceutical Ingredients Towards Regulatory Approval
Synopsis
11:10 am Panel Discussion: Designing an IP Strategy from the Ground Up that Will Give you the Edge
Synopsis
11:40 am Live Presenter Q&A
12.00 Speed Virtual Networking and Morning Break
Early Stage Drug Development Track
Clinical Development Track
Discovering the Next Generation of Novel Cannabinoid Pharmaceuticals
Using new discoveries in cannabinoid pharmacology and receptor biology to discover new therapeutics
Overcoming Clinical Trial Design Challenges for Greater Reliability
Improve clinical outcomes at all stages and assemble data for regulatory review
12.30 pm New Insights and Data on the Structure and Function of CB2
- The crystal structure of the human cannabinoid CB2 reveals how small molecules affect CB2 differently
- Structural analysis reveals a high degree of conformational similarity with the agonist bound CB1
- Foreseeing the yin-yang relationship of CB2 & CB2 facilitating the design of selective drugs
Alex Makriyannis, Director, Center for Drug Discovery, Northeastern University
12.30 pm CBD as a Pharmaceutical: Requirements and Phase 1 Clinical Trial Results
- Increasing the oral bioavailability of CBD, in a manner acceptable to regulatory authorities in the United States and elsewhere, is essential to making it a reliable medicine
- A Phase 1 PK shows confirms that ANANDA Scientific’s uniquely enhanced CBD, or Liquid StructureTM CBD, rapidly and prodigiously enters the body, with Tmax at 1 hour instead of the 2-3 hours seen with regular CBD
- Liquid Structure CBD may have a desirably heightened pharmacodynamic impact than does regular CBD, especially evidenced by sizable reductions in TNF-α, an inflammation protein associated with many autoimmune diseases as well as the deadly cytokine storms that outfall COVID-19 and influenza infection
Mark Rosenfeld, Chief Executive Officer & Chief Science Officer, Ananda Scientific
12.50 am Taking Aim at the ECS with Novel Small Molecules
Drug discovery - How small molecules can elicit effects at the endocannabinoid system:
- Small molecule drugs based upon THC’s structure have been developed to interact directly with CB1 and/or CB2 receptors, or impose allosteric modulation of the receptor responses to endocannabinoids or agonist drugs
- Small molecule drugs are being developed to intervene at synthesis, transport or metabolism of endocannabinoids, and thereby alter the body’s normal or pathological processes
- Drug interactions could arise due to Cannabis natural products competition with small molecule medicines that intervene at ECS processes
Allyn Howlett, Professor, Wake Forest School of Medicine
12.50 am Cannabinoids Delivered as Novel Solid Dosage Forms – Proof-of-Concept Clinical Data
- The effectiveness of cannabinoid medicines is negatively impacted by very low bioavailability, highly variable absorption, and erratic time to onset
- Currently available cannabinoid dosage forms attempt to compensate for some of these deficiencies with high doses that have the potential to produce undesirable side effects
- Receptor is developing solid dosage forms, both oral and inhaled, that address all of these cannabinoid delivery challenges. Data from 2 initial, proof-of-concept clinical studies will demonstrate the feasibility of this approach
Andrea Leone-Bay, Chief Scientific Officer and Founder, Receptor Life Sciences
1.10 pm Live Presenter Q&A
Allyn Howlett, Professor, Wake Forest School of Medicine
1.10 pm Live Presenter Q&A
Mark Rosenfeld, Chief Executive Officer and Chief Science Officer, ANANDA Scientific, Inc.
Andrea Leone-Bay, Chief Scientific Officer and Founder,Receptor Life Sciences
1.20 pm Drug Target Prediction and Development Using an Integrated Computational and High-Throughput Screening Approach
- Power of computational biology and machine learning for cannabinoid screening and optimization as a drug substance
- Drug product development through multiple differentiating, consistent and reliable formulation and delivery technologies
- Evidence-based medicine based on robust pre- and clinical development
Saeid Babaei, Chief Executive Officer, Orpheus Medica
1.20 pm A Fact-Based Approach to Training Medical Providers on the ECS: Demystifying Common Myths & Misconceptions of Medical Cannabis
- Describe the history of didactic ECS coverage for medical professionals
- Discuss evidence-based remedial strategies for prevalent misinformation
- Summarize implementable patient and medical provider educational tools
Monica Taing, Board Member, Doctors for Cannabis Regulation
1.40 pm Live Presenter Q&A
Saeid Babaei, Chairman and Chief Executive Officer, Orpheus Medica
1.40 pm Live Presenter Q&A
Monica Taing, Membership Director, Board of Directors,Doctors for Cannabis Regulation
1:50 pm Virtual networking Break
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Preclinical Testing for Safety and Efficacy of Potential Therapeutics |
Explore methods and technologies that will increase confidence in the clinical potential of cannabinoid therapeutics
Building Strong Clinical Trial Delivery and Patient Selection Strategies
Discuss the key principles that come into play when selecting a site for phase 1 trials
2.30 pm Rational Design of Cannabinoid-Containing Complex Mixtures and Establishing Proof of Concept for Disease-Specific Applications
- To discover novel disease-specific therapies, GBS utilizes rational design principles in creating Cannabinoid-Containing Complex Mixtures targeting the endocannabinoid system. GBS incorporates data from high throughput experiments using disease-specific cell and animal models that are combined with computer models of receptor-interactions in a predictive network pharmacology-based algorithm
- The bioavailability of GBS’ Cannabinoid-Containing Complex Mixtures is enhanced using novel oral delivery systems including: a. oral dissolving tablets, b. time-released nanoparticles for oral administration, c. oral thin films, and d. gel capsules
- Using an animal model of the disease, Proof of Concept has been established for GBS’ Parkinson’s disease therapy and the Mechanism of Action is being explored
Andrea Lee Small-Howard, Chief Science Officer, Director & Board Member, GBS Global Biopharma, Inc./GB Sciences, Inc.
2:30 pm Identifying Potential Sites for Trials and Setting Up Clinical Operations in Foreign Regulatory: Insights from a Phase 2a clinical trial in Insomnia
- Results from a Phase2 study assessing the safety and efficacy of a novel plant-derived medicinal cannabis oral formulation in patients with insomnia
- Two weeks of nightly sublingual administration of a cannabinoid extract (ZTL-101) significantly improved insomnia symptoms, sleep quality and daytime fatigue, and capacity to engage in everyday tasks
- The cannabinoid extract (ZTL-101) was associated with an acceptable short-term safety profile
Richard Hopkins, Managing Director ex USA, Zelira Therapeutics
2.50 pm Identifying and Validating Mechanism of Action of Action In vivo/vitro
- Identification of specific cannabinoids enhancing the immunogenicity of tumour cells and subsequent development of a potent selective compound for glioblastoma - PAS-403
- In vitro: Data showing the PAX-403 exerts its MOA as a mitotic inhibitor binding to the colchicine site of tubulin
- In vivo: AS-403 synergizes with radiation or Temozolomide in a mouse model of glioblastoma
Patrick Gray, CEO, Pascal Biosciences
2.50 pm Utilizing Diagnostics in Cannabinoid Medicine for Oncology
- A look into the clinical applications of Vrypharm Biopharmaceutical’s patented comprehensive medical cannabis and hemp testing methodology platform
- Employing diagnostics to improve the clinical management in oncology patients where cannabinoid medicines are recommended
Jerry Bryant, CSO, Vyripharm Biosciences
3.10 pm Analysis of Medicinal Properties of Cannabis Sativa Hybrids
- Cannabis sativa has enormous medicinal potential
- C. sativa is not generic, only certain varieties work for specific conditions
- Rigorous pre-clinical research is required to recommend the use of specific C. sativa cultivar for a clinical trial
Igor Kovalchuk , Professor, University of Lethbridge
3.10 pm Clinical Trial Design, Endpoints and Regulatory Strategies
- A look into the ART27.13 program, a high potency GPCR agonist for anorexia associated with cancer
- The importance of consultation with regulatory authorities throughout the progression of clinical development
- Challenges, approaches and critical path activities when developing cannabinoid derived pharmaceuticals
Andy Yates, Chief Scientific Officer, Artelo Biosciences
3.30 pm Live Presenter Q&A
Igor Kovalchuk, Professor, University of Lethbridge
3.30 pm Live Presenter Q&A
Andy Yates, Chief Scientific Officer, Artelo Biosciences
Jerry Bryant, CSO, Vyripharm Biosciences
3.40 pm Panel Discussion: Achieving the Ideal Pharmacokinetic and Pharmacodynamic Profiles in Drug Formulation
- Understand how to leverage preclinical data to improve your formulation
- Implement preclinical insights for the best clinical outcomes
Andrea Lee Small-Howard, Chief Science Officer, Director & Board Member, GBS Global Biopharma, Inc./GB Sciences, Inc.
Patrick Gray, CEO, Pascal Biosciences
Manuel de Pra, Research & Development Coordinator, Entourage Phytolab
3.40 pm Panel Discussion: Overcoming the Major Hurdles in Clinical Trials
- Understand strategies to identify and train capable investigators
- Recruit appropriate patients while maintaining timelines
- Understand the differences in therapeutic endpoints and study success
Richard Hopkins, Managing Director ex USA, Zelira Therapeutics
Steven James, Clinical Assistant Professor, Steven James MD
Mark Rosenfeld, Chief Executive Officer & Chief Science Officer, Ananda Scientific
Andrea Leone-Bay, Chief Scientific Officer and Founder, Receptor Life Sciences