Conference Day 2
8.20AM - 18.30PM EDT | Boston, MA
6:45 am Registration & Coffee
7:50 am Chair’s Opening Remarks
Harnessing New and Old Discoveries in Endocannabinoid Biology and Cannabinoid Pharmacology to Improve Bioavailability, Discover New Opportunities and Design New Drug Candidates
8:00 am Faah Inhibitors: The Innocent Pays for the Guilty – REMOTE
Synopsis
- Will discuss past research conducted on FAAH inhibitors by major players and small biotech companies
- Address concerns over safety
- Look at why so many companies are rediscovering this molecule now
Late-Stage Clinical Studies and Gaining Regulator Approval
8:30 am Factors Contributing to the Success or Failure of Chronic Pain Clinical Trials
Synopsis
- Pain clinical trials have a high failure rate due to near total dependency on subject patient assessments of pain perception before and after treatment especially due to placebo effects
- Therefore, there is an increasing demand for objective quantitative biomarkers to validate subjective patient perceptions of pain before and after treatment including the detection of a disease modifying effect
- Biomarker profiling reveals considerable neurochemical and morphometric differences between different types of chronic pain afflictions and variability among patients who presumably have the same affliction. Therefore, biomarker assessments could provide more effective inclusion/exclusion criteria to enhance success
9:00 am Morning Coffee Break
9:45 am Using Real World Evidence for Patient Stratification and Design of Medical Cannabis Trials – REMOTE
Synopsis
- RWE can uniquely be used in medical cannabis drug development to improve efficacy of therapies
- RWE provides powerful data to design RCTs to increase chances of positive outcomes
- RWE post-marketing surveillance may improve understanding of applicability of cannabis-based medicines
Cannabinoids and COVID-19
10:15 am Cannabidiol Inhibits SARS-CoV-2 Replication and Promotes the Host Innate Immune Response – REMOTE
Synopsis
- CBD and its metabolites but not congeneric cannabinoids, potently block SARS-CoV-2 replication in lung epithelial cells
- CBD acts after cellular infection, inhibiting viral gene expression and upregulating the interferon antiviral signaling pathway
- A cohort of human patients previously taking CBD had significantly lower SARS-CoV-2 infection incidence of up to an order of magnitude relative to matched pairs or the general population
10:45 am Advances in Cannabis research: Future Therapeutics and Ajunctive Treatment for COVID-19
Synopsis
• Biology effects of cannabis is mediated by action on human endocannabinoid system
• Explosion of new knowledge that the effects of cannabis are encoded in our genome on chromosomes 1 and Cannabinoid receptors and endocannabinoids are involved in reproduction and implantation of fertilized egg in the uterus
• Cannabinoid receptors are therapeutic targets for the treatment of mental and neurological disorders
Educating Physicians and Patients to Ensure Clinical Utility
11:15 am Educating Patients and Clinicians to Understand and Appreciate the Clinical Value of Cannabinoids
Synopsis
- Highlight the current understanding doctors have of cannabinoid medications and their attitudes towards them
- Discuss how both cannabinoid medications and medical cannabis can coexist by discussing their various applications
- Discuss the work of ACHEM and how cannabinoid pharmaceuticals can get involved
11:45 am Roundtable Discussion: Equipping Physicians with the Knowledge and Language to Best Represent Cannabinoid Pharmaceuticals and their Potential Benefits
Synopsis
- At your tables we will discuss what you believe are essential things to consider when communicating with clinicians and patients, you will:
- Describe and explain what a cannabinoid medicine is
- Describe the differences between a synthetic and plant based cannabinoid therapeutic
- Explain the potential risks of a medication
12:15 pm Lunch Break
Working With Regulators
12:45 pm FDA Perspective on Regulation of Cannabis Products and Research – REMOTE
Synopsis
• FDA authorities and regulatory programs applied to cannabis-derived drug products
• Federal landscape as impacted by the hemp provisions in the 2018 Farm Bill
• Scientific considerations of cannabis in drug development and FDA guidance and resources to support cannabis research
1:15 pm Regulatory & Clinical strategies to Develop Cannabinoid Ethical Drugs
Synopsis
• Commercial Opportunity & Unmet Medical Need in $3 billion global market
• Product Approval Strategy – New Drug 3-4 years to market
• Oral Dissolving Tablet (Zydis) delivery system benefits
Investment, Funding and Forming Valuable Partnerships to Drive Cannabinoid Pharmaceuticals Forward
1:45 pm Panel Discussion: Reviewing the Status of the Markets and Investment Trends
Synopsis
- Look back at the last 12 months of investment and identify key learnings we can take from the year
- Discuss what investors have taken away from the GW pharmaceuticals/Greenwich Biosciences acquisition and what it could mean for the entire field
Protecting Your Work with Strong Intellectual Property Strategy
2:15 pm Strategies for Building a Robust Patent Portfolio
Synopsis
- Leveraging the Power of Unexpected Results- how to distinguish from existing art
- The Power of Method Claims- how to combine method claims with regulatory approval, or with 271(g) enforcement strategies
- Multi-jurisdiction patent strategies
2:45 pm Fireside Chat: Meet the Cannabinoid IP Specialists
Synopsis
- Hear perspectives on IP strategy and enforcement from key opinion leaders at the heart of the cannabis and cannabinoid field
- Understand the IP lifecycle, and how work at one stage can influence another. For example what types of things your team can do during prosecution to prepare a company for litigation.
3:20 pm Afternoon Break
Preclinical and Early Clinical Development
3:45 pm Cannabinoid Receptor 2 Agonists on Their Way To Clinics – Snapshots Of A Drug Discovery Program – REMOTE
Synopsis
- Drug discovery
- Academia industry collaborations
- Biomarkers and chemical probes
4:15 pm Synthetic cannabidiol (CBD) oral solution as a novel investigational therapy to address unmet needs in Prader-Willi Syndrome (PWS)
Synopsis
• Potential utility of CBD to address hyperphagia and related anxiety in
Prader-Willi Syndrome (PWS)
• Synthetic cannabidiol (RAD011) overview
• Double-blinded, placebo-controlled, randomized phase 2 preliminary results in 7 individuals with PWS
4:45 pm The Development of Medical Cannabis Products for Epilepsy using Innovative Electrophysiological Techniques
Synopsis
• Enhanced deep tissue delivery formulation development results
• Evaluation of various cannabinoid combinations and ratios in osteoarthritis
• Safety and efficacy of RHO Phyto Deep tissue gels in animal model of osteoarthritis versus placebo and current available OTC pain gels
5:15 pm Carrying Out Translational Studies in Cannabinoid Medicine
Synopsis
- Discuss the critical decisions that must be made to ensure clinical studies yield meaningful results
- Identify useful biomarers for your specific condition