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

  • Mikael Sodergren Research Director & Managing Director, EMMAC Life Science & Sapphire Medical Clinics

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

  • Marsha R. Rosner Professor, Ben May Dept. for Cancer Research Gordon Center for Integrative Sciences, University of Chicago

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 CANCELLED Advances in Cannabis research: Future Therapeutics and Ajunctive Treatment for COVID-19

Synopsis

CANCELLED 

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

  • Dominic Chiapperino Director - Controlled Substances Staff , FDA
  • Cassie Taylor Chemist, Botanical Review Team, Office of Pharmaceutical Quality, FDA, Centre for Drug Research

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

  • Bruce Mackler Executive Vice President , Ethicann Pharmaceuticals

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

  • Uwe Grether Senior Principle Scientist, F. Hoffmann-La Roche Ltd.

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)

  • Elena Nikonova Senior Scientific and Medical Director, Radius Health

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

5:15 pm Carrying Out Translational Studies in Cannabinoid Medicine

  • Hunter Land Vice President, Research and Development, Alterola Biotech Inc.

Synopsis

  • Discuss the critical decisions that must be made to ensure clinical studies yield meaningful results
  • Identify useful biomarers for your specific condition

5:45 pm Closing Remarks End of Conference Day Two