8.20AM - 18.30PM EDT | Boston, MA
8:20 am Chair’s Opening Remarks
8:30 am Keynote Presentation: The Rise of GW: Keeping Patient Care as a Core Value
Synopsis
We will cover the 23-year journey from GW’s creation up to its acquisition by Jazz pharmaceuticals in 2021
- A look behind the veil at the challenges a company in the plant-based cannabinoid pharmaceuticals field faced from seed to FDA and MHRA approval
- Consistency of patient care as a value throughout this long journey
- What GW believes the future of cannabinoid medicine looks like
Establishing a Robust Clinical Program to Achieve Approval
9:15 am The FDA Orphan Drug Designation Voucher and the Benefits
Synopsis
The FDA Orphan Drug Designation Voucher and the Benefits
- What are the criteria to win the ODD designation
- If you do win an ODD, what the benefits are
- How to use this strategy to drive commercial success
9:45 am Strategic Considerations in Cannabinoid Based Drug Products
Synopsis
- Potential post approval protection methods
- Selecting a suitable delivery system
10:15 am Utility of Artificial Intelligence (AI) in Cannabinoid Drug Development
Synopsis
- AI can expedite throughput screening
- AI can expedite receptor modelling
- AI can draw on prior drug inventories for drug development
10:45 am Speed Networking and Morning Coffee Break
11:15 am Panel Discussion: Going Beyond THC and CBD – Identifying Compounds that Hold Clinical Potential
Synopsis
In this panel discussion the panelists will cover:
- The key minor cannabinoids that are showing most promise in the clinic and/or in mice
- Concerns around manufacturing minor cannabinoids in high volumes
- What the knock on effects will be across the field as minor cannabinoids gain more momentum
12:00 pm Discovering New Grounds in Cannabinoid Drug Discovery
Synopsis
- Understanding and leveraging the different potentials of cannabinoids and medicinal cannabis
- Navigating the chasm between drug substance and drug product- drug discovery into cannabinoids R&D: target ID and validation; early efficacy studies; safety and toxicology in pre-clinical stage; building
- Regulatory path: building bridges between pre-clinical work and regulatory needs
12:30 pm Lunch Break
1:30 pm Designing a Clinical Strategy that Harnesses the Strengths of Different Regulatory Jurisdiction
Synopsis
- Zelira is a company that operates in Australia and America
- Hear about how Zelira takes advantage of this multinational situation
- Discuss the programs Zelira has in play now
2:00 pm Cannabinoids for Obesity, Diabetes & NAFLD
Synopsis
- Funding research using wellness categories
- Proving Amelioration and Mechanism
- Commercial opportunities
2:30 pm Roundtable: Selecting a Strategy That is Optimal for Your Company’s Goals
Synopsis
In this session we will consolidate learnings from the clinical strategy section into discussions about what you believe are the three most important factors when it comes to building a strategy clinical strategy
The activity will involve an interactive discussion at your table followed by presenting your findings back to the audience via a nominated spokesperson
3:15 pm Afternoon Break
Late-Stage Clinical Studies and Gaining Regulator Approval
4:00 pm 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
4:30 pm Using Real World Evidence for Patient Stratification and Design of Medical Cannabis Trials
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
Harnessing New and Old Discoveries in Endocannabinoid Biology and Cannabinoid Pharmacology to Improve Bioavailability, Discover New Opportunities and Design New Drug Candidates
5:00 pm Cannabis Dosing is Complicated: Observations from Human Laboratory Studies
Synopsis
- Route of administration significantly impacts cannabis PK/PD
- Formulation and diet impact gastric absorption
- Drug-Drug interactions should be considered
5:30 pm Faah Inhibitors: The Innocent Pays for the Guilty
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
6:00 pm Thermal Stability of Cannabinoids, and Polymers Made of Cannabinoids CBD and CBG
Synopsis
- Many cannabinoids undergo thermal degradation at temperatures ca. 150°C with CBD being more thermally unstable to by-product formation than CBG
- Cannabinoids covalently incorporated into polymers in the form of polyesters significantly enhance thermal stability and decrease production of chemical by-products
- Polycannabinoids are scaleable and could hold potential in pharma as drug delivery vehicles