Conference Day 1
8.20AM - 18.30PM EDT | Boston, MA
6:45 am Registration & Coffee
7:50 am Chair’s Opening Remarks
8:00 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
8:40 am The FDA Orphan Drug Designation Voucher and the Benefits – REMOTE
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
9:10 am Removing CMC Barriers to enable Minor Cannabinoid Research and Development for Pharmaceutical Use
Synopsis
- Review current barriers for minor cannabinoid access
- Compilation of a minor cannabinoid drug master file
9:20 am Morning Coffee Break
10:20 am Discovering New Grounds in Cannabinoid Drug Discovery – REMOTE
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
10:50 am CANCELLED – Designing a Clinical Strategy that Harnesses the Strengths of Different Regulatory Jurisdiction
Synopsis
CANCELLED
11:20 am Cannabinoids for Obesity, Diabetes & NAFLD – REMOTE
Synopsis
- Funding research using wellness categories
- Proving Amelioration and Mechanism
- Commercial opportunities
11:50 am Successful Separation of Cannabidiol Enantiomers by LC-UV Analysis using Lux® Amylose Chiral Columns
Synopsis
• KinetoChem partnered with Phenomenex (chromatography company) on idea to find successful separation conditions for CBD enantiomers
• KinetoChem synthesized the opposite enantiomer of CBD (i.e. (+)-CBD) and sent both enantiomers (+)-CBD and (-)-CBD to Phenomenex to screen on all their chiral columns
• Multiple successful conditions were found for enantiomeric separation, saving time and money for pharmaceutical companies who can now capitalize on these
methods and compounds
12:00 pm Synthetic Superactive Supera-CBD Supersedes CBD
12:30 pm Lunch Break
1:30 pm The Art and Science of Commercializing Cannabinoids to Europeans – REMOTE
Synopsis
• Reverse-engineering the patient need (or consumer interest)
• Distinguishing between medical and wellness applications and channels
• Building infrastructure – from contract manufacturers to market research and go-to-market plans
2:00 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
2:30 pm Meeting Analytical Challenges for Cannabinoid Derived Products
Synopsis
• Analytical testing best practices
• Determine what to test and how to test
• GMP requirements for analytical testing
2:40 pm Minimizing variation in Cannabis plants
Synopsis
- – Genetic studies have shown variation in strains where there should me little or none
- Variation in phenotype (including chemotype) is a product of both genotype and environment
- Consistency in whole plant medicine requires confirmation of genetic identity
and standardized growing conditions
Building Reliable Supply Chains Around the World and Preparing for Commercialization
3:10 pm Engineering and Manufacturing for Sanitary Processing in the Pharma Environment
Synopsis
• Fit for purpose engineering and design for sanitary processes
• Pharma batching and mixing in stainless steel
3:20 pm Cannabinoid Base Camp: The Processing and Manufacturing Foundation supporting the climb to Breakthrough Research
Synopsis
• How the cannabinoid industry has evolved its manufacturing and refinement technology, mirroring other sophisticated nutraceutical categories, to support researchers with high-integrity inputs
• The current literature and potential of minor cannabinoids; how efficacy,
safety research, and different source material inputs will unlock a deeper level
of understanding in minor cannabinoids therapeutic potential
• Current enhancement research partnerships with academia and industry
stakeholders that will support prodrug and therapeutic applications that will support greater human health and wellbeing
3:50 pm Afternoon Break
4:30 pm Developing a Best-In-Class Cannabinoid-Based Inhaler
Synopsis
- Strategic, synergistic collaboration with a leading global player
- Advanced, efficient product based on proven technology
- Important aspects in product design: raw material, IP and more
5:00 pm Application of Pharma Standards in the Emerging Global CBD Market
Synopsis
• As the pharmaceutical industry evolves, the need for advanced medicine
and drug device combination products have evolved along with it through
lyophilization,nliposome and emulsion technology.
• The development and manufacturing of a drug device combination product is a complex process with many variables needed for consideration including interactions between the drug and device and finding the right material to
hold the drug.
• Manufacturers are required to fully understand the high level of control of
the product and the components going into it.
• These technologies can benefit patients suffering from serious health
conditions, such as cancer, diabetes, heart disease and others. The successful development of drug device combination products presents technical, clinical, and especially regulatory challenges.
5:30 pm Exploring the Oral Delivery of Cannabinoids: Challenges, Approaches, and Solutions – REMOTE
Synopsis
- Learn about the physiochemical challenges of cannabionoids
- An overview of the first pass metabolic issues with cannabionoids
- Discover the options available for formulating cannabinoids
6:00 pm Discovering multiple Cannabinoids Delivery Systems, to Enhance the Potency and Efficacy
Synopsis
• Exosomes have emerged as promising nanocarriers for drug delivery and targeted therapy.
• Liposomes loaded CBD for injectable for controlled administration
6:10 pm Enhancing bioavailability of topical cannabinoids for inflammatory skin conditions
Synopsis
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- Overview of Zylö’s silica-based, topical cannabinoid delivery platform
- Characterization of cannabinoid-loaded silica particles
- Efficacy of AEA-loaded particles in the treatment of cutaneous lupus erythematosus