8:00 am Morning Refreshments
8:55 am Chair’s Opening Remarks
CANNABINOID & ECS-TARGETING DRUG DEVELOPMENT: DECODING THE UNIQUE CONSIDERATIONS & UTILIZING INNOVATIVE TECHNOLOGIES
9:00 am CBD Dosage Forms: Oral, Transdermal & Buccal Transmucosal – Different Mechanisms to Increase Absorption
Synopsis
- Investigating techniques and outcomes in clinical trials to improve bioavailability and absorption in oral, transdermal, and buccal transmucosal delivery systems
- Evaluating formulation strategies and technologies designed to optimize CBD absorption and onset of action through different routes of administration
- Comparative analysis of patient outcomes and absorption rates in clinical trials for oral, transdermal, and buccal transmucosal CBD products
9:30 am Harnessing the Power of AI in Plant-Based Drug Discovery & Refining Precision Medicine
Synopsis
- What are the emerging synergistic methods to utilize traditional models and novel AI technologies in plant-based drug discovery?
- How can these combination methods accelerate phytocannabinoid drug development?
- What benefits can we gain from AI in supporting precision medicine and patient-centric care with phytocannabinoid drug development?
10:00 am Novel First-In-Class NCE Targeting GPR55, a Pro-Inflammatory Orphan Cannabinoid Receptor
Synopsis
- Assessing GPR55 as a target for reducing neuroinflammation and neuropathic pain in preclinical studies
- Advancing a GPR55-targeting drug in preclinical development to address chemotherapy-induced peripheral neuropathy, mitigating pain without interfering with cancer treatment, crucial for maintaining patient compliance with chemotherapy regimens
- Demonstrating the significant impact of this novel compound on mitochondrial health and GPR55 signalling, offering potential breakthroughs in treating Parkinson’s disease and various cancers
TRANSLATIONAL TRIUMPH: PROGRESSING CANNABINOID CLINICAL RESEARCH & OPTIMIZING TRIAL DESIGN
10:30 am Morning Break & Refreshments
11:00 am Developing a Framework for Scaling Preclinical Findings to Clinical Success in Cannabinoid Drug Development
Synopsis
- Navigating regulatory pathways for cannabinoid medicines – insights from the development of Epidiolex and Sativex, including botanical drug guidance, fixed dose concentration, and the FDA 505(b)(2) pathway
- Streamlining approval and compliance for minor cannabinoids – strategies for aligning with regulatory guidelines to ensure safety and efficacy, focusing on cannabinoid combination studies (entourage vs non-tourage)
- Discussing updates on recent findings and results from ongoing clinical trials in cannabinoid drug development
11:30 am Roundtable Discussion: Evolving Preclinical & Clinical Trial Design for Cannabinoid Drug Development
Synopsis
- Why have there been relatively few approvals to date of cannabinoid and CB1 and CB2 targeting drugs?
- What promising potential of cannabinoids is there beyond their approved use in conditions like multiple sclerosis, neuropathic pain, and obesity?
- How can we choose the right active ingredient, taking into account safety, efficacy, and therapeutic benefits?
- How can we design trials that prioritize patient experience and compliance?
- How can we address trial complications arising from diverse standards of care across different geographical regions?
Moderator Feedback & Audience Debate
Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtable discussions, they will present back to the entire delegation and open wider audience debate.
12:30 pm Lunch & Networking Break
CB2 TARGETING & ECS MODULATION: THERAPEUTIC BENEFITS OF TARGETING THE ENDOCANNABINOID SYSTEM
1:30 pm Realizing the Potential of the CB2 Receptor as a Therapeutic Target for AntiInflammatory Treatments
Synopsis
- Profiling CB2R’s role in the endocannabinoid system, and understanding the mechanism of action and how this translates to a clinical benefit
- Analyzing recent scientific advancements, including rationalising CB2 receptor structure-function relationships, AI approaches, and enhance ligand design
- Understanding how biased signalling and binding kinetics will improve tailored therapies
2:00 pm Using a Synthetic CB2-Targeting Compound to Target Neuroinflammation in the Brain, Mitigating Alzheimer’s Disease
Synopsis
- Keeping up with the evolving translational models of CB2-targeting compounds
- Understanding the pathways behind CB2-targeting to treat the neurological symptoms of AD through microglial-mediated neuroinflammation
- Preclinical and clinical research of a candidate compound, NTRX-07, that can readily penetrate the brain and modulate microglial activity via the CB2 receptor
- Exploring possible synergistic effects of NTRX-07 with other therapies used in the treatment paradigm
2:30 pm Fatty Acid Binding Protein (FABP) Modulation as a Novel Therapeutic Strategy
Synopsis
- Reviewing how FABPs, particular FABP5, are intracellular carrier proteins of endocannnabinoids, and inhibiting FABP5 decreases endocannabinoid uptake and increases endocannabinoid levels
- Introduction to ART26.12, the IND-approved lead small molecule FABP5, being developed for pain indications and the involvement of cannabinoid receptor activation in its analgesic effects
- The broader therapeutic utility of inhibiting FABP5 and other FABP isoforms
3:00 pm Afternoon Break & Refreshments
FUNDING & FUTURE DIRECTIONS: ADVANCING RESEARCH PRIORITIES IN CANNABINOID & ECS-TARGETING DRUG DEVELOPMENT
3:30 pm Build, Buy, or Partner: What are the Current Trends for Industry Growth & Organizational Expansion in Clinical Cannabinoid Drug Development
Synopsis
- What are the pros and cons of the “Build” approach in clinical cannabinoid drug development?
- How does the “Buy” strategy offer speed to market and access to talent?
- What advantages and challenges are associated with forming partnerships in this field?
4:00 pm Evolving Cannabinoid Drug Development: Next Generation Multi-Target Therapeutics
Synopsis
- Exploring a complex therapeutic mixture including cannabinoids, terpenes, and other flavonoids to target the neuro-degenerative effects of CNS disorders such as ALS
- Using innovative technologies to identify and extract the required rare polyphenols at high-potencies
- Utilizing artificial intelligence to help screen the cannabis plant for enhanced insight into which components to research