Overcoming Regulatory Restrictions at Home and Abroad
9:00 am FDA Regulation of Cannabinoid Pharmaceuticals – Breaking Down All Possible Routes to Approval
Synopsis
9:30 am The International Drug Control Landscape for Cannabinoid Derived Pharmaceuticals
Synopsis
10:00 am Rx and Non-Rx Cannabinoids: A Regulatory Framework for Market
Synopsis
10:30 am Morning Break and Networking
11:00 am Case Study: Brazilian Cannabis Regulation and its Impact for the Companys’ Clinical Trials Pipeline
Synopsis
11:30 am Key Regulatory Takeaways in Developing a Cannabinoid Pharmaceutical Development Strategy
Synopsis
Achieving Market Exclusivity and Building an IP Strategy
12:00 pm Can’t Protect the Molecule, What Can You Protect?
Synopsis
12:30 pm Panel Discussion: Designing an IP Strategy from the Ground Up that Will Give you the Edge
Synopsis
1:00 pm Lunch and Networking
Breaking Down Barriers to Investment
2:00 pm Panel Discussion: Dispelling Common Misconceptions About Biotech Funding and Applying this Understanding to Cannabinoid Pharmaceuticals
2:45 pm
Translational Clinical Development Track
Commercial Pipeline Development and Manufacturing Track
Efficiently take your cannabinoid formulation from in vivo/vitro testing into the clinic, with confidence
Maximizing the value that your therapeutics offer and ensuring quality in your supply chain
14.45 Assessing the Potential Clinical Value of the Next Hopefuls in Cannabinoid Pharmaceutical APIs: CBG, CBN and THCA
- Preclinical evidence for the use of novel minor cannabinoids
- Minor cannabinoid safety and toxicity
- Where is the clinical evidence?
Hunter Land, Associate Director of Cannabinoid Research, Canopy Growth Corporation
14.45 Analyzing Clinical Data to Extract Insights into Clinical Endpoints and Mechanism of Action
- Tetra Biopharma is currently pursuing a variety of clinical programs employing inhaled synthetic cannabinoid derived pharmaceuticals, including for pain and oncology indications
- Analysis, interpretation and comparison of data across programs also connects these and is invaluable for the design of future studies and in decision making when it comes to future indications to pursue
Aurélia De Pauw, Vice President, Clinical Programs and Medical Affairs, Tetra Bio Pharma
15.15 Getting to YES with FDA on:
- Cannabis safety is different
- Cannabis efficacy is different
- Botanic API/NDA or Chemical API/NDA
Steve Goldner, Chief Executive Officer and Chair, Board of Directors, Pure Green Pharmaceuticals
15.15 Strategically Selecting New Indications to Pursue
- Which data can be used to inform future therapeutic indications to pursue
- Clinical trial data for expanding the indications of existing pharmaceuticals
- Regulatory considerations in cannabis-based pharmaceutical development
Boaz Hirshberg, Executive Vice President, Chief Medical Officer, Head of Global Development, BOLPharma
15.30 Chair’s Closing Remarks and End of Conference
15.45 Panel Discussion: Building a Supply Chain that Has the Capability to Maintain a High-Level of Quality
- Discuss issues in both clinical trial and commercial supply of therapeutics
- Identify critical stages of the process to find where major issues might lie
Oludare Odumosu, Chief Executive Officer - USA, Zelira Therapeutics
Brandon Price, Executive Vice President, Business Development, Ethicann Pharmaceuticals
Matthew Callahan, Executive Chairman, Botanix Pharma
16.15 Chair’s Closing Remarks and End of Conference