Overcoming Regulatory Restrictions at Home and Abroad

9:00 am FDA Regulation of Cannabinoid Pharmaceuticals – Breaking Down All Possible Routes to Approval

  • Dominic Chiapperino Director - Controlled Substances Division, US Food & Drug Administration (FDA)

9:30 am The International Drug Control Landscape for Cannabinoid Derived Pharmaceuticals

  • Pavel Pachta Director for International Regulatory Affairs, International Cannabis and Cannabinoids Institute (ICCI)

10:00 am Rx and Non-Rx Cannabinoids: A Regulatory Framework for Market

10:30 am Morning Break and Networking

11:00 am Case Study: Brazilian Cannabis Regulation and its Impact for the Companys’ Clinical Trials Pipeline

11:30 am Key Regulatory Takeaways in Developing a Cannabinoid Pharmaceutical Development Strategy

  • Bruce Mackler Executive Vice President, Regulatory Affairs, Ethicann Pharmaceuticals

Achieving Market Exclusivity and Building an IP Strategy

12:00 pm Can’t Protect the Molecule, What Can You Protect?

12:30 pm Panel Discussion: Designing an IP Strategy from the Ground Up that Will Give you the Edge

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