Day One

Wednesday September 16 2020

Day Two

Thursday September 17 2020

9:00 am Preconference Virtual Networking

Overcoming Regulatory Restrictions at Home and Abroad

9:30 am FDA Regulation of Cannabinoid Pharmaceuticals – Breaking Down All Possible Routes to Approval

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

Synopsis

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9:50 am The International Drug Control Landscape for Cannabinoid Derived Pharmaceuticals

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

Synopsis

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10:10 am Rx and Non-Rx Cannabinoids: A Regulatory Framework for Market Access and Product Quality in Healthcare and Selfcare

Synopsis

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10:40 am Live Presenter Q&A

  • Dominic Chiapperino Director - Controlled Substances Division, US Food & Drug Administration (FDA)
  • Pavel Pachta Director for International Regulatory Affairs, International Cannabis and Cannabinoids Institute (ICCI)
  • Rob Dhoble Managing Director, Havas ECS

11:00 am Morning Break & Virtual networking

11:20 am Case Study: Brazilian Cannabis Regulation and its Impact for the Companys’ Clinical Trials Pipeline

Synopsis

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11:40 am Key Regulatory Takeaways in Developing a Cannabinoid Pharmaceutical Development Strategy

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

Synopsis

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12:00 pm Live Presenter Q&A

  • Caio Santos Abreu Founder & Chief Executive Officer , Entourage Phytolab
  • Bruce Mackler Executive Vice President, Regulatory Affairs, Ethicann Pharmaceuticals

Breaking Down Barriers to Investment

12:20 pm Panel Discussion: Dispelling Common Misconceptions About Biotech Funding and Applying this Understanding to Cannabinoid Pharmaceuticals

1:00 pm Lunch & Virtual Networking

1:55 pm

Efficiently Take your Cannabinoid Formulation from In Vivo/Vitro Testing into the Clinic, with Confidence

2:00 pm Assessing the Potential Clinical Value of the Next Hopefuls in Cannabinoid Pharmaceutical APIs: CBG, CBN and THCA

  • Hunter Land Associate Director of Cannabinoid Research, Canopy Growth

Synopsis

  • Preclinical evidence for the use of novel minor cannabinoids
  • Minor cannabinoid safety and toxicity
  • Where is the clinical evidence?

2:20 pm Analyzing Clinical Data to Extract Insights into Clinical Endpoints and Mechanism of Action

  • Aurelia De Pauw Vice President, Clinical Programs & Medical Affairs, Tetra Bio-Pharma

Synopsis

• 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

2:40 pm Strategically Selecting New Indications to Pursue

  • Boaz Hirshberg Executive Vice President, Chief Medical Officer, Head of Global Development , BOL Pharma

Synopsis

• 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

3:00 pm Live Q&A

  • Hunter Land Associate Director of Cannabinoid Research, Canopy Growth
  • Aurelia De Pauw Vice President, Clinical Programs & Medical Affairs, Tetra Bio-Pharma
  • Boaz Hirshberg Executive Vice President, Chief Medical Officer, Head of Global Development , BOL Pharma

3:15 pm Building a Supply Chain that Has the Capability to Maintain a High-Level of Quality

  • Brandon Price Executive Vice President, Business Development, Ethicann Pharmaceuticals

3:35 pm Chair’s Closing Remarks & End of Conference