8:20 am Chair’s Opening Remarks

Considerations from NIDA & Navigating the Regulatory Landscapes

8:30 am FDA Regulatory Roles Concerning Cannabis and New Drug Research

  • Dominic Chiapperino Director of Controlled Substances Staff, U.S. Food and Drug Administration

Synopsis

  • The presentation will discuss FDA regulatory roles for cannabis under both the
    Food, Drug & Cosmetic Act and the Controlled Substances Act
  • Under FDCA, FDA provides regulatory oversight, and scientific and regulatory
    support, for research conducted under an IND investigating potential therapeutic
    uses of cannabis
  • Under the CSA, FDA assists DEA with review and DEA registration of protocols
    involving Schedule I drugs and considers appropriate drug scheduling for
    cannabis-related substances

9:15 am NIDA Perspective on Cannabinoid Pharmaceuticals

  • Robert Walsh Chief OF Regulatory Affairs Branch NIH / NIDA
    Division of Therapeutics & Medical Consequences of Drug Abuse, NIDA

Synopsis

• Explore the ongoing research taking place within NIDA’s structure that can assist

• Discuss NIDA’s concerns about cannabinoids and cannabinoid research

• Explain how industry can collaborate with NIDA to advance this growing field quickly and safely

9:45 am Industry Perspective on the Regulatory Approval Pathway

  • Dennis Ahern Vice President - Global Regulatory Affairs, Greenwich Biosciences

Synopsis

• Explore the current system from the side of industry

• Identify the key gaps in clarity that industry have to face

• Discuss the key issues with the currently understood structure and how industry can work with regulators to improve it

10:15 am Speed Networking & Morning Break

Synopsis

This session is the ideal opportunity to meet face-to-face with many of thebrightest minds working in the Cannabinoid-Derived Pharmaceuticals field and establish meaningful business relationships to pursue for the rest of the conference.

Extraction, Synthesis & Sourcing of Cannabinoids

11:45 am The New Era of Ultra-Pure Pharmaceutical Cannabinoids: CBD, THC, and Beyond

  • Josh Hoerner Managing Director & Senior Director,
    Innovation & Product Development, Noramco Inc.

Synopsis

• Compare various technology platforms (botanical extraction, synthetic, and biosynthetic). Using the technology platform to unlock access to low weight percent constituent compounds of the cannabis sativa plant

• Building a bridge from naturally-occurring compounds to synthetic compounds via unequivocal structural elucidation

• Considerations for scale-up and commercialization of an ultra-pure, highly stable cannabinoid API

12:15 pm Panel Discussion: Whole Plant Vs. Synthetic Cannabinoids and Their Relative Potential in Pharmaceuticals

Synopsis

• Debate the relative importance of each source in relation to the current needs that developers have

• Break down the current understanding of each source’s therapeutic potential

• Consider how the rise of biosynthesis could impact cannabinoid research

1:00 pm Lunch

Key Updates in the Pharmacology of Cannabinoids, the ECS & Cannabinoid Receptor Biology

2:00 pm Updates on the Pharmacology of Low Weight Cannabinoids

Synopsis

• Non-psychotropic plant cannabinoids, exemplified by cannabidiol, show promising multiple therapeutic properties, most likely due to their capability of modulating the activity of several molecular targets, not all of which belong to the endocannabinoid system

• Fully understanding the implications of the polypharmacology of these phytocannabinoids is a complex task, and predicting their efficacy in a given disorder will require new bioinformatics and systems biology approaches

• Nevertheless, clinical data exist on the use of cannabidiol and other multi-target non-psychotropic cannabinoids in pathologies ranging from schizophrenia and metabolic disorders to epilepsy and cancer

2:30 pm The Importance of Understanding the ECS in Drug Design & Formulation

  • Ethan Russo Professor, International Cannabis and Cannabinoids Institute

Synopsis

• Link new discoveries about the ECS to new therapeutic potentials of Cannabis

• Discuss how much is known about new pathways that we are seeing cannabinoids act down and what effects they could lead to

3:00 pm Panel Discussion: Summarizing the Advances in Cannabinoid Pharmacology and ECS Targeting

  • Vincenzo di Marzo Director, Joint International Research Unit UMIMicroMeNu
  • Ethan Russo Professor, International Cannabis and Cannabinoids Institute

Synopsis

• Our experts in cannabinoid pharmacology and endocannabinoid biology will field questions from the audience

3:30 pm Afternoon Refreshments & Poster Session:

Synopsis

This session is a great opportunity to introduce yourself to the attendees that you would like to have more in depth conversations with. This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in cannabinoid drug development to establish meaningful business relationships.

Analyzing the Potential of Biosynthesis

4:30 pm Cannabinoid Biosynthesis: Engineering the Most Disruptive Technology in the Cannabis Industry

Synopsis

  • Cannabinoid biosynthesis, or cellular agriculture, is the practice of incorporating
    genetic instructions for producing the plant’s active molecules into simple
    organisms, like yeast or microalgae. In this way, the cells can be engineered to
    produce any cannabinoid, terpene, flavonoid, or derivatives thereof, at high
    volume and concentrations, using low-cost input materials.
  • This technology we see as fundamentally disruptive to the cannabis industry,
    which, presently, relies on cultivation to provide access to active cannabis
    ingredients. The orders-of-magnitude reduction in production footprint and capital
    requirement associated with cannabinoid biosynthesis relative to cultivation,
    not to mention the process’ scalability, reliability, and pure, bio-identical output
    molecules, will make it the source-of-choice for companies seeking introduce
    cannabis’ active molecules to global supply chains (i.e. pharmaceutical, food and
    beverage, consumer packaged goods markets).

5:00 pm Panel Discussion: The Potential Effects Biosynthesis Could Have on the Cannabinoid-Derived Pharmaceuticals Development Process and the Wider Industry

  • Michael Freeman Associate, Paradigm Capital
  • Brandon Zipp Director - Scientific Research & Development & Co- Founder, Vitality Biopharma
  • Eric Hsu Sr. Vice President,
    Preclinical Research and Development, InMed Pharmaceuticals

Synopsis

• With the potential of Biosynthesis growing more in the last few months than ever before, gain an insight into what has driven this sudden advance

• How could biosynthesis affect the cost and supply of APIs, with consideration of the potential in medical Cannabis as well as CDP and how these are related

The Investor’s Perspective

5:30 pm Panel Discussion: The Investor’s Perspective on the Cannabinoid Pharmaceuticals Field

  • Loren DeFalco Partner, CB1 Capital
  • Jeff Margolis Senior Vice President, Treasurer
    Secretary & Chief Financial Officer, RespireRx Pharmaceuticals
  • Josh Blacher Chief Financial Officer, InMed Pharmaceuticals

Synopsis

• Have an open and frank discussion about the issues at the heart of investor decisions with investment experts whose primary focus is the cannabinoid space

6:00 pm Chair’s Closing Remarks