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Agenda

Navigate Regulatory Hurdles and Leverage Medical Utility, Safety and Efficacy Data to Advance Clinical Research

November 30-December 2, 2016
  • San Francisco, CA

Agenda

Want more agenda details? Download the brochure.

DAY ONE Wednesday, November 30, 2016

7:30

Conference Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Dean Petkanas
Chief Executive Officer
Kannalife Sciences, Inc.

8:30

POLITICAL ADDRESS Gain Up-to-the-Minute Coverage on the Political Landscape as 2016 Election Unfolds

There is a lot of attention on marijuana legalization and potentially re-scheduling or removing its Schedule I status with the upcoming election. As the 2016 Presidential Election unfolds, this cutting-edge session analyzes the state of the political landscape and the election results’ impact on the future of cannabis research in the U.S.

  • Review impact as the former U.S. Attorney General pushes for rescheduling of marijuana
  • Address the opioid epidemic and impact of marijuana state legalization
  • Assess the potential for better regulations on health supplements and not contaminated with pesticides
  • Highlight political implications

John Hudak
Senior Fellow, Governance Studies;
Deputy Director, Center for Effective Public Management, Brookings Institution

9:15

Cannabis Clinical Development —
Insight into an Evolving Market within an Existing Regulatory Framework

  • Understand limitations of the clinical development process and how the industry must adapt cannabis research to fit that model
  • Analyze the shift in bias from investment community towards cannabis-based pharmaceuticals
  • Hear progress to date with clinical development programs

Dean Petkanas
Chief Executive Officer
Kannalife Sciences, Inc.

9:45

Gain Clarity on Regulatory Hurdles Impacting Cannabis-Based Research

MODERATOR:

Dean Petkanas
Chief Executive Officer
Kannalife Sciences, Inc.

PANELISTS:

Mahmoud A. ElSohly, Ph.D.
Research Professor and Professor of Pharmaceutics,
National Center for Natural Products Research
The University of Mississippi

Sazzad Hossain, Ph.D.
Co-Founder & Chief Scientific Officer
InMed Pharmaceuticals Inc.

Paul Lyons, M.D., Ph.D.
Medical Director
Virginia Comprehensive Epilepsy Program

10:30

Networking and Refreshment Break

11:00

Medical Professionals and Patients — Tackling Cannabis Education

  • Education available for physicians, pharmacists and patients on drug-interactions, safety and efficacy of cannabis-based therapies
  • Discuss current physician views on medical cannabis, the future role of the FDA in medical cannabis products and potential of FDAapproved cannabis-based therapies
  • Ensure ability of physicians to recommend cannabis-based therapies

Steph Sherer
Executive Director
Americans for Safe Access

11:45

KEYNOTE ADDRESS Current Status and Future Applications of Cannabis Research —
Unlocking the Potential Medical Utility of Cannabis

  • Uncover the possibilities of cannabis research as an evolving field in the pharmaceutical industry
  • Evaluate the potential therapeutic areas and various indications where cannabis-based therapies possess medical benefit
  • Assess the various preparation and delivery techniques required for these novel treatments and current constraints under the regulatory environment
  • Understand the successes and failures to date, U.S. and globally
  • Prepare for an evolving political and regulatory environment and its influences on the future of cannabis research

Ethan Russo, M.D.
Medical Director
PHYTECS

12:30

Networking Luncheon

1:45

Cannabis — Chemistry, Analysis and Product Development Activities

  • Review of the complex nature of the chemistry of the cannabis plant and the diversity of the cannabinoids
  • Examine the analytical aspects of cannabis, particularly those products on the illicit market
  • Assess current cannabis preparation for medical use
  • Evaluate new pharmaceutical products on the horizon and their advantages

Mahmoud A. ElSohly, Ph.D.
Research Professor and Professor of Pharmaceutics,
National Center for Natural Products Research
The University of Mississippi

2:30

Evaluate the Abuse Potential of Cannabinoids —
Evolving Methods and Requirements

Interest in the medical use of cannabis and cannabinoids continues to grow as patients and caregivers consider this option for treatment of unmet medical needs. Individual cannabinoids have been approved for use as appetite stimulants and anti-emetics and many more compounds are currently under clinical investigation. Understanding the safety and abuse potential of these compounds is integral to clinical development and is dependent on the psychoactive and non-psychoactive compounds in the final product. This session discusses the clinical trial methodology and challenges to testing the abuse and dependence potential as well as safety of cannabinoids and the regulatory pathway to obtain approval for use for various medical indications. Various aspects to be discussed include:

  • Route of administration
  • Dosing
  • Subject selection
  • Safety monitoring
  • PK evaluation
  • Clinical trial design

Beatrice Setnik, Ph.D.
Vice President, Clinical Pharmacology, Early Phase
INC Research

Pierre Geoffroy, MDCM, MSc, FCFP, DABAM
Vice President, Early Phase
INC Research

John Oldenhof, MSc, Ph.D.
Executive Director, Clinical Pharmacology
INC Research

3:30

Networking and Refreshment Break

4:00

Leverage Technology for the Development & Commercialization of Cannabis Drugs

  • Analyze the challenging drug properties posed by cannabis compounds
  • Determine the selection of formulation and process technologies based on drug properties and patient considerations
  • Evaluate formulation and process considerations including the selection of suitable shell formulations and closed processing to maximize quality and stability of the drug product
  • Assess next generation cannabis drug products — Can we improve therapeutic effectiveness and patient compliance?

David Fulper
Director of Technology Support
Catalent Pharma Solutions

4:45

Limitations of NIDA Cannabis — How to Navigate the DEA/NIDA Monopoly

Suzanne Sisley, M.D.
Principal Investigator
Scottsdale Research Institute

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Thursday, December 1, 2016

8:00

Continental Breakfast

8:00

Chairman’s Review of Day One

Dean Petkanas
Chief Executive Officer
Kannalife Sciences, Inc.

8:45

CASE STUDY Veterans and the Use of Cannabis as a Non-Opiate Based Treatment —
A Partnership with Battle Brothers

This case study reviews the collaboration with Battle Brothers and their support for non-opiate based cannabis treatment methodologies for both physical and psychological injuries related to military combat and service, including PTSD, TBI, alcoholism, acute pain and trauma.

  • Regain control through adequate, non-addictive cannabis care
  • Evaluate cannabis as a means of economic empowerment
  • Assess the social stigmas surrounding cannabis
  • Determine opportunities for veterans in the cannabis space
  • Gain insight into Battle Brothers’ belief in dignity through labor and how they are paving the way for economic growth through apprenticeship trade programs and burgeoning positions in the American cannabis space
  • Analyze the partnership with Battle Brothers to help pave the way for America’s Next Greatest Generation

Stephen Goldner, JD, RAC
Chief Security Officer
C3 International Inc., manufacturer of Idrasil

Steele Smith
Chief Executive Officer
C3 International Inc., manufacturer of Idrasil

9:30

CASE STUDY Leverage the Pharmacobiology of Cannabinoid Receptors for Drug Discovery and Pharmaceutical Product Development

  • Address the challenges of cannabinoid-based drug development * drug discovery and development perspectives
  • Discuss the phyto-cannabinoid pathway
  • Evaluate how re-engineering the native metabolic networks of the bacterium Escherichia coli and the yeast Saccharomyces cerevisiae for cannabinoid overproduction is the future of cannabinoid-based therapy development

Sazzad Hossain, Ph.D.
Co-Founder & Chief Scientific Officer
InMed Pharmaceuticals Inc.

10:15

Networking and Refreshment Break

TOPIC INTENSIVE CASE STUDIES

10:45

Medical Marijuana in Epilepsy —
A Medical Review of Epilepsy Syndromes, Pharmacology and the Use of Medical Cannabinoids in Case Reports and Human Studies

I Understand Epilepsy Syndromes and Associated Conditions

  • Definitions of epilepsy and epilepsy syndromes
  • Epilepsy and associated conditions

II Review Pharmacologically Refractory Epilepsy Definitions, Treatment Options and Challenges

  • First, second and third generation traditional antiepileptic medications
  • Dietary interventions
  • Epilepsy surgery
  • Responsive and non-responsive nerve stimulation

III Discover the Novel Class of Molecule Including Medical Marijuana

IV Evaluate the Use of Medical Cannabinoids in Epilepsy Case Reports

  • Historical references for the uses of derivatives of cannabis in medical conditions including epilepsy
  • Analyze the pharmacology of cannabis as it relates to epilepsy
  • Unique pharmacological profiles of CBD and THC
  • Animal models of epilepsy and phytocannabinoids — THC and CBD

V Human Studies of Cannabis and Derived Cannabinoids

  • Historical review of human studies of cannabis
  • 2012 Cochrane Review
  • GW Pharmaceuticals case studies
  • Recent randomized double-blinded, placebocontrolled trials of specific epilepsy syndromes

VI Legislative and Regulatory Process in Virginia

  • Collaboration with the FDA and DEA

Paul Lyons, M.D., Ph.D.
Medical Director
Virginia Comprehensive Epilepsy Program

12:45

Networking Luncheon

1:45

From the Eyes of the Rare Disease Patient — A Mock Patient Experience

Brian J. Fisher
Vice President of Operations & Corporate Partnerships
The Sturge-Weber Foundation

2:30

Analyze the Current Nutraceutical Cannabis Market as the Pharmaceutical Industry Advances Cannabis-Based Research

Tyler Strause
Founder and President
G. Randall & Sons Inc.

Linda Strause, Ph.D.
Co-Founder
G. Randall & Sons Inc.

3:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE Wednesday, November 30, 2016

7:30

Conference Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Dean Petkanas
Chief Executive Officer
Kannalife Sciences, Inc.

8:30

POLITICAL ADDRESS Gain Up-to-the-Minute Coverage on the Political Landscape as 2016 Election Unfolds

There is a lot of attention on marijuana legalization and potentially re-scheduling or removing its Schedule I status with the upcoming election. As the 2016 Presidential Election unfolds, this cutting-edge session analyzes the state of the political landscape and the election results’ impact on the future of cannabis research in the U.S.

  • Review impact as the former U.S. Attorney General pushes for rescheduling of marijuana
  • Address the opioid epidemic and impact of marijuana state legalization
  • Assess the potential for better regulations on health supplements and not contaminated with pesticides
  • Highlight political implications

John Hudak
Senior Fellow, Governance Studies;
Deputy Director, Center for Effective Public Management, Brookings Institution

9:15

Cannabis Clinical Development —
Insight into an Evolving Market within an Existing Regulatory Framework

  • Understand limitations of the clinical development process and how the industry must adapt cannabis research to fit that model
  • Analyze the shift in bias from investment community towards cannabis-based pharmaceuticals
  • Hear progress to date with clinical development programs

Dean Petkanas
Chief Executive Officer
Kannalife Sciences, Inc.

9:45

Gain Clarity on Regulatory Hurdles Impacting Cannabis-Based Research

MODERATOR:

Dean Petkanas
Chief Executive Officer
Kannalife Sciences, Inc.

PANELISTS:

Mahmoud A. ElSohly, Ph.D.
Research Professor and Professor of Pharmaceutics,
National Center for Natural Products Research
The University of Mississippi

Sazzad Hossain, Ph.D.
Co-Founder & Chief Scientific Officer
InMed Pharmaceuticals Inc.

Paul Lyons, M.D., Ph.D.
Medical Director
Virginia Comprehensive Epilepsy Program

10:30

Networking and Refreshment Break

11:00

Medical Professionals and Patients — Tackling Cannabis Education

  • Education available for physicians, pharmacists and patients on drug-interactions, safety and efficacy of cannabis-based therapies
  • Discuss current physician views on medical cannabis, the future role of the FDA in medical cannabis products and potential of FDAapproved cannabis-based therapies
  • Ensure ability of physicians to recommend cannabis-based therapies

Steph Sherer
Executive Director
Americans for Safe Access

11:45

KEYNOTE ADDRESS Current Status and Future Applications of Cannabis Research —
Unlocking the Potential Medical Utility of Cannabis

  • Uncover the possibilities of cannabis research as an evolving field in the pharmaceutical industry
  • Evaluate the potential therapeutic areas and various indications where cannabis-based therapies possess medical benefit
  • Assess the various preparation and delivery techniques required for these novel treatments and current constraints under the regulatory environment
  • Understand the successes and failures to date, U.S. and globally
  • Prepare for an evolving political and regulatory environment and its influences on the future of cannabis research

Ethan Russo, M.D.
Medical Director
PHYTECS

12:30

Networking Luncheon

1:45

Cannabis — Chemistry, Analysis and Product Development Activities

  • Review of the complex nature of the chemistry of the cannabis plant and the diversity of the cannabinoids
  • Examine the analytical aspects of cannabis, particularly those products on the illicit market
  • Assess current cannabis preparation for medical use
  • Evaluate new pharmaceutical products on the horizon and their advantages

Mahmoud A. ElSohly, Ph.D.
Research Professor and Professor of Pharmaceutics,
National Center for Natural Products Research
The University of Mississippi

2:30

Evaluate the Abuse Potential of Cannabinoids —
Evolving Methods and Requirements

Interest in the medical use of cannabis and cannabinoids continues to grow as patients and caregivers consider this option for treatment of unmet medical needs. Individual cannabinoids have been approved for use as appetite stimulants and anti-emetics and many more compounds are currently under clinical investigation. Understanding the safety and abuse potential of these compounds is integral to clinical development and is dependent on the psychoactive and non-psychoactive compounds in the final product. This session discusses the clinical trial methodology and challenges to testing the abuse and dependence potential as well as safety of cannabinoids and the regulatory pathway to obtain approval for use for various medical indications. Various aspects to be discussed include:

  • Route of administration
  • Dosing
  • Subject selection
  • Safety monitoring
  • PK evaluation
  • Clinical trial design

Beatrice Setnik, Ph.D.
Vice President, Clinical Pharmacology, Early Phase
INC Research

Pierre Geoffroy, MDCM, MSc, FCFP, DABAM
Vice President, Early Phase
INC Research

John Oldenhof, MSc, Ph.D.
Executive Director, Clinical Pharmacology
INC Research

3:30

Networking and Refreshment Break

4:00

Leverage Technology for the Development & Commercialization of Cannabis Drugs

  • Analyze the challenging drug properties posed by cannabis compounds
  • Determine the selection of formulation and process technologies based on drug properties and patient considerations
  • Evaluate formulation and process considerations including the selection of suitable shell formulations and closed processing to maximize quality and stability of the drug product
  • Assess next generation cannabis drug products — Can we improve therapeutic effectiveness and patient compliance?

David Fulper
Director of Technology Support
Catalent Pharma Solutions

4:45

Limitations of NIDA Cannabis — How to Navigate the DEA/NIDA Monopoly

Suzanne Sisley, M.D.
Principal Investigator
Scottsdale Research Institute

5:30

Close of Day One

Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Thursday, December 1, 2016

8:00

Continental Breakfast

8:00

Chairman’s Review of Day One

Dean Petkanas
Chief Executive Officer
Kannalife Sciences, Inc.

8:45

CASE STUDY Veterans and the Use of Cannabis as a Non-Opiate Based Treatment —
A Partnership with Battle Brothers

This case study reviews the collaboration with Battle Brothers and their support for non-opiate based cannabis treatment methodologies for both physical and psychological injuries related to military combat and service, including PTSD, TBI, alcoholism, acute pain and trauma.

  • Regain control through adequate, non-addictive cannabis care
  • Evaluate cannabis as a means of economic empowerment
  • Assess the social stigmas surrounding cannabis
  • Determine opportunities for veterans in the cannabis space
  • Gain insight into Battle Brothers’ belief in dignity through labor and how they are paving the way for economic growth through apprenticeship trade programs and burgeoning positions in the American cannabis space
  • Analyze the partnership with Battle Brothers to help pave the way for America’s Next Greatest Generation

Stephen Goldner, JD, RAC
Chief Security Officer
C3 International Inc., manufacturer of Idrasil

Steele Smith
Chief Executive Officer
C3 International Inc., manufacturer of Idrasil

9:30

CASE STUDY Leverage the Pharmacobiology of Cannabinoid Receptors for Drug Discovery and Pharmaceutical Product Development

  • Address the challenges of cannabinoid-based drug development * drug discovery and development perspectives
  • Discuss the phyto-cannabinoid pathway
  • Evaluate how re-engineering the native metabolic networks of the bacterium Escherichia coli and the yeast Saccharomyces cerevisiae for cannabinoid overproduction is the future of cannabinoid-based therapy development

Sazzad Hossain, Ph.D.
Co-Founder & Chief Scientific Officer
InMed Pharmaceuticals Inc.

10:15

Networking and Refreshment Break

TOPIC INTENSIVE CASE STUDIES

10:45

Medical Marijuana in Epilepsy —
A Medical Review of Epilepsy Syndromes, Pharmacology and the Use of Medical Cannabinoids in Case Reports and Human Studies

I Understand Epilepsy Syndromes and Associated Conditions

  • Definitions of epilepsy and epilepsy syndromes
  • Epilepsy and associated conditions

II Review Pharmacologically Refractory Epilepsy Definitions, Treatment Options and Challenges

  • First, second and third generation traditional antiepileptic medications
  • Dietary interventions
  • Epilepsy surgery
  • Responsive and non-responsive nerve stimulation

III Discover the Novel Class of Molecule Including Medical Marijuana

IV Evaluate the Use of Medical Cannabinoids in Epilepsy Case Reports

  • Historical references for the uses of derivatives of cannabis in medical conditions including epilepsy
  • Analyze the pharmacology of cannabis as it relates to epilepsy
  • Unique pharmacological profiles of CBD and THC
  • Animal models of epilepsy and phytocannabinoids — THC and CBD

V Human Studies of Cannabis and Derived Cannabinoids

  • Historical review of human studies of cannabis
  • 2012 Cochrane Review
  • GW Pharmaceuticals case studies
  • Recent randomized double-blinded, placebocontrolled trials of specific epilepsy syndromes

VI Legislative and Regulatory Process in Virginia

  • Collaboration with the FDA and DEA

Paul Lyons, M.D., Ph.D.
Medical Director
Virginia Comprehensive Epilepsy Program

12:45

Networking Luncheon

1:45

From the Eyes of the Rare Disease Patient — A Mock Patient Experience

Brian J. Fisher
Vice President of Operations & Corporate Partnerships
The Sturge-Weber Foundation

2:30

Analyze the Current Nutraceutical Cannabis Market as the Pharmaceutical Industry Advances Cannabis-Based Research

Tyler Strause
Founder and President
G. Randall & Sons Inc.

Linda Strause, Ph.D.
Co-Founder
G. Randall & Sons Inc.

3:15

Close of Conference