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Agenda and Abstracts | Evaluating the Therapeutic Potential of Cannabinoids: How to conduct research within the current regulatory framework

December 8, 2018

8 a.m.–5:15 p.m. (ET)

LIVESTREAM LINK is no longer active. A summary of the meeting will be posted soon.

Meeting Goals:

  • Gain an understanding of how to navigate this regulatory space
  • Inform the research/regulatory community of NCCIH and other IC’s interest in this area of research
  • Foster collaborations

Agenda

8:00 - 8:05a.m.

Opening Remarks

David Shurtleff, NCCIH

8:05 - 8:25a.m.

Speaker Introductions

8:05 - 8:25a.m.

Section 1 – Evaluating the Risks and Potential Benefits of Cannabinoids: The State of the Science

Moderator – David Shurtleff, NCCIH


Penny Whiting, University of Bristol


Kevin Hill, Harvard Medical School


Questions and Answers

9:30 - 9:40a.m.

Break

9:40a.m.-1:40p.m.

Section 2 – Supporting Cannabinoid Research: Balancing the Need for Federal Regulations and Knowledge

Moderator – Wen Chen, NCCIH; Inna Belfer, NCCIH



NIH perspective – Emmeline Edwards, NCCIH
Susan Weiss, NIDA
Mi Hillefors, NIMH
Amir Tamiz, NINDS


FDA perspective – Dominic Chiapperino, FDA

DEA perspective– James Arnold, DEA


Panel discussion


11:35a.m.–12:20p.m. – Break (Grab Lunch)


Scientific researchers’ perspective –
Emily Lindley, University of Colorado, Denver
Kent Hutchinson, University of Colorado, Boulder
Thomas Marcotte, University of California, San Diego


How Cannabis-Derived Medications Go Through the FDA Approval Process – Alice Mead, Greenwich Biosciences

Panel discussion

1:40 - 2:00p.m.

Break

2:00 - 3:35p.m.

Section 3 – Working Within the System: Advances in Cannabis-Related Production and Distribution

Moderator – Robert Walsh, NIDA


Resources available from the NIDA supply catalog and how to obtain them – Richard Kline, NIDA


Other cannabinoid formulations –
Brian Murphy, Nemus Bioscience
Santos Murty, Murty Pharmaceuticals


Emerging technologies – Anthony Farina, Librede, Inc.


Panel discussion

3:35 - 3:55p.m.

Break

3:55 - 5:15p.m.

Group Discussion – How to Move Cannabis-Related Research Forward

Moderator – Wendy Weber, NCCIH

Meeting discussant – Margaret Haney, Columbia University

Group discussion

Contact Information

For more information, contact Angela Arensdorf, Ph.D., Science Policy Analyst (Office of Policy, Planning, and Evaluations at NCCIH) at angela.arensdorf@nih.gov.

Speakers

James Arnold

Chief, Liaison and Policy Branch
Diversion Control Division, Drug Enforcement Administration

Inna Belfer, M.D., Ph.D.

Program Officer
National Center for Complementary and Integrative Health, NIH

Wen Chen, Ph.D.

Chief, Basic and Mechanistic Research Branch
National Center for Complementary and Integrative Health, NIH

Dominic Chiapperino, Ph.D.

Director, Controlled Substances Staff, Center for Drug Evaluation and Research
Food and Drug Administration

Emmeline Edwards, Ph.D.

Director, Division of Extramural Research
National Center for Complementary and Integrative Health, NIH

Anthony Farina, Ph.D.

Chief Scientific Officer
Librede, Inc.

Margaret Haney, Ph.D.

Professor of Neurobiology
Columbia University Medical Center

Kevin Hill, M.D., M.H.S.

Assistant Professor of Psychiatry
Harvard Medical School

Mi Hillefors, M.D., Ph.D.

Program Officer
National Institute of Mental Health, NIH

Kent Hutchinson, Ph.D.

Professor of Psychology and Neuroscience
University of Colorado, Boulder

Rik Kline, Ph.D.

Chief, Chemistry and Pharmaceutics Branch
National Institute on Drug Abuse, NIH

Emily Lindley, Ph.D.

Assistant Professor of Orthopedics
University of Colorado, Denver

Thomas Marcotte, Ph.D.

Professor of Psychiatry
Co-Director, Center for Medicinal Cannabis Research
University of California, San Diego

Alice Mead

Vice President, U.S. Professional Relations
GW Pharmaceuticals

Brian Murphy, M.D., M.P.H.

Chief Executive Officer & Chief Medical Officer
Nemus Biosciences, Inc.

Santos Murty, Ph.D.

Director of Regulatory Affairs; Associate Scientific Director
Murty Pharmaceuticals, Inc. (MPI)

David Shurtleff, Ph.D.

Deputy Director
National Center for Complementary and Integrative Health, NIH

Amir Tamiz, Ph.D.

Director, Division of Translational Research
National Institute of Neurological Disorders and Stroke, NIH

Bob Walsh

Chief, Regulatory Affairs Branch
National Institute on Drug Abuse, NIH

Wendy Weber, Ph.D., N.D., M.P.H

Chief, Clinical Research Branch
National Center for Complementary and Integrative Health, NIH

Susan Weiss, Ph.D.

Director, Division of Extramural Research
National Institute on Drug Abuse, NIH

Penny Whiting, Ph.D.

Senior Research Fellow
University of Bristol