May 14, 2019
- Call to Order—Nora Volkow, M.D. Director, NIDA
- Review of Policy and Procedures—Susan Weiss, Ph.D., Executive Secretary, National Advisory Council on Drug Abuse, Director, Division of Extramural Research, NIDA
Council Review of Grant Applications—Nora Volkow, M.D. Director
- Division of Epidemiology, Services, and Prevention Research (DESPR)—Carlos Blanco, M.D., Ph.D., Director
- Office of Translational Initiatives and Program Innovationa (OTIPI)—Elena Koustova, Ph.D., M.B.A., Director
- Division of Therapeutics and Medical Consequences (DTMC)—Kurt Rasmussen, Ph.D., Director
- Division of Neuroscience and Behavioral (DNB)—Rita Valentino, Ph.D., Director
- Opening and Welcome New Members—Nora Volkow, M.D. Director, NIDA
- NIDA Director's Report—Nora Volkow, M.D., Director, NIDA
- Council Discussion—Council Members
- Points to Consider Regarding Tobacco Industry Funding: Implications for Companies that Produce Electronic Nicotine Devices (ENDs)—Susan Weiss, Ph.D., Director, Division of Extramural Research, Executive Secretary, NACDA
- NIDA SBIR and STTR: building successful programs for a niche market—Elena Koustova, Ph.D., M.B.A, Director, Office of Translational Initiatives and Program Innovations (OTIPI), NIDA
- Necessity is the Mother of Invention: A Personal Perspective on Antimicrobial Resistance and A Forgotten Cure—Steffanie Strathdee, Ph.D., Associate Dean of Global Health Sciences, University of California, San Diego
Concept Clearances—NIDA Staff
- Step Up for Opioid Use Disorder (OUD): Translational Stepladder Initiative—Ramachandran Arudchandran, Ph.D., Health Scientist Administrator, OTIPI
- Renewal of the National Drug Abuse Treatment Clinical Trials Network (CTN)—Geetha Subramaniam, M.D. Deputy Director, Center for Clinical Trials Network
- Strategic Alliances for Medications Development to Treat Substance Use Disorders—Iván Montoya, M.D., Deputy Director, Division of Therapeutics and Medical Consequences (DTMC)
- Grand Opportunity in Medications Development for Substance Use Disorders—Iván Montoya, M.D., Deputy Director, Division of Therapeutics and Medical Consequences (DTMC)
- Public Comments
Minutes – May 14, 2019
The National Advisory Council on Drug Abuse convened its 132nd meeting at 9:00 a.m. on May 14, 2019 in Conference Rooms C & D, 6001 Executive Boulevard, Bethesda, Maryland. The closed portion of the meeting held on May 14th was for reviewing applications for Federal grant assistance and was open only to Council members and Federal employees. The open portion, which was open to the public, began at 10:30 a.m. and was also video cast. The Council adjourned on May 14, 2019 at 3:30 p.m.
Council Members Present
Judith Auerbach, Ph.D.
Julie Blendy, Ph.D.
Linda Chang, M.D.
H. Westley Clark, M.D., J.D.
Arthur Dean, M.A.
Lakshmi Devi, Ph.D.
Carlos del Rio M.D.
Gail D’Onofio, M.D.
Jay Giedd, M.D.
Christian Heidbreder, Ph.D.
Kenneth Mackie, M.D.
Lisa Marsch, Ph.D.
Edward Nunes, M.D.
Robert Rancourt, J.D.
Steffanie Strathdee, Ph.D.
Council Members Absent
John Carnevale, Ph.D.
Karl Deisseroth, M.D., Ph.D.
Nora Volkow, M.D.
Susan Weiss, Ph.D.
Federal Employees Present
Gillian Acca, Ph.D.
Alexei Kondratyev, Ph.D.
Members of the Public Present
Shannon Givens—NIDA Contractor
Nicolas Johnston, M.S.—NIDA Contractor
LaRisa McLennon, M.P.H.—DEA Contractor
Molly Natchipolsky, B.S.—NIDA Contractor
Ann Rea, M.A.—NIDA Contractor
Marushka Silveira, Ph.D.—NIDA Contractor
Peter Strumph—Amygdala Neurosciences
Closed Portion of the Meeting – May 14, 2019
Call to Order
This portion of the meeting was closed to the public in accordance with sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code and section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).
Dr. Nora Volkow, Director, NIDA, called the meeting to order and welcomed the Council and staff. She reminded those present that the Federal Advisory Committee Act applies to Council meetings and that this portion of the meeting was closed to the public.
Dr. Susan Weiss, Executive Secretary, summarized relevant NIH policies, provided detailed instructions on Council review procedures, and reminded those present about NIH confidentiality and conflict of interest policies. She presented the updated Council Operating Procedures which were approved by Council.
Drs. Carlos Blanco, Elena Koustova, and Rita Valentino, Directors of NIDA’s Division of Epidemiology, Services and Prevention Research, Office of Translational Initiatives and Program Innovations, and Division of Neuroscience and Behavior, respectively, and Dr. Iván Montoya, Deputy Director of the Division of Therapeutics and Medical Consequences presented their Division’s assigned and peer reviewed applications for consideration by the Council. For each, Council provided unanimous en bloc concurrence with the initial scientific review. Twelve Administrative Supplements, three MERIT Awards, one Appeal, and five Special Council Review applications were presented to Council for review, and Council concurred with program assessments. The initial reviews of all Trans-NIH Initiatives, including NIH Common Fund, Blueprint and BRAIN applications as well as foreign applications and applications with a secondary assignment to NIDA also received Council concurrence.
Council and staff were recused from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications for which there was a conflict of interest, real or apparent. Conflicts of interest statements were signed by each member of the Council. Members were not required to leave the room if an application in conflict with that member was acted upon en bloc.
Open Portion of the Meeting
Call to Order
Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed all attendees. She reminded the Council and audience that the meeting was open to the public in compliance with the Government in the Sunshine Act and indicated that time would be provided for public comment. She thanked the following Council members for their service as the May meeting of the NACDA will be their final meeting as Council members: Judith Auerbach, Julie Blendy, John Carnevale, Arthur Dean, and Steffanie Strathdee.
She then called attention to future Council meeting dates: September 5, 2019 (NACDA), January 30, 2019 (NACDA), May 12, 2020 (NACDA), and May 13, 2020 (CRAN).
Consideration of the Minutes of Council
The Minutes of the February 2019 NIDA Advisory Council were unanimously approved as written.
NIDA Director’s Report (NIH Videocast @ 0:02:35) — Nora Volkow, M.D., Director, NIDA
Dr. Volkow began with an overview of NIDA’s budget and portfolio with an emphasis on opioid appropriations. She addressed the trend of increased cannabis legalization across the US and NIDA’s interest in research regarding the potential effects of cannabis use on the developing adolescent brain. Dr. Volkow then discussed the evolution of the opioid crisis and how the Helping End Addiction Long Term (HEAL) initiative will speed scientific solutions to stem the national opioid public health crisis and emphasized the need for integrating interventions across healthcare, criminal justice, and community settings. She introduced two newly formed Council Workgroups - one focusing on NIDA’s efforts to develop therapeutics for substance use disorders and another focusing on the work of the NIDA Clinical Trials Network. Dr. Volkow highlighted the four sites chosen for the HEALing Communities Study, a multisite implementation research study to test the impact of an integrated set of evidence-based interventions across healthcare, behavioral health, justice, and other community-based settings. She also noted the rise in overdose death rates from psychostimulants and the increase in human immunodeficiency virus (HIV) and hepatitis C as a consequence of the opioid epidemic. Dr. Volkow concluded her talk by highlighting a study demonstrating the potential protective effects of social interactions against opioid use based on the findings of an animal study conducted in the NIDA Intramural Program.
Council thanked Dr. Volkow for her presentation and a discussion followed (NIH Videocast @ 0:57:15).
Points to Consider Regarding Tobacco Industry Funding; Implications for Companies that Produce Electronic Nicotine Devices (ENDs) (NIH Videocast @ 1:34:13 ) — Susan Weiss, Ph.D.,Director, Division of Extramural Research, NIDA, Executive Secretary, NACDA
Dr. Susan Weiss discussed NIDA’s Points to Consider Document, which was created by Council to highlight issues to be considered by NIDA and applicants for NIDA funding, should the applicant also be receiving support from a tobacco company. In 2016, the Points to Consider Document was updated to address research using Electronic Nicotine Devices (ENDs), to acknowledge that some may be used for tobacco cessation, and NIDA maintains the right to review each application on a case by case basis. NIDA sought recommendations from Council on considering applicants being offered e-cigarette products “in kind” for research studies. After a discussion with Council, the Council determined that no changes to the points to consider document were needed at this time.
Following the presentation, a discussion with Council followed (NIH Videocast @ 1:42:24).
NIDA SBIR and STTR: building successful programs for a niche market (NIH Videocast @ 1:58:42) — Elena Koustova, Ph.D., M.B.A, Director, Office of Translational Initiatives and Program Innovations (OTIPI), NIDA
Dr. Elena Koustova provided an overview of the small business innovation research program (SBIR) and small business technology transfer program (STTR) at NIH and specifically at NIDA. These programs with set aside funds support scientific excellence and technological innovations in response to the NIH mission. At NIDA, these programs are a part of the Office of Translational Initiatives and Program Innovation (OTIPI). Dr. Koustova emphasized the current research priorities and activities of OTIPI, including establishing networks with business accelerators and incubators, releasing new funding opportunity announcements and requests for information for patient feedback, coding events, entrepreneurship training, and start up challenges. The recent efforts of OTIPI have led to a large increase in applications to the program and they continue to work with awardees from startup stage to exiting and securing investments from outside partners.
Dr. Volkow and Council members thanked Dr. Koustova for her presentation and a discussion followed (NIH Videocast @ 2:35:39).
Necessity is the Mother of Invention: A Personal Perspective on Antimicrobial Resistance and A Forgotten Cure (NIH Videocast @ 2:42:30) — Steffanie Strathdee, Ph.D., Associate Dean of Global Health Sciences, University of California, San Diego
Dr. Strathdee presented on her personal and professional journey in which her husband became ill while traveling in Egypt. After learning he acquired a life-threatening infection with antibiotic resistant superbug Acinetobacter baumannii, Dr. Strathdee turned to phage therapy, an approach that had been abandoned years ago in the the US. She described the search for researchers with the skills to help her and found two teams willing to search for phages that would be a match for his infection. Once successfully found, this case became the first human intravenous phage therapy treatment in North America for a superbug infection. Dr. Strathdee then went on to develop the Center for Innovative Phage Applications and Therapeutics (IPATH) in 2018 to better test and develop phage therapy for antimicrobial resistant diseases.
Dr. Volkow and Council members thanked Dr. Strathdee for her presentation and a discussion followed (NIH Videocast @ 3:06:01).
Concept Clearances (NIH Videocast@ 3:13:48) — NIDA Staff
Ramachandran Arudchandran, Ph.D., Health Scientist Administrator, OTIPI presented: Step Up for Opioid Use Disorder (OUD): Translational Stepladder Initiative
Geetha Subramaniam, M.D. Deputy Director, Center for Clinical Trials Network presented: Renewal of the National Drug Abuse Treatment Clinical Trials Network (CTN)
Iván Montoya, M.D., Deputy Director, Division of Therapeutics and Medical Consequences (DTMC) presented: Strategic Alliances for Medications Development to Treat Substance Use Disorders
Iván Montoya, M.D., Deputy Director, Division of Therapeutics and Medical Consequences (DTMC) presented: Grand Opportunity in Medications Development for Substance Use Disorders
Each Concept was described in terms of its purpose, scope, and objectives. Council input was requested and following the discussion, Council was supportive of the concepts going forward in the initiative development process.
Public Comments (NIH Videocast @ 3:31:45)
There were no public comments.
Adjourn (NIH Videocast@ 3:33:00)
The 132nd meeting of the National Advisory Council on Drug Abuse was adjourned at 3:30 p.m.
I hereby certify that the foregoing minutes are accurate and complete.
Nora D. Volkow, M.D.
National Advisory Council on Drug Abuse
Susan Weiss, Ph.D.
National Advisory Council on Drug Abuse
Note: Informational materials provided to the public at the open session of the meeting may be obtained from the Executive Secretary.