Revised February 2016
Closed Session - September 1st
- 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 Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA) - Phil Skolnick, Ph.D., D.Sc. (hon.), Director
- Division of Basic Neuroscience and Behavioral Research (DBNBR) - Joni Rutter, Ph.D., Director
- Division of Clinical Neuroscience and Behavioral Research (DCNBR) - Joseph Frascella, Ph.D., Director
- Division of Epidemiology, Services, and Prevention Research (DESPR) - Carlos Blanco, M.D., Ph.D., Director
- End of Closed Session
Open Session - September 2nd
- Welcome and Presentation of Appreciation Certificates/Photographs - Nora Volkow, M.D. Director, NIDA
- NIDA Director's Report - Nora Volkow, M.D., Director, NIDA
- Council Discussion - Council Members
- NIH Strategic Plan - Lawrence A. Tabak, D.D.S., Ph.D., Principal Deputy Director, NIH
- NIDA Strategic Plan - Maureen Boyle, Ph.D., Chief, Science Policy Branch, Office of Science Policy and Communications (OSPC), NIDA
- NIDA IRP Update - Antonello Bonci, M.D., Scientific Director and Director, Intramural Research Program, NIDA
- Public Comments
Minutes - September 1-2, 2015
The National Advisory Council on Drug Abuse convened its 121st meeting at 1:00 p.m. on September 1, 2015 in Conference Rooms C & D, 6001 Executive Boulevard, Bethesda, Maryland. The closed portion of the meeting held on September 1st was for the purpose of 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 on September 2nd, 2015, began at 8:30 a.m. The Council adjourned on September 2, 2015 at 12:00 p.m.
Council Members Present
Anne Andorn, M.D.
Judith Auerbach, Ph.D.
Laura Bierut, M.D.
Julie Blendy, Ph.D.
Regina Carelli, Ph.D.
John Carnevale, Ph.D.
Arthur Dean, M.A.
James Hildreth, M.D., Ph.D.
Robert Lenox, M.D.
Kelvin Lim, M.D.
Michael Nader, Ph.D.
John Rotrosen, M.D.
Steffanie Strathdee, Ph.D.
Eric Verdin, M.D.
Nora Volkow, M.D.
Susan Weiss, Ph.D.
Federal Employees Present
Jane Acri, Ph.D.
Jacqueline Lloyd, Ph.D.
Members of the Public Present
Joseph Anderson - American Association of Colleges of Osteopathic Medicine
William Geary, Ph.D. - CADCA
Victoria Green - Student Intern
Debbie Grossman - Retired NIDA Research Psychologist
Katia Howlett, Ph.D. - Kelly Services
Luz Mahecha Martinez - A Bright Idea Communications
Marushka Silveira, Ph.D., M.P.H.
Penny Mills - American Society of Addiction Medicine
Dena Procaccini, MA - Kelly Services
Juli Rose, MA - A Bright Idea Communications
Susan Salva - The Farley Center at Williamsburg Place
Jen Sizemore - A Bright Idea Communications
Roy Walker - Synergy Enterprises, Inc.
Closed Portion of the Meeting – September 1, 2015
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.
In turn, the Director or a designee for the Division of Pharmacotherapies and Medical Consequences of Drug Abuse, the Division of Basic Neuroscience and Behavioral Research, the Division of Clinical Neuroscience and Behavioral Research, and the Division of Epidemiology, Services and Prevention Research presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc. Council also approved Administrative Supplements. Relevant applications were presented to Council for Special Council Review, and Council agreed with program assessments. All Trans-NIH Initiatives, i.e., Common Fund applications and NIDA Secondary applications also received Council concurrence.
Members must absent themselves from the Council meetings during discussion of, and voting on, individual applications from their own institutions or other applications in which there is 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 if an application in conflict with that member was acted upon en bloc.
Open Portion of the Meeting – September 2, 2015
Call to Order
Dr. Nora Volkow, Director, NIDA, called the open portion of the meeting to order and welcomed all attendees. She began by introducing two new Advisory Council members, Dr. Julie Blendy and Dr. John Carnevale. Dr. Blendy is a professor in the Department of Pharmacology at the University of Pennsylvania, and a member of the Center for Neurobiology of Behavior at the Institute of Translational Medicine and Therapeutics. She has melded her training in mouse genetics, molecular biology and pharmacology with her interest in neuropsychiatric disorders to develop a research program focused on investigating mechanisms underlying drug addiction. Dr. Volkow then introduced Dr. Carnevale. He has over 25 years of experience with substance abuse policy and practice. Dr. Carnevale served for 11 years as the Director of Programs, Budget, Research and Evaluation at the Office of National Drug Control Policy. Currently, he is the president of Carnevale Associates, LLC, a public policy consulting company that specializes in strategic planning, research and evaluation, policy analysis, and government budget. Dr. Volkow then acknowledged the work of six retiring Council members, Drs. Carl Hart, Terry Jernigan, Robert Lenox, Kelvin Lim, Michael Nader, and John Rotrosen, thanked them for their service to NIDA, and presented each with a certificate of appreciation. 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 then called attention to future Council meetings: February 10-11, 2016, May 3-4, 2016, and September 8, 2016. September Council will be a one-day meeting. She reminded all attendees that the CRAN Council meeting will take place on February 11, 2016 and will be held at Fischer’s Lane.
Consideration of the Minutes of Council
The Minutes of the NIDA May 2015 meeting were unanimously approved as written.
NIDA Director’s Report - Nora Volkow, M.D., Director, NIDA
Dr. Volkow began her presentation with an update on the budget. The Presidential Budget for FY 2016, if approved, would be an improvement over FY 2015’s budget and place NIDA’s total budget at a little over $1 billion, with the AIDS allocation at approximately one third of the total budget.
She then updated Council and the public on the status of the reorganization of the Division of Clinical Neuroscience and Behavioral Research per the National Advisory Council on Drug Abuse Work Group report and recommendations earlier in the year. One of the major themes that emerged from the evaluation was that translational neuroscience: development and neurobehavioral interventions research are at the heart of NIDA’s mission and regardless of how the Institute is structured, these research areas must be strongly supported. NIDA opted to restructure the institute and integrate clinical neuroscience, brain development, and treatment development into the other existing NIDA divisions to promote translational work. This encompassed the following: integrate clinical with basic neuroscience in the Division of Basic Neuroscience and Behavioral Research and rename the division as the Division of Neuroscience and Behavior (DNB); integrate behavioral and brain development research into both DNB and DESPR to enhance integration of developmental and translational science in these programs; integrate behavioral and integrative treatment into the Division of Therapeutics and Medical Consequences to enhance a unified approach to treatment development and rename the division as the Division of Therapeutics and Medical Consequences; and initiate Trans-Divisional Research Teams to address cross-cutting themes and emerging priorities. She then showed Council the proposed NIDA Organizational Chart, and stated that this reorganization will be implemented on October 1, 2015. She also thanked Dr. Wilson Compton for his leadership in this process.
Turning to what is new at NIH; Dr. Volkow began with the BRAIN Initiative, which was initiated by the President in 2014. NIH as a whole is targeting the development of tools and technologies as a way to better advance the understanding of how the brain works. In FY 2014, the BRAIN funded projects totaling $46.1 million. The funds came from the NIH Blueprint for Neurosciences Research, as well as additional funds from 4 of its institutes, the National Institute of Mental Health, the National Institute of Neurological Disorders and Stroke, the National Institute on Drug Abuse, and the National Institute of Biomedical Imaging and Bioengineering. Funding went up to $85 M in FY 2015, which included newly allocated funds for BRAIN and funds from the NIH Blueprint. For the upcoming FY 2016, $70 million in new funding was requested in the President’s budget, which will enable NIH to expand funding opportunity announcements (FOAs). One of the planned FOAs is Theories, Models and Methods for Analysis of Complex Data from the Brain (R01). It solicits research on new theories, conceptual frameworks, computational models, and statistical methods to derive understanding of brain function from complex neuroscience data. A second FOA is Foundations of Non-Invasive Human Brain Imaging and Neuro-Recording Techniques (R01), with participation by the Australian National Health and Medical Research Council. NIH is also planning an “Updates and Outreach Town Hall and Reception” at the October 2015 Annual Society for Neuroscience Conference in Chicago, IL.
Dr. Volkow next spoke about the Precision Medicine Initiative (PMI). The President has proposed a budget of $215 million for FY 2016; of this, $130 million will be used to start building the PMI research cohort. A PMI Working Group of the Advisory Committee to the NIH Director (ACD), including experts from many disciplines and sectors, was established to help plan for the creation and management of the PMI research cohort. The PMI Working Group’s report of recommendations will be delivered to the ACD sometime in September 2015. The advantage to NIDA with the PMI initiative is the opportunity to collect data and understand how the use of drugs influences medical outcomes; as well as gathering information on whether a decrease in the amount of a substance used has a beneficial effect on health outcomes. This would help the FDA alter its requirements and end points for studies on new addiction medications from total abstinence to decrease in amount used. One of the biggest challenges with gathering such data is maintaining individual privacy laws.
She then discussed the NIH Strategic Plan, which was requested by Congress and due by December 2015. Three major themes have been identified: Fundamental Science, Health Promotion and Disease Prevention, and Treatments and Cures. Dr. Lawrence Tabak, Principal Deputy Director for NIH has been leading this task, and will be presenting to NIDA Council following Dr. Volkow’s presentation.
Dr. Volkow then discussed progress in updating the federal regulations known as the Common Rule that were established in 1991 to protect individuals who participate in research. Although the regulations have been amended over the years, they have not kept pace with the evolving human research enterprise. Over the last several years, a set of proposed revisions have been developed and a Notice of Proposed Rule Making will soon be published in which input from the public will be sought. The overarching goals of the modernization efforts are to enhance protection of and respect for research participants, and to increase the efficiency of the oversight process. The expected major reforms are to calibrate oversight to level of risk, to enhance respect for research participants, to facilitate broad participation in research, to increase privacy and security safeguards, and to streamline the IRB review process.
NIH recognizes both the significance and complexity of this rule, and will support stakeholder meetings to ensure informed comments from the public, patient organization, and industry, in addition to investigators and institutions. Next steps will be to publish it in the Federal Register with a 90 day public comment period, consider public comments, and develop and publish the final rule.
The final NIH activity that Dr. Volkow spoke about was funding of AIDS-related research. It is critical to ensure that NIH AIDS funds are supporting the highest priorities for the next 3-5 years. These priorities are: 1) Reduced incidence, including vaccines, 2) next generation of HIV therapies with better safety and ease of use, 3) research toward a cure, 4) HIV-associated comorbidities and co-infections. The cross cutting areas that will influence funding are basic research, health disparities, and training. She then spoke about how the NIH Office of AIDS Research (OAR) is planning on implementing these priorities in January 2016. First, the Center for Scientific Review will revise its referral guidelines and restructure the AIDS IRG study sections; OAR will review draft FOAs and Requests for Applications to ensure that they are properly aligned with the new priorities; OAR in consultation with the NIH Director may utilize its 3% transfer authority to transfer AIDS funds between ICs; OAR will require that all new and competing renewal projects are aligned with the highest overarching AIDS priorities; and all new and competing renewal projects will be pro-rated on the basis of their AIDS proportion.
She reminded Council that since one third of NIDA’s budget is related to HIV/AIDS research, this will in turn affect which applications NIDA will be funding in the future. Thus she has requested the help of NIDA Advisory Council members (Drs. Verdin, Strathdee, Hildreth, Auerbach), as well as other NIDA staff to serve on a NIDA HIV Council Subcommittee Workgroup to help identify priority areas of research and strategies that blend the comorbidities of substance use disorders and HIV.
Dr. Volkow went on to highlight NIDA priorities, beginning with HIV. She noted that drugs continue to drive the HIV epidemic and thus, this area remains a priority. She provided examples of recent outbreaks that show how HIV can disseminate very rapidly among injection drug users (IDU). The first was a recent study in Greece showing how an outbreak of HIV linked to IDU occurred after budgetary constraints limited the operation of needle and syringe exchange programs, as well as medication-assisted treatment clinics. Greece then implemented an aggressive intervention to reverse this, and was able to decrease its new HIV cases in IDU to 84 in 2014 (down from 266 new cases in 2011 and 547 new cases in 2012). The second example was previously discussed at the May 2015 NIDA Advisory Council meeting, in which a recent (Jan, 2015) outbreak of HIV was linked to IDU of oxymorphone in Indiana.
She then shared the results of a study by Metzger, et al., AIDS from 1993 that showed how even a simple intervention, such as providing partial or continuous methadone to IDU significantly reduced the HIV seroconversion rate over 18 months. A more recent study published in the Journal of AIDS in 2014 by Woody et al., also shows that Medication Assisted Therapy decreased risky behavior associated with infection, HIV and HCV. It also showed that injection drug use decreased in those individuals sustained on buprenorphine, as opposed to those only provided buprenorphine for detoxification.
NIDA is also funding implementation studies, including Seek, Test, Treat, and Retain, in substance use disorder programs, Emergency Departments, Infectious Disease clinics, the criminal justice system, and in countries where IDU drives the HIV epidemic. Also, NIDA is funding research on new therapeutics for IDU using extended release medications to improve compliance; medications not based on opioid agonists; and vaccines and other immunotherapies to counteract HIV.
Dr. Volkow then went on to explain that NIDA has created an Avenir Award in HIV/AIDS research to attract new and creative junior scientists to the field of substance abuse. She presented the first four awardees and provided background information on their academic backgrounds and proposed research projects.
Dr. Volkow moved on to prevention and discussed the ABCD initiative led by Dr. Susan Weiss. Multiple RFAs were released, including one for an ABCD Coordinating Center (U24), ABCD Research Project Sites (U01), and a Data Analysis and Informatics Center (U24). NIDA received a robust response to the FOAs, the review of applications took place in July and grants will be awarded by the end of the fiscal year.
In basic science, she highlighted the Avenir Awards for genetics and epigenetics in substance abuse research. The awards support those in an early stage of their career who may lack the preliminary data required for an R01 grant, but who propose high impact research and show promise of being tomorrow’s leaders in the field. Dr. Volkow presented the awardees and their proposed research projects.
NIDA also issued new RFAs to better understand the long lasting effects of drug use on gene expression and function: 1) Tools for Monitoring & Manipulating Modified RNAs in the Nervous System—this RFA incentivizes small businesses to generate tools, technologies, and products for monitoring and manipulating covalently modified eukaryotic RNA; 2) Harnessing Genome Editing Technologies to Functionally Validate Genetic Variants in Substance Use Disorders to functionally validate and characterize genetic or epigenetic variants involved in SUD; and 3) Extracellular Vesicles and Substance Abuse to investigate the interplay between extracellular vesicles and addictive processes.
Dr. Volkow then discussed NIDA Treatment Research. She presented a study by Levin et al. published in 2015 in JAMA Psychiatry that tested extended release amphetamine for the treatment of individuals that had comorbid Attention-Deficit/Hyperactivity Disorder (ADHD) and cocaine abuse. The study used placebo vs. 2 high doses of extended release amphetamine salts (60 mg and 80 mg/day respectively). The 80mg/day cohort showed a significant reduction in cocaine use and ADHD symptoms. The results of this study are very encouraging.
Other exciting studies that she pointed to were by Justinova et al., and Caprioli et al., respectively, (Biological Psychiatry in press), studying AZD8529, a positive allosteric modulator of mGluR2, which is a receptor that modulates the release of glutamate. It has been shown in animal models to decrease nicotine and methamphetamine self-administration and reinstatement. NIDA is currently partnering with Astra Zeneca pharmaceuticals in a clinical trial to study its effects on nicotine addiction.
Next, Dr. Volkow presented a new NIDA Program Announcement (PAR), Fast-Track Development of Medications to Treat Cannabis Use Disorders (UG3/UH3). Its purpose is to accelerate the discovery and development of medications to treat Cannabis Use Disorders. The objective is to advance medications toward the ultimate goal of obtaining FDA approval. The PAR will have multiple application due dates, through March 2018.
Finally, Dr. Volkow moved on to NIDA hosted events. She first spoke about the NIDA and NIAAA sponsored mini convention, Frontiers in Addiction Research. This is the first jointly sponsored Frontiers mini convention and will take place in Chicago on October 16, 2015 right before the start of the Society for Neuroscience (SfN) annual meeting. The theme will be the Neurobiological and Behavioral Consequences of Drug and Alcohol Use during Development and it will be comprised of three sessions. The first session will be “Brain Development, Structure and Behavior”, the second “Genetics, Neurocognition and Behavioral Phenotypes”; and last “Molecular, Cellular and Behavioral Underpinnings of Substance Use Disorder Vulnerability.” The Joint NIDA-NIAAA Early Career Investigator Showcase will also occur during the mini-convention.
She then presented the three high school awardees of the 2015 Addiction Science Award. In first place is Glenn Yu from Hunter College High School in New York City. His project was on Naturalistic Painkillers: Design, Synthesis and Biological Evaluation of Novel Fatty Acid Binding Protein Inhibitors; Ralph Lawton from Pennsylvania Leadership Charter School-University Scholars Program in West Chester, PA came in second place. The title of his project was “Don’t Be Led Ashtray: Toxicological Effects of Electronic Cigarettes on Inflammation and Lung Cell Viability with Comparison by Brand, Flavor and Generation.” In third place was Kashfia Nehrin Rahman from Brookings High School in Brookings, SD and the title of her research project was “Nomophobia: Effects of Smartphone Dependence and Separation on Stress, Anxiety, Memory and Cognition in Developing Adolescent Brain.”
Dr. Volkow then told the audience that the NIDA 2016-2020 Strategic Plan will be presented by Dr. Maureen Boyle, Chief of the Science Policy Branch, later that afternoon. In addition, Dr. Anto Bonci, Director of the NIDA Intramural Research Program, will be presenting on a recent visit on August 24, 2015 from Congressman John Sarbanes (D-MD) to the NIH Bayview Facility. He was able to see the transcranial magnetic stimulation suite and how it is being used to treat substance use disorders, as well as the laboratory for neuroimaging where findings from human studies can be used to develop intervention based studies in animals, with the goal of future use in humans.
Council thanked Dr. Volkow for her presentation. Dr. Rotrosen commended Dr. Volkow and NIDA Staff for their efforts with the reorganization. First, he credited DCNBR for their leadership and highlighted the fact that advances in clinical neuroscience of addiction have rivaled every other brain disease. Second, he wanted to thank NIDA leadership for thoughtfully coming up with a new reorganization plan to improve and better align NIDA’s goals and research efforts. Council members also brought up a concern with the Office of AIDS Research’s new guidelines that do not place behavior as a high priority research area. However, further discussion led to understanding that although it might have not been expressed in the guidelines as a priority area, behavior is still considered a cross-cutting and important theme within the HIV/AIDS area by NIH leadership as a whole.
Developing the NIH-Wide Strategic Plan - Lawrence A. Tabak, DDS, Ph.D., Principal Deputy Director, NIH
Dr. Tabak thanked Dr. Volkow and the Advisory Council members for the opportunity to speak about the NIH Strategic Plan. He began by providing background information on why the strategic plan is being developed at this time. The CR Omnibus H.R. 83-346, which was enacted on December 16, 2014 states that the “NIH shall submit to Congress an NIH-wide 5 year scientific strategic plan no later than one year after enactment.” This indicates that it needs to be completed and provided to Congress by December 16, 2015. In addition, there is pending legislation, the 21st Century Cures Act, Section 1021, that references the NIH’s 5-year biomedical research strategic plan. It states that the plan should be used to identify research opportunities, develop individual strategic plans with a common template for the research activities of each Institute or Center, and identify strategic focus areas that consider return on investment.
Dr. Tabak continued by identifying the goals of the strategic plan, which are to develop a “living document” that will help guide NIH in fulfilling its mission over the next 5 years; articulate approaches and opportunities that are forward-looking and inspirational in nature; and identify major trans-NIH themes that will advance biomedical research. He then addressed what the Strategic Plan should and should not be to avoid misunderstandings and meet expectations. The Strategic Plan should clearly articulate the highest priorities of the NIH overall; it should describe how the NIH will achieve the highest priorities; and it should be a living document that will require refinement throughout its lifecycle. The strategic plan should not describe all the many important things that NIH does and will do in the future; and it should not address priorities of the individual Institutes, Centers and Offices (ICOs) since each of the ICOs has their own strategic plan and each is referenced in the executive summary of the NIH strategic plan.
The development of the strategic plan began with discussion and involvement by NIH senior leadership. NIH OD requested volunteers from various ICOs to form a working group. Overall, the working group has been critical in both developing the contents of the plan, as well as providing examples of research advances. In addition, Dr. Collins has solicited input from the Advisory Committee to the NIH Director (ACD). The ACD advocated for additional emphasis on the interconnected nature of the research, and the inclusion of clinical methodologies, data science, and workforce retention. The NIH Director is monitoring progress carefully and will oversee the development of the final document.
Dr. Tabak then presented a schematic to display the current framework of the strategic plan as the NIH OD envisions it. He described each element of the chart. The top portion is an overview, and within it is a concise description of the mission of NIH; an articulation of how this is a unique moment of opportunity in biomedical research; a description of the current breadth of NIH-supported research landscape; and the real constraints confronting the community in the face of lost purchasing power. This will be followed by what is referred to as areas of opportunity that apply across biomedicine. The figure displayed infers that there is continuum among the different areas of opportunity. The three areas are: fundamental science; health promotion and disease prevention; and treatments and cures. For each of the areas, there will be a succinct description of what the emergent opportunities are and what the agency needs to do to get there; as well as, highlights of specific and recent breakthrough examples.
He then elaborated on each of the areas of opportunity beginning with fundamental science. It is the foundation for everything that is done in biomedical research and for progress; however, emphasizing that consequences are often unpredictable; advances in clinical methodologies stimulate progress; technology leaps catalyze advances; and data science increases both impact and efficiency. He gave the example of how microbial biology has led to what is now referred to as the microbiome that informs the development of the immune system. He then moved on to the area of health promotion and disease prevention and began with the importance of studying healthy individuals; advancing early diagnosis and detection; and reducing or eliminating health disparities by using evidence-based science. Illustrative examples could be of the Vaccine Treatment and Evaluation Units that comprise a clinical trials network that evaluates promising vaccine candidates and can rapidly test vaccines designed to counteract emergent public health concerns; such as with the recent crisis in West Africa of Ebola. And finally with regard to treatments and cures, new opportunities are based on molecular knowledge; which has led to a breakdown of traditional disease boundaries, and will require new partnerships, that often come from unexpected directions, to form and tackle the most complex diseases and conditions moving forward. Opportunities to discover new treatments and cures on the basis of molecular knowledge are tremendous, such as cancer researchers discovering commonalities in the pathways and processes that lead to abnormal tissue growth in various cancer types. This resulted in breakthroughs in cancer immunotherapy.
The final components of the chart are the unifying principles: setting priorities and enhancing stewardship. For setting priorities, the strategic plan will incorporate disease burden as important, but not the sole factor; foster scientific opportunity, as well as need for nimbleness in decision making; advance research opportunities presented by rare diseases; and consider the value of permanently eradicating a pandemic. He spoke about the NIH’s Clinical Center as an important hub for rare disease research. How it facilitates intramural-extramural collaborations and accelerates new therapeutic discoveries; and it supports the undiagnosed disease program (UDP) which has recently been expanded to include several extramural sites.
As for enhancing stewardship, NIH will need to recruit and retain an outstanding research workforce; enhance workforce diversity; encourage innovation; optimize approaches to inform funding decisions; enhance impact through partnership; ensure rigor and reproducibility; reduce administrative burden; and employ risk management strategies across NIH business processes. An example that might be highlighted in the strategic plan, is the Accelerating Medicines Partnership, which is a program involving NIH, the Food and Drug Administration, ten pharmaceutical companies, and nonprofit organizations in developing new diagnostics and treatments by identifying and validating promising biological targets.
NIH leadership has been actively welcoming outreach and public feedback. They have set up three separate webinars and published a Request for Information (RFI). They received close to 460 responses to the RFI with mostly positive comments on the framework. The broad suggestions were to emphasize implementation and interdisciplinary science; specific suggestions were to promote use of big data, emphasize population health and change the peer review process; and there were some disease-specific comments advocating for greater focus on mental illness. Feedback from the webinars was related to workforce training, patient partnerships, more explicit inclusion of behavioral and social sciences, systems approaches, interdisciplinary research, and the process for developing the plan.
Dr. Tabak welcomed questions and concluded his presentation.
NIDA Council members thanked Dr. Tabak for his presentation. Multiple comments were made including, how useful the strategic plan would be. Dr. Tabak ensured the audience that the strategic plan is mandated by law and its goal is to help illuminate Congress and the public on proper stewardship and how NIH plans to reach its goals in the next 5 years. Another question was why the strategic plan does not specifically highlight health promotion and prevention. Dr. Tabak stated that this is a more granular and specific program that could be a part of the broader goals of the strategic plan, which sets up the framework for the NIH to scan the horizons for emerging opportunities of study so that appropriate funding and support is provided.
NIDA Strategic Planning: An Update - Maureen Boyle, Ph.D., Chief, Science Policy Branch, Office of Science Policy and Communications, NIDA
Dr. Boyle stated that the goal of her presentation was updating Council on the process for developing a strategic plan to guide NIDA programs over the next five years, from 2016-2020 and where NIDA is at this time in the process. She began by providing a review of the goals of the strategic plan. . The Strategic Plan will include both NIDA-wide as well as division-specific strategic plans that are to be inclusive by engaging a broad range of traditional and non-traditional stakeholders; to be innovative in leveraging recent advances in drug addiction research, the “omics”, biomedical and information technologies; and to be thoughtful, achieving NIDA’s mission most effectively, given the practical realities, and re-envisioning the landscape of substance use and addiction research.
She then moved to discuss the strategic planning process. It is a yearlong, cross divisional process with an anticipated final Strategic Plan release in the fall of 2015. The process includes a Request for Information (RFI), Bold Goals Challenge, and Priority Area Workgroups. The RFI was released on December 10, 2014 to solicit public comment on draft priorities, which were: Understanding of the basic science of drug use, addiction, vulnerability to addiction, and recovery; supporting development of new and better interventions and treatments; increasing the public health impact of NIDA research; and Enhancing the national research infrastructure. 181 comments were received and the general themes that emerged were: greater real world focus, basic science, leveraging technology, policy relevant research, complex patients, accelerating treatments, and training. Dr. Boyle provided more specific examples for each of the themes listed.
The next element of the strategic planning process is a Bold Goals Challenge. This is a challenge that will harness insights from other disciplines to advance drug abuse and addiction research; $25,000 in prizes was set aside for innovative ideas on the goals within NIDA’s research portfolio, it was released on challenge.com and closed on June 30, 2015. Unfortunately, none of the submissions were found to be scientifically meritorious and responsive to the challenge concept, thus no prizes were awarded.
The last element is the priority area workgroups to engage external experts on strategic priorities addressing: Gene x environment x development interactions (GEDI), patients with complexities, and big data. Priority area workgroups convened between April and June by webinar. All of the recommendations and related action items for the three domains are available on the NIDA Strategic Plan website.
The GEDI workgroup, chaired by NIDA’s Naimah Weinberg and Jonathan Pollock, had cross-cutting recommendations: to foster data sharing; facilitate interdisciplinary collaborations; fund for methods development and training; support secondary analysis of existing data sets; and focus on building translational bridges. Furthermore, more specific recommendations were made and are available to view for epigenetic approaches, phenotyping, environmental influences, animal studies, and gene identification.
The Patients with Complexities workgroup, chaired by Drs. Meyer Glantz and David Liu from NIDA, had the following three major recommendations: Study the different trajectories of substance-using individuals with complex conditions; characterize the complex phenotypes of people with SUDs; and improve treatment and prevention strategies. Within each of these recommendations, more specific goals were recommended and presented.
The Big Data workgroup was chaired by Drs. Little and Vahabzadeh from NIDA. In addition to recommendations within data sharing, data capture, curation and analytics, this group also made overarching priorities within their recommendations. This included leveraging existing technologies and resources, and adhering to widely-used practices; and to support development of platforms that allow data to be easily integrated from diverse sources that are replicable, validated, standardized, and that can be repurposed for the future.
She then moved on to the timeline. Currently, the Strategic Plan draft is being reviewed by NIDA senior staff. The draft structure includes high level goals: basic science, prevention, treatment, and public health impact. Priority focus areas: analysis of complex interactions influencing drug use trajectories; treatment development; addressing real world complexities; and bi-directional translation. She then added that the cross-cutting themes within the draft are: leveraging technologies; driving innovation; fostering collaboration; data and resource sharing; supporting health equality; and increased real world relevance. Many of those themes mimic ones in the NIH Strategic Plan as it was presented by Dr. Tabak.
Finally, Dr. Boyle spoke about next steps. She reiterated that the strategic plan draft is currently under review by NIDA senior staff; the expected release for public comment and Council review is September 2015; and comments will be integrated into the Final draft for senior staff review and approval. The expected release date for the final NIDA Strategic Plan is by the end of fall.
Dr. Boyle then thanked Council for their attention and opened the floor for questions.
Dr. Volkow and Council members thanked Dr. Boyle for her presentation and applauded the Science Policy Branch and the Office of Science Policy and Communications for their efforts in leading NIDA’s Strategic Plan. Questions that were posed by Council were related to whether NIDA’s strategic plan aligned with that of NIH’s, whether the strategic plan is an inward vs. outward facing document, and what types of evaluative milestones have been placed to track progress. Dr. Boyle responded that NIH’s strategic plan is very broad; however it does align with the high level goals within NIDA’s plan. NIDA used both: the process was largely inward-facing, filling the gaps and leveraging advances that have not been done previously, whereas the Strategic Plan document is largely outward-facing as it solicited and absorbed recommendations from outside organizations and experts. And Dr. Volkow requested the expertise of Council members in developing metrics to better monitor and set milestones for achieving program specific strategic plan goals in the next 5 years.
NIDA Intramural Research Program: An Update - Antonello Bonci, M.D., Scientific Director and Director, Intramural Research Program, NIDA
Dr. Bonci began his presentation by extending an invitation to all NIDA Advisory Council members to visit the IRP in Baltimore, MD at their convenience. Dr. Bonci said that he was hired 5 years ago to create a world class neuroscience institute focused on substance use disorders; to develop and maintain an environment where cutting edge science, human studies and drug abuse-related initiatives can thrive; and to have a highly interactive intramural-extramural environment.
In order to initiate interactions, the IRP structure has changed. The Office of the Scientific Director currently plays a very small role because the other components, the committees, the core facilities, programs and the branch chiefs have all been empowered to make independent decisions. Many of the branch chiefs work double duty and are collaborating with extramural programs and administration to better the science. .
He then spoke about Dr. Jean Lud Cadet’s role as the Associate Director for Diversity and Outreach. Dr. Cadet saw a need for having a pipeline for diversity and minority fellows in the intramural program and requested set aside funding. As of 2010, NIDA IRP sets aside approximately $500,000 to hire post-doctoral fellows that increase the diversity of the IRP. NIDA now maintains eight slots per year and is leading NIH in this effort. In addition, Dr. Steve Heishman, Associate Director for Education and Training, has dedicated his time to ensuring appropriate training; he also conducts annual evaluations of every faculty, student and post-doc member in the IRP.
Moving on, Dr. Bonci discussed the philosophy of the Board of Scientific Counselors (BSC), which has changed since he began leading the IRP. A new R01 style scoring system has been adopted and only the applications with an outstanding score of 1 are funded. This has led to the selection of research projects that have a larger emphasis on potential impact on science, on high-risk and big impact on the field, and on relevance to the NIDA mission.
He then displayed the IRP budget since 2011. Although it appears to have gone up by $3.9 million, the cost of leasing space and school taxes has gone up. This has led to an overall budget decrease of 30% to sustain current levels, and has limited faculty pay and compensation. In turn, the workload on the administrative staff has increased. The total number of IRP staff has decreased from 527 in 2010 to 494, with the majority of cuts in the research and clinical staff areas, resulting in the replacement of eight laboratories with five promising junior faculty to cover all of the different areas of science. Dr. Bonci presented the new laboratory investigators: Drs. Yka Aponte, Lorenzo Leggio, Lei Shi, Michael Michaelides, and Da-Ting Lin.
The IRP has also hired two new senior investigators, Dr. Geoff Schoenbaum from the University of Maryland, and Dr. George Koob from Scripps Research Institute. In addition, NIDA IRP is working with investigators across the NIH, under a joint appointment status to allow the investigators full access to NIDA core facilities, including the Clinical Director at NINDS, Dr. Avindra Nath. He brings with him a wealth of knowledge on HIV and substance abuse research; this collaborative effort might also help NIDA have an increased presence in the NIH Clinical Center and on NIH’s main campus.
Dr. Bonci then moved to the topic of ongoing initiatives at the IRP. The Medication Development program led by Dr. Amy Newman, who is working collaboratively with Dr. Phil Skolnick from DTMC; the Diversity and Outreach program with fellowships led by Dr. Jean Lud Cadet, who is also working closely with NIH’s Dr, Hannah Valentine to better identify candidates; the Intramural-Extramural Innovative Partnership program run by Dr. Michelle Leff; the Designer Drug initiative that is led by Dr. Mike Baumann, who is a national leader in this field and is working with extramural scientists on developing and studying these drugs; Dr. Da-Ting Lin is also working in Bioengineering in partnership with Purdue University with the goal of developing new biosensors to measure cocaine, heroin, metabolites, and stress; and finally Dr. Bonci is leading the Discovery Engine initiative; the goal of this initiative is to add new measures of significance of science to help the community better quantify publications with metrics. This will be done collaboratively with the National Institute on Aging.
Future plans for the IRP include continued improvement in data quality and number of publications; improvement in administrative efficiency; and strengthening the clinical program by strengthening partnerships across the NIH and other extramural institutes.
Council thanked Dr. Bonci for his leadership of the NIDA IRP. One of the Council members wanted to know how the new NIH Office of AIDS Research guidelines will affect HIV research at the IRP. Dr. Bonci stated that his staff are in the process of writing up a document that prioritizes HIV/AIDS research and that they are developing a unique, novel HIV mouse model. Dr. Volkow then added that the IRP is working closely with both NIAID to prioritize research projects, as well as with NINDS’s Dr. Nath who is an expert in HIV and brain reservoirs. She also thanked Dr. Bonci for all of his efforts and publication of high impact scientific papers, as well as his efforts with changing the culture of intramural programs across the NIH by reaching out and collaborating with other ICs.
There were no Public Comments
The 121st meeting of the National Advisory Council on Drug Abuse was adjourned at 12:00 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.