Revised September 2014
May 6-7, 2014
The National Advisory Council on Drug Abuse convened its 117th meeting at 2:00 p.m. on May 6, 2014 in Conference Rooms C & D, 6001 Executive Boulevard, Bethesda, Maryland. The closed portion of the meeting on May 6, 2014, 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 May 7, 2014, began at 8:30 a.m. The Council adjourned on May 7, 2014 at 2:30 p.m.
Council Members Present
Anne Andorn, M.D.
Laura Bierut, M.D.
Regina Carelli, Ph.D.
Nabila El-Bassel, Ph.D., D.S.W.
James Hildreth, Ph.D., M.D.
Elizabeth Howell, M.D.
Terry Jernigan, Ph.D.
Robert Lenox, M.D.
Kelvin Lim, M.D.
Michael Nader, Ph.D.
Marina Picciotto, Ph.D.
John Rotrosen, M.D.
Nora Volkow, M.D.
Mark Swieter, Ph.D., Acting
Federal Employees Present
Jane Acri, Ph.D.
Elena Koustova, Ph.D.
Members of the Public Present
Julie Croxford - RTI International
Anne Imrie - S-3
Geoffrey - American Psychological Association
Ashley Rutter - Am. Academy of Child and Adolescent Psychiatry
Michelle Rodrigues - SRI International
Roy Walker - Synergy Enterprises, Inc.
Patrick Zickler - Synergy Enterprises, Inc.
Closed Portion of the Meeting – May 6, 2014
- 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. Mark Swieter, Acting 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.
- Application Reviews
In turn, the Director or a designee for the Division of Epidemiology, Services and Prevention Research, the Division of Pharmacotherapies and Medical Consequences of Drug Abuse, Division of Basic Neuroscience and Behavioral Research, Division of Clinical Neuroscience and Behavioral Research, and the Office of the Director presented their applications for consideration by the Council. For each, Council provided concurrence with the initial scientific reviews en bloc. Council also approved one Method to Extend Research in Time (MERIT) Extension award. Administrative supplements were approved, including CRAN and NIDA T32 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 – May 7, 2014
- 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 called attention to future Council meetings: September 2-3, 2014, and February 3-4, 2015. She reminded all attendees that the CRAN Council meeting will take place on February 4, 2015.
- Consideration of the Minutes of Council
The Minutes of the NIDA February 2014 meeting were unanimously approved as written. In addition, the Minutes of the February 2014 CRAN Council meeting were unanimously approved as written.
- NIDA Director’s Report - Nora Volkow, M.D., Director, NIDA
Dr. Volkow began her presentation by recognizing the remarkable work of the recently deceased, Dr. Richard Denisco. Dr. Denisco was a medical officer with the Services Research Branch in the Division of Epidemiology, Services and Prevention Research at NIDA. His grant portfolio emphasized nicotine/tobacco use, chronic pain and prescription drug abuse and primary care medicine linkages. His extraordinary insight on the clinical management of pain and use of opioid analgesics, his contributions to the Pain Consortium, and his ability to facilitate partnerships, led to the development of an open access registry for the collection of data in patients with chronic pain. Dr. Denisco was also instrumental to NIDA in his work, along with Dr. David Thomas, on the NIH Pain Centers of Excellence. He will be greatly missed.
Dr. Volkow spoke about a recognition event that took place the afternoon of May 6th. It was the NIDA Lifetime Science Award recognizing the many achievements and contributions of Dr. Mary Jeanne Kreek. The impact of Dr. Kreek’s work on both the field and on people who suffer from substance use disorders is remarkable. Not only has she been instrumental in bringing methadone therapy into the clinic, but also she has been an extraordinary mentor to scientists in the basic and clinical practice of substance use disorders nationally and internationally.
Dr. Volkow also recognized two NIDA staff that have received awards for distinction. The first is, Dr. Elizabeth Robertson, former chief of NIDA’s Prevention Research Branch who has since retired. She received the Presidential Award for outstanding contributions to advancing the field of prevention science. The second is Dr. Amy Newman, Deputy Scientific Director of NIDA’s Intramural Research Program. She has been selected to receive the Marian Fischman Memorial Award for her incredible contributions to the field of drug abuse and addiction at the 76th Annual Meeting of The College on Problems of Drug Dependence (CPDD) that will be held on June 14-19th, 2014 in Puerto Rico.
Dr. Volkow then announced recent staff changes at NIDA, including the newly appointed Director of the Office of Diversity and Health Disparities (ODHD), Dr. Albert Avila. One of NIDA’s main missions is to try to increase the representation of minorities as researchers in the field of substance use. Dr. Avila’s remarkable work as the Acting Director of ODHD set the stage for him to take on this task.
Dr. Volkow then provided Council with an update on the budget. There were no changes to report since the February 2014 meeting. She explained that the budget for fiscal year 2014 will be a 3% increase over that of fiscal year 2013, but it still remains lower than that of 2012. The increase over fiscal year 2013’s budget may be due to the cuts related to the sequester. Shereminded the attendees that NIDA has a mandate to allocate approximately one third of its budget to research on HIV/AIDS and drugs and that most of the research directly related to neuroscience, medication development and epidemiology is covered by this mandate.
Turning to what is new at HHS; Dr. Volkow spoke about the new Director of HHS, Sylvia Mathews Burwell. Most recently, Secretary Burwell was the Director of the Office of Management and Budget. She is knowledgeable about some of the issues that the NIH is facing and has made a personal visit to the NIH.
Dr. Volkow then spoke about newly implemented NIH policies that will affect the grantee community. One new policy applies to applications with due dates after April 16, 2014. Following an unsuccessful resubmission (A1) application, applicants would be allowed to submit the same idea as a new (A0) application for the next appropriate new application due date, should they choose to do so. This should be a great opportunity, especially for young scientists, to improve their application and potentially have another chance at being funded. There is a concern that this may affect reviewer workload and the review process as a whole.
The second policy is to enhance reproducibility and transparency of research findings across the NIH. A paper by Drs. Francis S. Collins and Lawrence A. Tabak, published in Nature on January 30, 2014 indicated that approximately seventy percent of research cannot be reproduced. This is a particularly salient concern when one is addressing research with a potential for translation. Dr. Volkow pointed out that the article indicated it is believed that the lack of reproducibility is not likely due to misconduct, but rather that it relates to factors that could be improved upon. Training resources are being developed for implementation across the NIH to help improve reproducibility. For example, NINDS is working with the NIH Intramural Research Program on training modules in experimental design; also, NIH is planning a course on experimental design via FAES that could be adapted for online use by the end of 2014. NIDA also plans on improving the review process by requiring applicants to explicitly identify the experimental methodology in preclinical studies for reproducibility.
Dr. Volkow moved onto current activities at NIDA. She began by discussing the plan to reorganize and create a Division of Extramural Affairs (DEA) similar to how several other NIH institutes are organized. In addition to incorporating the various functions of the current Office of Extramural Affairs such as FOA development, extramural policies, receipt and referral, National Advisory Council on Drug Abuse, the new division would include the Grants Management Branch and would better allow NIDA to coordinate trans-NIH programs and initiatives such as CRAN and BRAIN.
Dr. Volkow then spoke about NIDA priority areas. She indicated that two major areas of NIDA science have recently captured the attention of the media, the public and the health care system: marijuana and prescription opioid drug abuse. Such attention makes it an opportune time to continue to foster a primary NIDA priority to incorporate the science of substance use disorders into the management of substance use disorders in the health care system.
This was evident at the National Rx Drug Abuse Summit that was held in April in Atlanta, GA, which was organized by U.S. House Committee on Appropriations Harold Rogers of Kentucky. The meeting brought together the heads of the major federal health agencies, including NIH Director Dr. Francis Collins; CDC Director Dr. Thomas Frieden; and FDA Commissioner Dr. Margaret Hamburg. A recent Institute of Medicine report estimated that 100 million Americans
suffer from moderate to severe pain. Opioids remain the most effective medications available to manage severe pain. However, they are not always useful and there is a growing epidemic of opioid morbidity and mortality nationwide, in part fueled by the diversion of prescription opioids for misuse and abuse. NIDA is putting a lot of resources into the development of medications that are non-addicting, that are not based on opioid medications or that are based on combinations that will minimize their abuse liability such as diversion resistant formulations.
Next, Dr. Volkow moved onto the area of basic science. She presented data from studies in animal models suggesting that, through epigenetic modifications, there may be trans-generational inheritance of the effects of drugs. The work focused on the effects of THC in males on modifying the epigenetic marks in histones or acting directly on DNA through methylation or other processes in the spermatozoa in such a way that they are transferred into the next generation. Moreover, the next generation showed a much greater sensitivity to the rewarding effects of heroin than controls. Such epigenetic inheritance has not yet been shown in humans.
Another important and emerging area of research that is leading policy is whether marijuana exerts harmful effects on the brain. There are data showing that marijuana use may interfere with connectivity and function of the adolescent brain in a way that may disrupt cognitive abilities, decrease intelligence and lead to apathy or amotivation. In addition, other recent studies have shown an association between marijuana use and increased risk for psychosis or schizophrenia in young adults that are vulnerable to these conditions. There are multiple studies currently focusing on schizophrenia with and without use of cannabis, and using PET technology to study dopaminergic signaling.
Dr. Volkow then spoke about upcoming Funding Opportunity Announcements (FOAs). The Avenir Award Program is for early stage investigators who may lack preliminary data for an R01 grant, but who propose high impact research and creativity. Effects of Cannabis Use and Cannabinoids on the Developing Brain FOAs aim to support research on the effects and functional consequences of cannabis use on the developing brain, from pre-, peri- and post-natal development through young adulthood in animal models and humans.
She went on to describe a new initiative on Adolescent Brain Imaging that stems from the government-wide BRAIN project. The Adolescent Brain Project is a large prospective, open-access study that will investigate trends and effects of exposure on kids in the United States from late childhood into adolescence and adulthood. Primary Investigators (PIs) will be encouraged to perform regular imaging and phenotypic and cognitive characterizations of these adolescents as they transition from childhood to adulthood. NIDA, NIAAA, NCI and NICHD have joined this effort. Efforts are underway to involve NIMH, NINDS as well. NIDA is also seeking participation from other federal agencies such as the FDA and the CDC. Dr. Volkow shared the planned strategy; a Request for Information will be published June/July of 2014 and the goal is to have the application receipt dates begin in early 2015.
Council thanked Dr. Volkow for her presentation. One line of questions focused on the urgent need to conduct more research on marijuana and heroin and the length of time it takes to get a DEA license to work with both since they are schedule I drugs and whether NIDA could play a role in speeding the licensing process. Council also complimented NIDA’s efforts at reaching and educating adolescents about the effect of drug use, and recommended expanding the reach to include college-age youth as well. And Council also provided suggestions and recommendations on the direction of the future Adolescent Brain Project.
- DBNBR: Discoveries in Basic Neuroscience and Behavioral Research - Joni Rutter, Ph.D., Director, Division of Basic Neuroscience and Behavioral Research, NIDA
Dr. Rutter began her presentation with DBNBR’s goal of bringing basic science to NIDA’s overall mission of leading the nation in bringing the power of science to bear on drug abuse and addiction. Her talk was to describe DBNBR’s scientific branches and cross-cutting activities that support HIV/AIDS, pain, sex differences and training research. She also wanted to highlight some flagship programs, such as the Cutting-Edge Basic Research Award (CEBRA), the NIDA Genetics Consortium Repository, the Early Career Award in Chemistry of Drug Abuse and Addiction, along with other trans-NIH interactions. Dr. Rutter began by describing the organizational structure of the Office of the Director of DBNBR and reported that Dr. Roger Little had accepted the offer as Deputy Director and would begin his role starting June 1, 2014. Within the OD are the robust Training and Career Development program led by Beth Babecki and Roger Sorensen that coordinate the K99/R00 program, the SBIR/STTR coordinator Kristopher Bough, the Common Fund and Blueprint through John Satterlee and Dana Procaccini, and finally the Analysis and Support group. The overarching goal of DBNBR’s OD is to direct, coordinate and support the division’s mission by supporting and also managing the science.
The first branch that Dr. Rutter spoke about was the Behavioral and Cognitive Science Research Branch (BCSRB), led by Dr. Minda Lynch. BCSRB’s main goal is to identify the behavioral processes that underlie drug addiction. This is achieved through strategic directions, namely through identifying how environmental variables and behavioral phenotypes influence risk and prediction; developing paradigms that model the complexity of human addiction; developing interventions to change behavioral trajectories of addiction; as well as examining the neurobiological correlates and mechanisms of abuse-related behaviors.
She then moved on to describe the work of the Functional Neuroscience Research Branch (FNRB) that is led by Dr. Nancy Pilotte. This branch’s strategic directions are to determine the interactions of drug exposure, development and microenvironment in shaping neural circuits; to map primary and compensatory connections and adaptations in neural circuits; and to identify the drug-related glia-neuronal adaptations.
The third is the Genetics and Molecular Neurobiology Research Branch (GMNRB), with Dr. Jonathan Pollock as Branch Chief. GMNRB’s strategic directions are to identify genes and genetic variations and their functions; identify epigenetic and non-coding regulators of gene expression; use systems approaches to understand molecular interactions; and identify molecular determinants of HIV latency modified by drugs of abuse. One of this branch’s flagship programs is the NIDA Genetics Consortium and DNA Repository, which has over fifty three thousand (53,000) well characterized DNA samples for genome-wide association studies (GWAS) and other studies.
The fourth and final branch that Dr. Rutter presented was the Chemistry and Physiological Systems Research (CPSRB), which is led by Dr. Rao Rapaka. This branch’s main goal is to characterize receptors and develop ligands to accelerate target identification. The strategic directions are to isolate target receptors and endogenous ligands, validate test emerging drug targets for tobacco addiction; to discover bioactive lipids in addiction and health; and to support computational modeling. For each division, Dr. Rutter provided examples of recent publications and novel research that NIDA is supporting. She also went on to describe the many projects that DBNBR is working on trans-NIH as part of the Common Fund.
Dr. Rutter closed her presentation by stating that each branch is working on scientific portfolio analysis, with the help of Dr. Jose Ruiz from OEA/NIDA, which is pertinent to its individual mission and strategic directions.
Council members thanked Dr. Rutter for her presentation and applauded DBNBR’s efforts at managing the scientific portfolios in order to direct the strategic plan and science of the division, as well as the efforts of bridging and connecting the scientific community.
- NIDA Participation in Major NIH Pain Consortium Initiatives - Dave Thomas, Ph.D., Deputy Director, Division of Clinical Neuroscience and Behavioral Research, NIDA
Dr. Thomas’ opening remarks were in honor and in memory of his late friend and colleague, Dr. Richard Denisco, with whom he worked on five (5) pain related initiatives. Dr. Thomas described each initiative and started with the Health Electronic Registry of Outcomes (HERO) Pain Registry. Congress mandated the NIH Pain Consortium, which is how the HERO Pain Registry initiative is funded. The registry allows patient and clinician information related to pain to be entered and coded in a standardized manner. This provides clinicians with real-time information on best practices to help manage pain for specific conditions. It also allows for the registry data to be used for research purposes. Currently the registry is housed at Stanford University, but it will soon expand to the University of Florida and there are plans to make this an open-access tool nationwide. The second initiative is Pathways to Prevention: weighing the evidence, identifying the research gaps, and determining next steps. The main goal of this initiative is an NIH final report on the efficacy of opioids for chronic pain. The third initiative that Dr. Thomas presented is an FDA-mandated post-market safety studies on opioids. Nine (9) pharmaceutical companies were asked to study the safety and effectiveness of opioids under FDA and NIDA’s close monitoring. The studies are complex and costly with the following five (5) main goals: 1) Identify the risks associated with long-term use of opioid analgesics for management of chronic pain, 2) Develop and validate measures of opioid-related adverse events, 3) Conduct a study to validate coded medical terminology, 4) Conduct a study to define and validate “doctor/pharmacy shopping” , and 5) Conduct a clinical trial to estimate the serious risk for the development of hyperalgesia following use of ER/LA opioid analgesics.
He then described the NIH Pain Consortium Centers of Excellence in Pain Education initiative. The main goals are to teach pain in medical schools, develop online pain education resources on the Pain Consortium website, and disseminate and evaluate. Dr. Thomas went on to describe the final initiative, the National Pain Strategy. It was initiated as a result of an IOM report that estimated 100 million Americans live with and suffer from pain. HHS leadership was assigned the task to develop a comprehensive, population health-level strategy for pain prevention, treatment, management, education, reimbursement, and research that includes specific goals, actions, time frames and resources. This in turn lead to five (5) working groups to come up with fifteen (15) recommendations by June, 2014 that can then be implemented starting in the fall of 2014. The five working groups are: 1) Professional Education and Training; 2) Public Education and Communication; 3) Population Research; 4) Public Health: Prevention, Care, and Disparities; and 5) Public Health: Services and Reimbursement. Dr. Thomas summarized his presentation by stating that the overarching goal of all of these initiatives is to address both topics: Improve pain treatment and reduce prescription opioid abuse through education, research and other means.
Dr. Volkow and Council members thanked Dr. Thomas for his presentation. One comment that was made was regarding efforts to study opioid induced hyperalgesia, especially in individuals on long-term methadone.
- NIDA Council Subcommittee Working Group On Diversity in the Extramural Research Workforce: Interim Report - Albert Avila, Ph.D., Director, Office of Diversity and Health Disparities, NIDA
Dr. Avila began his presentation by stating that his objective was to provide Council members with an update on the NIDA Council Subcommittee Working Group on Diversity and some of the outreach efforts the group is leading. He presented an overview of the Office of Diversity and Health Disparities (ODHD), formerly the Special Populations Office, including an introduction of the staff. In addition, he spoke about the goal of the ODHD, which is to strengthen the NIDA extramural research portfolio through a more diverse and robust workforce, attracting talented individuals from all populations. He then proceeded to explain that the ODHD has a two-fold mission: 1) Diversity outreach: increase the number of underrepresented scholars and researchers actively participating in drug abuse research, as well as increase the number of funded underrepresented scientists actively conducting drug abuse research; 2) Health disparities: ensure that research addressing minority/health disparity populations are adequately and appropriately represented in NIDA’s extramural research portfolio.
Dr. Avila then showed data from 2010 representing diversity of the NIH-funded workforce compared with the 2010 U.S. Census. He also provided results of the 2011 Survey Report on Neuroscience Programs that looked at U.S. racial and ethnic minorities as a percentage of total pre-doctoral, post-doctoral trainees, and tenure-stream faculty in neuroscience programs. Both studies indicating a smaller percentage of minority and underrepresented workforce and trainees, with a higher rate of attrition compared to whites. And finally, he showed the results of a study published in Science by Donna K. Ginther et al. “Race, ethnicity and NIH research awards.” The results indicate that applications from African-American investigators were 10% less likely to be awarded an R01 than white applicants even after controlling for education background, publication record and research awards.
NIDA is addressing all of the above listed concerns by funding training and research development awards at every career level for all populations. He added that NIDA has a very strong Summer Research Internship program to get high-school and undergraduate students to work with NIDA-funded investigators across the country. Dr. Avila then discussed the success of the NIDA Diversity Supplement, as well as the NIDA Grant Workshop and Mock Review programs. He also provided information on additional NIDA Diversity Outreach programs, such as NIDA Research Education Program for Clinical Researchers and Clinicians, the Intramural Research Program and 4 NIDA Extramural Diversity Workgroups.
Despite these and other efforts across the NIH for 30 years, there is still a disparity in the numbers of underrepresented minorities in the NIH and NIDA-funded scientific workforce. Dr. Avila is working with members of the NIDA Advisory Council to provide concrete recommendations on effective strategies to increase the number of underrepresented scientists in drug abuse research and to increase the number of grant applications submitted and funded from underrepresented minorities to the NIDA Director in June 2014. Dr. Avila then presented a list of draft recommendations that the Diversity Council subcommittee suggested which will be included in the final report. He concluded his presentation by providing additional NIH efforts to address diversity across the NIH workforce: 1) New NIH Office of Science Workforce Diversity; 2) National Institute on Minority Health and Health Disparities; and 3) Common Fund initiative “Enhancing the Diversity of the NIH-Funded Workforce” programs.
NIDA Council members thanked both Dr. Avila and Dr. Volkow for NIDA’s dedication to this issue and for implementing so many profound programs. Council members recommended incentivizing and encouraging assumption-free mentoring to underrepresented fellow and trainees.
- 10 Year Update on the Common Fund - James Anderson, M.D., Ph.D., Director, Division of Program Coordination, Planning and Strategic Initiatives, Office of the Director, NIH
Dr. Anderson spoke to NIDA Advisory Council members, NIDA Staff and the public about the current state of the Common Fund programs. There are 31 active programs with an overall budget of $540 million, and many of them receive co-funding from NIH Institutes and Centers (ICs). The programs cover a range of science linked by a theme that they all identified an obstacle to research progress that can be solved and removed within a finite period of time. He provided examples of the formidable resources the programs provide such as the Knockout Mouse Phenotyping and the Healthcare Systems Research Collaboratory. He went on to state that the Council of Councils is now reviewing the overall process of the Common Fund to identify if there are needed improvements to better manage the science. The NIH has spent over $4 billion over the past 10 years on the Common Fund and the programs involve 70 staff members across the NIH ICs that provide 50% effort on managing the programs.
He then outlined the goals of the presentation: Review of the Common Fund’s origin; review of unusual features of the Common Fund programs; provide an overview of Planning and Management; and to discuss the need for evaluation.
In 2002, there was no mechanism for NIH as a whole to consider and address challenges and opportunities. Dr. Elias Zerhouni, former Director of NIH, implemented the Roadmap at the same time that the National Academies’ 2003 IOM report recommended that the NIH Director develop and implement, with and through the ICs, a series of time limited trans-NIH initiatives that are identified through a strategic planning process open to participation by all internal and external stakeholders and transparent to the public. In 2006, through a Congressional reauthorization bill that affirmed the importance of NIH and its vital role in advancing biomedical research to improve the health of the nation, the Division of Program Coordination, Planning and Strategic Initiatives (DPCPSI) and the NIH Common Fund (CF) to provide a dedicated source of funding to enable trans-NIH research were formed.
The criteria that determine if a proposal should be supported by the CF are the following: 1) Transformative programs that are relevant to many diseases and ICs and set new standards for research or clinical practice; 2) Catalytic, short-term and goal-driven. The programs must have a deliverable within 5-10 years of initiation; 3) Synergetic/Enabling programs should be value-added to the ICs; 4) CF programs require a high level of trans-NIH coordination; and 5) Novel programs that provide new solutions to specific challenges.
Dr. Anderson moved onto the second goal of his presentation, which was to describe how the CF programs are unusual in that there are two phases of strategic planning. Two phases are required because the CF does not have a defined area of science. Phase 1 identifies strategic needs and opportunities, with a ‘rough draft’ proposal of initiatives that would be required; Phase 2 refines broad programs and is when a strategy is developed. The entire process (Phase 1 through Phase 2) lasts 18 months. The hardest part of CF program planning is articulating clear goals for a defined timeframe.
He then moved on to the planning and management of CF programs. Dr. Anderson stated that all CF program are managed by multi-IC teams. This ensures the most relevant NIH expertise to bear on the program and keeps the IC Directors engaged. It also helps ensure that the ICs benefit from the program. In addition, the Office of Strategic Coordination (OSC) staff is part of each team and provides a bidirectional link between each team and OD leadership.
Dr. Anderson then went on to describe three CF programs that are particularly successful and meet the criteria that he had just provided. He first began with the NIH Common Fund Human Microbiome Project (HMP) which began in 2007. It aims to develop tools and datasets for the research community for studying the role of these microbiomes in human health and disease. The first phase of HMP (2007-2012) characterized the composition and diversity of microbial communities which inhabit major mucosal surfaces of the human body, including nasal passages, oral cavities, skin, GI tract, urogenital tract and evaluated the genetic metabolic potential of these communities. The current phase of HMP (2013-2015) is focused on the creation of the first integrated dataset of biological properties from both the microbiome and host from cohort studies of microbiome-associated diseases.
The second program is the PROMIS: Patient-Reported Outcomes Measurement Information System. This program is creating new paradigms for how clinical research information is collected, used and reported. So far 40 different symptom measures have been developed, ranging from adult to pediatric area. The CF has begun the transition phase for NIH ICs to continue the funding of this program. And due to the high interest in health care systems, there has been interest from both the VA and the Department of Defense systems to use this as a vehicle for clinical research, as well as patient care.
The final program that Dr. Anderson addressed, was one that NIDA is heavily involved in, Epigenomics. This program includes a series of complementary initiatives aimed at generating new research tools, technologies, datasets, and infrastructure to accelerate our understanding of how genome-wide chemical modifications to DNA regulate gene activity without altering the DAN sequence itself and what role these modifications play in health and disease.
Dr. Anderson spoke about the need for evaluating the CF and the charge to the Council of Council CF Planning and Management Working Group (CPMWG). The goal of this working group is to assess and advise on the processes used to manage the CF, including those used to plan and implement/oversee programs. 1) Are planning processes optimal for identifying program areas that meet the CF criteria? 2) Are management/oversight processes optimal for achieving program goals? A report is due to the NIH Director in June 2014. He then listed the members of the CF Evaluation Working Group.
Lastly, Dr. Anderson provided NIDA Advisory Council members with two upcoming CF programs for fiscal year 2015. The first project is Accelerating Translation of Glycoscience: Integration and Accessibility to develop accessible new tools and technologies that make glycoscience possible for any biomedical investigator. SBIR grants will support this project in order to have commercially available products within 5 years. The second program is the 3D Neucleome, which would help identify regulatory sequences that contribute to disease; extract more meaningful information from genetic data; develop new diagnostic tools and tissue-specific therapeutics; and better understand individual disease risks, responses to medications, and biological impact of environmental factors. The 3D Neucleome program would achieve the above listed goals by providing comprehensive reference maps of the 3D architecture of the interphase nucleus; and by providing new and improved tools to explore the relationship between nuclear organization and gene expression in development and disease.
Council members applauded efforts to evaluate CF programs’ management, in order to maximize resources across the NIH and to ensure support of greater impact science and deliverables.
- IRP Update - Antonello Bonci, M.D., Scientific Director, Intramural Research Program, NIDA
Dr. Bonci began his presentation with his vision of the Intramural Research Program (IRP), which is to take full advantage of the unique IRP funding system and develop an environment where cutting edge science, human studies and drug-abuse related initiatives can be done, as well as to be of service to the community. He then introduced the external Board of Scientific Counselors (BSC) and their revised goals to ensure the best intramural investigators are at NIDA: Larger emphasis on potential impact of science; larger emphasis on high risk and big impact on field of research; and new scoring system. He also discussed some of the recent challenges faced by intramural research such as the inability to plan long-term due to overall NIH budget limitations, as well as the recent government shut-down that forced intramural research to halt for over 2 weeks, school tax and other fee increases that take away money from the science, and the recent travel restrictions which affects scientific and professional networking opportunities.
Dr. Bonci went on to discuss some of the IRP initiatives that have been implemented to help continue the production of high impact science during these difficult budgetary times. The first one is an Intramural-Extramural Innovative Partnership program in which an intramural investigator would find and work with an extramural investigator to analyze preliminary data that would eventually lead to an R01 award. The second is the Medication Development program lead by Dr. Amy Newman. This is a trans-NIH project that would create a single, very basic translation of the medication discovery program throughout other IC’s IRPs. The third is the Designer Drug initiative run by Dr. Mike Baumann and Dr. Marilyn Huestis, in which NIDA is culturing human hepatocytes and studying how they metabolize new emerging drugs. And the last program, which is highly successful, is the Diversity and Outreach Fellowship program. This is led by Dr. Jean Lud Cadet and it provides special fellowships to increase minority and diversity in the IRP.
The IRP has had to reorganize branches and close multiple labs, per guidance from the Blue Ribbon Panel in order to maximize efficiency and minimize randomness. This in turn has led to new IRP hires, in which multiple new staff are expert neuroscientists working collaboratively with NIAAA, NIDDK, and NEI.
Lastly, Dr. Bonci also spoke about a report on a 10 year plan for creating a trans-NIH center for development in neurobiology that has been requested by Dr. Frances Collins, Director of the NIH. A group of NIH leaders in neuroscience and applied chemistry are preparing to provide this report on May 16, 2014 for the NIH BSC chairs.
Council members thanked Dr. Bonci for his presentation and expressed concern about the budget constraints on IRP and especially on the diminished opportunities for travel and to attend conferences for the intramural scientific community.
- Concept Clearances:
Two new program concepts were presented to Council. Dr. John Satterlee, Health Science Administrator from the Genetics and Molecular Neurobiology Research Branch at NIDA presented a concept entitled “Extracellular Vesicles in Neuronal Function and HIV.” The purpose of this FOA is to encourage research in two major areas: 1) The role of exosomes in the nervous system, particularly with respect to neuroplastic processes and substance abuse exposures, and 2) The role of exosomes in HIV infection and progression.
Dr. Jonathan Pollock, Branch Chief, Genetics and Molecular Neurobiology Research Branch presented a concept on the Neuroscience Information Framework initiative. The Neuroscience Information Framework is a flexible and cost-effective production technology platform for researchers to discover, share, access, analyze, and integrate neuroscience-relevant information. This has been funded as a contract through the NIH Blueprint but is no longer viable as a contract since UCSD owns the site and should be funded as a U01. Blueprint has approved this change. The U01 will 1) support the Maintenance and upkeep fo the NIF Registry, 2) support the maintenance and upkeep of the NIF Data Federation, 3) support the maintenance and upkeep of the NIF ontologies, 4) support for infrastructure maintenance, 5) support of systems utilized to perform regular update release and releases of updates to core ontolgies, 6) maintenance of NIF applications, 7) outreach, training and user support, and 8) Create a NeuroSynth Heatmeat Visualization application that would assign metadata to a given 3D coordinate space in the nervous system. Such an application would identify lacuna of knowledge for different brain regions.
There were no Public Comments
The 117th meeting of the National Advisory Council on Drug Abuse was adjourned at 2:30 p.m.
I hereby certify that the foregoing minutes are accurate and complete.
|Nora D. Volkow, M.D.
National Advisory Council on Drug Abuse
|Mark Swieter, Ph.D.
Executive Secretary, Acting
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.