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NAMHC Minutes of the 237th Meeting

May 22, 2014

Department of Health and Human Services
Public Health Service
National Institutes of Health
National Institute of Mental Health

Introduction

The National Advisory Mental Health Council (NAMHC) convened its 237th meeting in open policy session at approximately 8:30 a.m. on May 22, 2014, in the Neuroscience Center in Rockville, Maryland, and adjourned at approximately 2:15 p.m. In accordance with Public Law 92-463, the policy session was open to the public. The NAMHC reconvened for a closed session to review grant applications at approximately 3:00 p.m. on May 22, 2014, at the Neuroscience Center in Rockville, Maryland, until adjournment at approximately 5 p.m. (See Appendix A: Review of Applications). Thomas Insel, M.D. Director, National Institute of Mental Health (NIMH) presided.

Council Members Present at the Grant Review and/or Open Sessions

(See Appendix B: Council Roster)

Chairperson

  • Thomas R. Insel, M.D.

Executive Secretary

  • Jane A. Steinberg, Ph.D.

Council Members

  • Patricia A. Areán, Ph.D.
  • Deanna Barch, Ph.D.
  • David A. Brent, M.D.
  • Randall Carpenter, M.D.
  • B.J. Casey, Ph.D.
  • Hakon Heimer, M.S.
  • Richard L. Huganir, Ph.D.
  • Steven E. Hyman, M.D. (via telephone)
  • Marsha M. Linehan, Ph.D.
  • Maria A. Oquendo, M.D.
  • Gene Robinson, Ph.D.
  • Gregory E. Simon, M.P.H., M.D.
  • J. David Sweatt, Ph.D.
  • Carol Tamminga, M.D.
  • Hyong Un, M.D.

Ex Officio Members

  • John W. Davison, M.B.A., Ph.D. Department of Defense (DoD)

Liaison Representative

  • Paolo Del Vecchio, M.S.W., Substance Abuse and Mental Health Services Administration (SAMHSA)

Others Present at the Open Policy Session

  • Stefano Bertuzzi, American Society for Cell Biology
  • Jason Conrad, NIH Interpreter
  • Kathi Hanna, Science Writer
  • Justin Harding, The National Association of State Mental Health Program Directors
  • William Narrow, American Psychiatric Association
  • Steven Saenz, NIH Interpreter
  • Randi Silverman, Parent Advocate

Open Policy Session Call to Order and Opening Remarks

NIMH Director Thomas Insel, M.D. called the open policy session to order and welcomed all in attendance.

Approval of Minutes of the Previous Council Meeting

Turning to the minutes of the January 23, 2014 Council meeting, Dr. Insel asked if Council members had any comments, revisions, or questions about the minutes. As he received none, the motion to approve the minutes was unanimously passed.

NIMH Director’s Report

Dr. Insel reviewed the agenda for the open policy session and provided an update on activities related to NIMH.

He began his remarks by noting the increased public discussion about mental illness and the mental health system, especially with regard to gun violence. Dr. Insel cited a New York Times opinion piece written by two high school students who were coping with depression, but who were not allowed to write about their experiences for their school newspaper. He also cited a planned USA Today series that will focus on the cost of not providing treatment for people with serious mental illness. Among the data included are statistics showing that there are 10 times more people with serious mental illness in state prisons and county jails than there are in state mental hospitals. The report includes a state-by-state assessment of treatment of people with mental illness in jails and prisons. In 44 of the 50 states, the largest single “mental institution” is a prison or jail. In addition, the New York Times will be publishing a series on mental health in the military.

Dr. Insel next spoke about the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative, announced by President Obama on April 2, 2013. The National Institutes of Health (NIH) BRAIN Working Group, an advisory group to the NIH Director, will provide a report which is expected to include timelines and deliverables to the NIH Director in early June 2014. Other agencies involved in the initiative are the Defense Advanced Research Projects Agency (DARPA), the National Science Foundation (NSF), and the Food and Drug Administration (FDA). The Department of Energy (DOE) is likely to join as well. NIMH is responsible for administering three of six Requests for Applications (RFA) issued in December 2013, which are under review and are expected to be funded in September 2014. New RFAs will likely be issued in Fiscal Year (FY) 2015. The President’s plan calls for $100 million in FY 2014 (roughly $40 million to NIH, $50 million to DARPA, and $10 million to NSF). NIH’s share could grow to $100 million in FY 2015, with the potential for the initiative to grow to $500 million annually. Dr. Insel said that Vice President Biden addressed the American Psychiatric Association in May 2014 and linked the BRAIN Initiative to better mental health.

At the congressional level, Congress advanced the Excellence in Mental Health Act, signed into law, as part of larger legislation, in April 2014, providing funding for community health programs. Other bills are under consideration, but often with overlapping goals, such as restructuring the way mental health is covered in the Federal Government, including the creation of an assistant secretary for mental health either in the Department of Health and Human Services (HHS) or in the White House. The Helping Families in Mental Health Crisis Act, introduced by Representative Tim Murphy (R-PA), would transform the country’s mental health system. This bill, as well as another mental health bill introduced by Representative Ron Barber (D-AZ), also supports improving the science underlying mental illness.

At the HHS level, the appointment of Sylvia Burwell to replace Secretary Kathleen Sebelius is pending congressional confirmation. Undecided issues to be resolved at the department level are the ways in which the Parity Act is implemented through the Affordable Care Act, the possible mental health implications of legalization of marijuana, and substance abuse, particularly prescription drug abuse. It is expected that there will be future efforts to bring together NIMH, SAMHSA, and other agencies focused on serious mental illness to work on new initiatives.

Dr. Insel discussed recent developments in RAISE (Recovery After Initial Schizophrenia Episode), an NIMH-funded research project addressing treatment for first-episode psychosis. A feasibility study was completed in December 2013. An efficacy study is ongoing within 25 states at 37 community mental health programs. The FY 2014 budget includes a requirement for SAMHSA to implement a program similar to RAISE to address the needs of individuals with early serious mental illnesses in all 50 states and 8 territories. Dr. Insel thanked Robert Heinssen, Ph.D., Amy Goldstein, Ph.D., and Susan Azrin, Ph.D., for their collaboration with SAMHSA on this project.

With regard to NIH issues, Dr. Insel described recent concerns about the inability of pharmaceutical companies to replicate preclinical studies. NIH Director Francis Collins, M.D., Ph.D., and Deputy Director Lawrence Tabak, Ph.D., published an article in Nature discussing initiatives to restore the self-correcting nature of preclinical research. One initiative includes a checklist for scientists; other efforts will provide training opportunities for basic scientists in replication and reproducibility of data, transparency, and expansion of the methods sections of scientific journals. Dr. Insel asked Council to consider these concerns as it conducts its reviews.

A second issue raised at the NIH level is that of sex differences in cell and animal studies. Dr. Collins and Janine Clayton, M.D., Associate Director for Research on Women’s Health and Director of the Office of Research on Women’s Health at the NIH, published an article in Nature, recommending better balance of male and female cells and animals in preclinical studies in all future applications.

Dr. Insel also drew Council’s attention to an article recently published in Proceedings of the National Academies of Science of the United States of America by four thought leaders in biomedical research warning that the “new normal” is decreased budgets for research. The authors claimed that an unsustainable hyper-competitive system currently exists that negatively affects creativity, especially among young investigators. They offered several recommendations: 1) work with Congress to obtain stable, long-term funding that recognizes inflation and extends beyond the one-year budget cycle; 2) review training plans for sustainability and career opportunities and growth; 3) assess funding mechanisms to consider longer-term support and consideration of overall accomplishments and productivity of investigators; and 4) revise the grant resubmission policy, which can produce low funding rates and insufficient opportunity for new investigators.

In discussing NIMH topics, Dr. Insel referred to an assessment conducted by National Institute of Neurological Disorders and Stroke of its portfolio from 1997 to 2013, which found the Institute had decreased support for basic science from 57 percent to 32 percent. Concerned that it might have also cut its support of basic science, NIMH conducted a similar assessment and found support for basic science to be stable at roughly 20 percent from 2002 to 2013.

Dr. Insel drew attention to three blog posts he published on major transformations in the field and the NIMH portfolio. The first discussed the need to standardize, integrate, and share data on a large scale in the Research Domain Criteria (RDoC) project. To accelerate the pace of the project, in FY 2015, Bruce Cuthbert, Ph.D. will no longer serve as Director of the NIMH Division of Adult Translational Research and Treatment Development (DATR), but will assume full-time responsibility for building the infrastructure needed to develop a web presence and capacity to receive large amounts of data. On this same timeline, NIMH will merge its two translational divisions onto one Division of Translational Research and will recruit a new director to oversee approximately $400 million in assets and 35 employees.

A second blog post describes how NIMH is committed to viewing mental illnesses as neurodevelopmental disorders that need to be studied longitudinally across trajectories. A third editorial describes NIMH’s new policy regarding clinical trials. Applications for clinical trials will not be considered unless they come through specific funding announcements, which will include clear stipulations requiring a target, an experimental medicine approach, timelines, and milestones. This policy is intended for medication trials as well as psychosocial interventions, in recognition of the requirement through the Patient Protection and Affordable Care Act of 2010 to provide information about dose and duration for reimbursement.

Dr. Insel said that currently the NIMH Division of AIDS Research (DAR) is approximately 12 percent of the NIMH budget and has a focus on behavioral prevention, neuro-AIDS, and global health. The NIH Office of AIDS Research has been reviewing spending programs, and in FY 2014 moved $27 million of NIMH’s budget to the National Institute of Allergy and Infectious Diseases (NIAID) to facilitate integration. As a result, NIMH will move DAR staff to co-locate them with NIAID staff, and will require grantees to include NIAID as a secondary funder.

Dr. Insel concluded his report by thanking the Institute’s social media team and Peter Schmidt, M.D., from the Division of Intramural Research Programs for a successful Twitter chat on postpartum depression; 1.5 million accounts followed the chat.

Budget Update

The FY 2014 budget provides NIH with $30.15 billion. This amount is a $1 billion increase over FY 2013, but still lower than the FY 2012 budget by $0.71 billion. There are $22 million in additional funds for the BRAIN initiative and a general increase for institutes and centers of 3 percent over the FY 2013 amount (before internal transfers). The FY 2015 budget has not been decided; the President recommended a $200 million increase over the current year ($30.36 million), which is still a lower overall total than FY 2012. Dr. Insel warned that in FY 2016, the sequestration situation will return unless Congress finds a fix.

Pending congressional appropriation, approximately 1 in 5 applications (19 percent) could get awarded, for a total of over 500 new grants. Dr. Insel concluded his remarks on the budget by referring to a study by Michael Lauer, M.D. of the National Heart, Lung, and Blood Institute published in Circulation Research, which found little correlation between the percentile ranks of applications and one measure of quality (citations), when controlling for the size of the award. NIMH conducted a similar analysis of its portfolio and found similar results. In sum, the percentile score is not always predictive of future scientific impact.

Discussion

David A. Brent, M.D., asked Dr. Insel why the term “development” was not retained in the merger of the Division of Developmental Translational Research (DDTR) and DATR, since all neuropsychiatric disorders are developmental. Dr. Insel responded that a developmental focus is implied and that the new division will consider disorders across the lifespan. Deanna M. Barch, Ph.D., added a concern that the focus on neurodevelopment and trajectories not be lost in the merger. Dr. Insel added that DDTR has been very successful in its career and training awards and has built a fine cadre of investigators who can conduct the type of work that will be the focus of the new division. He said that the developmental focus will not be lost and used the example of autism, which is a large NIMH program with an increasing focus on transition to adulthood, which gets lost when there are separate divisions for child and adult concerns.

B.J. Casey, Ph.D. echoed concerns about the merger, saying there are significant differences between the developing brain and the developed brain. Dr. Insel said that the staff is mindful of these concerns, and that the merger also gains in administrative efficiency. Carol Tamminga, M.D., said that the merger could provide richness in understanding the transitions between the developing brain and the adult brain.

Dr. Tamminga expressed support for the cooperation between NIAID and NIMH on AIDS research and asked if similar inter-institute cooperation could be pursued, for example with the National Institute for Child Health and Human Development (NICHD). Dr. Insel said that similar cooperation occurs across institutes in autism research, through the HHS Interagency Autism Coordinating Committee. AIDS has been more challenging because it takes up such a large portion of the NIH budget, at 10 percent, and involves multiple institutes.

Marsha M. Linehan, Ph.D., asked whether there was a reduction in emphasis on behavioral psychosocial interventions in the new focus of clinical trials, and whether there is a requirement for behaviorists to look for biological and brain factors. Conversely, will brain scientists be required to look at behaviors that change the brain? Dr. Insel replied that the brain need not be a part of every application, but a mechanism should. The mechanism could involve, for example, a pathway in the brain or one in the family. Understanding mechanisms will lead to more effective interventions, because mechanisms can demonstrate how a target was altered. The target could be related to, for example, brain function or cognitive state.

Progress on Updating the NIMH Strategic Plan

The NIMH Strategic Plan is now more than five years old and although still valid, it needs updating. He reviewed the four Strategic Objectives informing the 2014 Plan: 1) define the biological basis of behavior and pathophysiology of mental disorders; 2) chart mental illness trajectories to determine when, where, and how to intervene; 3) develop new and better interventions; and 4) strengthen the public health impact of NIMH-supported research. Each broad Objective contains a set of underlying and specific Strategies. The 2008 Plan provides a solid foundation for currently funded research. However, changes in the neuroscience landscape require a new focus for the Strategies. Several cross-cutting themes have emerged since the 2008 Plan which influence NIMH’s strategic thinking, such as the BRAIN initiative, RDoC, new policies and external activities such as the Patient Centered Research Outcome Research Institute (PCORI), and the digital enterprise, to name a few. RAISE is an example of NIMH’s implementation and dissemination success, achieved over a very short period of time. Other efforts that shorten the timeframe or lower the cost of research, such as the Learning Healthcare System, provide new opportunities for the greatest public health impact.

Brent Miller, Ph.D., from the NIMH Office of Science Policy, Planning, and Communications, initiated the discussion of the digital enterprise (big data) by providing some background information. The Council had been given the opportunity to supply comments about the Institute’s role in the digital enterprise prior to the meeting. Dr. Miller used this input to develop a preliminary objective statement: “Promote the scientific community’s ability to increase the utility of the digital enterprise to impact mental health.” Within that overarching objective statement, four themes arose from Council’s pre-meeting input: 1) research resources (broadly available data, resources compatible with emerging technology, cross-study integration); 2) treatment resources (e.g., mobile devices to rapidly deliver diagnosis and treatment or inform basic neuroscience); 3) data collection resources (tools to collect validated and standardized data about the physical and social environment); and, 4) validity resources (systematic data collection that permits monitoring of delivery and outcomes within the mental health system). In sum, Council agreed with these themes but needs to see the details. Council urged NIMH to make practical changes for the R01 scientist in light of transformative technologies, and to take practical steps to ease the integration of insights from basic to clinical research.

Discussion

Patrician A. Areán, Ph.D., asked how we can ensure that people trained in the RAISE model are actually delivering it as intended, because differing delivery strategies will influence measures or quality and effectiveness. She suggested that mobile technologies or distance surveillance technologies could be used to determine whether the interventions were being delivered properly. Philip S. Wang, M.D., Dr.P.H., Deputy Director, NIMH, agreed that quality assurance for the purpose of reimbursement would be challenging for psychosocial intervention development. There might be a need to study natural experimentation with continuous feedback. Dr. Areán added that digital technologies could be leveraged to assist with clinical decision-making and implementation practices. Big implementation projects could be more rapidly and efficiently conducted.

Dr. Linehan said that the mental health field has a history of people claiming they are providing an effective treatment without adequate training. If evidence-based treatment is required then we will have to ensure that people have actually been trained. Dr. Insel added that the paradox of mental health parity is that although it aims to ensure people with mental illness get all the treatments they need, it also means payers will be asking for dose and duration and evidence that the intervention works.

Dr. Wang described an ongoing, NIMH-funded study of the Institute of Medicine (IOM) that centers on how to measure effectiveness of psychosocial interventions in ways that go beyond measuring symptoms and symptom reduction. Measuring outcomes will be critical to reimbursement and has implications for training, certification, and licensure. The IOM committee is looking at structural and process measures. Hyong Un, M.D., reinforced the importance of this effort. Dr. Insel suggested there be an update on the IOM effort at the next Council meeting.

Big Data: What Is NIMH’s Niche?

Dr. Insel introduced Phil Bourne, Ph.D., Associate Director for Data Science, NIH, who oversees the Big Data to Knowledge (BD2K) Initiative. Dr. Bourne began with a story of a young student who was able to conduct studies on pandemic modeling based on existing data. This example demonstrates that openness in science and data sharing have deinstitutionalized and democratized science. The emergence of big data has highlighted systemic problems with reproducibility and sustainability (i.e., keeping up with the massive accumulation of data given budget constraints). These challenges call for the development of business models at NIH to achieve efficiency and cost-effectiveness, for example, a 50 percent model for funding projects, merger of resources, centralization, partnerships, or fee-for-service options.

Importantly, NIH has to assess how current data are being used. Dr. Bourne has begun discussions with the National Library of Medicine and the National Center for Biotechnology Information to look at usage patterns of individual data to better inform the design of data resources and to create and test a data commons. Companies such as Netflix, Google, and Amazon conduct such analyses routinely. Better reward for “useful” data is needed. Dr. Bourne said that citation counts don’t necessarily indicate value, and that valuable data often cannot find a home; these issues have implications for scholarship. In addition, data scientists should be treated as scholars and recognized for the value they can add to biomedical science.

Dr. Bourne presented some possible solutions being considered by NIH, such as new policies on data sharing and the use of blanket informed consent. Shared infrastructure and new reward systems for sharing data are under consideration. Dr. Bourne and his team are cognizant of the need to find mechanisms for identifying, collecting, organizing, and storing existing and emerging data. Discussions about creating a data commons have included other federal agencies, academia, and the private sector. A commons would enable Dropbox-like storage, the opportunity to apply quality metrics and standards, ability to compute the data, and a place to collaborate. Finally, Dr. Bourne’s office is attempting to ascertain what training currently exists in the area of data and data science.

Discussion

Stephen Friend, M.D., Ph.D., President, Sage Bionetworks, opened by noting that this is a time of transition: symptoms are being replaced by molecular components, there are singular syndromes to variable presentations, and set ontologies are being replaced by context-dependent ontologies. We need better rules and tools to find coherence in big data. New tools have emerged in the past five years, including the ability to generate massive amounts of “omics” data, network modeling approaches for diseases, and IT infrastructure and cloud computing capacity. In addition, patients are more willing to generate and share their data and open social media allows patients and experts to solve problems collaboratively. Dr. Friend said it is important to uncouple the linkage between those who generate data and those who analyze it.

Sage Bionetworks was founded to accelerate the testing of new ideas for conducting research. One of its projects, Synapse, is a platform to support open, collaborative data analysis for reproducible science—a “GitHub” for biomedical data. It is premised on provenance, which allows credit to be assigned appropriately as data are developed and refined; this provenance provides an incentive for sharing. The Synapse platform is composed of a set of shared web services that facilitate collaboration among scientific teams. In addition to being a data repository Synapse creates a computational platform for real-time research collaboration. Synapse is currently in use by the National Cancer Institute (NCI), in which 30 institutions are feeding in data for use in The Cancer Genome Atlas pan-cancer consortium analysis working group. The output is versioned, citable datasets. Within nine months, 12 papers were submitted to Nature Publishing Journals.

Sage Bionetworks is working on multiple projects that foster collaboration and data sharing. For example, Sage Bionetwork is working with the National Institute on Aging through NIH’s Accelerating Medicines Partnership efforts in Alzheimer’s disease. Another project is the CommonMind Consortium. It brings DNA- and RNA-level data through Synapse, with no intellectual property held on the primary data, for shared access and analyses. Additionally, Mindboggle is compiling imaging data for extracting features of the brain. The goal of all of these projects is to create accessible, open-source data that are structured in the cloud and facilitate analysis and predictive work. The emphasis is on collaboration to accelerate research through issued challenges. Another example is Sage Bionetworks’s DREAM Breast Cancer Program Challenge, which uses crowdsourcing to forge a computational model that accurately predicts breast cancer survival. Dr. Friend said that participation in team challenges has grown over time. Finally, Sage Bionetworks has been funded by the Robert Wood Johnson Foundation to explore how to collect phenotypic data in addition to genotypic data. Dr. Friend said the organization is developing applications to collect data directly from patients, starting with Parkinson’s patients and cancer survivors. Dr. Friend concluded by saying we need to navigate the emerging discontinuity between the state of our research institutions and the state of our technology.

Discussion

Gregory E. Simon, M.P.H., M.D., said that separating the collection or generation of data from its analysis is essential to breaking down “vertically integrated cartels,” which maximizes the benefit to the cartel but not to the commons. This effort requires a fundamentally different approach to funding, because an R01 award would not support this type of analysis. Dr. Bourne responded that one approach might be to have shorter grants that stop at the point at which data are generated. At that point the investigator or another investigator could get a grant to analyze the data. Another incentive is to enable the individual research components to be well identified and used by others. NIH could make a contribution by supporting the development of data citation and the metrics for those citations.

In response to a question from Dr. Insel, Dr. Bourne confirmed that more attention will be paid to data sharing plans in applications and whether they are followed after funding. Policies for sharing genome data laid the groundwork. Dr. Friend suggested that applications might include plans for how data will be shared and with whom it will be shared, as well as provide specific information on how data will be structured to enable sharing.

In response to a question from Gene E. Robinson, Ph.D., about incentives, Dr. Friend said that Sage Bionetworks relies on teamwork and uses a facilitator to ensure coordination. He said that people who serve in this role need to get credit at their academic institutions. Dr. Linehan added that it is difficult to break out of silos and share data with multiple sites, especially when there are no standards or metrics for the data to reduce variability. Dr. Insel said that efforts are underway at NIH to build a large common data element project for PTSD and suicide, which will inform other efforts. RDoC also will provide data standards and a data dictionary.

Steven E. Hyman, M.D., expressed skepticism that the current regulatory and privacy environment will actually allow widespread sharing of patient data, especially phenotypic data. He said that institutional interests impede sharing. Dr. Simon said that the patient privacy issues are not intractable and are sometimes used as smokescreens by investigators and institutions to avoid sharing. Dr. Bourne added that funding agencies have to find ways to support sharing efforts because institutions will respond if it makes financial sense. Dr. Linehan said NIH should consider ways to support supplemental data collection by investigators, that is, to collect data or samples not directly relevant to an investigator’s work, but which may be valuable to others’ research. To this point, Dr. Barch said that her involvement in the Human Connectome Project has necessitated a cultural shift in her own work. She has collected data that are not necessarily relevant to her own work, but that she knows would be useful to others based on extensive consultation. This data collection was made easier by having tenure: Dr. Barch said that junior investigators have a harder time justifying the collection of data for research that is not theirs. She also said that the Human Connectome Project worked to include data sharing in the consent forms to ensure it could happen, and that Institutional Review Boards may not prevent data sharing after its inclusion in consent forms. Dr. Friend added that the Structural Genomics Consortium is another model that is working. However, it can be challenging to get people to share data when they have invested resources in obtaining them.

Hakon Heimer, M.S., cited an example from Alzheimer’s disease research: the Semantic Web Application for Neuroscience, which was not used because scientists did not see a benefit from sharing unpublished data or negative results. He suggested that funding be available for scientists to perform such tasks. Relatedly, Dr. Insel noted the example of the National Database for Autism Research (NDAR). NDAR had a slow start until funding was provided for submission of data and a data dictionary was created. However, even though the database includes information on over 75,000 people with autism, it has been a slow process turning that data into knowledge. He asked whether NIMH should fund something akin to an X Prize for people to mine the data. Dr. Friend said that the Allen Brain Institute learned that powerful data is enriched by having defined projects and funding. Dr. Bourne added that it is important to learn from past experiences, for example, the need for common data elements and quality review of those elements.

Dr. Friend said that one way to foster broader sharing is to put control of the data in the hands of the patient or citizen because the person becomes the advocate for permissible sharing. In his experience, that has broadened, not narrowed, sharing.

Dr. Tamminga commented that the Clinical and Translational Science Award (CTSA) institutions have been successful in sharing data and encouraging institutions to institute policies that increase patient willingness to share de-identified data. Data are stored in warehouses with rules for access. Dr. Insel asked if there was a different standard for psychiatric records. Dr. Tamminga responded that a therapist can decide if there is information that should not be shared.

J. David Sweatt, Ph.D., asked if there are mechanisms through which NIMH could contract with a group such as Sage Bionetworks in areas of relevance to the portfolio. Dr. Insel said that contracting mechanisms are feasible with a statement of work and a competitive process. He said that other models should also be considered, for example One Mind for Brain Research’s strategy to have 50,000 patients share their data on a website. Dr. Hyman encouraged NIMH to find ways to minimize institutional and proprietary control over data. Dr. Insel said that it is not only institutions that have to change but also NIH. One barrier is the R01 mechanism, which gives ownership of data to the awardee institution. NIH leadership is discussing how to enforce data sharing, even via the R01 mechanism.

Dr. Insel asked Greg Farber, Ph.D., Director, NIMH Office of Technology Development and Coordination, to address the Institute’s common data element effort. Dr. Farber said that efforts are underway to complete the set of data elements and publish a notice in the guide encouraging the NIMH community and others to use them. They will be available for download, free of charge, from a central location. Dr. Insel said NIMH is discussing how much direction it should provide in data collection efforts that it funds. Dr. Linehan suggested that NIMH take a supportive, helpful stance rather than a directive one.

Concept Clearances

Dr. Insel opened the session by stating that the concepts are developed in response to scientific needs identified by NIMH, NIH, HHS, or the White House. They are open for discussion and contingent on available funding. Dr. Insel reminded Council members and members of the public that the cleared Concepts will be posted on the NIMH Web site and there will be opportunity for additional comment through those Web pages.

Connectome Coordination Facility

Greg Farber, Ph.D., Director, Office of Technology Development and Coordination, discussed several ongoing data efforts, such as NDAR, the 1000 Functional Connectomes Project, and the Human Connectome Project (managed by NIMH on behalf of the NIH Blueprint for Neuroscience Research). Although two awards have been made under the Human Connectome Project for instrument technology development, the real focus has been on data sharing, which is a requirement. The grantees have provided high-quality imaging and phenotypic data. The concept before Council involves creating a Connectome Coordination facility to: 1) maintain a central data repository for existing Connectome data; 2) create a helpdesk service to answer investigators’ questions about data collection protocols; and 3) to serve, in a limited capacity, as a quality control resource for new data that are deposited. Investigators with access to the appropriate imaging equipment (e.g., a 3T MRI) will be able to collect compatible data.

Discussion

David A. Brent, M.D., asked if industry could be asked to pay for some of this effort. In response, Dr. Farber said NIH would try to encourage more than one manufacturer to get involved in some way. In response to a question from Dr. Robinson about foundation involvement, Dr. Farber said he was not aware of any at this time.

Biomarker Development and Validation: Establishing Standards of Evidence for their Context of Use in Clinical Trials

Linda Brady, Ph.D., Director, Division of Neuroscience and Basic Behavioral Science, introduced a proposed effort to develop and validate biomarkers for use in clinical trials. This initiative is conceptualized as a partnership between a number of different entities, the first being FDA. Therapeutic development has lagged because of the lack of quantitative biomarkers that can be used to drive both the clinical trial effort and understanding of the mechanism of action of novel treatments. There are several biomarkers that are used at the molecular, cellular, and circuit levels in Alzheimer’s disease, ranging from cerebrospinal fluid levels of Abeta42 and tau to beta amyloid imaging to cognitive measures. Once biomarkers are standardized for their technical performance across multiple sites and qualified for a given use, biomarkers can be used to provide information about the stage of the disease, risk stratification, subtyping, and as an enrichment strategy for enrolling subjects into trials. The academic community requires assistance in understanding the FDA process and how to qualify a marker for its intended use. The expected outcome is identification of prognostic and predictive biomarkers with reliability of their analytical performance for use across multiple sites. In addition, the biomarkers could be used to understand symptom domains and severity of illness in order to become more sensitive or relatively correlated with clinical endpoints or rating scales used by regulatory agencies to approve a drug or therapeutic intervention.

Discussion

In response to a question from Dr. Simon, Dr. Brady said that the initiative could include behavioral and psychosocial interventions, even though there would be no regulatory context in those areas. Dr. Simon suggested using the words “mediators” and “moderators” as well as biomarkers. Dr. Linehan suggested that efforts will be needed to bring behaviorists and neuroscientists together to ensure that behaviorists are trained in these approaches. Dr. Insel agreed that regulatory and reimbursement policies will require more rigor regarding biomarkers and measures of clinical effect. He said that the language could include reference to biomarkers such as eye-tracking for autism or attention bias. Dr. Brady said that measures of circuit- or system-level function could be included as biomarker measures. Dr. Casey asked if the term biobehavioral marker might be used; Dr. Robinson said the field might be better served by stating that behavior is a biomarker. Dr. Simon urged clarity in how biomarker is defined in the funding announcement. Discussion ensued clarifying that biomarker is a term that is generally understood by the scientific community and by FDA. Maria Oquendo, M.D., said that it is misleading to suggest there is a linear sequence of biomarkers when in fact there are complex interactions, which calls for panels of markers as opposed to just one.

Novel Assays to Address Translational Gaps in Treatment Development

Lois Winsky, Ph.D., Division of Neuroscience and Basic Behavioral Science, introduced this concept, which addresses a translational gap between preclinical therapeutic assays and evaluation of effects in patients. Less than 10 percent of compounds for CNS drugs ever make it from early-phase trials into clinical development. The reasons for this failure are varied, but NIMH has implemented new requirements for Institute-supported clinical trials that there be some evidence of target engagement so that early trials can address the relationship between target engagement, circuit activation, and functional domains in relation to a clinical effect. As a result, even negative data will be informative. Existing preclinical assays that are used to select clinical candidates have low ability to predict efficacy in mental illness clinical trials and generally do not address circuit-specific effects. The purpose of this initiative is to encourage the development of translational assays to address this problem, with an emphasis on quantitative measures that are robust and reliable, and with an emphasis on the physiology and circuits that are the fundamental mediators of processes that are disrupted in mental disorders. The initiative will foster basic and clinical partnerships by requiring that assays be evaluated in both preclinical species and in healthy control humans.

The expected outcomes are: 1) to give the field alternatives to using the traditional preclinical measures with low predictive ability, and 2) to begin to build a science base to determine which preclinical assays have value in predicting circuit-based effects in early-phase experimental medicine trials in people. The data emerging from the initiative will provide a basis to identify those kinds of measures that are unlikely to be worthwhile to pursue further, and others that deserve more attention in a therapeutic screening pipeline.

Discussion

Dr. Casey endorsed the importance of linking the preclinical and human assays. Dr. Barch added that it will require cultural shifts in both the animal and human experimentation communities. Dr. Tamminga also supported the concept, citing efforts at her institution to link a Fragile X syndrome mouse model directly with patient data to create congruence between the models. This effort could enable direct translation in a genetic pair. Dr. Robinson asked what strategy could be used when the models don’t line up. Dr. Winsky said that negative results tell you not to go forward with the assay.

In response to a question from Dr. Sweatt about how broadly novel measure will be considered, Dr. Winsky said use of non-vertebrate models might have more limited value in later stage testing, due to species differences in drug metabolism and unique challenges in determining circuit conservation. Randall L. Carpenter, M.D., recommended moving closer to the molecular signaling pathway and molecular dysfunction and not focus on later-stage behaviors, which don’t translate well from animal to human models. He suggested that something that is preserved across evolution in a signaling pathway is probably going to be modulated the same way in the human. However, circuit function does not translate well from animals to humans, and a higher order animal might be necessary.

Discussion followed about the best way to fund such collaborative efforts between basic and clinical scientists.

Psychiatric Gene Networks: Solving the Molecular Puzzle of Psychiatric Disorders

Geetha Senthil, Ph.D., Division of Neuroscience and Basic Behavioral Science, said that the rational for this initiative stems from the recent genomic findings on complex genetic architecture of psychiatric disorders and the heterogenetic nature of these disorders. Over the last few years, large-scale, genome-wide studies have led to the discovery of hundreds of genetic loci to produce signals associated with psychiatric phenotypes. For example, an analysis of 30,000 schizophrenia cases and controls led by the Psychiatric Genomic Consortium identified more than 118 genetic loci associated with this disorder. In addition to the growing catalog of common variants, the repertoire of genetic signals associated with psychiatric disorders has expanded to other levels of molecular analysis, including copy number variants, rare de novo mutations, non-coding functional elements, transcriptome, quantitative loci analysis, and so on. From these studies it is increasingly clear that psychiatric phenotypes are influenced by many genes, most of which confer small to moderate risk.

Despite these studies, there is still a large gap in our understanding of how the combination of these risk factors can lead to the development of mental illnesses. This initiative would encourage investigators to focus on determining how the interactions of these diverse genetic factors contribute to the development of psychiatric phenotypes. It will support studies to mine existing large, multi-scale datasets to construct molecular networks through computational approaches and functional validation experiments. To gain an understanding of how these genetic interactions drive complex neurobiological processes underlying the pathophysiology of psychiatric phenotypes, there is a need to move beyond traditional, one-to-one association tests to more comprehensive, system-level analyses that integrate multiple levels of molecular information to arrive at non-linear molecular network models that could drive biological processes within the brain.

Constructing such molecular interaction networks gives us an opportunity to identify novel genetic factors that otherwise would remain hidden, and follow-up validation experiments could be conducted on these functional candidates to inform and refine this network analysis in an iterative manner to improve understanding of the molecular mechanisms underlying these clinical phenotypes. The studies under this initiative would identify novel genetic factors and the causal associations with the disease phenotype. It is expected that these studies would identify how diverse genetic signals converge in molecular networks across psychiatric phenotypes, and how these interactions are regulated across development and brain regions to arrive at molecular networks that drive critical neurobiological processes underlying the pathophysiology of these psychiatric disorders.

Discussion

Dr. Robinson asked if the initiative would only be focused on existing data sets. Dr. Senthil said new empirical data sets could be generated.

Dr. Sweatt suggested linking this type of initiative with the effort described earlier under Sage Bionetwork’s Synapse program. Dr. Wang said that because many datasets are already held by academic or private interests, NIMH is exploring ways to support the “spine” of the data commons. Dr. Sweatt added that NIMH might consider including a data-sharing requirement to the initiative.

Dr. Barch asked if there could be a way to back-fill phenotypic data on existing datasets that are sparsely populated. Drs. Senthil and Insel replied that they would hope patients could be re-contacted, but for now, the focus is building the infrastructure. Richard L. Huganir, Ph.D., encouraged first focusing on populations that have been more phenotyped than others, and building from there. Examples include aspects of RDoC and NDAR. Citing the heterogeneity of some illnesses and variability in diagnostic criteria, Dr. Carpenter asked if we have enough phenotypic characterization to make sense of the common variants in complex networks. Dr. Insel said that even for heterogeneous disorders like schizophrenia, there is heritability and a core set of common variants. However, we do not know how the many variants fit together.

More Targeted and Safe Use of Antipsychotics in Youth

Benedetto Vitiello, M.D., Division of Services and Interventions Research, said that this initiative aims to improve the way that antipsychotics are used in the treatment of children and adolescents. The use of antipsychotics in children has increased fivefold over the past 20 years; much of this increased use has been to manage mood and behavior dysregulation, such as extreme irritability, impulsive aggression, and temper outbursts. However, antipsychotic use involves a high risk for metabolic adverse effects, and nonhuman models show antipsychotic use to be associated with a cortical gray matter loss. It is possible that interventions other than antipsychotics could be used to manage mood and behavior dysregulation with a more favorable risk/benefit ratio.

The goals of this initiative are to: 1) develop an algorithm to treat children and adolescents with non-psychotic behavioral and mood disturbance conditions for which antipsychotics are currently used; 2) pilot-test the algorithm for feasibility in practice settings (rather than research settings); and, 3) test the effectiveness of the algorithm versus current practice. An evidence-based treatment algorithm could minimize and rationalize the use of antipsychotics, so that antipsychotics use is delayed, applied more parsimoniously, and for a limited period of time for symptom stabilization, and then discontinued. Ideally, the pilot testing would involve partners such as PCORI and the Agency for Health Care Research and Quality.

Discussion

Dr. Simon said this is an important concept, because there is treatment variability prior to antipsychotic prescription sometimes based on health insurance status, race, and ethnicity. He added that it would be important to collect information from families about the initiation of antipsychotics regarding, for example, whose idea it was and whether risks were discussed. Dr. Un suggested including pediatricians in the process, as there is increased prescribing in the no-psychiatric provider groups. Dr. Un added that an algorithm plus a pharmacy benefit management plan would be appropriate.

Dr. Simon noted that often people are prescribed these medications in a crisis, and asked if this is an antipsychotic prevention program or one aimed at getting people off antipsychotics as quickly as possible by offering an alternative. Dr. Tamminga said these drugs have an adverse effect on cognition; thus children should not be subject to cognitive disrupting agents for a long period of time. Although a child in crisis might need the medication, perhaps prescriptions should be time-limited. Dr. Areán added that adverse effects on cognition have been found in adults as well; therefore it would be a good idea to measure impact on cognition.

Mr. Heimer asked why these drugs are called antipsychotics, which is pejorative. Dr. Vitiello agreed that it is a misnomer because they are also approved for mood disorders, bipolar disorder, and nonpsychotic conditions. The European College of Neuro-Psychopharmacology is proposing a new term, for example, anti-dopaminergic beta blockers. Dr. Linehan said that some parents might avoid antipsychotics because of that label, although Dr. Vitiello said that current community use does not suggest that the term is discouraging users.

Improving Mental Health of Populations with Access to Cutting-edge Technologies (IMPACT)

Adam Haim, Ph.D., Division of Services and Interventions Research, introduced the concept, which aims to support the research, development, and testing of technology-based solutions focused on the diagnosis and treatment of mental illness. Over the last decade there has been a surge of innovative technology development quickly integrated into daily life that has fundamentally changed how we communicate and interact with each other, such as mobile devices, gaming, telemedicine, wearable sensors, and virtual reality. Recent data show that 60 percent of U.S. adults currently own a smart phone, compared to two percent 10 years ago; 42 percent of U.S. adults own a tablet compared to six percent a decade ago; and the average U.S. teen currently sends over 100 text messages a day, and texting appears to be the dominant form of communication in that specific population. Where appropriate, NIMH has encouraged the integration of this technology into its research portfolio, but one of the challenges encountered is that traditional biomedical research does not keep up with the pace of technology development. A typical grant can take up to nine years from award to dissemination. By contrast, over the same nine-year period, technology has progressed at a much more rapid pace. In terms of interventions that are evaluated within the NIMH grant portfolio, more often than not the technology or intervention being developed remains static during the course of the grant. Thus, in many ways the traditional NIH research life cycle is not well matched to technology development and results in the rigorous testing of technology that is often obsolete at the completion of the grant.

Within the mainstream health IT space, there are around 100 million smart phone users in the U.S., and 20 percent of these individuals use one or more of the 40,000 mobile health apps which have been developed by programmers who can move from the design stage to the rollout stage in a matter of months, if not weeks. The problem is that many of these apps have little to no evidence base and are often ineffective. The ultimate goal of this initiative is to move from the current development model and combine the expertise of the health IT industry with clinical researchers to promote the efficient development and testing of technology-based solutions that are empirically based, effective, and easily disseminated. NIMH has identified a model that facilitates collaborations between mental health researchers and technology developers. Within this model, NIMH will provide programmatic oversight, promote the development of novel partnerships, and identify funding mechanisms and incentives. The initiative also aims to encourage the rapid development and testing and use of robust platforms. This model could promote rapid development and evaluation of cost-effective interventions that meet FDA guidelines.

Examples within the IMPACT initiative include: 1) leveraging biosensors to detect early signals before the onset of clinically significant symptoms; 2) adapting and evaluating effective social prosthetics to enhance social skills training for individuals with deficits in social functioning; and, 3) developing and evaluating systems to provide clinicians and patients with clinical decision support to personalize and optimize treatment. The ultimate goal of this initiative is to develop and test low-cost, scalable, IT-enhanced interventions that can prevent or change the trajectory of mental illness.

Discussion

Dr. Brent offered some examples of where technology could be used for prevention efforts as well, such as detecting harassing or risky sexual behaviors.

Dr. Simon said that because the lifecycle of technologies is so short, the focus should be on the behavioral and biological principles rather than on the software or hardware. Dr. Haim agreed that the focus should be on device-independent applications.

Dr. Areán encouraged flexibility in the devices and apps used, and said that investigators might have to go back to IRBs as new potential for data collection emerges. She added that it would be important to have interoperability of these data so they can be pooled and shared.

Dr. Linehan encouraged a long-term focus with a concentrated research group that can conduct evaluations over time, for example the intramural research program. Dr. Insel said that NIMH does fund ongoing work studying the value of devices and apps for depression and anxiety disorders. He added that IMPACT will not be wedded to randomized controlled trials as a methodology.

In response to a question from Dr. Tamminga about extramural access to the outputs of IMPACT, Dr. Haim said that the goal of IMPACT is not to follow a linear, R01 model in which data are tightly held, but rather a model that provides a source of accessible data that are constantly refreshing.

Concepts from the Division of AIDS Research

Dianne Rausch, Ph.D., Director, Division of AIDS Research, introduced three concepts from her division and reminded Council that funding for AIDS research comes through the NIH Office of AIDS research rather than the NIMH budget. Because NIMH is collaborating with NIAID, the three concepts have been discussed with its leadership and will be co-sponsored by NIAID.

The first concept, Monitoring Antiretroviral Adherence to Improve HIV Treatment and Prevention, will support the development of approaches to monitor antiretroviral adherence to improve HIV treatment and prevention. Adherence is essential to antiretroviral-based treatment and prevention, and it is challenging to sustain. Timely intervention for poor antiretroviral adherence can improve outcomes for HIV treatment and prevention in clinical trials. In a treatment cascade model based on Centers for Disease Control and Prevention (CDC) data, of the 1.2 million people estimated to be infected with HIV in this country, about 80 percent are tested and linked to care, and even those linked to care may drop-off during the course of treatment. For many reasons, patients on antiretroviral therapy do not maintain adherence, and ultimately only about 28 percent of the people that are known to be infected in this country are effectively virally suppressed. Viral suppression through drugs essentially eliminates the virus, rendering a virally suppressed individual non-infectious. Thus, not only does treatment improve health outcomes, but is also an effective prevention strategy. Methods are required to assess real-time antiretroviral adherence to target interventions that can be implemented when adherence monitoring reveals a treatment lapse.

The initiative would also support research to1) develop and test predictive models to produce actionable information regarding future likelihood that a person will experience viral failure; and 2) develop technology-assisted monitoring to improve feedback loops to identify patients at the time they are no longer adherent to facilitate a timely intervention. NIMH’s initiative would be developed in collaboration with an NIAID initiative to develop improved viral load assays that could be done at the point of care.

Methodologies to Enhance Understanding of HIV Associated Social Determinants aims to enhance understanding of social determinants which impact efforts to prevent new HIV infections and improve health outcomes in individuals living with HIV. These determinants include overlapping social and economic factors that can influence health at multiple levels. Some examples of these factors include: stigma and discrimination which have been shown to impede medication adherence; economic factors such as food insecurity are associated with high-risk sexual behavior; and social and intimate partner violence are associated with deleterious HIV-related health outcomes; and legal factors, such as laws restricting syringe access, are associated with higher rates of HIV among drug users. Thus, social determinants cannot be fully controlled and behavior is difficult to change, therefore it is important to target interventions in the context of their social and community environment. Factors that explore the interplay of resilience and risk over time are critical to understand in order to identify new targets for interventions. The goals of this initiative are to 1) increase the understanding of the mechanisms at multiple levels that underlie the association between social determinants and HIV outcomes; 2) develop appropriate scales and models to measure these social determinants and how they bring about their effects ; 3) define factors associated with resilience; 4) use existing databases and novel analytic methods to identify modifiable factors; and 5) determine scales and theoretical models to better understand the mechanisms that drive the relationship between social determinants and positive HIV outcomes.

In introducing Exosomes and HIV Neuropathogenesis, Dr. Rausch stated that HIV-associated neurocognitive disorders (HAND) remain prevalent even in the era of antiretroviral therapy. There are gaps in our understanding of the pathophysiological mechanisms that drive this neurocognitive decline even in well-treated individuals. Chronic low-level inflammation likely plays a key role in the continued high prevalence of AIDS. Therefore, we need to understand the inflammatory mediators and regulators of gene expression that lead to HAND.

Exosomes have been shown to potentially play a role in the progression of neurodegenerative pathology such as in Alzheimer’s disease. They are released from neuronal cells, microglia, astrocytes and immune cells, and they may affect the neuropathology of HIV infection through central nervous system (CNS) immunomodulatory molecules. These exosomes can be formed in the infected cell, transferred to an uninfected cell, and then have pathophysiological impact that can lead to neuropathogenesis or impaired neural function. The goals of this initiative are to: 1) stimulate further research on the central role of exosomes in HAND; 2) study their contribution in modulating chronic infection and inflammation in HAND; 3) explore their potential for delivering therapeutics to the central nervous system; 4) find the exosomal cargo that is derived from infected cells and its potential impact on cell impairment; 5) study gene regulation in the CNS following exposure to these; and, 6) evaluate the potential role of exosomes as biomarkers for HAND progression and response to therapy.

Discussion

Dr. Robinson suggested considering the use of synthetic biology to enhance the operation of the exosomes.

Richard L. Huganir, Ph.D., commented that the exosome initiative seemed narrowly constructed, and asked if it could be broadened to include other aspects of membrane trafficking. Dr. Rausch responded that this is a targeted effort because there are researchers working on this concept right now and they want to stimulate them to work in the CNS. The goal is to get neuro-AIDS researchers partnered with non–neuro-AIDS researchers. Dr. Insel added that since the description of the transmission of tau through the cross-brain areas, the focus has been on Alzheimer’s disease but not AIDS; thus, this aims to stimulate exploration in AIDS.

Dr. Tamminga asked if it is possible to get 100 percent suppression, to which Dr. Rausch responded, yes, in theory. Dr. Rausch said that some long-acting antiretroviral drugs are in development. Dr. Insel added that NIAID is funding two Phase 2 trials of long-acting injectable forms of antiretrovirals. In response to a comment from Dr. Linehan about adherence, Dr. Rausch noted that simplification of the drug regimen has helped adherence and linked prevention and treatment. Dr. Un said that adherence is a problem with all chronic illness; if more could be learned about resilience that might be generalizable to other chronic illnesses. John Davison, M.B.A., Ph.D., asked if the focus on resilience was a new concept in HIV psychosocial determinants, to which Dr. Rausch said it was not, but that this would be the first time it had been called out specifically in a neuro-AIDS funding announcement. Dr. Insel added that the low adherence rate to antiretroviral drugs suggests much more must be known about what is underlying that rate. Dr. Linehan said it is not so much resilience, as self-regulation.

With regard to the social determinants initiative, Dr. Simon urged NIMH to include “resilience factors” in the title to signal clearly that this concept is included.

Council made and passed a motion to approve all of the concepts described above with a goal to move more quickly on the concept, For a More Targeted and Safer Use of Antipsychotics in Youth.

Public Comment

Dr. Insel invited members of the audience to make any comments to the Council. Hearing none, Dr. Insel thanked all who participated in the meeting. He recessed the open session meeting at approximately 2:13 p.m.

Appendix A

Summary of Primary MH Applications Reviewed

May 2014

Category IRG Recommendation
Scored
#
Scored
Direct Cost $
Not Scored
(NRFC)
#
Not Scored
(NRFC)
Direct Cost $
Other
#
Other
Direct Cost $
Total
#
Total
Direct Cost $
Research 532 $613,738,859.00 460 $457,098,671.00 8 $1,604,167.00 1000 $1,072,441,697.00
Research Training 0 $0.00 0 $0.00 0 $0.00 0 $0.00
Career 62 $42,346,939.00 22 $14,209,256.00 0 $0.00 84 $56,556,195.00
Other 0 $0.00 0 $0.00 0 $0.00 0 $0.00
Totals 594 $656,085,798.00 482 $471,307,927.00 8 $1,604,167.00 1084 $1,128,997,892.00

Appendix B

Department of Health and Human Services
National Institutes of Health
National Institute of Mental Health
National Advisory Mental Health Council

(Terms end 9/30 of designated year)

Chairperson

  • Thomas R. Insel, M.D.
    Director
    National Institute of Mental Health
    Bethesda, MD

Executive Secretary

  • Jane A. Steinberg, Ph.D.
    Director
    Division of Extramural Activities
    National Institute of Mental Health
    Bethesda, MD

Members

  • Patricia A. Areán, Ph.D. (16)
    Professor
    Department of Psychiatry and Langley Porter
    Psychiatric Institute
    University of California, San Francisco
    San Francisco, CA
  • Deanna M. Barch, Ph.D. (16)
    Gregory B. Couch Professor of Psychiatry
    Department of Psychology, Psychiatry and Radiology
    Washington University
    Editor-in-Chief
    Cognitive, Affective and Behavioral Neuroscience
    Director, Conte Center for the Neuroscience
    of Mental Health
    St. Louis, MO
  • Virginia Trotter Betts, M.S.N, J.D. (14)
    Professor of Nursing and Public Policy
    University of Tennessee Health Science Center
    College of Nursing
    Memphis, TN
  • David A. Brent, M.D. (17)
    Academic Chief
    Child & Adolescent Psychiatry
    Endowed Chair in Suicide Studies
    Professor of Psychiatry, Pediatrics and Epidemiology
    Director, Services for Teens at Risk
    University of Pittsburgh School of Medicine
    Pittsburgh, PA
  • Randall L. Carpenter, M.D. (15)
    Co-Founder, President and Chief Executive Officer
    Seaside Therapeutics
    Cambridge, MA
  • BJ Casey, Ph.D. (16)
    Sackler Professor
    Department of Psychiatry and Neuroscience
    Sackler Institute for Developmental Psychobiology
    Weill Medical College of Cornell University
    New York, NY
  • Lisa Greenman, J.D. (15)
    Staff Attorney
    Federal Public Defender Organization
    District of Maryland
    Washington, DC
  • Hakon Heimer, M.S. (16)
    Founding Editor
    Schizophrenia Research Forum
    Brain and Behavior Research Foundation
    Providence, RI
  • Richard L. Huganir, Ph.D. (17)
    Professor and Director
    Department of Neuroscience
    Investigator, Howard Hughes Medical Institute
    Co-Director, Brain Science Institute
    The Johns Hopkins University School of Medicine
    Baltimore, MD
  • Steven E. Hyman, M.D. (15)
    Director, Stanley Center for Psychiatric Research
    Broad Institute
    Cambridge, MA
  • Marsha M. Linehan, Ph.D. (17)
    Professor and Director
    Behavioral Research and Therapy Clinics
    Department of Psychology
    University of Washington
    Seattle, WA
  • Maria A. Oquendo, M.D. (17)
    Vice Chair for Education
    Professor of Clinical Psychiatry
    Department of Psychiatry
    Columbia University/NYSPI
    New Columbia University/NYSPI
    New York, NY
  • Gene E. Robinson, Ph.D. (14)
    Director, Institute for Genomic Biology
    Swanlund Chair
    Center for Advanced Study Professor in Entomology
    And Neuroscience
    University of Illinois at Urbana-Champaign
    Urbana, IL
  • Mary Jane Rotheram, Ph.D. (16)
    Bat-Yaacov Professor of Child Psychiatry
    And Behavioral Sciences
    Director, Global Center for Children and Families
    Director, Center for HIV Identification Prevention
    And Treatment Services (CHIPTS)
    Semel Institute and the Department of Psychiatry, University of California, Los Angeles
    Los Angeles, CA
  • Gregory E. Simon, M.P.H., M.D. (14)
    Senior Scientific Investigator
    Center for Health Studies/Behavioral
    Health Service
    Group Health Cooperative
    Seattle, WA
  • J. David Sweatt, Ph.D. (16)
    Professor
    Evelyn F. McKnight Endowed Chair
    Department of Neurobiology
    Director, McKnight Brain Institute
    University of Alabama at Birmingham
    Birmingham, AL
  • Carol A. Tamminga, M.D. (15)
    Professor and Chair
    Department of Psychiatry
    University of Texas
    Southwestern Medical Center
    Dallas, TX
  • Hyong Un, M.D. (17)
    Head of EAP & Chief Psychiatric Officer
    AETNA
    Blue Bell, PA

Ex Officio Members

Office of the Secretary, DHHS

  • Sylvia M. Burwell
    Secretary
    Department of Health and Human Services
    Washington, DC

National Institutes of Health

  • Francis Collins, M.D., Ph.D.
    Director
    National Institutes of Health
    Bethesda, MD

Veterans Affairs

  • Ira Katz, M.D., Ph.D.
    Department of Veterans Affairs
    Office of Mental Health Services
    Washington DC

Department of Defense

  • John W. Davison, M.B.A., Ph.D.Director, Behavioral Medicine Division
    Office of the Chief Medical Officer (OCMO)
    TRICARE Management Activity, OASD (HA)
    Falls Church, VA

Liaison Representative

  • Paolo del Vecchio, M.S.W.
    Director
    Center for Mental Health Services
    Rockville, MD