Director’s Report to the 228th National Advisory Mental Health Council — May 6, 2011

Welcome

I am pleased to welcome members of the National Advisory Mental Health Council (NAMHC), speakers and guests to our 228th meeting. In this report I will share with you information about new and ongoing initiatives at the National Institutes of Health (NIH) and the National Institute of Mental Health (NIMH).

Budget

A major concern since our last meeting has been the uncertainty of the NIH budget. After three successive threatened government shutdowns due to a terminating budget resolution, a full year budget was ultimately passed late on April 8, more than six months into the current fiscal year (FY). The result is a full year Continuing Resolution (CR) operative through September 30, 2011. The budget for FY 2012 is now under consideration. Of note, the President’s budget for FY 2011 was $1.540B (a 3.4 percent increase over FY 2010); for FY 2012 is $1.517B (a 1.9 percent over the President’s FY 2011 budget).

The NIMH FY 2011 CR budget is $1.477B. This is roughly a 1 percent decrease from FY 2010. While this is the first decrease in NIMH funding in the past three decades, it is considerably less than the cuts to many other agencies during this period of financial restraint. Following the productive two years of the American Recovery and Reinvestment Act of 2009, FY 2011 will feel like a period of austerity to our research community. We expect to support 452 new and competing awards in FY 2011, which is nearly 20 percent below our average annual target of 550 new grants. This drop reflects not only the budget reduction, but also an increase in the cost of non-competing grants, amounting to an extra $30M this year relative to recent years.

Consistent with NIH policy for non-competing awards, we will be reducing budgets for previously funded grants by 1 percent below the FY 2010 amount (for both modular and non-modular grants). Going forward, future inflationary adjustments for recurring costs on new and competing grants will be set at 2 percent. NIMH will continue to support new investigators on R01 awards at success rates equivalent to that of established investigators submitting new R01 applications. Research training awards will receive a 2 percent increase at all stipend levels.

With expectations that our budget will be flat or lower in FY 2012 and beyond, NIMH has been reviewing its funding strategy to ensure (a) a robust pool of R01s; (b) a continuing pipeline for new investigators; and, (c) a focus on innovation relevant to the NIMH Strategic Plan. To this end, we are initiating a plan of “select pay” for grants beyond our nominal payline, and we will continue to support a different payline for new investigators. In addition, in continued support of our Strategic Plan, we will continue to invest at least 15 percent of our funds in RFAs that target gap areas in which we are not receiving unsolicited grant proposals.

NIH-Wide Updates

NIH Common Fund Programs and Initiatives

The NIH Roadmap is a trans-NIH effort to support innovative science, stimulate interdisciplinary research and reshape clinical research to accelerate medical discovery and improve public health. Roadmap programs span all areas of health and disease research and boundaries of NIH Institutes and Centers (ICs). These programs might not have been supported otherwise by the NIH ICs, usually because of their scope. Roadmap Programs are expected to have exceptionally high potential to transform the manner in which biomedical research is conducted. They are also expected to be short term, 5–10 year programs. This incubator space time frame is intended to allow the major roadblocks that were defined for each program to be overcome, thereby stimulating further research conducted through the ICs.

• Molecular Libraries Program (NIMH Program Leads: Linda Brady, Ph.D., Ingrid Li, Ph.D.)

  The six-year investment in the Molecular Libraries Program (MLP) by the NIH Common Fund has successfully contributed to NIH’s vision and strategy for advancing translational medicine and therapeutics development. In January 2011, a probe project executed by the Scripps Research Institute (SRI), a funded center of the MLP, has become the program’s first to yield a drug candidate tested in humans. The initial probe compound resulting from the MLP efforts, an agonist of the sphingosine-1-phosphate receptor 1 (S1P1) and related molecules, were further developed outside of the MLP by SRI and Receptos, Inc., eventually resulting in administration to the first human subject in a Federal Drug Administration-approved Phase 1 clinical safety study undertaken by Receptos, Inc. The clinical study has been initiated as a potential treatment for multiple sclerosis (MS), a neurodegenerative disease that affects the central nervous system (brain and spinal cord). MS is currently believed to be an immune-mediated disorder. Although many MLP probes have been tested in behaving animal models, this is the first example of an MLP probe to have been developed sufficiently to be tested in humans, a landmark achievement for the MLP program.

• The GTEx (Genotype-Tissue Expression) Project NIMH Program Leads: Su Koester, Ph.D., Roger Little, Ph.D.)

  The Genotype-Tissue Expression (GTEx) project’s goal is to understand how genetic variation may control gene activity across organs and tissues of individuals. GTEx aims to provide to the scientific community a resource with which to study human gene expression, regulation, and its relationship to genetic variation. This project focuses on the collection and analysis of multiple human tissues from donors who are densely genotyped, to assess genetic variation within their genomes. By analyzing global RNA expression within individual tissues and treating the expression levels of genes as quantitative traits, variations in gene expression that are highly correlated with genetic variation can be identified as expression quantitative trait loci (eQTL).

• Science of Behavior Change Program (NIMH Program Leads: Shelli Avenevoli, Ph.D., Bettina Osborn, Ph.D.)

  The Science of Behavior Change (SOBC) program aims to promote basic research on the initiation, personalization and maintenance of behavior change. By integrating work across disciplines, this effort will lead to an improved understanding of the underlying principles of behavior change. Ten new awards for a SOBC Funding Opportunity Announcement (FOA) were made in fiscal year 2010. The FOA focused on improving the understanding of basic mechanisms of behavior change that play a role in initiating or maintaining behavior change across a broad range of health-related behaviors. The projects bridge work done in laboratories and in the field, and are intended to stimulate investigations of basic mechanisms at the social, contextual, behavioral, psychological, neurobiological or genetic level of analysis. Details of the awarded projects can be found on the SOBC webpage. The first annual investigators meeting, for awardees of this FOA and other investigators in this field, will be held June 20-21, 2011 on the NIH main campus. The meeting will include a keynote address by Matthew Nock, Ph.D. and addresses by other prominent scientists in the areas of behavioral economics, genetics, social policy, and emotional self-regulation.

• NIH Director’s Early Independence Award

  The NIH Common Fund established the Independence Awards in 2010 to provide a mechanism for exceptional, early career scientists to omit traditional post-doctoral training and move into temporary, independent academic positions at U.S. institutions directly upon completion of their graduate degrees (Ph.D. or M.D. equivalent). The application deadline was March 31, 2011.

NIH Blueprint for Neuroscience Research

The NIH Blueprint for Neuroscience is a framework to enhance cooperation among the 16 NIH ICs that support research on the nervous system. Created in 2004, the NIH Blueprint has already funded a number of innovative cross-cutting projects. Recent initiatives include:

• Grand Challenge on New Drugs for Diseases and Disorders of the Nervous System

  This initiative will set up a pipeline to move candidate drugs for nervous system disorders through preclinical development into early clinical trials. Successful applicants to the program will receive funding to conduct biological testing in their laboratories and unprecedented access to a full range of industry-style drug development services and expertise. The investigators will retain the intellectual property rights for compounds they develop through this program. Seven applications are in the process of being funded in response to the first release of the funding announcement (RFA-NS-11-002). The RFA was re-released as RFA-NS-12-002 on March 16, 2011, with receipt dates set for June 10, 2011 and December 15, 2011.

• NIH Blueprint for Neuroscience Research Science Education Award (R25)

  The goal of this initiative (RFA-DA-11-013) is to improve K-12 science education in areas relevant to the NIH Blueprint. Applicants were asked to provide a clear plan for improving science knowledge and enthusiasm for science among the targeted students or teachers, as well as a plan for evaluation. Partnerships between educators and scientists in the development of the science education project were highly encouraged. Applications were accepted through April 11, 2011.

• Innovative Neuroscience K-12 Education (SBIR [R43/R44])

  This initiative (PAR-10-054) encourages Small Business Innovation Research (SBIR) grant applications to develop innovative neuroscience educational tools to be used by or benefit children in kindergarten through 12th grade (K-12). Educational tools can be designed using any media (e.g., paper, electronic, etc.) or format (e.g., simulations, games, videos, notebooks, etc.) for use in or out of school settings, targeting children in groups or alone, with or without adult or teacher participation. Innovative neuroscience educational tools should promote neuroscience knowledge acquisition and application of that knowledge to one’s own life, promote an interest in neuroscience learning and careers and present a positive and realistic representation of the diversity of people who engage in neuroscience-related research and occupations. Educational tools targeted to increase the diversity of students (i.e., American Indian/Alaskan Native, Black or African American, Hispanic, female, disabled or otherwise underrepresented) pursuing neuroscience learning are especially encouraged.

• NIH Blueprint for Neuroscience Research Short Courses in Neurotherapeutics Development (R25)

  The goal of this initiative (RFA-NS-12-001) is to develop and implement short courses on Neurotherapeutics development for academic neuroscientists. The short courses will provide participants with an overview of the neurotherapeutics development process such that they may (1) understand the steps required for therapeutics development; (2) anticipate and overcome common challenges in the process; and, (3) interact effectively with collaborators who have expertise in various aspects of therapeutics development. The short courses will primarily target independent academic neuroscience researchers and senior post-doctoral fellows interested in incorporating treatment development into their research programs. The application due date was April 11, 2011.

NIMH Updates

Office for Research on Disparities and Global Mental Health

On April 8, 2011, Senator Benjamin L. Hardin, Congresswoman Barbara Lee, and Assistant Secretary for Health, Howard Koh, M.D., M.P.H., released the National Stakeholder Strategy for Achieving Health Equity and the HHS Action Plan to Reduce Racial and Ethnic Health Disparities at the National Press Club in Washington, DC. These documents are the result of three years of intense collaboration among public and private entities, with oversight provided by a Federal Interagency Health Equity Team (FIHET).

The National Stakeholder Strategy for Achieving Health Equity provides a common set of goals and objectives for public and private sector initiatives and partnerships to help racial and ethnic minorities and other underserved groups reach their full health potential. The strategy—a product of the National Partnership for Action (NPA)—incorporates ideas, suggestions and comments from thousands of individuals and organizations across the country. Local groups can use the National Stakeholder Strategy to identify which goals are most important for their communities and adopt the most effective strategies and action steps to help reach them.

The HHS Action Plan to Reduce Racial and Ethnic Health Disparities outlines goals and actions HHS will take to reduce health disparities among racial and ethnic minorities. With the HHS Disparities Action Plan, the Department commits to continuously assessing the impact of all policies and programs on racial and ethnic health disparities. It will promote integrated approaches, evidence-based programs and best practices to reduce these disparities. The HHS Action Plan builds on the strong foundation of the Patient Protection and Affordable Care Act of 2010 and is aligned with programs and initiatives such as Healthy People 2020, the First Lady's Let's Move initiative and the President's National HIV/AIDS Strategy.

Pamela Y. Collins, M.D., M.P.H., Director of the Office for Research on Disparities and Global Mental Health (ORDGMH), and Robert A. Mays, Jr., Ph.D., M.S.W., Chief, Rural Mental Health Research Program, Office of Rural Mental Health Research, NIMH, serve on the FIHET. Dr. Collins and LeShawndra Price, Ph.D., Deputy Director for Research, ORDGMH, serve on the Data, Research, and Evaluation Subcommittee. Dr. Mays is Co-Chair of the Leadership Subcommittee.

Recent NIH and NIMH Meetings of Interest

NIMH Workshop on the Maturation of Functional Brain Networks: Insights into the Origins and Course of Mental Disorders

On January 27-28, 2011, NIMH convened a workshop of experts to discuss the promise and challenges of studying the maturation of neural networks in healthy and clinical populations of children and adolescents. The neurodevelopment of functional connectivity is a rapidly evolving field, and as such, the workshop focused on the following topics: (a) technical and analytical advances in studying large-scale neural networks; (b) the dynamic nature of structure-function relationships over the course of development; (c) the current state of knowledge on functional connectivity in typical and atypical development; and, (d) the pros and cons of applying prospective, longitudinal designs to study neural network maturation. Participants discussed the potential value gained from more comparative studies of neural network development,and the promise of applying support vector machine learning to provide predictive knowledge at the level of the individual. Participants strongly cautioned against inferring network properties in children based on existing adult connectivity; they agreed that a rigorous, comprehensive understanding of normative developmental connectivity was needed to disentangle the rapid changes during typical development from those that define the etiological roots of mental illness.

NIMH Alliance for Research Progress, Winter Meeting

The NIMH convened the fourteenth meeting of the NIMH Alliance for Research Progress (the Alliance) on February 18, 2011. The Alliance is a group of leaders from patient and family-related advocacy organizations directly concerned with mental illnesses. NIMH brings this group together twice a year to provide Alliance members with the opportunity to learn about scientific advances in mental health research, to discuss important information related to changes in the field, and to engage in day-long direct dialogue with NIMH leadership through which they provide crucial input and feedback for NIMH. Guest speakers included The Honorable Patrick Kennedy, Former U.S. Congressman, Rhode Island; Susan Dentzer, M.A., Editor-in-Chief, Health Affairs; David A. Lewis., M.D., Director, Translational Neuroscience Program, University of Pittsburgh and Member of the NAMHC; and Myrna M. Weissman, Ph.D., Professor, Epidemiology and Psychiatry, Columbia University and Chief, Division of Epidemiology, New York State Psychiatric Institute.

Sex Differences in Brain, Behavior, Mental Health and Mental Disorders

On February 28-March 1, 2011, the Division of Neuroscience and Basic Behavioral Science (DNBBS) and the Division of Developmental Translational Science (DDTR) co-sponsored a workshop entitled, “SexDifferences in Brain, Behavior, Mental Health and Mental Disorders.” The workshop focused on sex differences in affective, cognitive and social behaviors. Expertise of the 19 participants varied from epigenetic processes to human brain imaging studies. Four panelists served as moderators: Arthur Arnold, Ph.D., Catherine Woolley, Ph.D., Jill Goldstein, Ph.D., M.P.H. and Stuart Tobet, Ph.D. Special emphasis was placed on moving the field from descriptive studies to mechanistic approaches and ways to orient the field toward those neural mechanisms underlying sex differences in risk and resilience for mental illness. The workshop attracted nearly 100 attendees from NIMH, the wider NIH community, and external academic institutions.

Annual Autism Centers of Excellence Principal Investigators Meeting

On March 7-8, 2011, NIMH, in collaboration with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute of Environmental Health Sciences (NIEHS), and NINDS convened the second annual meeting of the principal and project investigators of the 11 centers and networks of the Autism Centers of Excellence (ACE) program. The principal investigators from each center and network provided highlights and updates on their respective research projects. In a new format designed to encourage more in-depth exchange of ideas, the meeting attendees were divided into three separate breakout groups to discuss the progress and future directions for the characterization of autism spectrum disorder (ASD), the causes of ASD, and ASD treatments/interventions. Separate sessions were also devoted to discussing data sharing through the NIH National Database for Autism Research. NIH program staff in attendance also had the opportunity to discuss the relevance of the ACE projects to achieving the goals of the Interagency Autism Coordinating Committee’s Strategic Plan for ASD Research, as well as the strengths and weaknesses of the ACE program overall.

Outreach Partnership Program 12th Annual Meeting

On March 21, 2011 NIMH convened the annual meeting of the Outreach Partnership Program, a national science dissemination and clinical trials promotion initiative carried out through Outreach Partners from all 50 states, the District of Columbia, and Puerto Rico. During the course of the three-day meeting, Outreach Partners heard about research on numerous topics, such as sensitive periods for development of mental disorders, the effects of and interventions for traumatic experiences, risk and resilience, suicide risk detection and depression prevention in adolescents, the mental health needs of victims of intimate partner violence, depression in preschool children, cognitive training for young people with or at risk for psychosis, aggression prevention among urban African American girls, cultural adaptation of prevention programs, and community re-entry of multi-ethnic female inmate populations.

Building Research Capacity and Collaboration in Global Mental Health

ORDGMH hosted a workshop entitled “Building Research Capacity and Collaboration in Global Mental Health” on March 24-25, 2011 in Bethesda, Maryland. The gathering occurred in response to the growing need to build global mental health research capacity in and outside of the US. A total of 62 stakeholders from around the world took part in this workshop to discuss strategies for developing and sustaining research capacity in genetics, child mental health, and implementation science. During the course of the two days, participants identified barriers, opportunities, strategies, and models for increasing and sustaining research capacity in global mental health research. The workshop demonstrates NIH/NIMH’s commitment to advancing global research as it continues to reflect and invest in this important area.

Keystone Symposia: Evolving Early Stage Drug Discovery

April 3-7, 2011, Linda Brady, Ph.D., Director of DNBBS, NIMH and Craig Lindsley, Ph.D., Professor of Chemistry and Pharmacology, Vanderbilt University, co-organized a Keystone Symposia on “Evolving Early Stage Drug Discovery.” The meeting focused on diverse approaches to early stage discovery in a resource constrained environment, evolution of preclinical drug discovery in academia, evolution of drug leads/target validation from the NIH MLP, funding early stage/risky programs, external licensing of programs, and advances in biomarkers/imaging to enable target selection and rapid go/no go decisions.

NIMH Professional Coalition for Research Progress Annual Meeting

NIMH convened the seventh annual Professional Coalition for Research Progress Meeting on April 13, 2011. The Coalition consists of representatives from professional organizations with an interest in NIMH research. The meeting served as an opportunity for NIMH to share information about research advances, current and new directions for NIMH, and possible future strategies. The meeting is structured as a dialogue with ample time for representatives to share their views on NIMH research or other NIMH-related issues. Attendees heard presentations from NAMHC Council Member Gregory E. Simon, M.D. on the Mental Health Research Network; Pamela Collins, M.D., M.P.H. on Grand Challenges in Global Mental Health; and Raquel E. Gur, M.D., Ph.D., Karl and Linda Rickels Professor of Psychiatry at Pennsylvania University, who gave an overview of the Developmental Genomics project.

NIMH Awards and Honors

• Jacqueline Crawley, Ph.D., Chief of the Laboratory of Behavioral Neuroscience in the DIRP was elected as a Fellow in the American Association for the Advancement of Science (AAAS). She was inducted during the AAAS Annual Meeting in February and recognized “for generating new rodent behavioral tasks and applying emerging technologies to investigate genes regulating complex behavioral traits.”
• Christian Grillon, Ph.D., Chief of the Section on Neurobiology of Fear and Anxiety, DIRP was awarded NIH tenure in January 2011. Dr. Grillon is internationally renowned for his paradigms designed to separate the realms of fear and anxiety in clinical populations. The Section conducts research on the neurocognitive mechanisms of fear and anxiety using the tools of cognitive and affective neuroscience, including psychophysiology and neuroimaging techniques, to advance knowledge of the development, maintenance and treatment of anxiety disorders.

NIMH Staff News

Arrivals/Moves

• Kwangmi Anh, Ph.D., has been appointed as a Staff Scientist in the Child Psychiatry Branch of the DIRP. Dr. Anh will be serving as the lead epidemiologist and statistician in Judith Rapport, M.D.’s group and will conduct genetics research on childhood-onset schizophrenia, sex chromosome disorders, and ADHD.
• Melissa Brotman, Ph.D., has been appointed a Staff Scientist in the Section on Bipolar Spectrum Disorders in the Emotion and Development Branch of the DIRP. Dr. Brotman received her Ph.D. in Clinical Psychology from the University of Pennsylvania and completed her post-doctoral training under the mentorship of Ellen Leibenluft, M.D. Her research involves studying the behavioral and neural correlates of pediatric bipolar disorder.
• Michael Huerta, Ph.D., who has been the Director of the NIMH Office of Technology Development and Coordination and the DNBBS Office of Cross-Cutting Science and Scientific Technology, will be leaving NIMH to become Associate Director of the National Library of Medicine.
• Erica Rosemond, Ph.D., Program Manager in the DNBBS Office of Research Training and Career Development has accepted a position as Health Scientist Administrator in the Training Branch of the National Cancer Institute.
• Julia Tossell, M.D., has accepted a position as the attending physician on the adult inpatient psychiatry unit at Walter Reed National Military Medical Center. For the past nine years, Dr. Tossell has been the Staff Clinician for the inpatient pediatric unit for studies in the Child Psychiatry Branch in the NIMH DIRP.

Retirements

• David Shore, M.D., who worked as Associate Director for Clinical Research in the Office of the Director, retired from NIMH in early April. Dr. Shore has served the Institute in many capacities since he first arrived in 1978 as a Senior Staff Fellow in the Neuropsychiatry Branch of the DIRP. More recently, he has been the NIMH Associate Director for Clinical (Human Subjects) Research, Scientific Administrator of NIMH Data and Safety Monitoring Boards, Acting Director of the NIMH Division of Services and Interventions Research, and Acting Director of the NIMH Division of Clinical and Treatment Research.

National Institute of Mental Health
FY 2011 Full Year C.R.
(Dollars in Thousands)