Forum on Neuroscience and Nervous System Disorders: 2010 Annual Report (2011)

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BOARD ON HEALTH SCIENCES POLICY Forum on Neuroscience and Nervous System Disorders 2010 Annual Report 

About the Neuroscience Forum The IOM in 2006 established the Forum on Neuroscience and Nervous System Disorders. The Forum is designed to provide its members with a neutral venue for exchanging information, sharing individual views, and allowing a structured opportunity for dialogue and discussion while scrutinizing critical and possi- bly contentious scientific and policy issues. Representatives from government, industry, academia, patient advocacy organizations, and other interested parties serve as Forum members. It convenes three times a year to confer on subject areas of mutual interest and concern. At its meetings, the Forum identifies and discusses emerging scientific and policy issues related to basic neuroscience and nervous system disorders, as well as effective clinical inter- ventions and policy options. The Forum also sponsors workshops (symposia) as an additional mechanism for informing the mem- bership of the Forum, other relevant stakeholders, and the public. Information about past or upcoming meetings is available at the Forum’s website, www.iom.edu/neuroforum. About the Institute of Medicine The Institute of Medicine serves as adviser to the nation to improve health. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The mission of the Institute of Medicine embraces the health of people everywhere. Cover Image Credits Left: Greg Hood, John Burkardt, and Greg Foss, Pittsburgh Supercomputing Center Right: Paul Thompson and Arthur Toga, UCLA 

Message from the Chair The Institute of Medicine (IOM) established the Forum on Neuroscience and Nervous System Disorders to provide a venue through which neuroscience lead- ers from private sector sponsors and users of biomedical and clinical research, federal agencies sponsoring and regulating research, private foundations, the academic community, and other consumers could consider critical issues and how they might be dealt with. Discussions in 2010 have focused on a diverse array of topics, including the implications of recent cutbacks by top pharmaceutical companies in drug devel- opment for central nervous system disorders, and great opportunities for the field, including Patrick Kennedy’s “Moon shot” effort to increase the funding and coordination of neuroscience research. With an agenda set by the members, the Forum undertook a variety of initiatives to address these challenges and opportunities. Looking ahead to 2011, the Forum plans to host an array of activities, including workshops examining such topics as: • Public-Private Partnerships in CNS Research and Development • US and European Animal-research Regulations: Impact on Neuroscience Research • Follow-up to the 2009 Sub-Saharan Africa Quality of Care Workshop • Animal Models of Nervous System Disorders We look forward to another productive and interesting year for the Forum. Alan Leshner Chair 

Reflecting Back Forum Activities in 2010 Sex Differences and Implications for Translational Neuroscience Research The Forum hosted a workshop to explore the key principles and strategies used by basic translational researchers and industry in studying sex dif- ferences in the neurosciences for the therapy development pathway. Basic research that involves delineating meaningful drug effects and behavioral and physiological responses that differ between the sexes can be costly and time consuming because they require additional experiment groups and protocols. However, epidemiological and clinical studies indicate substantial sex differences in response to drugs. The sex differences cut across other parameters such as socioeconomic factors, race, age, etc. In the current era of translational research and personalized medicine, it is increasingly important to take sex differences into account, so that these drug effects can be more accurately understood. Report available for download. Glutamate-related Biomarkers for Disorders of the Nervous System In June, the Forum hosted a workshop that explored current and emerging technologies with potential as reliable glutamate biomarkers to advance drug development for nervous system disorders. Present medications, while advanced over initial compounds, nevertheless provide unsatisfactory treat- ment for individuals with a range of central nervous system disorders with persistent negative symptoms, significant cognitive deficits, and poor func- tion. Biomarkers that specifically measure glutamate signaling and related circuitry are a promising means to accelerate drug development by providing quantitative measures for diagnosis, patient stratification, and assessment of drug efficacy. The workshop also outlined strategies to accelerate develop- ment, validation, and implementation of these biomarkers. Report available for download. NEURO FORUM TIMELINE 2006 Oct 4–5 1st meeting 

Reflecting Back: Forum Activities in 2010 Future Opportunities to Leverage the Alzheimer’s Disease Neuroimaging Initiative In July, the Forum hosted a public workshop at the 2010 International Conference on Alzheimer’s Disease (ICAD), which was designed to explore future opportunities to leverage the Alzheimer’s Disease Neuroimaging Initiative (ADNI), with particular focus on the second phase of the ADNI project, ADNI 2. Panelists from industry, academia, and government exam- ined the key elements of success of the research partnerships established as a result of ADNI. Included in the workshop were presentations outlining current efforts by the Japanese, European, and Australian ADNI projects. Discussions focused on the establishment of future multi-sector efforts to explore central nervous system developmental and neurodegenerative disorders. Report available for download. Facilitating Translational Research for Clinical Neuroscience Applications Throughout 2010, individuals from pharmaceutical and diagnostic industry, academia, and the NIH have joined members of the Forum in meetings on facilitating translational research for clinical neuroscience applications. The meetings stimulated discussion aimed at improving the understand- ing between what pharmaceutical and diagnostic developers are looking for and how academic researchers can best contribute to the partnership in a meaningful way in order to improve the neuroscience translational research pipeline. Discussions focused on ways to bridge the interface between basic and drug/diagnostic development researchers in the neurosciences. Feb 27 Apr 18 2nd meeting Autism & Environment Workshop 2007 Feb 26 Jul 30–31 Biomarkers Workshop 3rd meeting 

Looking Forward Forum Activities in 2011 U.S. and European Animal-research Regulations: Impact on Neuroscience Research The Forum, in collaboration with the National Research Council’s Committee on Science Technology and Law and the Institute for Laboratory Animal Research, will host a workshop that will bring together representatives from the United States and Europe to examine laws, directives, and policies designed to regulate the use of non-human animals in the medical research enterprise, including a particular focus on the neurosciences. Specifically participants will identify and discuss current animal use regulations, examine the implications of current policies on the research enterprise, and discuss activity in the courts that may affect the use of animals in research. The workshop will provide an opportunity for international dialog around public relations and development of core principles and outcomes for animal research. Greg Hood, John Burkardt, and Greg Foss, Pittsburgh Supercomputing Center 2008 Oct 24–25 Jan 30 4th meeting 5th meeting 

Looking Forward: Forum Activities in 2011 Sackler U.S.A.-U.K. Scientific Forum on Neuroscience and the Law The National Academy of Sciences and the U.K. Royal Society will host the Second Raymond and Beverly Sackler U.S.A.-U.K. Scientific Forum on Neuroscience and the Law. The meeting will be held on March 2–3, 2011 and is being organized through a collaborative effort between the Royal Society; the Committee on Science, Technology and Law; and the Forum. The Raymond and Beverly Sackler Forum was launched in 2008 as a venue where scientific conferences and meetings could be held to “help the scientific leadership of the United Kingdom and the United States forge an enduring and productive partnership on pressing topics of worldwide scientific concern with benefit to all people.” The meeting will draw on the conven- ing power of the sponsoring organizations to bring together experts for presenta- tions and moderated discussions in the following topic areas: neuroscience in court; mind reading (to include a discussion of lie detection, pain, and false memory); criminal responsibility and sentencing; moral reasoning and psychopathy; and the developing brain. Animal Models for Nervous System Diseases and Disorders The poor predictive power of preclinical studies in animal models of candidate therapeutics has been recognized as a major reason for the high failure rate of candidate CNS drugs in clinical trials. The Forum will plan and host a workshop that will bring together key stakeholders to discuss potential opportunities for maximizing the translation of effective therapies from animal models to clinical practice. Specifically, participants will examine current methods of animal model characterization, preclinical testing design, and data reporting. Jun 25 Molecules to Mind: Oct 15–16 Grand Challenges Workshop 7th meeting 2009 Jun 24 Oct 3 6th meeting Venture Philanthropy Strategies Workshop 

Working Groups Working groups are established and maintained by interested members and are open to all members. The Forum’s working groups engage in regular discussions, usually via telecon- ferences, on topics of interest to that group. Workshop topics often originate from working groups and are organized by an independently appointed workshop planning committee. Translational Neuroscience The translational neuroscience working group was established to focus on identifying areas of synergy where public and private sector stakeholders can partner to improve the efficiency and effectiveness of drug discovery and development for neurological and mental disorders. The group is currently developing a workshop aimed at improving the understanding between what pharmaceutical and diagnostic developers are looking for and how academic researchers can best contribute to the partnership in a meaningful way in order to improve the neuroscience translational research pipeline. Grand Challenges in Neuroscience This working group continues to follow up on the efforts set out by the Forum’s 2008 workshop on grand challenges in neuroscience titled “From Molecules to Mind: Challenges for the 21st Century.” The group is currently focusing on aiding former Rhode Island Congressman Patrick Kennedy’s initiative “One Mind for Brain Research.” The project aims to create a new space for key stakeholders to harness vital knowledge and resources and hasten the development of treatments and cures for neurological disorders. The catalysts to this effort are the 300,000 American veterans suffering from post traumatic stress disorder (PTSD) and traumatic brain injury (TBI). In addition, the working group is helping to develop strategic plans for federal research—engaging the community in identifying and prioritizing opportunities. Feb 25 Jun 17 Aug 4–5 8th meeting 9th meeting Sub-Saharan Africa Workshop Jun 16 Nov 3 Suicidality Workshop 10th meeting 

Paul Thompson, Arthur Toga, and Colin Holmes, UCLA Working Groups Training Translational Neuroscientists The pace of new therapeutic discovery for central nervous system disorders has notice- ably slowed over the last decade. Advancing translational neuroscience, the application of fundamental research to therapeutic development, will be critical in efforts to reverse this trend. There is an increasing need for investigators who are able to bridge the gap between basic and clinical neuroscience. A working group will be established to examine current practices of training scientists and identify opportunities for increasing and strengthening translational neuroscience programs. Mental Health, Neurological, and Substance Use Disorders in Sub-Saharan Africa In collaboration with the World Health Organization mental health Gap Action Programme (mhGAP), the Forum is currently exploring potential opportunities for additional efforts to build on the 2009 “Mental Health and Neurological Disorders in Sub-Saharan Africa” workshop. The working group is focused on identifying innovative solutions to enhance care for mental, neurological, and substance use disorders in sub-Saharan Africa. Special attention is being paid to finding solutions to increasing human and financial resources to support current and future efforts. Jul 12 Nov 9 Jun 22 ADNI-2 Animal Law Workshop Glutamate Workshop Workshop 2010 Mar 8–9 Jun 23 Sex Differences Workshop 11th meeting 

Forum Members (as of December 2010) Alan Leshner (Chair) Katie Hood Paul Sieving American Association for the The Michael J. Fox Foundation National Eye Institute Advancement of Science for Parkinson’s Research Rae Silver Huda Akil Steven Hyman Columbia University University of Michigan Harvard University William Thies Marc Barlow Thomas Insel Alzheimer’s Association GE Healthcare National Institute of Mental Health Nora Volkow Daniel Javitt National Institute on Drug Abuse Mark Bear New York University School Kenneth Warren Massachusetts Institute of Medicine National Institute on Alcohol Abuse of Technology Story Landis and Alcoholism David Bredt National Institute of Neurological Frank Yocca Eli Lilly and Company Disorders and Stroke AstraZeneca Pharmaceuticals Daniel Burch Husseini Manji CeNeRx Biopharma Stevin Zorn Johnson & Johnson Pharmaceuticals Lundbeck USA Dennis Choi Eve Marder The Simons Foundation Charles Zorumski Brandeis University Washington University, St. Louis Timothy Coetzee David Michelson FastForward of the National Merck & Co., Inc. Multiple Sclerosis Society Jonathan Moreno David Cohen University of Pennsylvania School Columbia University, Society of Medicine IOM Staff for Neuroscience representative Bruce Altevogt, Ph.D., Kathie Olsen Project Director John Dunlop Association of Public and Pfizer Inc. Land-grant Universities Diana Pankevich, Ph.D., Emmeline Edwards Associate Program Officer Atul Pande National Center for Complementary GlaxoSmithKline Lora Taylor, and Alternative Medicine Senior Project Assistant Menelas Pangalos Richard Frank AstraZeneca Pharmaceuticals IOM Board on Health Sciences Policy GE Healthcare, Inc. Steven Paul Andrew M. Pope, Ph.D., Myron Gutmann Weill Cornell Medical College Director National Science Foundation William Potter Richard Hodes Foundation for the National National Institute on Aging Institutes of Health Mar 2–3 Sackler Neuroscience and the Law Forum 2011 Dec 10 Feb 2 12th meeting 13th meeting 

Forum Sponsorship Forum Members and Sponsorship Financial support for the Forum is derived from federal agencies, patient advocacy organizations, industry, and a non-profit membership society. Alzheimer’s Association AstraZeneca Pharmaceuticals CeNeRx Biopharma Non-profit Eli Lilly and Company GE Healthcare 19% GlaxoSmithKline Federal Johnson & Johnson Pharmaceuticals 38% Lundbeck, USA Merck Research Laboratories The Michael J. Fox Foundation for Parkinson’s Research National Eye Institute 43% National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse Industry National Institutes of Health Neuroscience Blueprint National Institute of Mental Health National Institute of Neurological Disorders and Stroke National Multiple Sclerosis Society National Science Foundation Society for Neuroscience Wyeth Research Jul 26–27 Animal Regulations Workshop Jun 28–29 Nov 29–30 14th meeting 15th meeting 

The Institute of Medicine serves as adviser to the nation to improve health. Established in 1970 under the charter of the National Academy of Sciences, the Institute of Medicine provides independent, objective, evidence-based advice to policymakers, health professionals, the private sector, and the public. The mission of the Institute of Medicine embraces the health of people everywhere.