Forum on Neuroscience and Nervous System Disorders: 2011 Annual Report (2012)

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BOARD ON HEALTH SCIENCES POLICY Forum on Neuroscience and Nervous System Disorders 2011 Annual Report 

About the Neuroscience Forum The Institute of Medicine 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 allow- ing a structured opportunity for dialogue and discussion while scrutinizing critical and possibly 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 disor- ders, as well as effective clinical interventions and policy options. The Forum also sponsors workshops (symposiums) as an addi- tional mechanism for informing the membership 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. 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 better approached. Discussions in 2011 focused on a diverse array of topics, including the implica- tions of recent cutbacks by major pharmaceutical companies in drug develop- ment for central nervous system disorders, and how to better coordinate and facilitate research across the various stakeholders that make up the neurosci- ence community. With an agenda set by the members, the Forum undertook a variety of initiatives to address these challenges and opportunities. Looking ahead to 2012, the Forum plans to host an array of activities, including meetings on topics such as: • Enhancing Public-Private Partnerships in CNS Research and Development • Neurodegeneration: Opportunities for Collaboration Across Disease- Specific Research and Development Communities • Opportunities to Expand the Workforce and Improve Access to Medications Necessary to Care for Individuals with Mental, Neurological, or Substance Use Disorders in Sub-Saharan Africa • 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 2011 U.S. and European Animal-Research Regulations: Impact on Neuroscience Research Numerous regulations, laws, directives, and policies are in place to ensure the ethical use of animals in medical and life-sciences research. These regulations are intended to ensure that animals in research receive humane care and use and that practical steps are taken to use the smallest number of animals to give significant results while ensuring that each individual animal experiences minimum pain or distress. The goal of the workshop was to bring together researchers, legal scholars, administrators, and other key stakeholders to discuss current trends and cross-national differences in animal regulations. Particular attention was to be paid to identifying poten- tial implications of new regulations on neuroscience research. The workshop also provided an opportunity for international dialogue around engaging the public regarding animal use in research and the development of core prin- ciples and outcomes for animal care and use. Validation of Alzheimer’s Disease Diagnostic Guidelines At the request of the Alzheimer’s Association, the Forum hosted a public workshop at the 2011 Alzheimer’s Association International Conference. The session was designed to bring together key stakeholders and audience members to identify a set of core principles that could be used to validate the newly proposed diagnostic guidelines for Alzheimer’s disease. While valida- tion has been acknowledged as a critical next step, the mechanisms for vali- dation remain unclear. A panel discussion with leading experts engaged the audience in examining the types of studies needed, their design and execu- tion, and how the guidelines will be used in broader populations outside the clinical research environment. In particular, validation and standardization of biomarker use in predicting and diagnosing the symptomatic predementia and dementia phases of Alzheimer’s disease was included. NEURO FORUM TIMELINE 2006 2007 Oct 4–5 1st meeting 

Reflecting Back: Forum Activities in 2011 Facilitating Translational Research for Clinical Neuroscience Applications Throughout 2011, individuals from pharmaceutical and diagnostic industry, academia, the National Institutes of Health (NIH), and the Food and Drug Administration have joined members of the Forum in meetings on facilitating translational research for clinical neuroscience applications. The meetings stimulated discussion aimed at improving the understanding of differences between what pharmaceutical and diagnostic developers are looking for and how academic researchers can contribute to the partnership in the most meaningful way. Discussions focused on ways to bridge the interface between basic and drug/diagnostic development researchers in the neurosciences. Sackler U.S.A.-U.K. Scientific Forum on Neuroscience and the Law The National Academy of Sciences, in collaboration with the U.K. Royal Society, hosted the Second Raymond and Beverly Sackler U.S.A.-U.K. Scientific Forum on Neuroscience and the Law. This forum series 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 meet- ing drew on the convening power of the sponsoring organizations to bring together experts for presentations and moderated discussions in the follow- ing topic areas: neuroscience in court; mind reading (to include a discussion of lie detection, pain, and false memory); criminal responsibility and sentenc- ing; moral reasoning and psychopathy; and the developing brain. Feb 27 Apr 18 2nd meeting Autism & Environment Workshop 2008 Feb 26 Jul 30–31 Oct 24–25 Biomarkers Workshop 3rd meeting 4th meeting 

Looking Forward Forum Activities in 2012 Neurodegeneration: Opportunities for Collaboration Across Disease-Specific Research and Development Communities Neurodegenerative diseases are becoming increasingly prevalent in the United States. In 2000, approximately 4 million people had Alzheimer’s disease and another million had Parkinson’s disease. The workshop will explore commonalities across neurodegenerative diseases such as Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, and frontotemporal dementia, and identify potential opportunities for collaboration across the respective research and development communities. Participants will be invited from academia; pharmaceutical and biotechnology industries; government agencies such as the NIH, National Science Foundation, and Veterans Administration; and patient advocacy groups. Animal Models for Nervous System Diseases and Disorders Animal models have significantly increased our understanding of nervous system disorders. Yet a large gap remains for many diseases in treatment options that are high in efficacy, but low in side effects. Given the tremendous burden associated with nervous system diseases and disorders, the Forum will host a workshop that will Greg Hood, John Burkardt, and Greg Foss, Pittsburgh Supercomputing Center Jun 25 Molecules to Mind: Grand Challenges Workshop 2008 Oct 24–25 Jan 30 Jun 24 4th meeting 5th meeting 6th meeting 

Looking Forward: Forum Activities in 2012 bring together key stakeholders to discuss potential opportunities for maximizing the translation of effective therapies from animal models to clinical practice. Specifically, participants will discuss key issues that contribute to poor translation and examine case studies that highlight successes and failures. In addition, participants will iden- tify next steps that will be critical for improvement of the development and testing of animal models and key infrastructure components required for implementation. Building Partnerships for Scaling Up Care for Mental, Neurological, and Substance Use Disorders in Sub-Saharan Africa Sub-Saharan Africa has one of the largest treatment gaps for mental, neurological, and substance use (MNS) disorders in the world. These three groups of disorders incur a substantial burden on the continent’s population, and in the absence of both the necessary number of specialists and access to essential medicines for each of these, any remedy of the gap should target the MNS disorders together. Critical to this effort includes increasing the number of health care workers with expertise in MNS disorders, strengthening medical neuroscience education systems, and build- ing clinical and research neuroscience capacity in African medical schools and clini- cal training programs for nurses, medical officers, and primary care workers. The Forum, in collaboration with the World Health Organization (WHO), will organize a workshop that focuses on strategies to increase availability and expertise of the MNS disorders workforce, a critical barrier to strengthening services for these disorders. Issues such as local production, bulk purchasing, pricing, supply chain, drug banks, and drug donations will be targeted in order to achieve sustainable models for pro- viding access to essential medicines. The Forum, in collaboration with WHO, will organize a workshop that will include key stakeholders to discuss opportunities to establish partnerships for improving access to essential medicines for MNS disor- ders in sub-Saharan Africa. Oct 15–16 Feb 25 Jun 17 Aug 4–5 7th meeting 8th meeting 9th meeting Sub-Saharan Afri 2009 Oct 3 Jun 16 Venture Philanthropy Strategies Workshop Suicidality Workshop 

Working Groups The Forum has created a series of working groups to provide an opportunity for subsets of the broader group to work together on selected topics. Workshop topics often result from these groups and are organized by an independently appointed workshop planning committee. Translational Neuroscience The translational neuroscience working group was established to identify areas of synergy where public- and private-sector stakeholders can work together to improve the efficiency and effectiveness of drug discovery and development for neurological and mental disor- ders. The group is currently addressing barriers to repurposing and reusing existing com- pounds. In addition, it is discussing strategies to improve 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 neuro- science translational research pipeline. Training Translational Neuroscientists The pace of new therapeutic discovery for central nervous system disorders has noticeably slowed during the past 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. Jun 17 Aug 4–5 Nov 9 Jun 22 9th meeting Sub-Saharan Africa Workshop Animal Law Workshop Glutamate Workshop 2010 Jun 16 Nov 3 Mar 8–9 Suicidality Workshop 10th meeting Sex Differences Workshop 

Working Groups Paul Thompson, Arthur Toga, and Colin Holmes, UCLA Mental Health, Neurological, and Substance Use Disorders in Sub-Saharan Africa In collaboration with WHO mental health Gap Action Programme (mhGAP), the Forum is continuing to explore potential opportunities 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. Mar 2–3 Jul 12 Neuroscience and ADNI-2 Workshop the Law Workshop 2011 Jun 23 Dec 10 Feb 2 11th meeting 12th meeting 13th meeting 

Forum Members (as of December 2011) Alan Leshner (Chair) Daniel Javitt Marc Tessier-Lavigne American Association for the New York University School of The Rockefeller University Advancement of Science Medicine William Thies Huda Akil Story Landis Alzheimer’s Association University of Michigan National Institute of Neurological Nora Volkow Disorders and Stroke National Institute on Drug Abuse Marc Barlow GE Healthcare Husseini Manji Kenneth Warren Johnson & Johnson Pharmaceuticals National Institute on Alcohol Mark Bear Massachusetts Institute David Michelson Abuse and Alcoholism of Technology Merck & Co., Inc. Doug Williamson Daniel Burch Jonathan Moreno Lilly Research Laboratories CeNeRx Biopharma University of Pennsylvania School John Wingfield of Medicine National Science Foundation Timothy Coetzee FastForward of the National Kathie Olsen Frank Yocca Multiple Sclerosis Society Association of Public and AstraZeneca Pharmaceuticals Land-Grant Universities David Cohen Stevin Zorn Columbia University, Society Alexander Ommaya Lundbeck USA for Neuroscience representative Department of Veterans Affairs Charles Zorumski John Dunlop Atul Pande Washington University, St. Louis Pfizer, Inc. GlaxoSmithKline Emmeline Edwards Menelas Pangalos National Center for Complementary AstraZeneca Pharmaceuticals and Alternative Medicine Steven Paul Weill Cornell Medical College IOM Staff Richard Frank Bruce Altevogt, Ph.D. GE Healthcare, Inc. William Potter Project Director Myron Gutmann Foundation for the National Institutes of Health Diana Pankevich, Ph.D. National Science Foundation Associate Program Officer Richard Hodes Todd Sherer National Institute on Aging The Michael J. Fox Foundation Lora Taylor, for Parkinson’s Research Senior Project Assistant Steven Hyman Harvard University Paul Sieving IOM Board on Health Sciences Policy National Eye Institute Andrew M. Pope, Ph.D. Thomas Insel Judy Siuciak Director National Institute of Mental Health Foundation for the National Institutes of Health science and Jul 26–27 Mar 28 m Animal Regulations Workshop 16th meeting 2012 Jul 18 Aug 10 Nov 30 Mar 28–29 AAIC 2011 Session 14th meeting 15th meeting Animal Models Workshop 

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 Department of Veterans Affairs Eli Lilly and Company 19% Foundation for the National Institutes of Health Federal GE Healthcare 38% GlaxoSmithKline Johnson & Johnson Pharmaceuticals Lundbeck USA Merck Research Laboratories 43% The Michael J. Fox Foundation for Parkinson’s Research National Eye Institute National Institute of Mental Health Industry National Institute of Neurological Disorders and Stroke National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Institute on Drug Abuse National Institutes of Health Blueprint for Neuroscience Research National Multiple Sclerosis Society National Science Foundation Pfizer Society for Neuroscience Jul 11 17th meeting May 10–11 Sep 3–6 Nov 28 Neurodegeneration Workshop SSA Workforce Workshop 18th 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.