Forum on Neuroscience and Nervous System Disorders 2016 Annual Report (2017) / Chapter Skim
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Forum on Neuroscience and Nervous System Disorders: 2016 Annual Report
Forum on Neuroscience and Nervous System Disorders: 2016 Annual Report
Pages 1-20
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Forum on Neuroscience and Nervous System Disorders 2016 Annual Report
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The National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders provides an important venue for candid discussions about emerging and critical issues among key stakeholders, including federal agencies that serve as research sponsors and regulators; the private sector; the academic community; and the nonprofit sector, including foundations and groups focused on nervous system disorders. Through the Forum's activities, participants have been better able to share information and concerns and to understand each other's goals and priorities.
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In collaboration with the Organisation for Economic Co-operation and Development and other international stakeholders, the Forum also held a session that used non-invasive neuromodulation as a case study to discuss how ethical, legal, and social issues and responsible research innovation are integrated throughout research, development, and regulation of novel neurotechnologies. Looking ahead to 2017, the Forum plans to address important topics including biomarker identification and development in neuroinflammation, a process implicated in a wide range of neurological and psychiatric disorders; barriers and opportunities in therapeutic delivery to the central nervous system by improving methods for traversing the blood–brain barrier; and the development of pharmaceutical strategies to address the opioid crisis.
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Better methods -- from clinical study design through execution and evaluation -- could help enhance the feasibility, efficiency, and economic viability of clinical therapeutics development for brain disorders. The Forum convened a public workshop bringing together key stakeholders to discuss opportunities to improve the design and conduct of clinical trials for nervous system disorders (focusing specifically on Phase II and Phase III trials)
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Building on previous Forum workshops (Improving Translation of Animal Models for Nervous System Disorders [2012] and Accelerating Therapeutic Development for Nervous System Disorders Toward First-in-Human Trials [2013]
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Workshop participants discussed several innovative modeling paradigms for nervous system disorders, such as computational modeling of brain circuits using quantitative systems pharmacology, modeling disease in human induced pluripotent stem cells, and using gene editing techniques in nonhuman primates to create models that more closely resemble humans. In addition, several workshop participants noted the importance of using human clinical trial data to further the field's understanding of disease mechanisms and opined closer collaborations between clinicians and researchers.
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Building on the Forum's 2015 workshop, Non-Invasive Neuromodulation of the Central Nervous System, the public session organized by the Forum used non-invasive neuromodulation as an example to explore how ethical, legal, and social issues and responsible research and innovation are integrated into research, development, and regulation in different countries. Given the low adoption rate of non-invasive neuromodulation in clinical settings, session participants discussed the importance of aligning regulatory requirements with reimbursement decisions, educating providers and the public on the potential benefits and harms of these technologies, and developing professional guidelines informing clinical and over-the-counter uses.
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This public workshop will bring together key stakeholders from government, academia, industry, and disease-focused organizations to explore and advance efforts to identify biomarkers of neuroinflammation that can be validated and used in clinical development and regulatory decision making.
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Looking Forward: Forum Activities in 2017
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Few substances readily traverse the BBB to reach the brain or spinal cord, including most small molecules and the vast majority of large molecules such as proteins like antibodies, growth factors, oligonucleotides, and viral vectors. However, there are now emerging clinical data suggesting that certain monoclonal antibodies may have disease-modifying effects in various neurodegenerative and neuroinflammatory disorders, such as Alzheimer's disease and multiple sclerosis.
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Specifically, the meetings will bring together pharmaceutical industry leaders to explore the formulation of opioid drugs, develop additional drugs to treat opioid overdoses, and create non-opioid alternatives for pain. The Forum will host a public workshop that brings together key stakeholders to build on the discussions from the NIH meetings and to examine potential implementation challenges and opportunities to address them.
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Priorities and action items are determined by action collaborative participants and executed by them, with National Academies staff support, in their individual and organizational capacities. Training a Neuroscience Workforce Building on discussions from the 2014 Forum workshop Defining the Expertise Needed for the 21st Century Neuroscience Workforce, the Forum established a working group to continue to examine the current challenges and gaps in neuroscience training and identify opportunities to strengthen training programs so that they are tailored to meet the current and future workforce needs.
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Using tools set forth by the World Health Organization, the Forum, in collaboration with global entities, is continuing to explore additional opportunities to contribute in this area.
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2016 Publications Developing Multimodal Therapies Neuroscience Trials of the Future: for Brain Disorders: Proceedings of a Proceedings of a Workshop Workshop
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2016 Forum publications have been downloaded in more than 123 countries, for a total of more than 5,300 times.
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LLC Stuart Hoffman Department of Veterans Affairs Todd Sherer Joseph Buxbaum The Michael J Fox Foundation for Icahn School of Medicine at Mount Michael Irizarry Parkinson's Research Sinai Eli Lilly and Company David Shurtleff Sarah Caddick Inez Jabalpurwala National Center for Complementary Gatsby Charitable Foundation Brain Canada Foundation and Integrative Health Rosa Canet-Aviles Frances Jensen Paul Sieving Foundation for the National Institutes University of Pennsylvania Health National Eye Institute of Health System Doug Williamson Maria Carrillo George Koob Lundbeck Alzheimer's Association National Institute on Alcohol Abuse and Alcoholism Nora Volkow E
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Fox Foundation for Parkinson's Research National Eye Institute National Institute on Aging National Institute on Alcohol Abuse and Alcoholism National Center for Complementary and Integrative Health National Institute on Drug Abuse 54% National Institute of Mental Health 36% National Institute of Neurological Disorders and Stroke National Institutes of Health Blueprint for Neuroscience Research National Multiple Sclerosis Society National Science Foundation One Mind for Research Industry Federal Pharmaceutical Product Development, Inc. Pfizer Inc.
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Timeline 2006 | Establishment October 4–5 1st meeting 2010 | March 8–9 Sex Differences Workshop | June 22 Glutamate Workshop | June 23 11th meeting | July 12 ICAD 2010 Session | December 10 12th meeting 2007 | February 26 Biomarkers Workshop | February 27 2nd meeting | April 18 Autism & Environment Workshop | July 30–31 3rd meeting | October 24–25 2011 | February 2 13th meeting | March 2–3 4th meeting Neuroscience and the Law Workshop | July 18 AAIC 2011 Session | July 26–27 Animal Regulations Workshop | August 10 14th meeting | November 30 2008 | January 30 5th meeting | June 24 6th meeting 15th meeting | June 25 Molecules to Mind: Grand Challenges Workshop | October 3 Venture Philanthropy Strategies Workshop | October 15–16 7th meeting 2012 | March 28 16th meeting | March 28–29 Animal Models Workshop | May 10–11 Neurodegeneration Workshop | July 11 17th meeting | September 4–5 SSA 2009 | Feb 25 8th meeting | June 16 Suicidality Human Resources Workshop | October 4–5 Sharing Workshop | June 17 9th meeting | August 4–5 Uganda Clinical Research Data Workshop | November 28 18th Workshop | October 18 SFN: Social Issues Roundtable meeting | November 3 10th meeting | November 9 Animal Law Workshop 2013 | March 5 19th meeting | April 8–9 Accelerating Therapeutic Development Workshop | August 22 Meeting on Developing dMRI Standards | December 2 20th meeting
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2014 | January 13–14 SSA Essential Medicines 2017 | March 20–21 29th meeting and Biomarkers of Workshop | February 18 21st meeting | June 17 22nd Neuroinflammation Workshop | September 8 Bloodmeeting | October 28 23rd meeting | November 15 Brain Barrier Workshop | October 11–12 30th meeting Dry AMD Workshop | November 16 The Neuroscience and Opportunities and Challenges to Developing Nonof Gaming Session Opioid Alternatives for Treating Pain Workshop 2015 | January 13–14 Providing Sustainable Access to Mental Health Care: Kenya Workshop | January 20–21 Financial Incentives Workshop | February 24 Cognitive Dysfunction in Depression Workshop | March 2–3 Non-Invasive Neuromodulation Workshop | April 28–29 Providing Sustainable Access to Mental Health Care: Ghana Workshop | June 4–5 24th meeting | July 20 Assessing the Impact of Applications of Digital Health Records on Alzheimer's Disease Research Session | November 10 25th meeting 2016 | February 23 26th meeting | March 3–4 Neuroscience Trials of the Future Workshop | June 14–15 27th meeting and Multimodal Therapies Workshop | September 12–13 28th meeting and Therapeutic Development in the Absence of Predictive Animal Models Workshop | September 15–16 OECD Workshop
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At its The National Academy of Engineering was established in 1964 under meetings, the Forum examines significant -- and sometimes contentious -- the charter of the National Academy of Sciences to bring the practices of issues concerning scientific needs and opportunities, priority setting, and engineering to advising the nation. Members are elected by their peers for policies related to neuroscience and nervous system disorders research; the extraordinary contributions to engineering.
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