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Medical University of South Carolina NIH Roadmap November 1, 2004 Dr. Patricia A. Grady Director, National Institute of Nursing Research NIH Roadmap NIH Roadmap www.nihroadmap.nih.gov • Conception • Infrastructure • Progress • Implications 2 Roadmap Questions • What are today’s scientific challenges? • What are the roadblocks to progress? • What do we need to do to overcome roadblocks? • What can’t be accomplished by any single Institute – but is the responsibility of NIH as a whole? 4 Imperatives for NIH • Accelerate pace of discoveries in life sciences • Translate research more rapidly from laboratories to patients and back • Develop novel approaches in orders of magnitude never before undertaken • Develop new strategies: NIH Roadmap 5 The Problem Bench Bedside Practice 6 NIH Roadmap Theme: New Pathways to Discovery Bench Bedside Practice New Pathways to Discovery • Building Blocks and Pathways • Molecular Libraries • Bioinformatics • Computational Biology • Nanomedicine 7 NIH Roadmap Theme: Research Teams of the Future Research Teams of the Future Interdisciplinary Research Teams Pioneer Awards Public-Private Partnerships Bench Bedside Practice •New Building Blocks to and Pathways Pathways Discovery •Building Molecular Libraries Blocks and Pathways • Bioinformatics Libraries •Molecular Computational Bioinformatics Biology •Computational Nanomedicine Biology Nanomedicine 8 NIH Roadmap Theme: Re-engineering Clinical Research Research Teams of the Future Interdisciplinary Research Teams Pioneer Awards Public-Private Partnerships Bench Bedside Practice New Pathways to Discovery Integrated Research Networks Building Blocks and Pathways Clinical Research Informatics Molecular Libraries NIH Clinical Research Associates Clinical outcomes Bioinformatics Clinical Research Policy Computational Translational Research Training Biology Initiatives Nanomedicine Re-Engineering the Clinical Research Enterprise 9 Criteria for Roadmap Initiatives • Is it ‘transforming’ -- will it change how or what biomedical research is conducted in the next decades? • Would its outcome enhance the ability of all Institutes and Centers to achieve their missions? • Can the NIH afford NOT to do it? • Will it be compelling to our stakeholders, especially the public? • Is it something that no other entity can or will do? 10 NIH Roadmap for Medical Research New Pathways to Discovery NIH Research Teams of the Future Re-engineering the Clinical Research Enterprise 11 NIH Roadmap for Medical Research FY2004 Funding New Pathways to Discovery $64.1 $26.6 Research Teams of the Future NIH $37.6 Re-engineering the Clinical Research Enterprise 12 Roadmap Funding FY04 FY05 FY06 FY07 FY08 FY09 Total Pathways to Discovery 64 137 169 182 209 188 948 Research Teams 27 39 44 92 96 93 390 Clinical Research 38 61 120 174 214 227 833 128 237 332 448 520 507 2172 Total 13 Integrating the NIH Roadmap at NINR NINR Themes • Identifying effective strategies to reduce health disparities • Changing lifestyle behaviors for better health • Managing the effects of chronic illness to improve quality of life • Harnessing advanced technologies to serve human needs • Enhancing the end-of-life experience for patients and their families NIH Roadmap Themes • New research teams • New paths to discovery • Re-engineering the clinical research enterprise 14 Integrating the NIH Roadmap at NINR • What are the science gaps that nurse researchers in particular can fill? • What areas of the Roadmap are we already addressing? • What directions should we take to be Roadmap leaders? • What will spur the community to be a part of the Roadmap? 15 NINR Roadmap Integration NIH Roadmap Link NINR Roadmap Integration 16 NIH Roadmap October 14th Briefing: NIH Roadmap for Medical Research One Year Later “Early success claimed for Zerhouni's NIH roadmap” 17 Research Teams of the Future: A Closer Look New Pathways to Discovery Building Blocks, Biological Pathways, and Networks Molecular Libraries & Imaging Structural Biology Bioinformatics & Computational Biology Nanomedicine Research Teams of the Future High-Risk Research Interdisciplinary Research Public Private Partnerships Re-Engineering the Clinical Research Enterprise Clinical Research Policy Analysis and Coordination Integration of Clinical Research Networks Enhance Clinical Research Workforce Training Enabling Technologies for Improved Assessment of Clinical Outcomes Regional Translational Research Centers Translational Research Service Cores Clinical Center’s Clinical Research Training Program 18 Research Teams of the Future: Working Groups and Co-Chairs • Interdisciplinary Research – Patricia Grady, NINR – Ken Olden, NIEHS – Larry Tabak, NIDCR • High-risk Research – Ellie Ehrenfeld, NIAID – Stephen Straus, NCCAM • Public-Private Partnerships – Andy von Eschenbach, NCI – Richard Hodes, NIA 19 Research Teams of the Future NIH Director's Pioneer Award 20 Research Teams of the Future Pioneer Award Criteria: – Evidence of scientific innovation and creativity; – Testimony of intrinsic motivation, enthusiasm and intellectual energy; and – Potential for scientific leadership and evidence of, or potential for, effective communication skills. 21 Research Teams of the Future Interdisciplinary Research – – – Planning grants for interdisciplinary research centers (P20 Centers) Innovative training programs Development of methodologies aimed at integrating behavioral and social science into interdisciplinary research 22 Research Teams of the Future P20 Exploratory Centers for Interdisciplinary Research – – Lower organizational barriers that impede research Enable scientists to conduct research across disciplines 23 Research Teams of the Future P20 Exploratory Centers—Examples • Behavioral Epidemiology – Integrate theoretical methodological and analytic aspects of economic sciences, population sciences, and behavioral sciences to develop a new approach to discovery and intervention in youth vulnerable to HIV/AIDS • Imaging Genetics – Draw from genomics, image analysis, statistics, and neuropsychiatry to improve diagnosis and treatment of mental illness and other brain disorders 24 Research Teams of the Future P20 Exploratory Centers—Examples • Antimicrobial resistance – Integrate new disciplines to address the fast growing problem of antimicrobial resistance using novel new strategies developed by interdisciplinary research teams using long-term strategies • Obesity research – Integrate disciplines of neuroendocrinology, genetics, and lipid& intermediate metabolism , and clinical epidemiology to better treat and prevent obesity 25 Research Teams of the Future Interdisciplinary Training Programs • New funding mechanisms – Support interdisciplinary work from undergraduate students through postdoctoral researchers • Provide foundation for diverse interdisciplinary scientific teams necessary for success of future endeavors • Include short and long term: – – – Training Curriculum Methodological development 26 Research Teams of the Future Interdisciplinary Training ProgramsExamples • Clinical Research Experience for Engineers – Undergraduate engineers engage in clinical research projects with clinical and bioengineering mentorship, • Regenerative Sciences Training Program – Biologists, engineers, and clinicians augment training via didactic and research experiences with focus on musculoskeletal systems • Clinical Biodetective Training – Trainees to develop novel methods for detection of disease states, markers of good health, and therapeutic markers 27 Research Teams of the Future Private-Public Partnerships NIH Private Industry Nonprofit Organizations 28 Public Trust Initiative Committee Co-Chairs Dr. Patricia A. Grady Director, National Institute of Nursing Research Dr. Yvonne T. Maddox Deputy Director, National Institute of Child Health & Human Development Public Trust Initiative Goal – To improve the public’s health by promoting public trust in bio/medical and behavioral research 30 Public Trust Initiative Defining Public Trust – Public • – Individuals, patients, families, and communities. Trust • “Confidence placed by the people in an institution or process” 31 Public Trust Initiative NIH cannot control the public’s perceptions in the area of research… …but we at NIH can improve how we communicate and interact with the public. 32 The Process of Biomedical Research The presence of an untreatable problem generates a research need. Health problem in a patient A safe, effective drug, device, or treatment is then used for treatment of the problem. Clinical Trials: Testing on volunteers Studies performed in humans Where are the Issues of Public Trust? Epidemiological studies: Who is affected? Surveys, population studies Basic Research: What are the mechanisms? Information obtained from basic research generates ideas for drugs, devices, or techniques to treat the problem. Drug/Medical Device Discovery and Development Drug/Medical Device Testing: Efficacy and toxicity/complications Drugs, devices, and treatments are tested for safety and efficacy, first in laboratory assays, then in animals, finally in human volunteers Studies performed in the laboratory Studies performed in animals The entire process from initiation of a research project to development of a treatment may take many years and cost hundreds of millions of dollars. Public Trust Initiative Obtaining a Baseline: Initial Steps – Inventory of current NIH activities • • – Ongoing and planned activities Research related to public trust National survey of the public to discern issues regarding public trust and the research enterprise 34 Public Trust Initiative Categories of Public Trust – – – – – Clinical research involving human participation Including the public in IC business Promoting the visibility of NIH Teaching and developing course materials for science education Education and outreach programs for extramural and intramural clinical and research communities 35 Public Trust Website http://publictrust.nih.gov 36 NIH Roadmap Website http://nihroadmap.nih.gov/ 37