Medical University of South Carolina NIH Roadmap November 1, 2004

1. Medical University of South CarolinaNIH RoadmapNovember 1, 2004 Dr. Patricia A. Grady Director, National Institute of Nursing Research

2. NIH Roadmap NIH Roadmap www.nihroadmap.nih.gov • Conception • Infrastructure • Progress • Implications

3. 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 Pathways to Discovery • Building Blocks and Pathways • Molecular Libraries • Bioinformatics • Computational Biology • Nanomedicine • Building Blocks and Pathways • Molecular Libraries • Bioinformatics • Computational 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 • Building Blocks and Pathways • Molecular Libraries • Bioinformatics • Computational Biology • Nanomedicine Integrated Research Networks Clinical Research Informatics NIH Clinical Research Associates Clinical outcomes Clinical Research Policy Training Translational Research Initiatives 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

11. NIH Roadmap for Medical Research FY2004 Funding $64.1 NIH $37.6 $26.6

12. Roadmap Funding

13. NINR Themes Integrating the NIH Roadmap at NINR NIH Roadmap 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 • 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 “Early success claimed for Zerhouni's NIH roadmap” October 14th Briefing: NIH Roadmap for Medical Research One Year Later

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 Programs-Examples • 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

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

29. 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 Where are the Issues of Public Trust? The presence of an untreatable problem generates a research need. • Community issues • Access to information Epidemiological studies: Who is affected? Surveys, population studies Health problem in a patient Information obtained from basic research generates ideas for drugs, devices, or techniques to treat the problem. • Communication of results Drug/Medical Device Discovery and Development Basic Research: What are the mechanisms? • Health • impact A safe, effective drug, device, or treatment is then used for treatment of the problem. • Translation to public domain • Informed consent Drug/Medical Device Testing: Efficacy and toxicity/complications Clinical Trials: Testing on volunteers • Community linkages 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. Drugs, devices, and treatments are tested for safety and efficacy, first in laboratory assays, then in animals, finally in human volunteers • Harmoni-zation Studies performed in humans Studies performed in the laboratory Studies performed in animals

33. 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/