1. Medical University of South Carolina NIH Roadmap November 1, 2004 Dr. Patricia A. Grady Director, National Institute of Nursing Research

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

3. 3 Acute to chronic conditions Evolving Public Health Challenges Health Disparities Emerging Diseases Aging Population Biodefense

4. 4 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?

5. 5 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

6. 6 BenchBedside Practice The Problem

7. 7 BedsidePractice New Pathways to Discovery Building Blocks and Pathways Molecular Libraries Bioinformatics Computational Biology Nanomedicine Bench NIH Roadmap Theme: New Pathways to Discovery

8. 8 NIH Roadmap Theme: Research Teams of the Future BedsidePractice Building Blocks and Pathways Molecular Libraries Bioinformatics Computational Biology Nanomedicine Research Teams of the Future Interdisciplinary Research Teams Pioneer Awards Public-Private Partnerships Bench New Pathways to Discovery Building Blocks and Pathways Molecular Libraries Bioinformatics Computational Biology Nanomedicine

9. 9 NIH Roadmap Theme: Re-engineering Clinical Research BedsidePracticeBench Re-Engineering the Clinical Research Enterprise New Pathways to Discovery Building Blocks and Pathways Molecular Libraries Bioinformatics Computational Biology Nanomedicine Research Teams of the Future Interdisciplinary Research Teams Pioneer Awards Public-Private Partnerships Integrated Research Networks Clinical Research Informatics NIH Clinical Research Associates Clinical outcomes Clinical Research Policy Training Translational Research Initiatives

10. 10 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?

11. 11 NIH Roadmap for Medical Research NIH

12. 12 NIH Roadmap for Medical Research FY2004 Funding New Pathways to Discovery Re- engineering the Clinical Research Enterprise Research Teams of the Future NIH $64.1 $26.6 $37.6

13. 13 FY04FY05FY06FY07FY08FY09Total Pathways to Discovery 64137169182209188 948 Research Teams 27 39 44 92 96 93 390 Clinical Research 38 61120174214227 833 Total1282373324485205072172 Roadmap Funding

14. 14 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 New research teams New paths to discovery Re-engineering the clinical research enterprise NIH Roadmap Themes Integrating the NIH Roadmap at NINR

15. 15 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?

16. 16 NINR Roadmap Integration NIH Roadmap Link NINR Roadmap Integration

17. 17 NIH Roadmap “Early success claimed for Zerhouni's NIH roadmap” October 14 th Briefing: NIH Roadmap for Medical Research One Year Later

18. 18 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

19. 19 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 Research Teams of the Future: Working Groups and Co-Chairs

20. 20 NIH Director's Pioneer Award Research Teams of the Future

21. 21 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.

22. 22 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

23. 23 Research Teams of the Future P20 Exploratory Centers for Interdisciplinary Research – Lower organizational barriers that impede research – Enable scientists to conduct research across disciplines

24. 24 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 Research Teams of the Future

25. 25 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 Research Teams of the Future

26. 26 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 Research Teams of the Future

27. 27 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 Research Teams of the Future

28. 28 Research Teams of the Future Private-Public Partnerships NIH Nonprofit Organizations Private Industry

29. 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

30. 30 Public Trust Initiative Goal – To improve the public’s health by promoting public trust in bio/medical and behavioral research

31. 31 Public Trust Initiative Defining Public Trust – Public Individuals, patients, families, and communities. – Trust “Confidence placed by the people in an institution or process”

32. 32 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.

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

34. 34 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

35. 35 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

36. 36 Public Trust Website http://publictrust.nih.gov

37. 37 NIH Roadmap Website http://nihroadmap.nih.gov/