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  1. Archived File The file below has been archived for historical reference purposes only. The content and links are no longer maintained and may be outdated. See the OER Public Archive Home Page for more details about archived files.

  2. The NIH Roadmap

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

  4. Imperatives for NIH • Accelerate pace of discoveries in life sciences • More rapid translation from laboratories to patients and back • Develop novel approaches orders of magnitude more effective than current ones • Develop new strategies = NIH Roadmap

  5. Roadmap Participants were asked: • 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?

  6. The Problem Bench Bedside Practice

  7. NIH Roadmap: three themes emerged • New Pathways to Discovery • Research Teams of the Future • Re-engineering the Clinical Research Enterprise

  8. 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 ICs to achieve their missions? • Can the NIH afford to 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?

  9. New Pathways to Discovery Bench Bedside Practice • Building Blocks • and Pathways • Molecular Libraries • Bioinformatics • Computational • Biology • Nanomedicine

  10. Biological Pathways and Networks Understand in quantitative terms how gene regulatory networks, signal transduction pathways, and metabolic pathways are integrated to orchestrate normal development Understand responses to internal and external stimuli in highly complex organisms Understand how pathways and networks are perturbed in disease.

  11. Destructive Qualitative Uni-dimensional Low temporal resolution Low data density Variable standards Non-cumulative Non-destructive Quantitative Multi-dimensional and spatially resolved High temporal resolution High data density Stricter standards Cumulative The Biological Data of the Future

  12. Bioinformatics and Computational Biology Deploy a rigorous biomedical computing environment to analyze, model, understand and predict dynamic and complex biomedical systems. Be able to integrate data and knowledge at all levels of organization.

  13. Molecular Libraries • Chemical Diversity • -Publicly available database • -Biologically relevant chemical space optimally populated with naturally occurring and synthetic compounds • Screening • -Small molecule activators and inactivators available to researchers for individual functions of every gene product in human genome • Drug development as needed

  14. Structural Biology:Life in Three Dimensions Focus on trans-membrane proteins

  15. Research Teams of the Future Interdisciplinary Research Teams; Innovator Award Public-Private Partnerships Bench Bedside Practice Building Blocks and Pathways Molecular Libraries Bioinformatics Computational Biology Nanomedicine

  16. The Scientist of the Future • Need to examine role and status of postdoctoral fellowships • Need for multi-disciplinary and inter-disciplinary teams • Need for larger, coordinated, resource sharing teams • Need for new career pathways • New approaches to training • Need to examine the balance between Projects vs. People • Need for pioneering high-risk research • Need to preserve the investigator-initiated strategy

  17. Challenges to Interdisciplinary Research • The current system of academic advancement favors the independent investigator • Most institutions house scientists in discrete departments • Interdisciplinary research teams take time to assemble and require unique resources

  18. Interdisciplinary Recombination Biological Sciences Computer and Information Sciences PhysicalSciences Behavioral Sciences

  19. Lowers barriers that slow interdisciplinary studies Allows the interdisciplinary team to evolve Interdisciplinary Research Centers

  20. NIH Director’s Innovator Award • New program to support individuals with untested ideas that are potentially groundbreaking • Encourages innovation, risk-taking • Totally new application and peer review process • Provides $500 K/year for 5 years • Expected to be highly competitive

  21. Re-engineering Clinical Research Interdisciplinary Research Innovator Award Public-Private Partnerships Bench Bedside Practice Building Blocks and Pathways Molecular Libraries Bioinformatics Computational Biology Nanomedicine Integrated Research Networks Clinical Research Informatics NIH Clinical Research Associates Clinical outcomes Harmonization Training Translational Research Initiatives

  22. Integrated Network of NetworksTypical NIH Network

  23. Need for Interoperable Networks

  24. Integration of Clinical Research Networks • Link existing networks so clinical studies and trials can be conducted more effectively • Ensure that patients, physicians, and scientists form true “Communities of Research”

  25. Translational Research • Clinical Research evolved haphazardly • Started as cottage industry and select centers • Now has more complex requirements: regulation, technology, speed, efficiency • Need for greater links to basic science • Need transformation to move into the 21st Century • Apprenticeship  discipline of clinical research • Uniformity  harmonize rules, build infrastructure and create networks • Mentoring  multidisciplinary teams • Need for access to well characterized cohorts of patients and biological samples

  26. Translational Research • Translational Research Centers • Pre-clinical drug synthesis, toxicity testing • Enabling technologies for improved assessment of clinical outcomes

  27. National Electronic Clinical Trials/Research Network (NECTAR) • Common data standards, informatics • Software application tools for protocol preparation, IRB management, adverse event reports • Use existing networks to rapidly address questions beyond their traditional scope

  28. Multidisciplinary Clinical Research Team Principal Investigator Pharmacologist; Medicinal Chemist Tech Transfer; Regulatory Affairs Clinical Research Team Clinician Study Coordinator Statistician Public; Industry How to make each path viable?

  29. National Clinical Research Associates

  30. Trans-NIH Multidisciplinary K12 Career Development Program (RFA)

  31. Harmonization of Clinical Research Regulatory Processes Goal: Harmonize and simplify requirements for clinical research in ways that enhance public trust • Adverse event reporting • Human subjects protection • DSMB-IRB interactions • Consent procedures • Auditing and monitoring clinical trials • HIPAA, privacy, conflict of interest policies • Investigator registration, financial disclosure • Standards for electronic data submission/reporting

  32. Roadmap Implementation Groups • Molecular Libraries and Imaging • Building Blocks, Biological Pathways and Networks • Structural Biology • Bioinformatics and Computational Biology • Nanomedicine • Interdisciplinary Research • High-risk Research • Public-Private Partnerships • Re-engineering the Clinical Research Enterprise

  33. Roadmap Implementation • All Institutes and Centers committed to invest jointly in a pool ofresources to support current and future Roadmap initiatives • $128 M in FY 2004 (DDF funds and 0.34% each ICs budget) • Over $2 B by FY 2009

  34. Common Pool Roadmap Fundingdollars in millions

  35. Current RFAs (as of December 3, 2003) • Supplements for Methodological Innovations in the Behavioral and Social Sciences • Dynamic Assessment of Patient-Reported Chronic Disease Outcomes • Interdisciplinary Health Research Training: Behavior, Environment and Biology • Short Programs for Interdisciplinary Research Training • Curriculum Development Award in Interdisciplinary Research • Centers for Innovation in Membrane Protein Production • Multidisciplinary Clinical Research Career Development Programs • Development of High Resolution Probes for Cellular Imaging • Metabolomics Technology Development • Exploratory Centers (P20) for Interdisciplinary Research • National Technology Centers for Networks and Pathways • National Centers for Biomedical Computing

  36. Consultation Participation, consultation, collaboration, and funding are needed from patients, health care providers, foundations, industry, academia, Federal partners …all stakeholders www.nihroadmap.nih.gov

  37. The NIH Roadmap:A Work in Progress

  38. NIH Ideas People Resources

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