medical university of south carolina nih roadmap november 1, 2004

Medical University of South Carolina

NIH Roadmap

November 1, 2004

Dr. Patricia A. GradyDirector, National Institute of Nursing Research

2

NIH Roadmapwww.nihroadmap.nih.gov

NIH Roadmap

• Conception• Infrastructure• Progress• Implications

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

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

Bench Bedside Practice

The Problem

7

Bedside Practice

New Pathways to Discovery

• Building Blocks and Pathways

• Molecular Libraries• Bioinformatics• Computational

Biology• Nanomedicine

Bench

NIH Roadmap Theme:New Pathways to Discovery

8

NIH Roadmap Theme:Research Teams of the Future

Bedside Practice

• Building Blocks and Pathways

• Molecular Libraries• Bioinformatics• Computational

Biology• Nanomedicine

Research Teams of the Future

Interdisciplinary Research TeamsPioneer Awards

Public-Private Partnerships

Bench

New Pathways to Discovery

Building Blocks and Pathways

Molecular LibrariesBioinformaticsComputational

BiologyNanomedicine

9

NIH Roadmap Theme:Re-engineering Clinical Research

Bedside PracticeBench

Re-Engineering the Clinical Research Enterprise

New Pathways to Discovery

Building Blocks and Pathways

Molecular LibrariesBioinformaticsComputational

BiologyNanomedicine

Research Teams of the Future

Interdisciplinary Research TeamsPioneer Awards

Public-Private Partnerships

Integrated Research NetworksClinical Research Informatics

NIH Clinical Research AssociatesClinical outcomes

Clinical Research PolicyTrainingTranslational Research

Initiatives

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

NIH Roadmap for Medical Research

New Pathwaysto Discovery

Re-engineering theClinical Research Enterprise

Research Teamsof the Future

NIH

12

NIH Roadmap for Medical Research FY2004 Funding

New Pathwaysto Discovery

Re-engineering the ClinicalResearch Enterprise

Research Teamsof the Future

NIH

$64.1

$26.6 $37.6

13

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

Total 128 237 332 448 520 507 2172

Roadmap Funding

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

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

NINR Roadmap Integration

NIH Roadmap Link

NINR Roadmap Integration

17

NIH Roadmap

“Early success claimed for Zerhouni's NIH roadmap”

October 14th Briefing: NIH Roadmap for Medical Research

One Year Later

18

Research Teams of the Future:A Closer Look

New Pathways to DiscoveryBuilding Blocks, Biological Pathways, and Networks

Molecular Libraries & Imaging

Structural Biology

Bioinformatics & Computational Biology

Nanomedicine

Research Teams of the Future High-Risk ResearchInterdisciplinary Research Public Private Partnerships

Re-Engineering the Clinical Research Enterprise Clinical Research Policy Analysis and Coordination

Integration of Clinical Research NetworksEnhance Clinical Research Workforce TrainingEnabling Technologies for Improved Assessment of Clinical OutcomesRegional Translational Research CentersTranslational Research Service CoresClinical Center’s Clinical Research Training Program

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

NIH Director's Pioneer Award

Research Teams of the Future

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

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

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

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

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

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

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

Research Teams of the Future

Private-Public Partnerships

NIH

Nonprofit Organizations

PrivateIndustry

Committee Co-Chairs

Dr. Patricia A. GradyDirector, National Institute of Nursing Research

Dr. Yvonne T. MaddoxDeputy Director, National Institute of Child Health & Human Development

Public Trust Initiative

30

Public Trust Initiative

Goal– To improve the public’s health by

promoting public trust in bio/medical and behavioral research

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

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.

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 informatio

n

Healt

h

impact

Communicati

on of results

Translation

to public

domain

Harmon

i-zation

Informe

d consent

Communit

y linkages

Communit

y issues

The Process of Biomedical Research

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

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

Public Trust Website

http://publictrust.nih.gov

37

NIH Roadmap Website

http://nihroadmap.nih.gov/