# Presentation: 495921

## NIH Roadmap For Medical Research Overview Prepared by the National Cancer InstituteSeptember 2004

**NIH Roadmap For Medical Research**** ****Overview ****Prepared by the ****National Cancer Institute****September 2004**

## NIH Roadmap for Medical Research

**Why Create an NIH Roadmap**
**Development and Governance**
**Three Theme Areas**
**Roadmap Initiatives of Interest to NCI**
**Key Elements of Roadmap Funding and Management**
**Next Steps**

**Notes:**
One Year into the NIH Roadmap
Responsibility coordinating our strategic involvement in the RM, monitoring the NIH RM activities, coordinating communication about the RM is split between Dr. Carl Barrett and his assistant Dr, Michelle Bennett and the Office of Science Planning and Assessment.
I want to provide you today with a broad overview of the RM—touching on
Why it was developed?
How it was developed?
How is it coordinated at the NIH Level
Three themes
NCI interest in RM
Next Steps

Today I plan to cover briefly how the roadmap was developed, the governance structure, the three main theme areas, NCI’s participation in the RM, Funding and what to expect over the next year.

## The NIH is faced with many challenges

**Revolutionary and rapid changes in science**
**Increasing breadth of mission and growth**
**Complex organization with many units****(27 institutes and centers, multiple program offices, e.g., OWHR, OAR, ORD, ...)**
**Structured by Disease, Organ, Life stage, Disciplines ....**
**Rapid convergence of science**

**Notes:**
Dr Zerhouni became director of NIH in May 2002.  Soon after this time, he convened a series of meetings to chart a roadmap for medical research in the 21st century. 
Within the next year, with input from more than 300 nationally recognized leaders in academia, industry, government, and the public along with input form IC directors, the Roadmap was developed and launched one year ago.
It lays out a vision for a more efficient and productive system of medical research.

## Acute to Chronic Conditions

**Evolving Public Health Challenges**

**Health Disparities**

**Emerging Diseases**

**Aging Population**

**Biodefense**

##  Critical NIH Priorities

**Accelerate the pace of life science discovery**
**Translate research more rapidly from laboratories to patients and back**
**Explore novel approaches that are orders of magnitude and more effective than currently available**

## How the NIH Roadmap was Developed?

**In extensive consultations with stakeholders, scientists, health care providers and the public**
**Participants were asked to address the following questions:**
- What are today’s scientific challenges?
- What are the roadblocks to progress?
- What do we need to do to overcome roadblocks?

## What is The NIH Roadmap?

- A **framework of priorities** the NIH as a whole must address in order to optimize its entire research portfolio.** **
- A **vision for a more efficient, innovative and productive system** of biomedical and behavioral  research.** **
- A **set of initiatives that are central to extending the quality of healthy life** for people in this country and around the world.** **

## Roadmap Coordination and Implementation Structure

**Roadmap Coordination and Implementation Structure**

## The NIH Roadmap for Medical Research 3 Themes

**Reengineering the**
**Clinical Research Enterprise**

**Research Teams**
**of the Future**

**NIH**

**New Pathways to Discovery**

## New Pathways to Discovery

**Initiatives address technologies and **
**approaches necessary to meet contemporary**
**Challenges.**
**Including:**
- Grasping the emerging complexity of biology
- Understanding biological systems
- Accessing biological data, technologies, and other scientific resources
- Promoting Multi-and Interdisciplinary research

## New Pathways to Discovery:Initiative Examples

**Building Blocks, Biological Pathways, and Networks**
**Molecular Libraries and Imaging**
**Structural Biology**
**Bioinformatics and Computational Biology**
**Nanomedicine**

## Research Teams of the Future

**Initiatives provide mechanisms for **
**interdisciplinary research, high risk strategies and **
**public private partnerships. **
**Including:**
- Encouraging Multi-and interdisciplinary research teams
- Supporting larger, coordinated, resource sharing
- Preserving investigator-initiated  strategy
- Promoting Investigators to take creative, unexplored avenues of research

## Research Teams of the Future:Initiative Examples

**High Risk Research**
**NIH Director’s Pioneer Award**
**Interdisciplinary Research**
**Interdisciplinary Research Centers (Planning grants)**
**Interdisciplinary Research Training Initiative**
**Public Private Partnerships**

**Notes:**
NIH Pioneer Award

The NIH Director’s Pioneer Award (NDPA) program is being established to identify and fund investigators of exceptionally creative abilities and diligence, for a sufficient term (five years) to allow them to develop and test far-ranging ideas. Awardees are expected to commit the major portion of their effort to activities supported by the NDPA. The program is not intended to support ongoing research projects or simply expand the funding of persons already well supported. 

## Reengineering the Clinical Research Enterprise

**Including:**
**Promoting better integration of existing clinical research networks**
**Encouraging the development of technologies to improve the assessment of clinical outcomes**
**Harmonizing regulatory processes**
**Enhancing training for clinical researchers**

**Initiatives within this theme address the need for creating better integrated networks of academic centers that work together in developing new strategies to reenergize the clinical research workforce.**

## Re-Engineering the Clinical Research EnterpriseInitiative Examples:

- Integrating and Expanding Clinical Research Networks, including NECTAR (National Electronic Clinical Trials and Research Network)
- Translational Research CORE Services (RAID-like program)
- Regional Translational Research Centers
- Dynamic Assessment of Patient-reported Chronic Disease Outcomes

## Roadmap Initiatives with NCI Playing a Key Role

**In the Molecular Libraries and Imaging Implementation Group:**
**Comprehensive Trans-NIH Imaging Probe Database**** ****	**
**2 prototype databases have been developed for consideration; (one based on prior work done within NCI and the other based on NLM format)**
**Goal: Imaging Agent Database integrated with PubChem (database of small molecules under development****)**
**In the Reengineering the Clinical Research Enterprise Implementation Group:**
**Clinical Research Informatics: NECTAR**
**National Electronic Clinical Trials and Research Network**
**Blueprint for a national informatics network**
**Maximize connectivity among existing and newly created clinical research networks**

**Notes:**
Comprehensive Trans-NIH Imaging Probe Database Initiative is in the Molecular Libraries and Imaging Implementation Group under New Pathways to Discovery.

Clinical Research Informatics: NECTAR Initiative and Translational Research Core Services (RAID-like)  is in the Clinical Research Implementation Group under Reengineering the Clinical Research Enterprise Theme.

## Roadmap Initiatives with NCI Playing a Key Role(continued)

**Translational Research Core services:  RAID-like program**
**Rapid Access to Intervention Development: expansion of NCI RAID Program**
**Provides applicants access to impressive centralized contract resources and expertise**
**Regional Translational Research Centers**
**Academic centers that will provide robust infrastructure for both preclinical and early phase clinical investigations. Planning Grants in FY05**
**Poised for hand-off between two processes-typically at stage  of IND application.**

## Key Elements of Roadmap Funding and Management

**All Institutes:**
**Participate with their scientific community in defining all components of the Roadmap**
**Contribute equally and proportionately**
**Participate directly in decision making and have a direct liaison to the Roadmap ****	**
**All Roadmap initiatives are offered for competition to researchers from all fields and all communities**
**The peer-review process will ensure appropriate expertise**

## NIH Roadmap For Medical ResearchBudget

**Roadmap initiatives are funded through**:
**	****- **NIH Director Discretionary Funds
- 	- Contributions from the Institutes and     		Centers (.34 percent of FY 2004 dollars 		and .63 percent of FY 2005)
**Fiscal Year 2004 Funding = $128 M**
**Fiscal Year 2005 Estimate = $ 237 M**

**Notes:**
NCI contribution for FY 2004 = $16.3 M  and $30.7 M estimated for FY 05

## “How does the NIH Roadmap benefit cancer research?”

**Speeding removal of major and fundamental roadblocks common to all diseases **
**Institutes working together to solve issues**
**This is a common trans-NIH pool of transforming investments open to all disease areas for competition**

**Notes:**
Initiatives that may be of interest to ONS.
Interdisciplinary Research Training Initiatives
Training for New Interdisciplinary Workforce
Interdisciplinary Health Research Training: Behavior, Environment and Biology (will be reissued in FY 05)
Short Term Programs in Interdisciplinary Research Training (will be re-issued in FY 05)
Curriculum Development Award in Interdisciplinary Research
Meetings and Networks for Methodological Development in Interdisciplinary Research
meetings or networks to develop methodologies that will facilitate interdisciplinary health research among behavioral or social scientists and investigators in the biomedical, mathematical/computational, physical sciences and/or engineering. The purpose of this RFA is to stimulate the development of methods and measures in the behavioral or social sciences in order to more fully integrate the scientific approaches and advances in these disciplines into interdisciplinary research designed to solve complex health problems. NIH is especially interested in applications that identify a topic in human health/well-being research that can be significantly advanced by using an interdisciplinary approach bringing together a new combination of disciplines and by developing innovative, interdisciplinary approaches and methods. 

Re-engineering the Clinical Research Enterprise
Dynamic Assessment of Patient –Reported Clinical Disease Outcomes 
This RFA solicits two types of applications; (1) individual research proposals, with added concept proposals for network-wide collection of self-report data on specific domains of patient-reported outcomes, symptoms, or quality of life in large and diverse samples, and (2) proposals for a statistical coordinating center that will serve as a data repository, conduct analyses, and develop a computerized system to administer, collect, and report PRO data. 

## NCI’s 2015 Challenge Goal:Seven Strategic Priority Areas

**Prevention, Early Detection, and Prediction**
**Integrative Cancer Biology**
**An Integrated Clinical Trials System**
**Strategic Development of Cancer Interventions**
**Advanced Technologies**
**Overcoming Cancer Health Disparities**
**Molecular Epidemiology**

**Notes:**
New Pathways to Discovery:
Integrative cancer Biology
Prevention, Early Detection and Prediction
Strategic Development of Cancer Interventions
Advanced Technologies
Molecular Epidemiology

Research Teams of the Future
Molecular Epidemiology
Integrative Cancer Biology
Cancer Prevention, Early Detection and Prediction

Re-Engineering the Clinical Research Enterprise
Integrative clinical trials system
Advanced Technologies

## Next Steps

**Fiscal Year 2004 Awards were announced on September 30**
**Fiscal Year 2005 Initiatives and concepts are being posted on the NIH Roadmap Website (**_**[http://](http://nihroadmap.nih.gov/)**__**[nihroadmap.nih.gov](http://nihroadmap.nih.gov/)**_**)**
**The NIH Office of Evaluation, Office of Science Policy is responsible for evaluation activities related to the NIH Roadmap.**

## Summary

**The NIH Roadmap pools resources for specific enabling investments that individual Institutes could not undertake**
** **
**The NIH Roadmap will accelerate our understanding of the complexity of molecular interactions that lead to disease, allow pioneering research, and enable rapid development of promising breakthroughs**
**The NCI Strategic Priority Areas complement the NIH Roadmap Initiative**

**Notes:**
Several of our new strategic initiatives relate to Re-engineering the Clinical Research Enterprise on the NIH roadmap.

For an Integrated Clinical Trials System:
	-Clinical trials informatics resources will be standardized across all NCI-supported clinical trials research communities to facilitate time management and information sharing.  
	-An NCI-FDA Working Group will review current policies, scientific data, and technical information and reach consensus on new policies and novel research practices that will maximize the effectiveness of clinical trials.  
In Bioinformatics:
	-The cancer Biomedical Informatics Grid will serve as a platform that integrates diverse data types and analytic tools and serves as the standard in common use by NCI supported clinical research centers nationwide.