# Presentation: 089028

## NIH at the Crossroads: Myths, Realities and Strategies for the Future

**NIH at the Crossroads: Myths, Realities and Strategies for the Future**
- Elias A. Zerhouni, M.D.
- Director, National Institutes of Health

## NIH Budget Facing a “Perfect Storm” in 2006

- Federal & Trade Deficits
-  Defense and Homeland Security needs
- Katrina
- Pandemic flu
- Post- Doubling effects
- Physical Sciences focus
- Biomedical research inflation- 3 to 5%

## NIH Budget: 

**Myths and Realities...**

## What is Driving Success Rates?

- Is NIH placing more emphasis on applied as opposed to basic science
- Is NIH shifting towards solicited research (RFAs and PAs) at the expense of unsolicited, investigator-initiated research?
- Is it due to the Roadmap?

## Basic and Applied Research

- 56.6%

- 53.9%

- 55.2%

- 56.4%

- 52.1%

- 53.0%

- 55.2%

- 55.8%

- 55.2%

- 56.1%

- 40.5%

- 39.2%

- 38.4%

- 38.5%

- 39.8%

- 40.8%

- 43.5%

- 41.0%

- 41.0%

- 40.8%

- 5.0%

- 7.0%

- 3.7%

- 5.7%

- 5.5%

- 5.2%

- 4.8%

- 3.6%

- 3.1%

- 3.1%

- 0.0%

- 10.0%

- 20.0%

- 30.0%

- 40.0%

- 50.0%

- 60.0%

- FY 1998

- FY 1999

- FY 2000

- FY  2001

- FY 2002

- FY 2003

- FY 2004

- FY 2005

- FY 2006

- FY 2007

**Basic Research**

**Applied Research**

**Other**

**Basic and Applied Research**

## What is Driving Success Rates?

- Is NIH placing too much emphasis on translational science at the expense of basic research?
- Is NIH shifting towards solicited research (RFAs and PAs) at the expense of unsolicited, investigator-initiated research?
- Is it due to the Roadmap?

## Grants: Unsolicited Far 

**Outnumber Solicited**

- 0%

- 10%

- 20%

- 30%

- 40%

- 50%

- 60%

- 70%

- 80%

- 90%

- 100%

- 1994

- 1996

- 1998

- 2000

- 2002

- 2004

- 2006

**Fiscal Year**

**Percentage of Grants **

- Unsolicited

- Solicited

**91%**

**93%**

## What is Driving Success Rates?

- Is NIH placing too much emphasis on translational science at the expense of basic research?
- Is NIH shifting towards solicited research (RFAs and PAs) at the expense of unsolicited, investigator-initiated research?
- Is it due to the Roadmap?

## NIH Roadmap for Medical Research

**Roadmap**
**0.8%**
**($237 Million)**

**Non-Roadmap**
**99.2%**
**($28,520 Million)**

**FY2005 Request = $28,757M**

- Developed to increase   synergy across NIH
- Not a single initiative but over 345 individual awards in FY05:
-  40% basic
-  40% translational
-  20% high risk

## What Is Really Happening?3 Fundamental Drivers

- Large capacity building throughout U.S. research institutions and increase in number of tenure-track faculty
- Large increase in applicants and applications occurring *after* 2003
- Budgets:
- Appropriations below inflation after 2003 ( +3 % in ‘04, 2.2% in ‘05 and 0% in 06 ) while BRDPI in 2004 was ~ 5%
- Budget cycling phenomenon

**Notes:**
	BRDPI	FY04 (actual) 3.5%	
			FY05 (est.)     3.3%	
			FY06 (est.)     3.2%	
			FY07 (est.)     3.2%

## New Grant Applications  and Success Rates During and After Doubling Period

**Success Rates**

**Applications**

**Projected**

- Number of Applications

- % Success Rate of Grants Funded

**31%**

**19%**

**0%**

**5%**

**10%**

**15%**

**20%**

**25%**

**30%**

**35%**

- 1998

- 1999

- 2000

- 2001

- 2002

- 2003

- 2004

- 2005

- 2006

- 2007

**0**

**10,000**

**20,000**

**30,000**

**40,000**

**50,000**

**60,000**

- 22%

- 49,656

- 43,069

- 24,154

## As Many New Applicants in the Last 2 years as during the previous 5 years!

- 		     ≈

## The Budget Cycling Phenomenon:What Funds are Really Available in Any One Year? 

**NIH Appropriations**

**Committed Funds**

**Uncommitted Funds**

**Budget Increase**

- From ending grants
- started 4-5 years ago

- From current year to
- previous year

- Continuing grants

## NIH Congressional Appropriations 

**Billions of Dollars**

**DOUBLING**

**$13.7**

**$15.6**

**$17.8**

**$20.5**

**$23.3**

**$27.1**

**$28.0**

**$28.6**

**$28.6**

**$28.6**

**$0**

**$5**

**$10**

**$15**

**$20**

**$25**

**$30**

**FY**

**1998**

**FY**

**1999**

**FY**

**2000**

**FY**

**2001**

**FY**

**2002**

**FY**

**2003**

**FY**

**2004**

**FY**

**2005**

**FY**

**2006**

**FY**

**2007**

**?**

## The Bottom Line: Demand for Grants “Took Off” Just as NIH Budget Was “Landing!” 

- NIH managed well in 2004 and 2005 by shifting “one time” funds from 2003 to 2004, and obtaining small increases in 2004 (2.9%) and 2005 (2%)
- Katrina requirements led to a flat 2006 NIH while rest of HHS underwent a 2.5% cut
- Budget cycling effect will improve demand vs supply of grants in 2007 but *we need to educate public about need for sustainability in research*

##  The Question on Everyone’s Mind:“What are MY chances of being funded?”

- Payline is not the funding cut-off line!
- Success rate per application understates funding rate per applicant
- FY 2005- 22.3% success rate for applications, but 27.6% for applicants
- FY 2006- 19.8% for applications, but ~25% for applicants

## Success Rate is Higher than the Percentile Payline

- 0

- 10

- 20

- 30

- 40

- 100

- 0

- -

- Percentile Score

- Percent R01s Funded

## Success Rates are always higher for Applicants than for Applications 

- 0%

- 5%

- 10%

- 15%

- 20%

- 25%

- 30%

- 35%

- 40%

- 1995

- 1997

- 1999

- 2001

- 2003

- 2005

- Applicant

- Applications

- Success Rate for R01 Equivalents

- Fiscal Year

**Success Rates are always higher **_**for Applicants**_** than **_**for Applications **_

- Success Rate files as of May 3, 2006.  Program srf_indiv_060103_rfm
- Individuals are determined using the pi_profile_person_id in IMPAC-II

## Where Do We Go From Here?Adaptive Strategies A Vision for the Future  

## Strategies

- First: Know the facts
- Second: Develop adaptive strategies
- Protect the essential: ***Knowledge and Discovery***
- Increase number of competing grants (supply/demand management)
- Support new investigators
**New Pathway to Independence Program**
**Institutes and Centers efforts to assist new investigators**
- Third: Convey a unified message
- Increase communications about positive impact of NIH at local, regional and national levels
- Fourth: NIH’s exciting vision for the future

## The First HapMap Success Story:Age-Related Macular Degeneration

- Two other risk variants have
- 	been identified in the last two
- 	months
- Together these account for 74%
- 	of risk, and point to powerful
- 	new approaches to prevention
- 	and treatment

**Notes:**
Several independent research groups representing NEI intramural scientists and extramural grantees have identified a common variant in complement factor H gene as a risk factor for developing AMD. 
The CFH gene is responsible for a protein that helps regulate inflammation in part of the immune system that attacks diseased and damaged cells. In certain patients with AMD, inflammation in the eyes may trigger a biological process leading to the disease. 
People whose genetic make-up includes a variant of the CFH gene are 7.4 times more likely to develop AMD. The study was based on whole genome analysis of participants from the NEI-sponsored Age-Related Eye Diseases Study, a major clinical study that closely followed nearly 5,000 patients with varying stages of AMD. 

These reports result from long term NIH investments in generating state-of-the-art research tools and reagents through the Human Genome Project and genetic initiatives supported by the NEI.

## Human Genome Project and HapMap: The Foundation of a New Medical Era

**1990 - 1997**

**1998 - 2002**

**2003 - 2006**

- New powerful  DNA sequencing technologies
- Transformation of Genomics from technology to biology- driven science
- 2007 Genes, Environment, and Health Initiative
- Identify roots of 10 most common diseases within 3 years
- Devise new ways of monitoring personal environmental exposures
- Guide new treatments

**Notes:**
Involvement in Roadmap:
Co-lead on Molecular Libraries and Imaging             
             -Managing Molecular Libraries Screening Centers
             -Cheminofmatics Centers
             -Instrumentation (high-throughput measurement of novel biological assays)

Involved in Bioinformatics and Computational Biology 
                -Have one center grant for Biomedical Computing

Involved in Building Blocks, Biological Pathways, and Networks initiative

Involved in Interdisciplinary Research Initiative

## Basic Discovery Today Provides the Foundation for Tomorrow’s Medicine

- Basic Research
- and
-  Technology Development

- Translational
-  Research

- Clinical
- Applications

## The Future Paradigm: Transform Medicine from Curative to Preemptive

**The Future Paradigm: ***Transform Medicine from Curative to Preemptive*

- Preemptive

- Personalized

- Predictive

## NIH

**NIH**

*Transforming medicine through discovery*