# Presentation: 184413

## NCI Director’s Update

- NCI Director’s Update

- Dr. John E. Niederhuber
- Director, National Cancer Institute

- National Cancer Advisory Board
- February 5, 2008

## Why What We Are Doing is So Important

- 1,444,920 Americans were diagnosed in 2007
- 559,650 died of cancer in 2007
- $206.3 billion spent         on healthcare costs         for cancer in 2006
- 47 million Americans lack health insurance

- Human and Economic Burden of Cancer

- 2007 1,444,920

- 1998 1,228,600

- Estimated # of New U.S. Cancer Cases

## Reversing the Curve: Cancer Deaths Decline

**Number of cancer deaths (ACS)**

**Rate per 100,000 (NCI)**

**225-**
**220-**
**215-**
**210-**
**205-**
**200-**
**195-**
**190-**
**185-**
**180-**
**175-**

## U.S. Death Trends: Cancer of All Sites, 1975-2004

**1993-2003: overall decline -1.1%**
**2002-2004: -2.1% per year**
**1993-2002, decline for men -1.6% per year**
**2002-2004: -2.6% per year**
**1992-2002, decline for women     -0.8% per year**
**2002-2004: -1.8% per year**
**Incidence rate for female breast cancer dropped 3.4% per year from 2001 through 2004**

- Mortality

**Males**

**Both sexes**

**Females**

- Rates are age-adjusted to the 2000 U.S. standard million population.
- Sources: Incidence data – NCI SEER Program; Mortality data – CDC NCHS NVSS

**Notes:**
Breast cancer incidence drop is possibly related to declining use of hormone replacement therapy as well as the recently reported decline in use of screening mammography.

Colon Cancer Incidence drop as a result of screening. 

For Colon Cancer (not adjusted for reporting delays so the declines may be overestimated)
         Men & Women:  significant annual decline of -2.3% per year  1998 thru 2004
         Men:                  significant annual decline of -2.7 % per year  1998 thru 2004
         Women:             significant annual decline of -3.9 % per year  2001 thru 2004  

The declines in colon and in colorectal cancer incidence (from the SEER  9 data) are seem among the white population but not among the African American population (some indication of a decline in colorectal cancer incidence among Asian Pacific Islanders based on data from SEER and registries supported by CDC & in the 2007 Annual Report to the Nation but not for other racial or ethnic populations).

## Estimated Number of Cancer Survivors in the United States

- 11,941,043 survivors in 2007

## NCI’s Challenge

**$4.8B**

**$4.8B**

**$4.3B**

*** BRDPI: Biomedical Research and Development Price Index (****http://officeofbudget.od.nih.gov****)**

**Funds available**

**Adjusted by BRDPI***

**-12% loss in purchasing power since 2004**

## Director’s Update

- NCI FY08 budget
- President’s budget FY09
- Some thoughts about the future

## NCI FY 2008 Operating Budget Development

**(dollars in thousands)**

| FY 2007 operating budget | $4,797,639 |
| --- | --- |
| FY 2008 appropriation | $4,805,088 |
| Difference ’07 to ’08 |         $7,449 |
| Percent Change ’07 to’08 |        +0.16% |

## NCI FY 2008 Operating Budget Development

**Less Est. NIH Taps/Assessments**

- Potential NIH Director’s 1% Transfer

**?**

- Potential DHHS Secretary’s Transfer

**?**

**-20,000**

- -0.26%

**Subtotal Available**

- -12,551

**Percent**
**change**

- 0.16%

**Subtotal Available**

- $7,449

**     ****Amount**
**(in thousands)**

**Notes:**
We have a placeholder for potential transfers by the NIH Directory or by the HHS Secretary.  We haven’t heard of any but they could happen.

Increase in Roadmap contribution to $43 million

Increase in taps and assessments.  Hopefully, $33 million is high but we won’t know all of them until this summer.  Last year increase was about $20 million 

## NCI FY 2008 Operating Budget Development

**Subtotal Available**

- 1.44%

**NCI-wide Requirements:**

- Mandated Salary Increases

**- 21,500**

- Rent/Lease/Utilities/Renovations Incr

- - $12,551

**- 10,000**

**Subtotal Available**

- - 69,051

-  -0.26%

**Percent**
** ****change**

**    ****Amount**
**(in thousands)**

- Small Business Program Increase

**0**

**NCI Director’s Reserve**

**- 25,000**

**Notes:**
We’ll set aside funds to pay the mandated salary increases and increases in rent

We have also added funds to RPGs to meet the NIH funding policies

Director’s Reserve

So what are the next steps?

## NCI FY 2008 Operating Budget Development

- SPORES

- Centers

**Subtotal Available**

- - 1.44%

- - $69,051

- - 7,855

- -3,588

- - 1.98%

**Subtotal  Available**

- -94,998

**Partial Restoration of Cuts**

**Percent**
** ****change**

**    ****Amount**
**(in thousands)**

- Coop Groups/CCOPs

- -8,504

- Infrastructure Restorations/Increases

- -6,000

## NCI FY 2008 Operating Budget Development Process

- NCI leaders evaluated programs with an eye toward reduced or flat budgets ahead
- FY08 operating budget target for each Division, Office and Center (DOC) is based on a 3% reduction
- Created a pool of funds for NCI-wide mandatory increases and reallocation for specific initiatives

## NCI FY 2008 Operating Budget Development

- Phaseouts/Reductions Res DOCs

**Subtotal Available**

- - 1.98%

- - $94,998

- 49,382

- $55,526

- Available for New Initiatives/
- Expansions/Restorations

**Potential Recoveries/Redeployments: **

- Noncompeting RPGs

- 46,228

**Percent**
** ****change**

**     ****Amount**
**(in thousands)**

- Competing RPGs

- 8,136

- Phaseouts/Reductions Infrastructure

- 6,778

- NCI-Frederick Redeployment

- 40,000

## NCI FY 2008 Operating Budget:     NCI Operating Policies

- NCI operating policies
- 1% inflationary adjustments on non-competing grants
- ~2% decrease from commitment for non-modular grants
- No cut to modular non-competing grants
- NCI to award fewer competing RPGs than FY 2007 (1,312 to 1,283)
- Average cost of competing RPGs 3% above FY 2007

**Notes:**
All NCI operating policies are aligned with the “Published NIH Guidelines”
NIH plans to award fewer competing RPGs than in FY07
-10,323 competing RPGs in 07
-projected 9.711 in ’08 – a reduction of 5.3%
NIH has reduced the number of grants to be awarded and allowed Institutes more flexibility on how to manage modular Type 5’s largely due to an outcry by the IC Directors.  Cutting new and non-competing grants in order to continue to increase the number of awards severely diminished the quality of research able to be conducted.

## NCI FY 2008 Operating Budget:     NCI RPG Policies

- NCI RPG policies
- Type-2 (competing continuing grants) will receive 3% above current levels
- Type-2 modular grants recommended for 7 modules or fewer will receive 5% above current levels
- Type-1 (new competing grants) will be   cut ~17%

**Notes:**
Notes:  Type 2’s will receive 3% above current levels which in most cases is last year’s award.  UNLESS the PI requested less than 3% or perr review recommend less than 3%
Type-1’s will be cut 17% from the level requested and approved by peer review

## NCI FY 2008 Operating Budget:     NCI RPG Paylines

- NCI RPG Paylines
- R01: 12th percentile
- *R01s: 19th percentile (will hit NIH target)
- Large R01s (over $700K):
- 14th percentile for 1st and 2nd rounds
- TBD for 3rd round
- P01: Selected on a case-by-case basis

**Notes:**
R21:  14th percentile
R03:  210 priority score
R33:  155 priority score

## Examples of Downsized and Stopped Programs

- Office of Centers, Training, and Resources
- Integrating Aging and Cancer Research (co-funded with NIA)
- NCI funding of $4M-$5M will not be renewed
- Supplements for Imaging Response Assessment Teams in Cancer Centers
- NCI funding of $2M will not be renewed

**Notes:**
Integrating Aging and Cancer Research project’s objective was to expand the knowledge base on aging- and age-related aspects of cancer in older persons.

Supplements for Imaging Response Assessment Teams in Cancer Centers’ main purpose is to advance the role of imaging in assessment of response to therapy.

## Examples of Downsized and Stopped Programs

- Div. of Cancer Control & Population Sciences
- Transdisciplinary Tobacco Use Research Centers
- FY2008 is final year of RFA, funded at $7.2M. No proposed RFA renewal
- NCI is joining a NIDA PA; For TTURC program, anticipate spending $2M-4M, rather than $7.2M/yr
- Long Term Cancer Survivors research RFA
- FY2008 funding reduced by $1.7M

**Notes:**
TTURCs are a multiIC collaborative led by NCI

## Examples of Downsized and Stopped Programs

- Division of Cancer Prevention
- CCOP cancer treatment trial accrual
- FY05: 7,948 patients
- FY06: 6,402 patients
- FY07: 6,100 patients (estimate)
- CCOP cancer prevention & control trials:
- FY05: 5,211 patients
- FY06: 4,994 patients
- FY07: 4,500 patients (estimate)

**Notes:**
In the last few years, the budgets have been held constant or decreased due to funding restrictions; CCOPs have had to reduce staff and, subsequently, their accrual.

## Examples of Downsized and Stopped Programs

- Division of Cancer Treatment and Diagnosis
- CTEP Interdisciplinary Research Teams for Molecular Target Assessment
- Eliminated in FY07; $1.4M
- Cancer Imaging Program’s Development of Contract Imaging Drugs and Enhancers
- Eliminated in FY07; $1.6M
- Cancer Diagnosis Program: breast and prostate cancer tissue resources unfunded or eliminated

## FY 2009 President’s Budget

**(dollars in thousands)**

| FY08 NCI appropriation | $4,805,088 |
| --- | --- |
| FY 2009 PB for NCI | $4,809,088 |
| Difference ’08 to ’09 |          $4,000 |
| Percent Change ’08 to’09 |            +0.1% |

**Notes:**
Total NIH President’s Budget (PB) request is $29.5 billion – flat with the FY 2008 Omnibus Appropriation

NCI PB is $4.8 billion - $4.7 million or .1% higher than the FY 2008 Omnibus

NIH Roadmap in FY 2009 is $534 million – an increase of $38 million or 7.7%.

## Diagnostics

- Therapeutic
- Developments
-  Gene Therapy
-  Drug Therapy

- Preventive
- Medicine

- Disease with Genetic Component

- Accelerated
- by Human
- Genome Project
- and HapMap

- Identify Genetic Defect(s)

- Pharmaco-
- genomics

- Time

**Courtesy Francis Collins, NHGRI**

## Functional Genomics

**Alterations in cellular function**
**Cell biology and                                  protein carbohydrate     chemistry**
**Regulation of                          gene expression**
**Whole genome                  sequencing**
**Genome-                                      wide                                association                             studies**

**Normal vs. abnormal phenotype**

**Genes and environment**

**Germline markers of risk**

**Somatic mutations**

**Therapy**
**Prevention**

**Behavioral science**

**Populations w/ disease (environmental risk exposure)**

**Large populations**
**Longitudinal history**

## Theoretical Physics

- Feb. 25-27, 2008
- “Integrating and Leveraging the Physical Sciences to Open New Frontiers in Oncology”
- Workshop to explore opportunities to incentivize collaborations
- Leaders in physics, chemistry, mathematics and cancer research

## AACR/NCI Cancer Prevention Think Tank

- Bring together scientists and clinicians from basic, translational, and behavioral research areas, to think broadly about molecular prevention
- Develop a comprehensive cancer prevention strategy
- Bring technology into prevention program
- Emphasize translational science in prevention
- Enhance behavioral science program
- Co-chairs: Raymond DuBois, John Niederhuber

**Notes:**
In notes:  This meeting will be immediately following the AACR Annual Prevention Meeting scheduled for November, 2008 in Washington.  AACR is also launching a new Prevention Journal in 2008.  All this coincides with Ray DuBois’s Presidential Year.

## Annual Translational Research Meeting

- Replace the summer SPORE meeting with an annual meeting
- Co-Chaired by Drs. Sheila Prindiville and Lynn Matrisian
- Planned for the Fall 2008 in Washington, D.C.

## The SBIR Bridge Award in Drug Development

**Commercialization**

**NDA**
**Review**

**Clinical**
**Trials**

**Safety**
**Review**

**Preclinical Development**
**(Lead Development, Animal Studies, File IND)**

**Target Identification**
**& Validation**

**Private Investment**

**Notes:**
Recommendations:
Bridge SBIR Projects Toward Commercialization (Phase IIB Bridge Awards)
Establish an SBIR Development Center (consolidating SBIR and STTR) – Open to other ICs
Focus Solicitation on Commercially Viable Technologies (Between FY07 and FY08 NCI increased the total number of contract proposals by 43%)
Assemble an Advisory Committee

SBIR = Small Business Innovation Research
STTR = Small Business Technology Transfer Program

## TRWG Implementation

- Dr. Lynn Matrisian (co-chair of the TRWG) now at NCI on an IPA
- Integrating with the CCCT
- Translational Research Operation Committee planned
- Established under the Clinical Trials Advisory Committee (a Federal Advisory Board)

**Notes:**
In notes:  This meeting will be immediately following the AACR Annual Prevention Meeting scheduled for November, 2008 in Washington.  AACR is also launching a new Prevention Journal in 2008.  All this coincides with Ray DuBois’s Presidential Year.

## Translational Research Working Group Goals

- Improve coordination and collaboration and instill a culture of active, goal-oriented management
- Improve identification of the most promising early translation research opportunities
- Tailor new and existing programs to facilitate early translational research progress
- Enhance operation al efficiency and effectiveness

**Notes:**
In notes:  This meeting will be immediately following the AACR Annual Prevention Meeting scheduled for November, 2008 in Washington.  AACR is also launching a new Prevention Journal in 2008.  All this coincides with Ray DuBois’s Presidential Year.

## Role of Clinical Research Center 

- Role of Clinical Research Center

- Continue to strengthen Medical Oncology
- Recruiting new chief of Laboratory of Pathology
- Pathology space renovations in Bldg 10
- Developing an Oncology Imaging Center
- Exploration of a Satellite Center at Suburban Hospital
- Strengthening fellowship training
- Participation in rare diseases clinic

- NCI Initiatives

**Notes:**
Develop a trans-NIH initiative on inflammation, immunology and autoimmunity  to bridge the separation between basic immunologists and physicians who care for patients with immune-mediated and autoimmune diseases. 

Facilitate interesting cases or patients with rare or difficult problems to be see at the CRC by creating screening protocols across Institutes.

Emphasize recruitment and retention of Clinical Investigators – create a culture and reward system based upon team science. 

6 subcommittees – each chaired by an IC Director
Also looking at infrastructure (core resources and identification of barriers to clinical research); looking at the CRC in the CTSA structure; facilitating extramural collaborations at the CRC> 

## The Clinical Research Center as a National Resource

## 2009 Professional Judgment Budget

| Fiscal Year 2008 estimate | $4,925,740 |
| --- | --- |
| Current services increase | $334,638 |
| Subtotal | $5,260,378 |
| Fiscal Year 2009 professional judgment |  |
| Increase success rate for RPGs | 65,000 |
| Basic and translational science for personalized medicine | 289,902 |
| Linking science and technology | 209,600 |
| Reaching all communities | 72,100 |
| Prevention and early detection | 131,406 |
| Subtotal | 768,008 |
| Total, NCI | $6,028,386 |

- Dollars in thousands

**Notes:**
Bypass budget was based on the conference committee mark in the fall; does not reflect the current appropriation, which is about $120 million less.

## www.cancer.gov

**www.cancer.gov**

## Slide 34