# Presentation: 071054

## Specialized Program of Research Excellence (SPORE)

- Director, National Cancer Institute
***John Niederhuber, M.D.***
- Director, Office of Centers, Training and Resources
***Ernest T. Hawk, M.D., M.P.H***
- Chief, Organ Systems Branch
***Jorge Gomez, M.D., Ph.D.***
*(*_[http://spores.nci.nih.gov](http://spores.nci.nih.gov/)__)_

## Recent Developments

- 2001-present
- Guidelines (2001, 2006)
- Program expansion (new organ sites)
- P30/P50 Working Group Recommendations
- Program stabilization (59 SPOREs/14 organ sites)
- Assessment of the NCI SPORE pipeline
- Translational Research Working Group
- SPORE Guidelines

## SPORE Guidelines (2006)

- Updated August and October 2006
- http://spores.nci.nih.gov/applicants/index_applicants.html

## Policy Changes after 2004

- NCI establishes a payline for all SPOREs competing in a given year
- No funds available for new organ sites: all applicants (sites) are competing for the same pool of funds (coming from competing renewal applications)

## SPORE PROGRAM

|   | 1992-93 | 1995-96 | 1999 | 2000 | 2001 | 2002 | 2003 | 2004 | 2005 | 2006 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Breast | 4 | 6 | 6 | 9 | 9 | 9 | 9 | 10 | 8 | 10 |
| Prostate | 2 | 3 | 3 | 4 | 8 | 11 | 11 | 11 | 11 | 11 |
| Lung | 2 | 3 | 3 | 3 | 6 | 6 | 7 | 7 | 7 | 7 |
| GI | 1 | 2 | 2 | 2 | 2 | 4 | 4 | 5 | 4 | 4 |
| Ovary |   |   | 4 | 4 | 4 | 4 | 4 | 5 | 4 | 4 |
| GU |   |   |   |   | 1 | 1 | 2 | 2 | 2 | 2 |
| Skin |   |   |   |   | 1 | 2 | 2 | 3 | 3 | 4 |
| Brain |   |   |   |   |   | 4 | 2 | 4 | 4 | 4 |
| Head & Neck |   |   |   |   |   | 3 | 3 | 4 | 4 | 4 |
| Lymphoma |   |   |   |   |   | 2 | 2 | 3 | 3 | 3 |
| GYN |   |   |   |   |   |   | 2 | 2 | 2 | 2 |
| Leukemia |   |   |   |   |   |   | 1 | 1 | 1 | 1 |
| Myeloma |   |   |   |   |   |   | 1 | 1 | 1 | 1 |
| Pancreas |   |   |   |   |   |   | 3 | 3 | 3 | 3 |
| Total  | 9 | 14 | 18 | 22 | 31 | 46 | 53 | 61 | 57 | 60* |
| Budget (M) | 20 | 30 | 39 | 48 | 68 | 112 | 123 | 135 | 133 | 127 |

- *Includes 6 SPOREs in bridge funding/no-cost extension

**       ****<------------RFA-----------X----------------------------------PAR----------------------------->**

## Receipt Dates for SPORE Applications

**In 2006, all organ sites will be accepted for the September 20****th**** receipt date. **
**In 2007, all organ sites will be accepted for the January 23****rd ****, May 22****nd****, and September 21****st**** receipt dates .**** **

## Definition of Translational Research

**	****Translational research uses knowledge of human biology to develop and test the feasibility of cancer-relevant interventions in humans *****AND/OR *****determines the biological basis for observations made in individuals with cancer or in populations at risk for cancer**

## Bi-Directional Translational Research

## SPORE Eligibility and General Features

- Institution (domestic for profit and not for profit)
- Basic and Clinical Research Base
- Access to Patients
- Budget Cap
*	**(reduced to $2.5M)*
- Team Concept

- Inter-SPORE and NCI/NIH Network Collaborations *(greater emphasis)*
- Flexibility to Realign Resources
- Scientific Outreach
- Data/Resource Sharing *(NEW)*
- Standing Special Review Panel *(NEW)*
*	** *

## SPOREs Budget Caps

- $2.5 mil. Total Cost for Year 1
- No cap for Direct Cost for Year 1
- Up to 3% Cost of Living Increase for Year 2 and Subsequent Years
- Applications that Exceed these Caps (including cost of living allowance) will be Returned without Review

## SPORE Requirements

- Statement of Institutional Commitment
- Intellectual Property Management Plan *(NEW)*
- 4 Translational Research Projects
- 	(including “required”)
- Shared Cores
- 	(specimen core required; adm, stats, & clinical are common)

- Developmental Research Program
- Career Development Program
- Commitment to attend and participate in SPORE Workshop and related NCI/NIH Meetings *(NEW)*
- Other Provisions for NCI designated Comprehensive Cancer Centers

## SPORE:Institutional Commitment

- Letters of Support from the Institution
- Incorporation of the SPORE within its Institutional Priorities
- Allocation of Discretionary Resources to the SPORE Program (e.g., funds for DRP, CDP)
- Facilitation and Promotion of Scientific Progress
- Integration of SPORE activities with NCI-designated Cancer Center

## Integration of SPORE with NCI-designated Comprehensive Cancer Center (CCC)

- Principal Investigator: **P****rominent within CCC**
- Lines of Authority
- Organizational Relationships
- Separate Institutional Commitment
- Augmentation of Existing CCC Resources:  Cores
- Program Coordination with CCC Activities

## SPORE Principal InvestigatorQualifications:

- Basic/Clinical Investigator Recognized Scientific Leader in the Field
- Provides Leadership/Direction to the SPORE
- Oversees and Conducts Planning Activities
- Project Leader/Co-investigator/Core Director
- Appropriate Time Commitment (>25%)
- Understands Translational Research Objectives
- Identifies New Translational Research Opportunities

## Research Projects

- Test Novel Translational Ideas
- Balance between Basic and Applied Research
- Human Application within 5 yr of the Award
- Project Co-Leaders (2-3)
- Interdisciplinary Interactions
- Human Subjects/Animal Protections
- Consortium/Contractual Arrangements
- Data/Resource Sharing Plan
- Consultants/Commercial Agreements

## SPORE Cores

- Tissue Collection and Distribution *(Required)*
- Parameters of collection and preservation; pertinent analytical considerations; essential pathological, clinical, family history information and linkage to databases, etc.  *(more detail)*
- Other Specialized Cores
- Administrative
- Clinical
- Biostatistical
- Bioinformatics
- Others
- Building on Pre-Existing Resources; Avoidance of Duplication
- Cross-talk between Cores and Projects
*Data Management within Program Description* *(NEW)*

## Career Development Program

- Encourages New and Established Investigators to Develop Careers in Translational Cancer Research
- Provides Salary and Other Support
- Promotes Mentoring of New Investigators
- Recruitment Plan for Selection of Candidates, including Women & Minorities
*Plan for Solicitation, Review, and Award*
- (Promotion to Full Project on SPORE)

## Developmental Research Program

- Pilot Projects that Explore Innovative Ideas
- Basic Research Projects with _*Translational Potential*_
- Early Phase Clinical Studies; Pilot Epidemiology Projects
- Takes Advantage of New Research Opportunities
- Promotes Collaborations Among Scientists at the Same or Different Institutions
- Supports Research Proposed by *Independent* Investigators
*Plan for Solicitation, Review, and Award*
- Promotion to Full Project on SPORE

## Annual SPORE Investigator’s Workshop

- Statement of Commitment *(within Program Description)*
- Budget to Fund 10 Investigators to the Workshop *(Admin Core)*
- Promote Inter-SPORE Collaborations
- Share New Ideas, Materials, and Technologies
- Identify New Research Opportunities
- Establish Research Priorities that will Impact Upon Cancer Detection, Prevention, or Treatment
- Resolve Research Needs by Making Recommendations to the NCI Leadership
- Interact with Patient Advocates, NCI Staff, and industrial representatives