1. Cancer Center: A Pathway to Collaborative Research and NCI Designation Mark Reeves, MD, PhD, Cancer Center Director 2016 Research Symposium, 10/21/16
5/8/2018

2. Synopsis
The LLU Cancer Center is on a long-term disciplined pathway towards designation as a Comprehensive Cancer Center by the NCI
This will stimulate and support collaborative research efforts at Loma Linda University Health

3. Outline Describe the Cancer Center Support Grant (CCSG) mechanism
Describe the Cancer Center’s pathway towards NCI designation
Outline how NCI designation supports collaborative cancer research

4. *
CCSG Mechanism

5. CCSG Cancer Center Support Grant (CCSG)
The funding mechanism through which the NCI designates Cancer Centers
P30 mechanism
5 years
Direct costs of $1 million per year
Does not fund new research
Funds infrastructure to integrate and translate funded cancer research

6. CCSG Cancer Center Requirements
Depth and breadth of cancer research in three areas
Basic laboratory research
Clinical research
Prevention, control, and population-based science
Either a stand-alone or consortium center
Must serve a defined catchment area

7. CCSG Cancer Center Requirements
Unique CCSG sections include
Shared core facility support
Cancer clinical research support (including early phase clinical research support)
Research Programs
Stated minimum is 1, but most CCCs have 3-6
Often organized around cancer types, fundamental cancer questions, cancer therapies, or cancer population sciences
Minimum 5 funded research projects from at least 3 Pis for each Research Program
Some are separately established and funded as SPOREs (Specialized Programs of Research Excellence)

8. CCSG Cancer Center Requirements
More on SPOREs
Specialized Programs of Research Excellence
Not required, but often used, to develop CCSG Research Programs
P50 “Center Grants” funded by the NCI
Typically 5 years
Direct cost budgets of up to $2.5 million per year
Focus on an organ site (eg: breast cancer) or pathway (eg: hyperactive RAS)

9. CCSG Cancer Center Requirements
More on SPOREs
Designed to enable the rapid and efficient movement of basic scientific findings into clinical settings
Required to reach a human end-point within the 5-year funding period
65 SPOREs in US
3 SPOREs in California (UCLA, City of Hope, UCSF)
Typically attract cancer scientists, bringing additional grant funding to the institution beyond the SPORE itself

10. CCSG Funding Requirements
Requires a funding base of at least $10 million in annual direct costs of peer-reviewed, cancer-related funding
For a consortium Cancer Center, the funding base sums that of all the partner institutions
Cancer-related funding
NCI peer-reviewed grants, cooperative agreements, and contracts
Cancer-related funding from other NIH institutes
Cancer-related funding from other approved funding organizations

11. LLU Cancer Center Pathway Towards NCI Designation*
LLU Cancer Center Pathway Towards NCI Designation

12. Context 45 NCI designated Comprehensive Cancer Centers
5 NCI designated CCCs in Southern California
UCLA, City of Hope, UCI, UCSD, USC
Examples of undesignated CCs in Southern California
Cedars Sinai, John Wayne Cancer Institute, Loma Linda University

13. Pathway Disciplined, multiyear process Two phases Phase 1
Investment in recruitment and support of cancer research at LLUH
Goal is to reach $10 million in yearly cancer research funding
“Silent” phase
5 years

14. Pathway Disciplined, multiyear process Two phases Phase 2
Application and direct steps to NCI designation
Often leads to distinct cancer hospital and research space
Typically attracts philanthropic support of $50-$500 million for naming of Comprehensive Cancer Center
“Public” phase
After Vision 2020 finished
3 years

15. Pathway Will pursue designation as a Consortium Center
Distinct scientific institutions partner to comprise the Comprehensive Cancer Center
The $10M funding base requirement is the sum of the funding bases of all participating institutions
Partners might include
Loma Linda University Health
VA Loma Linda Healthcare System
University of California, Riverside
Others?

16. Uniqueness
LLU Cancer Center would be the only overtly faith-based Comprehensive Cancer Center
Catchment area
No other CCC in Inland Empire, Southeastern California
Nearest CCCs to the North and East are in Tuscon (U of Arizona) and Salt Lake City (U of Utah)
Significant health disparities region currently with no CCC

17. Pathway
CCSG (Cancer Center Support Grant) Steering Committee has been established
Funding base
Currently at about $6M
Has increased by ~ $1M each of last 3 years
Establishing membership procedures/criteria
Determining feasibility of consortium approach
Starting to discuss research programs

18. NCI Designation Supports Collaborative Cancer Research*
NCI Designation Supports Collaborative Cancer Research

19. General Benefits of NCI Designation
Research
Supports cross-discipline, cross-institutional, and translational research
Aids recruitment of scientists and grant applications
Education
Supports cancer training grants
Patient care
Slow out-migration of cancer patients to other CCs
Population health
Supports cancer population health programs, benefitting population health in other diseases

20. CCSG/Collaborative Research
Does not fund new research
Funds infrastructure to integrate and translate funded cancer research, and build collaboration between defined research programs
“The CCSG focus on research derives from the belief that a culture of discovery, scientific excellence, transdisciplinary research, and collaboration yields tangible benefits extending far beyond the generation of new knowledge”

21. CCSG/Collaborative Research
Highlighted areas of CCSG support of collaborative research
Shared core facility support
Cancer clinical research support
Early phase clinical research support
Developmental funding
Development of defined Research Programs

22. CCSG/Collaborative Research
Shared core facility support
“Provide access to technologies, services, and scientific consultation that enhance scientific interaction and productivity”
Can support existing cores (inside or outside the Cancer Center) or establish new ones

23. CCSG/Collaborative Research
Shared core facility support
Typical examples
Bioinformatics/biostatistics
Tissue banking/molecular pathology
“Omics” (genomics/proteomics/metabolomics/etc)
Imaging (small animal, microscopy, etc)
Immune monitoring (FACS, etc)
Reagent/vector/animal preparation (transgenic, knockout, etc)
Molecular pharmacology (pharmacokinetics, etc)
Therapeutics development

24. CCSG/Collaborative Research
Shared core facility support
Specialized examples
Circulating tumor cells
Genetic counseling
Xenograft development
Antibody development
Tobacco product assessment
Experimental radiation
Many others

25. CCSG/Collaborative Research
Early phase clinical research support
Highlights the CCSG emphasis on translating basic research results into clinical care
Explicitly acknowledges that these studies are difficult to fund through traditional mechanisms

26. CCSG/Collaborative Research
Early phase clinical research support
Pilot (phase 0) or phase 1 studies
Short term support
Meant to accumulate data to support development of higher level clinical trials (phase 2, 3, 4)
Examples of support
IND/IDE applications
Purchase core support
Pharmacokinetics
Early phase trials personnel

27. CCSG/Collaborative Research
Developmental funds
Allow Cancer Centers to
Take risks
Strengthen weaker scientific areas
Explore innovative ideas
Explore new collaborations
Explore new technologies

28. CCSG/Collaborative Research
Developmental funds
Recruitment of faculty level scientists in areas of strategic need
Interim salary and research support
Support of pilot projects
Allow Center scientists to pursue innovative, high-risk ideas or stimulate high priority research areas
Development of new Shared Resources
Support of Staff Investigators
Defined, special role in helping the Center achieve scientific objectives above and beyond their own research

29. CCSG/Collaborative Research
Research programs
Used to establish “depth and breadth of cancer research” in three areas
Basic laboratory research
Clinical research
Prevention, control, and population-based science
The area that typically receives the most support from CCSG funding

30. CCSG/Collaborative Research
Research programs
Typical organizations
Cancer types (eg: sarcoma, breast cancer, prostate canceretc)
Fundamental cancer questions (eg: DNA repair, cell stress, cell growth, cellular carcinogenesis, stem cell biology, cell-cell communication, etc)
Cancer techniques (eg: genetics, structural biology, oncologic imaging, etc)
Cancer therapeutics (eg: immunotherapeutics, experimental therapeutics, solid tumor therapeutics, etc)
Cancer population sciences (eg: cancer control, epidemiology, health outcomes and behavior, etc)

31. CCSG/Collaborative Research
LLUH has many strengths and some challenges
Many shared core facilities that can be strengthened, further developed, or new ones developed
Many existing strengths that can be supported and organized into research programs
Will require significant work for early phase clinical research support (easiest to start)

32. *
Summary

33. Summary
LLU Cancer Center pursuing long-term strategy toward NCI designation
Comprehensive Cancer Center designation will have a huge impact on the support of collaborative, transdisciplinary research