Transcript Mark Reeves, MD, PhD - LLU Research Affairs

Cancer Center: A Pathway to Collaborative
Research and NCI Designation
Mark Reeves, MD, PhD, Cancer Center Director
2016 Research Symposium, 10/21/16
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
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
CCSG Mechanism
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
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
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)
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)
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
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
LLU Cancer Center Pathway
Towards NCI Designation
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
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
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
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
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Loma Linda University Health
VA Loma Linda Healthcare System
University of California, Riverside
Others?
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
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
NCI Designation Supports
Collaborative Cancer
Research
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
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”
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
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
CCSG/Collaborative Research
• Shared core facility support
• Typical examples
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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
CCSG/Collaborative Research
• Shared core facility support
• Specialized examples
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Circulating tumor cells
Genetic counseling
Xenograft development
Antibody development
Tobacco product assessment
Experimental radiation
Many others
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
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
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IND/IDE applications
Purchase core support
Pharmacokinetics
Early phase trials personnel
CCSG/Collaborative Research
• Developmental funds
• Allow Cancer Centers to
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Take risks
Strengthen weaker scientific areas
Explore innovative ideas
Explore new collaborations
Explore new technologies
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
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
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)
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)
Summary
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