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

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 * 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 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 * 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 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 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 IND/IDE applications Purchase core support Pharmacokinetics Early phase trials personnel

CCSG/Collaborative Research Developmental funds Allow Cancer Centers to 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