NCI BSA approves 11 new and reissued concepts

The NCI Board of Scientific Advisors approved 11 new and reissued concepts at a joint meeting of the BSA and the National Cancer Advisory Board Dec. 7-9.

Also at the meeting, NCI Director Ned Sharpless welcomed 14 new BSA members and seven new NCAB members, while recognizing the NCAB members retiring this year—Peter C. Adamson, Deborah Watkins Bruner, Timothy J. Ley, Max S. Wicha, and Yuan Chang.

The following concepts were presented and approved. Presentation slides are available here. 

Global Implementation Science for Equitable Cancer Control (New RFA)

The goal of this RFA is to bridge gaps in the implementation of cancer interventions in low- and middle-income countries. The project aims to build LMIC-based implementation science hubs that can:

• Address implementation gaps in cancer control in LMICs
• Build research capacity for cancer control implementation science in LMICs
• Foster stakeholder engagement between LMIC researchers and practitioners
• Enhance the ability of LMIC institutions to serve as regional experts in implementation science 

The project, submitted by the Office of the Director, will receive funding through the U54 grant.

The RFA anticipates supporting four research projects lasting five years. $4 million is slated to be set aside for the first year of each project, with a total budget of $20 million for the whole project period. 

Each award will include two investigator-initiated research projects and two core projects. The award date is summer 2023. 

These research projects may focus on, for example, understanding modifiable barriers and facilitators to implementation, evaluating implementation processes and better integrating cancer control services, or testing the cost-effectiveness and impact of strategies to deliver cancer control interventions.

Priority research questions include: 

• How do we adapt cancer control interventions to LMIC settings?
• How do we efficiently bundle cancer control services?
• How do we integrate cancer control into primary care and other care settings?
• What are the best ways to decentralize cancer control services to community settings?
• How do we enhance retention across the continuum of cancer care in typically fragmented systems?

Eligibility criteria for institutions include: 

• PI or MPI must be from an LMIC-based institution
• Applicants from US-based institutions must have LMIC-based MPI
• Applicants must propose two implementation research projects and two cores (i.e., administrative and research capacity-building)

Additional review criteria include: 

• Demonstrate strong partnerships and history of collaboration
• Demonstrate implementation science expertise
• Address high priority cancer control implementation gaps in LMIC
• Use appropriate implementation science approaches
• Demonstrate LMIC institutional support for implementation science

There are several metrics that may indicate the success of this RFA, such as: the number of new LMIC-based investigators trained in implementation science and applying for implementation science grants; the number of new collaborations across LMIC-based institutions; peer-reviewed publications demonstrating the use of implementation science approaches in LMIC-based studies; and the generation of evidence that informs national and international policies and practice in LMICs.

PREVENT Cancer Preclinical Drug Development Program (Reissue RFP)

This reissued RFP aims to develop innovative agents and biomarkers for cancer prevention toward clinical translation, with a focus on molecularly targeted or immuno-preventive agents and response-predictive biomarkers.

The RFP was submitted by the Division of Cancer Prevention. PREVENT is not a grant program. 

PREVENT was established 10 years ago. Over this time, the focus of the project has shifted from organ-site centric preventative agents to precision prevention. Since 2011, PREVENT has expanded its portfolio of molecular agents, developed higher-tech research capabilities, and improved oversight of its projects. PREVENT has advanced seven agents to clinical development, six of these since 2017. 

Key research questions, based on lessons from terminated projects, include: 

• Are preclinical models based not only on organ-site specific pathology, but the involvement of oncogene(s) of interest?
• Are molecular or antigenic targets expressed in the target tissue?
• Are the phenotypic outcomes of new animal models reproducible?
• Have PK/PD studies been incorporated to ensure test agents reached the target tissue?
• Is immunogenicity linked to antitumor activity?
• Have specific target cohort(s) been envisioned at the outset? Have clinical trial teams been consulted for input?

Applications for PREVENT projects are peer-reviewed, ranked by an external review panel, and then selected by a management committee. PREVENT projects are contract-based. 

The already approved FY22 budget for PREVENT totals $11 million, with $3.6 million dedicated to efficacy, $3.7 million to toxicology and pharmacology, and $3.7 million to Current Good Manufacturing Practice adherence. With the expectation that PREVENT will expand over the next five years, the projected budget increases annually to a total of $17 million in 2027. 

Cancer Epidemiology Cohorts: Research Opportunities in Established Studies (PAR)

This program announcement with review (PAR) aims to provide continued support for established cohort studies that address novel research questions across the cancer control continuum. It replaces the expiring PAR 20-294 (Cohort Infrastructure for Cancer Epidemiology Cohorts), such that projects funded by PAR 20-294 must see through the expiration of their current grants before applying for more funding. 

Proposed by the Division of Cancer Control and Population Sciences, the PAR will receive funding through the U01 grant. 

There is no specific budget cap for projects under this PAR; projects will receive funding twice per year for three years, and applicants should propose up to five years of funding. There must be an Awaiting Receipt of Application for above $500,000 in direct costs per year and pre-submission meetings are required for budgets above $700,000 per year. 

A program announcement with review by a special emphasis panel is requested.

There are currently 31 cancer epidemiology cohorts in the DCCPS portfolio, with the following characteristics:

• 1.1 million participants
• More women (76%) than men
• Racial/ethnic distribution: 66% white, 17% Black, 7% Asian, and 6% Hispanic
• Many of the longstanding cohorts have older populations (>65 years old)
• Distribution roughly reflects the proportion of white, Black, and Asian Americans, but the number of Hispanics included in these cohorts is considerably less than current U.S. population (18% in the 2020 Census)

Guidelines for applicants include: 

• Must address key scientific gaps
• Aims must include hypothesis-based research questions
• Core infrastructure support is expected
• Must justify study methods (e.g., data collection, proposed assays) based on the research in aims
• Priority given to novel research that includes understudied populations or directly informs future interventions, guidelines, and/or clinical management strategies

Projects that do the following will not be reviewed:

• Initiate new cohorts
• Do not include hypothesis-based research based on data from an established longitudinal cohort study in the specific aims
• Have data and/or resource sharing plans that do not comply with NIH policy and follow the FAIR (Findability, Accessibility, Interoperability, Reusability) principles.

The NCAB Working Group on Population Science made several recommendations related to this PAR, advising that: NCI should continue providing sufficient infrastructure support for cohorts to conduct or facilitate research that addresses critical scientific gaps; peer-review processes should include review of justification for continued follow-up of the cohort, including scientific yield; cohorts should consider current and emerging gaps in research and comprise appropriate populations; and survivor cohorts should address current and emerging research gaps by cancer type and/or treatment.

Cancer Epidemiology Cohorts: Building the Next Generation of Research Cohorts (Clinical trials not allowed) (PAR)

The goals of this proposed concept are to support the next generation of population-based cancer epidemiology cohorts that address critical scientific and resource gaps, such as emerging and unique exposures in relation to cancer risk and outcomes and understudied populations.

The PAR was submitted by the Epidemiology and Genomics Research Program/Division of Cancer Control and Population Sciences. 

The concept will receive funding through the U01 grant.

No budget cap for projects under the PAR is specified. Projects will receive funding twice a year for three years; applicants can propose up to five years of funding. There will be a review process to assess the scope and appropriateness of budgets. There must be an Awaiting Receipt of Application for above $500,000 in direct costs per year and pre-submission meetings are required for budgets above $700,000 per year. 

According to the presentation of this PAR, new cohorts are needed for a number of reasons:

• Changing demographic and environmental landscape
  • Evolving cancer-related burden with implications on cancer control and prevention
• Next generation cancer epidemiology cohorts
  • Meet critically needed resource gaps
  • Enable investigations of new scientific questions
  • Foster scientific innovation and adaptation of new technologies

Criteria for applicants include: 

• Must address key scientific and resource gaps
  • Review existing cohorts
  • Justify sample size, study population, and data collection
• Key features: Methodological work and community engagement
• Applicants responsive may include, though not limited to:
  • Testing of recruitment and retention strategies, relevant for hard-to-reach populations
  • Testing novel methods/approaches for data collection and/or assessment
  • Assessing intermediate markers of carcinogenesis, behavioral outcomes, or healthcare utilization
• Established cohorts are not appropriate for this funding opportunity announcement

The PAR prioritizes methodological work to assess the achievement of identified scientific and resource gaps. This permits investigators to focus on: 

• Approaches to engage, recruit, and retain
• Optimal and novel methods for data collection and assessment
  • Diverse exposures and biospecimens
  • Linkage to existing databases to obtain other information/data (SES-factors, neighborhood factors, geographic/environmental, healthcare delivery)
• Short-term research questions

Cancer Control Research in Persistent Poverty Areas (RFA/Coop. Agr.)

This RFA/Coop. Agr. aims to conduct cancer control and prevention research in partnership with communities and clinics in persistent poverty areas. Its goals include:

• Developing data integration and sharing processes, leveraging existing data resources, and/or conducting preliminary data collection to improve understanding of the cancer burden
• Conducting multilevel/multifactorial interventions developed with communities and clinics located in or serving persistent poverty areas
• Developing and implementing training of transdisciplinary teams of junior researchers to conduct research in underserved communities for cancer prevention and control

Submitted by the Division of Cancer Control and Population Sciences, the RFA/Coop. Agr. will receive funding through the U54 grant. 

The RFA/Coop. Agr. is requesting $10 million per year to support four U54 centers, for a total cost of up to $50 million over five years (with funding beginning FY2023). There is an anticipated direct cost of $1.5 million per center per year. 

Persistent poverty areas are defined as having poverty rates of 20% or more in U.S. Census data from the 1980, 1990, and 2000 decennial censuses and the 2007-11 American Community Survey 5-year estimates. There are 353 counties across 30 states matching this definition; 85.3% of the counties are nonmetro and nearly 84% are located in the South. 

Identifying persistent poverty using the county level definition is limited because it excludes smaller areas of extreme poverty. The NCI has worked with USDA to extend the definition to the census tract level for this funding announcement, to achieve broader representation. 

Targeting persistent poverty areas for cancer prevention control is important because an NCI study found that people who live in persistent poverty counties are more likely to die from cancer than people in other counties. This risk was greater than the heightened risk seen in areas experiencing current—but not persistent—poverty.

Each research center can be managed by multiple PIs, and may include multiple institutions, health systems, and community partners—therefore, the estimated ceiling per research center is based on the structure of each grant and the need to include both full research and pilot studies.

The grant supports two pilot projects, for which applicants are asked to set aside 1.5% of the direct costs per year for the entire funding period. One pilot project will be an intervention study. The RFA/Coop. Agr. also encourages a cross-center (multisite) pilot. Pilot projects will be decided by the steering committee.

Study criteria include: 

• Studies should be proposed from the provided list of census tracts
• To address issues related to persistent poverty, studies are to focus on community, institutional, and structural levels
• Studies should be multilevel and multifactorial
• Studies should include measures of the social context and needs of the population(s)
• Intervention studies can adopt quasi-experimental designs (RCT is preferred but not required)
• No drug or clinical trial recruitment studies are allowed
• Studies should address issues of sustainability of the program and training 

Proposed centers must include the following required components:

• Administrative core
• Research/data infrastructure core
• Research projects (minimum two, with one intervention project)
• Pilot research projects (minimum two, with one intervention project)
• Investigator development core

Projects should focus on investigating the effects of poverty and its associated factors at the structural and institutional levels. This may involve studying interrelated factors inherent to the economy—like employment, income, and education.

Targeted outcome examples include: 

• Increase cancer screening (mammography, colonoscopy, low-dose CT, Pap test)
• Increase cancer control prevention strategies (physical activity, nutrition, smoking)
• Improve care coordination
• Increase HPV vaccination rates
• Improve survivorship care

Evaluation methods include:

• Formation of a steering committee comprised of NCI staff, project PIs, and collaborators will meet monthly to assess both short- and long-term accomplishments that determine whether the major scientific aims are being met among the various project components
• Formation of working groups (and ad hoc groups) in accordance with the needs of the centers, such as junior investigators, methodology, etc., will assist in providing feedback to the steering committee.
• Annual meetings and monthly calls will allow for progress on projects to be assessed periodically

Pediatric Immunotherapy Network (RFA/Coop. Agr.)

The Pediatric Immunotherapy Network aims to develop translatable novel immunotherapy approaches for children and adolescents with solid tumors, including brain tumors, toward eventual clinical applications, with clinical trials optional.

The project has identified several gaps and opportunities in the treatment of pediatric solid and brain tumors, including: 

• Targetable antigenic epitopes, binders, and immunotherapy agents
• Elucidation of immune evasion mechanisms
• Pediatric preclinical models especially for brain tumors
• Resources for developing protein therapeutics, IND-enabling studies, and cGMP manufacturing
• Predictive biomarkers, analytical technologies for immune monitoring and opportunities for reverse translation

This RFA will receive funding through the U01 grant. PIN was submitted by the Division of Cancer Treatment and Diagnosis/Division of Cancer Biology. 

PIN anticipates six to eight awards between 2023-2027, each with a yearly total cost of $450,000. Collaborative administrative supplement awards (given between years 2-4) and network support funds are anticipated to cost $0.5-1 million in total cost per year, depending on the number of awards given. 

Thus, the total cost per year of PIN is anticipated to be $6 million and the total network cost over five years is $30 million. 

PIN will include a steering committee, consisting of the U01 project investigators and NCI staff. Patient advocates and additional NIH-funded pediatric immunotherapy researchers will be added as associate members. Administrative coordination for PIN will be provided by one of the U01 sites in partnership with NCI staff.

Example implementation plans include: 

• Discover novel pediatric tumor-associated antigens
• Analyze pediatric-specific immune responses associated with response or resistance
• Molecular and immune profiling of pediatric solid tumors
• Modulate the pediatric tumor microenvironment to make immunotherapy agents (e.g., CAR T cells) more effective
• Develop, test, and optimize preclinical agents for cold pediatric tumors
• Reverse translation studies using clinical specimens to interrogate mechanisms of action or resistance to immunotherapy

Successes of PIN at the end of a five-year cooperative agreement term may include:

• Discovery, development, and validation of novel immuno-oncology targets
• Pre-clinical testing and development of single or combination of immunotherapy agents
• Novel mechanistic insights into the tumor microenvironment, response or resistance to immunotherapies
• Conduct of IND-enabling studies
• Promotion of novel immunotherapy agent(s) into a pilot clinical trial

Integrating Health Disparities into Immuno-Oncology Research (RFA)

This RFA aims to integrate health disparities into immuno-oncology research. The end goal is to build a cohort of immuno-oncology P01s, or other multidisciplinary research projects, with integrated health disparities research.

There are currently research gaps in health disparities in immuno-oncology, such as: 

• Understanding inflammatory, metabolic, and immune profiles of immunotherapy treatment response across under-represented populations 
• Investigating genetic, immune signatures, immune infiltrates, and/or distinct tumor immune microenvironments that may underlie the cancer health disparities

An analysis found that between FY2017-21, 333 investigator-initiated P01 applications were submitted to NCI. Out of these applications, 18% (n=59) had to do with immunotherapy—12 were awarded, none addressing health disparities. Just 1.5% of the applications submitted (n=5) addressed health disparities—one was awarded, but it wasn’t related to immunology. 

Example research projects integrating health disparities include:  

• Characterizing unique gene expression and immune infiltration profiles in breast cancer subtypes across African American and Caucasian patients
• Understanding how distinct genetic and immune signatures in the tumor microenvironment are associated with colon cancer disparities
• Developing animal models that recapitulate the breadth of immune responses across underrepresented populations
• Characterizing disparities in immunotherapy response, resistance, and immune-related adverse events

This RFA was submitted by the Division of Cancer Biology/Office of the Director. It will be funded through the P20 grant. 

The budget accounts for two to three awards, each lasting two years, capped at $250,000 in direct costs per year. The total budget allotted for the first year is $1 million.

Multidisciplinary research projects funded through this initiative will support ongoing NCI programs through NOSIs (Notice of Special Interest) and will use P20s (exploratory grants) to launch feasibility and planning studies to build collaborations, compile appropriate sample sets, and generate preliminary data for subsequent application submissions.

These P20 grants will generate:

• Initial studies to establish sufficiently powered and/or well-curated specimens from groups under-represented in clinical trials
• Feasibility/pilot studies to test exploratory or novel hypotheses on immune mechanisms, immune response, and/or treatment response/resistance underlying cancer health disparities
• Planning studies to build collaborations/teams, generate resources (e.g., tools, reagents), or other collaborative research infrastructure

Requirements for funding include: 

• Integration of underserved populations
• Multidisciplinary teams with complementary expertise in both cancer health disparities and immuno-oncology research

Evaluation criteria and metrics of success include: 

• Establishment of complementary, multidisciplinary research teams with strengths in both cancer health disparities and immuno-oncology research
• Pre-application or submission of well-integrated multidisciplinary research projects (e.g., P01s or R01s)
• If the P20 team is developing an investigator-initiated program project (P01), has the P20 team formed an advisory board to review an initial P01 application submission plan?
• Publications and metrics of collaboration

A Data Resource for Analyzing and Supporting Blood and Marrow Transplants and Cellular Immunotherapy Research (Reissue RFA/Coop. Agr./Limited Comp.)

This reissued limited competition RFA/Coop. Agr. aims to renew the Center for International Blood and Marrow Transplant Research Registry. 

The RFA was submitted by the Division of Cancer Treatment and Diagnosis. It will receive funding through the U24 grant. 

Funded by NCI for 30-plus years with support by NHLBI and NIAID, the CIBMTR is:

• The only publicly available, comprehensive U.S. Data Resource for hematopoietic stem cell transplant (HCT) and adoptive cell therapy (ACT) research
• A resource for researchers, clinicians, HHS policymakers, and pharmaceutical companies
• Supporting FDA CAR T-cell product safety and efficacy data and CMS coverage with evidence development trials

CIBMTR accomplishments between 2018-2020 included:

• Enrolled ~72,000 new cell therapy patients
• Enrolled 5,000 recipients receiving ACT for transplants or as a primary therapy
• Adapted forms to collect COVID-19 data, producing five scientific papers
• Created new forms to capture data on solid tumors
• Published 267 data analysis and research manuscripts
• Distributed 13,000 samples for secondary research
• Enhanced data quality by training 85 data managers
• Piloted technology platforms to automate data acquisition and reduce the burden of data entry
• Engaged in five Medicare Coverage with Evidence Development Trials

CIBMTR facilitates CAR T-cell data collection via public and private partnerships. With its industry partners, CIBMTR has launched five long-term follow-up studies for FDA required Post-Market Safety Reporting since 2018. The organization also works with NCI-funded collaborators, such as the AIDS Malignancy Consortium, Blood and Marrow Clinical Trials Network, and National Clinical Trials Network.

Plans for the RFA reissuance include: 

• Expand HCT and ACT data collection used to treat malignant and non-malignant blood disorders 
• Focus on special initiatives including HHS evidence gathering programs:
  • FDA-required long-term follow-up studies with industry—expected to be over 9000 ACT annually in next few years
  • CMS Medicare Coverage with Evidence Development Trials 
• Adapt the database for the collection of ACT for solid tumors as well as new ACT products (as appropriate)
• Support trial designs and data analyses for observational and interventional studies

Patient Derived Xenograft Development and Trial Centers Network & PDX Data Commons and Coordinating Center for PDXNet (Reissue RFA)

The original goals of the Patient Derived Xenograft Development and Trial Centers Network (PDXNet) in 2017 were to:

• Develop PDX trials that test original therapeutic strategies in large scale PDX collections, that could then provide preclinical in vivo evidence to support novel early phase clinical trials
• Address critical scientific issues related to the use of PDXs as predictive models for clinical benefit through the collaborative network structure of PDXNet
• Contribute new PDX models to NCI’s Patient Derived Models Repository (PDMR) for distribution to the wider research community

For this reissued RFA, the following goals were added: 

• Increase diverse representation and study of racial/ethnic minority populations in PDXNet and in the PDMR
• Advance cancer health disparity research

The reissue RFA was submitted by the Division of Cancer Treatment and Diagnosis (DCTD)/Office of the Director. The reissue for the PDXNet: Patient Derived Xenograft (PDX) Development & Trial Centers (PDTCs) uses the U54 grant and the PDX Data Commons and Coordinating Center (PDCCC) for PDXNet uses the U24 grant. 

The current annual total cost for PDXNet is $10.5 million. The estimated total cost for the full project period (FY23-27) is $40 million. 

Currently, the four Division of Cancer Treatment and Diagnosis U54 PDTCs cost $1.25 million each. The two Center to Reduce Cancer Health Disparities (CRCHD) U54 PDTCs cost $1.25 million each. The one PDXNet U24 PDCCC costs $1.5 million total per year. The supplement program costs $1.5 million total per year. 

The proposed annual total cost for the second grant cycle is $8 million per year. The breakdown of this proposed budget follows: 

• A decrease from six U54 PDTCs to five U54 PDTCs (three or four from DCTD and one or two from CRCHD based on priority score), costing $6.25 million per year (a decrease of $1.25 million)
• PDXNet U24 PDCCC will cost $1 million per year (a decrease of $0.5 million)
• The supplement program will cost $0.8 million per year (a decrease of $0.7 million)

In its first four-year grant cycle, the collaborative PDXNet achieved the following steps: 

• Established collaboration with CRCHD to bring in two PDTCs focused on disparity research
  • Developed a culture of collaboration among all grantees with multiple collaborative research projects
  • Demonstration of multicenter experimental reproducibility of drug response studies using PD models published in Cancer Research
  • Demonstration of CNV fidelity in successive PDX passages published in Nature Genetics
  • Demonstration of therapeutic target pathway identification in PDXNet PDX collections published in Nature Communications 
  • Ongoing cross-network collaborative study of drug efficacy evaluation methods in PDX models, manuscript in preparation
  • 10 other active intra-network collaborations coordinated by PDCCC
• 690 unique PDX models donated to the NCI PDMR
  • Most in the process of expansion and characterization prior to public distribution
• Preclinical evidence developed for 10 CTEP LOIs
• Website established for internal network collaboration and public access
  • Development of the PDXNet portal as a platform for data sharing, described in a paper submitted for publication and posted online
• Collaborative projects necessitated development of workflows to facilitate collaboration; 15 validated workflows publicly shared via PDXNet portal
• 88 publications from original research projects

Deliverables in the second grant cycle will include:

• Develop and apply drug response evaluation standards across PDXNet; advocate for these to be adopted across the wider research community
• Provide robust preclinical in vivo data of targeted agent combinations to prioritize at least 20 clinical trials in NCI clinical trials networks (double from first cycle)
• Establish more strategic donations of models to PDMR—identify significant gaps in the NCI PDMR PDX repository collection, and orchestrate targeted contributions to fill those gaps
  • Ex. racial/ethnic underserved and clinical relapsed/resistant models
• Create methods and workflows to integrate complex omic and imaging data from multiple sites into a searchable PDX database for model selection; make these tools available
• Create productive collaborations between PDXNet scientists and early phase clinical trialists

The U54 grants and U24 grants support different research projects with different requirements. 

PDX Development and Trial Centers (PDTCs) (U54) comprise: 

• Research projects (at least two) in mechanism-based drug combinations in genetically or histologically defined tumor subgroups that explore the relation of the tumor characteristics to tumor drug response
  • Primary goal is preclinical evidence generation to support early phase studies of NCI-IND agents in NCI-funded clinical trial networks
  • Focus on new NCI-IND agents coming into portfolio to accelerate trials
  • CRCHD track: Focus on models relevant to cancer health disparities
• Four required cores
  • Administrative core
  • Bioinformatics core—to facilitate data sharing and to interact with PDCCC data commons
  • PDX core—including PDX maintenance and animal facilities
  • Pilot projects core—for PDXNet intra-network collaboration and to interact with investigators chosen through administrative supplement program

The PDXNet Data Commons and Coordinating Center (PDCCC) (U24) will comprise:

• Bioinformatics Core
  • Lead development and implementation of data collection standards, workflows, and SOPs for harmonization and data integration across different PDTCs
  • Centralized center for analysis of PDX response to agents across PDTCs
  • Maintain the PDXNet website and database
  • Share PDXNet data with NCI GDC and the larger research community
• Administrative Core
  • Grant administration of the PDTC and PDCCC
  • Scientifically-informed project management of PDXNet collaborative projects
  • Logistical and administrative assistance in arranging network-wide meetings, workshops and PDXNet Executive Committee

Non-U54 investigators may apply for PDXNet collaboration through an administrative supplemental award application process. In the current RFA, laboratory scientists apply to collaborate with PDXNet scientists. In the proposed RFA, to boost productivity, clinician scientists can apply to collaborate with PDXNet scientists.

Systematic Testing of Radionuclides in Preclinical Experiments (PAR)

Systematic Testing of Radionuclides in Preclinical Experiments (STRIPE) is requesting a PAR to solicit proposals that address knowledge gaps in how radiopharmaceutical therapy (RPT) agents affect the biology of cancer cells, normal cells, and the microenvironment. 

The project seeks to support interdisciplinary collaborations across the fields of RPT and pre-clinical cancer biology, strengthening the pre-clinical foundation of the RPT field and promoting advances in biology-based targeting strategies.

This PAR was submitted by the Division of Cancer Treatment and Diagnosis/Office of the Director. The PAR will solicit R01 and R21 applications, with funding from a research project grants source—there is currently no funding set aside for the project. STRIPE anticipates 7-10 applications per round for three years. 

STRIPE seeks to address the following gaps:

• Unmet needs in foundational pre-clinical RPT research
  • Limited knowledge on radionuclide radiation biology effects in tumor and normal tissues (e.g., guide particle choice, low dose-rate exposure, optimizing combinations (RPT + chemo, timing), late effects)
  • Inadequate level of pre-clinical research to catalyze targeting strategy development 
  • Integration of RPT with –omic, molecular characterization, and enabling technologies
• Threshold for wider adoption of RPT into cancer research
  • Radioactivity license (open-source lab) can be an impediment for non-RPT researchers
  • Isolating effect on RPT field in leveraging full range of cancer modeling for discovery, optimization, and validation

With these unmet needs in mind, the goal of STRIPE is to form interdisciplinary projects that will launch pre-clinical experiments to understand RPT effects on the biology of cancer cells, normal cells, and the microenvironment toward the development of targeted interventions.

This research will ​​help identify new targeting strategies for RPT and test/optimize novel RPT-molecular targeted therapy combinations.

Informatics Technology for Cancer Research (Reissue RFA/Coop. Agr.)

The Informatics Technology for Cancer Research (ITCR) at NCI promotes the integration of IT development with cancer research, supports different stages of the IT development lifecycle, enables technology dissemination and software reuse, and fosters communication among development teams. 

The program has granted 130 awards to date. Some example areas of research include: 

• Data management, storage, organization, and data sharing resources
• Data mining, visualization, and analytics tools and platforms
• Data annotation tools, including common data elements and ontologies
• Statistical methods and machine learning methods
• Natural language processing and text mining approaches
• Clinical decision support and treatment planning tools
• Technology to support next generation clinical trials and clinical trial matching

The ITCR toolkit can be found here.

Submitted by the Office of the Director, this ITCR renewal proposal includes the goals of  balancing early and late stage development funding through program team prioritization, engaging SBIR for collaboration with industrial partners and focused contract topics, and discontinuing Competitive Revisions due to a low response rate. 

There are a number of new awards included in the ITCR renewal. 

The proposed budget accounts for: five R21 awards per year, each costing $275,000 over two years; five U01 awards per year, each costing $300,000 annually for three years; four U24 Advanced Development awards per year, each costing $600,000 annually for up to five years; and one U24 Sustainment award per year with no funding cap, lasting up to five years. Out of these award amounts, 10% will be set aside annually for collaborations. 

The total requested budget for the renewal is $8 million.