NCI BSA approves 11 new and reissued concepts – The Cancer Letter

The Cancer Letter
Inside information on cancer research and drug development
The Cancer Letter
Inside information on cancer research and drug development
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
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:
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: 
Eligibility criteria for institutions include: 
Additional review criteria include: 
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.
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: 
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. 
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:
Guidelines for applicants include: 
Projects that do the following will not be reviewed:
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.
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:
Criteria for applicants include: 
The PAR prioritizes methodological work to assess the achievement of identified scientific and resource gaps. This permits investigators to focus on: 
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:
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: 
Proposed centers must include the following required components:
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: 
Evaluation methods include:
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: 
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: 
Successes of PIN at the end of a five-year cooperative agreement term may include:
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: 
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:  
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:
Requirements for funding include: 
Evaluation criteria and metrics of success include: 
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:
CIBMTR accomplishments between 2018-2020 included:
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: 
The original goals of the Patient Derived Xenograft Development and Trial Centers Network (PDXNet) in 2017 were to:
For this reissued RFA, the following goals were added: 
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: 
In its first four-year grant cycle, the collaborative PDXNet achieved the following steps: 
Deliverables in the second grant cycle will include:
The U54 grants and U24 grants support different research projects with different requirements. 
PDX Development and Trial Centers (PDTCs) (U54) comprise: 
The PDXNet Data Commons and Coordinating Center (PDCCC) (U24) will comprise:
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 (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:
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.
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: 
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. 
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