Novel approaches to support therapeutic development in ultra-rare cancers
Food and Drug Administration
Description
The purpose of this program is to support new approaches that can be applied to facilitate therapeutic development in ultra-rare pediatric and adult cancers, including molecularly-defined subsets of more common cancers.
Specific areas of interest include, but are not limited to, the following examples:
• Development of infrastructure for a coordination network and data repository for patient-level data across institutions and internationally to support drug development and regulatory decision-making for one or more ultra-rare cancers.
• Investigations to explore opportunities to develop and validate early clinical endpoints and other novel efficacy endpoints for evaluation of treatments for ultra-rare cancers.
• Development and implementation of a collaborative multi-stakeholder effort to support generation and use of real-world data leveraging a registry framework for use in development of new therapies for pediatric patients with diffuse midline glioma (DMG) (including diffuse intrinsic pontine glioma, DIPG).
• Innovative approaches to identify new biologically-driven opportunities for clinical development of previously approved drugs or biologics (hereafter referred to as drugs), including drugs for which development has been discontinued, in ultra-rare cancers.
• Research to develop novel approaches to preserve the availability of drugs for which commercial developers have discontinued adult development that have strong potential in ultra-rare cancers but lack financial incentives for commercial development
• Development of methods to incorporate use of telemedicine and/or pragmatic trial design elements (e.g., collecting laboratory and/or imaging data from local facilities) for patient assessments to facilitate enrollment of patients with ultra-rare cancers
• Development of nanoparticle-based delivery approaches for therapeutic nucleic acids targeting onco-fusion transcription factors in metastatic tumor animal models using targeted bioPROTAC degradation or genomic editing strategies. Successful efforts should demonstrate effective delivery and expression in-vivo to tumor cells, and downregulation of the target transcription factor protein while minimizing off-target effects and limiting sequestration of the nanoparticle by the liver, spleen, and lungs.
• Research to exhaustively characterize the plasma-membrane protein expression (surfaceome) of an ultra-rare cancer and the presumed healthy tissue of origin, as well as the resident-tissue stem cells, by single-cell transcriptomics and proteomics. These studies, and available correlative database analyses, should be designed to identify possible combinatorial signatures of plasma membrane proteins unique to the ultra-rare tumor. Tumors of interest include Sclerosing epithelioid fibrosarcoma and atypical teratoid rhabdoid tumors (ATRT).
Award amount
Varies, see official page
Eligibility
See the funder's official page.
Who can apply: Schools & Colleges, Nonprofits, Government & Tribal, For-Profit Businesses, Small Businesses
This is a forecasted opportunity. Watch Grants.gov for the official notice; applications open once it is posted. You'll need SAM.gov (UEI) and Grants.gov registrations.
The National Library of Medicine (NLM) intends to publish a Notice of Funding Opportunity (NOFO) to solicit applications for Regional Medical Libraries of the Network of the National Library of Medicine (NNLM).
Established in 1965 and organized geographically across the United States and its territories, the NNLM promotes and supports the initiatives, products, and services of the NLM and the National Institutes of Health (NIH). Over the years, the network has expanded its impact through strategic partnerships with a broad array of member organizations, including health sciences, hospital, academic, and public libraries; health professionals; data organizations; and community-based groups.
The NNLM’s core mission is to enable the effective use of - and contribution to - health information and data made available by the NLM and NIH. The network achieves this by providing professional development for librarians and information specialists, and by supporting access to health information and outreach through libraries and community organizations. A central emphasis of the NNLM is increasing awareness of and engagement with NIH programs and resources.
While the NNLM has traditionally focused on promoting NLM-specific products, it is now poised to expand its reach across the broader NIH community. The network will play a vital role in disseminating research findings, fostering community engagement and partnerships, and supporting participation in local clinical research. In doing so, the NNLM will enhance public understanding of NIH’s contributions and increase the use of NIH-supported information and data resources.
The NNLM consists of three major components: 1) the Network Coordinating Center (NCC), 2) Regional Medical Libraries (RMLs), and 3) the Network Training Center (NTC). This announcement specifically pertains to RMLs, with companion NOFOs forthcoming for the NCC and NTC.
The RMLs will be responsible for generating and maintaining an active, engaged membership of organizations focused on biomedical health information and data dissemination, training, and literacy. The RMLs will work with the NCC and NTC to promote the activities, products, and services of the NLM as well as the NIH. The RMLs will work with the NCC to evaluate progress, performance, and impact of the Network, including the use of common metrics (standardized measures collected and reported), as well as proposed site-specific goals. The RMLs will collaborate with the NTC to identify training needs and execute professional development or information access programming.
The RMLs should have strong competencies in building and managing long-term partnerships with groups and organizations, deep understanding of biomedical information and data sciences, and institutional connections with a health science library.
Grant authority that allows NLM to forecast this opportunity is as follows: Medical Library Assistance Act of 1965 (MLAA, P.L. 89-291).
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