Project Grant R01FD008718
- Federal Project Grant Award Summary The Food and Drug Administration (FDA) awarded a $3.22 million Project Grant to the Research Institute at Nationwide Children's Hospital on September 25, 2025, under CFDA 93.103 (Food and Drug Administration Research) to conduct a Phase II, multi-arm, molecularly-guided umbrella clinical trial for children and young adults with high-grade gliomas (HGGs), including diffuse intrinsic pontine glioma (DIPG). This research initiative addresses a critical...
- Federal Cooperative Agreement Summary The Association of Food & Drug Officials (AFDO) received a $900,000 Cooperative Agreement from the Food and Drug Administration's Office of Regulatory Affairs under the Food and Drug Administration Research program (CFDA 93.103), awarded September 20, 2025, with completion targeted for August 31, 2028. AFDO will develop and maintain innovative information-sharing and research tools through the Integrated Food Safety System (IFSS) Collaboration/Research...
- Federal Grant Award Summary This $598,000 Project Grant, awarded March 15, 2026, by the National Institute on Drug Abuse under the Drug Use and Addiction Research Programs (CFDA 93.279), supports advanced research to detect emerging patterns in the illicit drug supply and their correlation with overdose trends. Massachusetts General Hospital's Research Management Division will deliver machine learning-driven analytical services to identify spatiotemporal change points in the prevalence of key...
- Federal Project Grant Award Summary The National Institutes of Health (NIH) Office of the Director awarded the University of Montana $727,781 under the Trans-NIH Research Support program (CFDA 93.310) on July 15, 2026, to examine the impacts of pharmacy-based preventive services (PPS) in pediatric populations. The research will leverage cross-state variation in PPS policies and policy changes over time to determine whether allowing pharmacists to deliver preventive services—including screenings,...
- Federal Project Grant Award Summary The Division of Information and Intelligent Systems, under the National Science Foundation's Computer and Information Science and Engineering program (CFDA 47.070), awarded a $280,000 Project Grant to The Ohio State University effective August 1, 2025, through July 31, 2027. This collaborative research initiative, titled "ACED: Building Molecule Generative Models for Drug Development via Conditional Diffusion and Multi-Property Optimization,"...
- Federal Project Grant Award Summary The National Institutes of Health (NIH) Office of the Director awarded $157,000 through the Trans-NIH Research Support program (CFDA 93.310) to Henry Ford Health + Michigan State University Health Sciences, effective August 18, 2025, with completion targeted for July 31, 2027. This project grant supports the development and evaluation of UTS-1401, a small-molecule radiation-mitigating agent designed to serve as a medical countermeasure for hematopoietic...
- Federal Project Grant Award Summary The Food and Drug Administration (FDA) awarded Boston Children's Hospital a $3.58 million Project Grant on September 25, 2025, under CFDA 93.103 (Food and Drug Administration Research) to conduct a clinical trial evaluating the safety and effectiveness of atipeksen, an antisense oligonucleotide (ASO) therapeutic for ataxia-telangiectasia (A-T). The trial, designated IND#144349, targets individuals with A-T who carry the specific ATM c.7865C>T mutation, a...
- Federal Project Grant Award Summary Harvard Medical School received a $125,000 Project Grant from the National Institute of General Medical Sciences (NIGMS) under the Biomedical Research and Research Training program (CFDA 93.859), awarded April 1, 2026, with completion targeted for March 31, 2028. The award funds research focused on developing chemical biosensors to accelerate pharmaceutical biocatalyst engineering, directly addressing manufacturing bottlenecks that contribute to drug...
- Federal Grant Award Summary The University of Michigan's Office of Research and Sponsored Projects received a $303,257 Project Grant award from the National Institutes of Health (NIH) Office of the Director under the Trans-NIH Research Support program (CFDA 93.310), effective June 10, 2025, with a completion date of May 31, 2026. The grant funds development and validation of ASGARD Version 2.0, an advanced computational drug repurposing framework designed to identify personalized cancer...
- Federal Grant Award Summary Nostopharma LLC received a $815,584 Project Grant award from the National Center for Advancing Translational Sciences (NCATS), CFDA 93.350, effective July 3, 2025 through June 30, 2027. The award funds preclinical proof-of-concept research for a novel localized drug delivery treatment addressing Fibrodysplasia Ossificans Progressiva (FOP), an ultrarare genetic disease affecting approximately 1 in 1.5-2.0 million live births. The primary deliverable is the...
The American Society of Health-System Pharmacists Inc. (ASHP) received a $3.0 million Project Grant from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research under the Food and Drug Administration Research program (CFDA 93.103), awarded September 25, 2025, with completion scheduled for August 31, 2028. The grant funds a comprehensive initiative to identify drugs vulnerable to supply-chain shortages or fraudulent activity and develop mitigation strategies through outsourcing facility production. ASHP will conduct a two-phase expert panel review process that applies supply-chain vulnerability assessments and shortage clinical impact analyses to prioritize drugs with shortage histories, older approval dates, essential medicine designation, or fraud risk. The assessment will evaluate factors including previous shortage duration, market consolidation, single/multi-source availability, product sales volume, therapeutic alternatives, and health outcome impacts. The project deliverables include a matrix categorizing drugs into four priority quadrants based on vulnerability and clinical impact levels, with prioritized drugs forwarded to a second expert panel. This panel, composed of specialists in sterile compounding, outsourcing facility good manufacturing practices, and pharmacy operations, will determine feasibility for production by outsourcing facilities while considering production scale capabilities and the needs of special populations such as pediatric patients. The initiative directly addresses FDA's regulatory science mission by providing actionable intelligence to prevent critical drug shortages and reduce supply-chain vulnerabilities that could compromise patient access to essential medications.Federal Project Grant Summary
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| Not listed | $3.0m | 9/24/25 |