Definitive Contract 75F40124C00106
- Not listed
- This is a $787,013 cost-reimbursement contract awarded by the Food and Drug Administration (FDA) to The Critical Path Institute (C-Path), a non-profit organization, for the "Clinical Evaluation and Qualification of Translational Kidney Safety Biomarkers." The contract, which does not have a set-aside designation, was awarded on September 8, 2016 and has a completion date of June 29, 2019. C-Path's work under this contract involves collaborating with industry, academia, and patient...
- This federal contract award is for $4,418,256.96 to The Critical Path Institute (C-Path), a non-profit organization, by the Food and Drug Administration (FDA). The contract was awarded under the FDA's Broad Agency Announcement (BAA) EETWP #63 to develop "A STANDARDIZED FRAMEWORK TO SUPPORT FDA QUALIFICATION OF COMPLEX IN VITRO MODELS FOR USE IN REGULATORY SUBMISSIONS." The BAA solicits research and development proposals to advance regulatory science in various areas of interest for...
- The Food and Drug Administration (FDA) awarded a definitive, cost-no-fee contract valued at $2.74 million to The Critical Path Institute (C-Path), a non-profit research organization based in Tucson, Arizona, under a Broad Agency Announcement (BAA) solicitation. The contract, awarded on September 30, 2019, supported the development of novel clinical outcome assessments for pediatric asthma to facilitate innovative, patient-focused drug development and aid regulatory decision-making. C-Path, which...
- This is a $727,115.00 firm fixed price delivery order contract awarded by the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Administration to Research Triangle Institute (RTI) International, a non-profit research organization. The contract is for the evaluation of the Kidney Innovation Accelerator (KidneyX) program, which is a public-private partnership between HHS and the American Society of Nephrology to accelerate the development of innovative therapies...
- This is a firm-fixed-price definitive contract awarded by the Food and Drug Administration (FDA), a civilian federal agency, to the Institute for Clinical Pharmacodynamics, Inc., a minority-owned for-profit organization based in Schenectady, New York. The $248,553.46 contract is for the development of modernized susceptibility guidance for the antibiotic nitrofurantoin using a dynamic urinary tract in vitro infection model and pharmacometric approaches. This award is part of the FDA's Broad...
- This is a Firm Fixed Price contract awarded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a civilian agency, to Talaria Inc., a small business contractor, under the Small Business Innovation Research (SBIR) Program Phase I. The contract, with a ceiling value of $113,644.00, is for the development of an "Adaptive Goal-Directed Adherence Tracking Enhancement" (TOPIC 033) for the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The contract...
- This is a federal contract awarded by the National Center for Advancing Translational Sciences (NCATS), a civilian agency within the Department of Health and Human Services (HHS), to Cyprotex US LLC, a leading contract research organization specializing in predictive toxicology and ADME (absorption, distribution, metabolism, and excretion) research. The $18,024.00 firm fixed-price purchase order contract is for the testing of two compounds against key ADME and DMPK (drug metabolism and...
- This federal contract award was issued by the National Center for Advancing Translational Sciences (NCATS), a civilian agency within the U.S. Department of Health and Human Services. The $3,053,804.06 task order was awarded to the IIT Research Institute (IITRI), a non-profit division of the Illinois Institute of Technology, to provide non-clinical safety assessment of a drug candidate (PTH-1A, inverse agonist) to support the development of a treatment for Jansen Metaphyseal Chondrodysplasia...
- This is a firm-fixed price contract awarded by the U.S. Food and Drug Administration (FDA) to the Icahn School of Medicine at Mount Sinai (Icahn School) for a research project titled "PREDICTOX- A KNOWLEDGE ENVIRONMENT FOR PREDICTION OF DRUG INDUCED ADVERSE EVENTS". The potential value of the contract is $1,400,000.00. The contract does not have a set-aside designation. The Icahn School, a private university and non-profit organization, will be the prime contractor performing the...
- Toxicologic Pathology Associates Inc. was awarded a $20.7 million definitive contract by the Department of Health and Human Services' Food and Drug Administration to provide onsite pathology services from July 2015 through July 2020. The contract has a small business set aside designation. As part of its mission to protect public health, the FDA utilizes pathology expertise to evaluate samples for issues impacting medical products and the safety of the food supply. This award draws on the...
This is a definitive, firm fixed-price federal contract awarded by the Food and Drug Administration (FDA) to the non-profit organization The Critical Path Institute (C-Path), doing business as C-Path. The contract, which is not set aside for specific business types, has a ceiling value of $3,376,000.00 and a completion date of August 21, 2028. The contract is for the development of drug development tools for autosomal dominant tubulointerstitial kidney disease (ADTKD). C-Path, the prime contractor, will ingest, map, and curate ADTKD clinical phenotyping patient-level data, which will be combined with biomarker measurements. C-Path will also perform a landscape analysis to assess the utility of other biochemical and imaging tools for ADTKD. Additionally, C-Path has a subcontractor, Wake Forest University Health Sciences (WFUHS), which will identify ADTKD patients and perform fluid and imaging longitudinal biomarker measurements. This contract award is part of the FDA's efforts to support the development of novel tools and approaches that can enhance decision-making in drug development and regulatory science. C-Path has a history of receiving federal contract and grant awards from the FDA to develop standardized frameworks, patient-reported outcome measures, and other drug development tools for various therapeutic areas.
ContractNumber | Description | Subcontractor | Prime Award | Dollars Obligated | Updated At |
|---|---|---|---|---|---|
FDA75F40124C00106WF2024AMD1S | Wake Forest University Health Sciences | Definitive Contract 75F40124C00106 | $323.2k | 10/28/25 | |
FDA75F40124C00106WF2024S | Wake Forest University Health Sciences | Definitive Contract 75F40124C00106 | $441.9k | 11/26/24 |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00004 | Other Administrative Action | $0 | 8/22/25 | |
| P00003 | Exercise an Option | $900.0k | 7/15/25 | |
| P00002 | Other Administrative Action | $0 | 5/1/25 | |
| P00001 | Other Administrative Action | $0 | 10/7/24 | |
| Not listed | Not listed | $951.0k | 8/16/24 |