This is a definitive contract awarded by the Department of Health and Human Services' Food and Drug Administration (FDA) to The Critical Path Institute (C-Path), a non-profit organization. The contract, which does not have a set-aside designation, is for $1,594,872.00 and is for the development of novel kidney transplant drug development tools to enhance regulatory decision making and enable innovation in medical product development. The contract was awarded on September 19, 2018, with a...
This is a definitive contract awarded by the Department of Health and Human Services' Food and Drug Administration (FDA) to The Critical Path Institute (C-Path), a nonprofit organization, to provide services in support of the agency's Model-Informed Drug Development (MIDD) program for the evaluation and development of neurological drug products. The $1,128,848.00 firm fixed-price contract has an anticipated completion date of August 31, 2023. C-Path has previously supported the FDA's...
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 U.S. Food and Drug Administration (FDA) awarded a $2,757,771.00 definitive contract to The Critical Path Institute (C-Path), a non-profit organization, to develop novel clinical outcome assessments for pediatric asthma. The contract, which is not set aside for a specific business type, aims to facilitate innovative patient-focused drug development and aid regulatory decision-making. C-Path, a neutral third party, will collaborate with industry, academia, and patient groups to generate...
This is a $1,904,355.00 definitive cost-no-fee contract awarded by the Food and Drug Administration (FDA), a civilian government agency, to the Institute Of Quantitative Systems Pharmacology, a non-profit organization. The contract is for basic and applied research with two key objectives: (1) to test the hypothesis that variabilities in nanoparticle (NP) properties and tumor targets cause uncertainties in "FORMULA", and (2) to develop computational models to predict the...
This is a $724,461 firm-fixed-price definitive contract awarded by the Food and Drug Administration (FDA) to PPD Development LP, a global contract research organization (CRO) and subsidiary of Thermo Fisher Scientific. The contract is for the Cardiovascular-Kidney-Metabolic (CKM) Syndrome Patient-Reported Outcome (PRO) Burden Measure project, referenced as FDABAA-24-00123, with a performance period ending on November 15, 2026. PPD Development LP has significant experience supporting federal...
<p>This is a $9,671,431.00 Firm Fixed Price contract awarded by the Food and Drug Administration (FDA), a civilian federal agency, to Safe Health Systems, Inc., a self-certified small disadvantaged business. The contract is for stimulating innovation in clinical evaluations and personalized medicine to improve product development and patient outcome. The contract has no set-aside designation and has an ultimate completion date of March 27, 2026.</p>
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...
The Department of Health and Human Services' Food and Drug Administration (FDA) awarded a $1,275,361.26 definitive cost-no-fee contract to Alliance Nctn Foundation, a non-profit organization and foundation, to conduct the "Integrating Clinical Trials and Real World Endpoints Data (ICAREDATA) Data Capture and Standardization Study". This contract, with a performance period ending on September 29, 2024, is part of the FDA's broader efforts to advance regulatory science and support public...
This is a Cost No Fee definitive contract awarded by the Food and Drug Administration (FDA) to the Arkansas Research Alliance, a non-profit organization, for "Scientific and Methodological Advancements in Liquid Biopsies to Further the Development of Lung Cancer-Based Precision Medicine." The contract has a ceiling value of $754,003.90 and a performance period ending March 31, 2019. This contract was not set aside for any particular socioeconomic program. The contract supports the...