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 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 $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...
The Federal Contract Award ID 75F40119C10135 was issued by the Food and Drug Administration (FDA), a civilian agency, to The Critical Path Institute (C-Path), a non-profit organization, to develop novel clinical outcome assessments for pediatric asthma. The purpose is to facilitate innovative patient-focused drug development and aid regulatory decision-making. This is a definitive cost-no-fee contract with a ceiling value of $2,757,771.00 and a completion date of September 29, 2025. The contract...
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...
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 definitive, firm fixed-price contract was awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to CFD Research Corporation, a for-profit organization, to develop a multiscale computational framework for assessing the bioequivalence of orally inhaled drugs. The $499,761 contract does not have a set-aside designation. The original solicitation was a Broad Agency Announcement (BAA) seeking research and development to advance FDA's mission of protecting...
The U.S. Food and Drug Administration (FDA) awarded a $1,155,442.55 Cost Plus Fixed Fee contract to Cubrc, Inc. to conduct research and development on the "Immunogenicity Risk of Peptide Drug Generics and Their Impurities: In Silico and In Vitro Assessment and Validation Methods." The contract, which has a period of performance ending September 27, 2022, was issued under the FDA's Broad Agency Announcement (BAA) solicitation for advanced research and development to support regulatory...
This is a $950,450 cost-plus-fixed-fee contract awarded by the Food and Drug Administration (FDA) to CFD Research Corporation, a small business, to develop a Computational Fluid Dynamics (CFD)-Physiologically-Based Pharmacokinetic (PBPK) framework to support the bioequivalence evaluation of ophthalmic drugs. The contract is part of the FDA's Broad Agency Announcement (BAA) for research and development to advance regulatory science and innovation, with no set-aside used. CFD Research...
This federal contract award, valued at $811,126.00, was issued by the U.S. Food and Drug Administration (FDA) to Digital Medicine Society Inc., a non-profit organization based in Boston, Massachusetts. The contract was awarded under a Broad Agency Announcement (BAA) solicitation for research and development to support the FDA's regulatory science and innovation mission. The contract is a Definitive Contract with a Firm Fixed Price pricing type, and has an ultimate completion date of December 31,...