This is a $4,999,953.00 firm fixed price definitive contract awarded by the Food and Drug Administration (FDA) to the National Institute for Pharmaceutical Technology & Education Inc. (Nipte), a non-profit organization. The contract was awarded under the FDA's Broad Agency Announcement mechanism to support research and development on a "model-based systems engineering approach to end-to-end pharmaceutical manufacturing of liquid" products. This contract is not associated with a...
This is a $5,000,001.00 definitive contract awarded by the Food and Drug Administration (FDA) to the Massachusetts Institute of Technology (MIT) for "APPLICATION OF SMART DATA ANALYTICS FOR BIOMANUFACTURING." The contract has no set-aside designation and is a cost-type contract without fee. The contract was awarded under the FDA's Broad Agency Announcement for Advanced Regulatory Science, which solicits research and development proposals across various regulatory science areas to...
This federal contract award to The Trustees of Princeton University, valued at $2,692,771.30, is for an Integrated Platform for Continuous RNA Nanoparticle Formulation and Drying. The award was made by the Food and Drug Administration (FDA) and is not associated with a set-aside program. The contract supports research and development to advance regulatory science in areas of interest to the FDA, as outlined in a Broad Agency Announcement (BAA) solicitation. Key subcontractors include Seran...
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...
<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 federal contract award, valued at $347,762.49, was issued by the Food and Drug Administration (FDA) to Northwestern University to conduct research and development supporting the FDA's Oncology Center of Excellence's Patient-Focused Drug Development (PFDD) program. The contract is a definitive, cost-no-fee contract with an ultimate completion date of December 30, 2024. The original solicitation was a Broad Agency Announcement (BAA) seeking proposals across eight areas of regulatory science...
This is a $3,956,154 cost-no-fee definitive contract awarded by the Food and Drug Administration (FDA) to The Leland Stanford Junior University (Stanford University) on September 30, 2020. The contract is for pathology and pathogenesis research on coronavirus infections in animal models, with a performance period through September 30, 2025. The contract was issued under a Broad Agency Announcement (BAA) from the FDA that solicits advanced research and development proposals to support...
This is a definitive cost-plus-fixed-fee contract awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to Physical Sciences Inc., a for-profit research and development company. The contract was awarded under FDA Broad Agency Announcement BAA-18-00123, titled "Single Vial Mass Flow Rate Sensor Assessment of Freeze Drying Heterogeneity", with Proposal Number PMQWP#195. The contract has a potential value of $959,248.00 and a completion date of December...
This is a $1,530,889.00 definitive contract awarded by the Food and Drug Administration (FDA) to the University of Connecticut (UConn) to conduct a research study titled "Investigating the Impact of API Purity, Excipient Source and Manufacturing Process on Performance and Quality of Complex siRNA Lipid Nanoparticles". The contract has a performance period ending on September 21, 2027 and is a cost-type contract with no fee. UConn, a non-profit 1862 land-grant university, has...
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...