Definitive Contract 75F40122C00186
- Not listed
- This federal contract award to Purdue University, a non-profit educational institution, is valued at $794,004.00. The award was made by the Food and Drug Administration (FDA) under its Broad Agency Announcement for Advanced Regulatory Science, which is a research and development program focused on modernizing regulatory science to support the FDA's mission. The contract requires Purdue to construct extensive databases and develop statistical analysis tools using Python and SAS software to...
- 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 federal contract was awarded by the Department of Health and Human Services Food and Drug Administration (FDA) to Rutgers, The State University for an "Integrated Toolbox for Digital Design, Scale-up, Control, and Optimization of Advanced API Manufacturing Processes" with a potential value of $4,198,914.00. The contract is a definitive, cost-no-fee agreement with a completion date of September 30, 2024. Rutgers University is serving as the prime contractor, with Purdue...
- This is a $699,087 firm-fixed price definitive contract awarded by the Food and Drug Administration (FDA) to Duke University, a prestigious private research institution located in Durham, North Carolina. The contract is for basic and applied research and development to support regulatory science and innovation, in alignment with the FDA's mission to protect and promote public health. This award is part of the FDA's agency-wide Broad Agency Announcement (BAA) for research and development. The...
- The U.S. Food and Drug Administration (FDA) awarded a $696,359 firm-fixed-price contract to Duke University's Office of Research Administration Division to conduct research and development activities in support of regulatory science and innovation. The contract, which does not have a set-aside designation, originated from a Broad Agency Announcement (BAA) that solicits advanced proposals across nine key areas to advance scientific knowledge in support of the FDA's mission to protect public...
- This is a $999,347.00 definitive contract awarded by the Food and Drug Administration (FDA) to Rutgers, The State University, a non-profit research university, to develop and implement an AI/ML toolbox for the digitalization of advanced modular continuous API manufacturing processes. The contract is part of the FDA's Fiscal Year 2025 Broad Agency Announcement (BAA) for Research and Development to Support Regulatory Science and Innovation, which seeks to advance scientific knowledge in areas that...
- 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...
- The U.S. Food and Drug Administration (FDA) has awarded a Firm Fixed Price Definitive Contract worth $1,531,286.00 to Purdue University to perform research on "ADVANCING BISPECIFIC ENGAGERS FOR NK IMMUNOTHERAPY IN PEDIATRIC GLIOMAS" under Broad Agency Announcement FY24C1BP30. The contract has a period of performance through September 29, 2029. Purdue University, a not-for-profit 1862 Land Grant College and educational institution, will serve as the prime contractor. This award is not...
- This is a Definitive Contract awarded by the Food and Drug Administration (FDA) to the Massachusetts Institute of Technology (MIT) for the development of an integrated cGMP facility for mRNA manufacturing. The contract is valued at $82,182,000.00 and has a completion date of September 28, 2026. It is a Firm Fixed Price contract with no set-aside designation. MIT has subcontracted with The Pennsylvania State University and Rensselaer Polytechnic Institute to perform research related to mRNA...
- This federal contract, awarded by the Food and Drug Administration (FDA), provides $2,565,626.00 to the Massachusetts Institute of Technology (MIT) to conduct research and development on "Technologies to Enable Continuous Production of RAAV from SF9/Baculovirus Culture". The contract has no set-aside designation. The work is being performed under the FDA's Broad Agency Announcement for Advanced Regulatory Science, which seeks proposals across eight areas of regulatory science 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 Bioscience, LLC and Purdue University, who will support formulation, processing, and testing of the RNA nanoparticle platform. This award aligns with the FDA's mission to protect and promote public health through the development of new tools, standards, and approaches for evaluating the safety, efficacy, and quality of FDA-regulated products.
Name | Description | Solicitation Number | FederalAgency | Type | PostedDate |
|---|---|---|---|---|---|
FY22 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | FDABAA-22-00123 | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Solicitation 1/2 | 11/10/21, 11:48 AM | |
FY22 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science | FY22_BAA_Awards | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Award Notice 2/2 | 10/12/22, 1:17 PM |
ContractNumber | Description | Subcontractor | Prime Award | Dollars Obligated | Updated At |
|---|---|---|---|---|---|
SUB0000687S | Seran Bioscience, LLC | Definitive Contract 75F40122C00186 | $1.3m | 12/23/24 | |
SUB0000686S | Purdue University | Definitive Contract 75F40122C00186 | $2.3m | 10/23/24 |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00002 | Terminate for Convenience | $0 | 4/1/25 | |
| P00001 | Other Administrative Action | $0 | 11/15/23 | |
| Not listed | Not listed | $2.7m | 9/29/22 |