Definitive Contract 75F40120C00157
- Not listed
- The Department of Health and Human Services Food and Drug Administration awarded a $1,064,514.29 cost plus fixed fee contract to Cubrc, Inc. for research and development services related to "Immunogenicity Risk of Peptide Drug Generics and their Impurities: In Silico and In Vitro Assessment and Validation Methods." This contract was awarded as a definitive contract, with no set-aside designation, under a Broad Agency Announcement that sought to advance scientific knowledge to support...
- The Food and Drug Administration awarded a $2.16 million firm fixed-price definitive contract to Cubrc, Inc., a Buffalo, New York-based non-profit research and development organization, on August 16, 2024, for developing universal control peptides for T-cell assays supporting immunogenicity research. The contract is scheduled for completion by September 30, 2026, and will be performed in Cheektowaga, New York. This award does not carry a small business set-aside designation. Cubrc brings...
- This federal contract award was made by the Food and Drug Administration (FDA), a civilian agency, to Qrono, Inc., a for-profit company specializing in medical and scientific research and development. The $694,584.58 cost-plus-fixed-fee contract, titled "Computational Drug Delivery: Leveraging Predictive Models to Develop Bioequivalent Generic Long-Acting Injections," is focused on developing innovative drug delivery systems and immunotherapy approaches. The contract has an ultimate...
- 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 $92,322 firm fixed-price purchase order awarded by the Food and Drug Administration (FDA) to Proimmune, Inc., a small business contractor, to provide services to the FDA's Center for Biologics Evaluation and Research (CBER), Office of Division of Plasma Protein Therapeutics' (DPPT) / Hemostasis Branch (HB). The contract is for determining a reliable and comprehensive identification of FVIII-derived peptides to compare processing by antigen presenting cells between wild-type and...
- This is a $1,085,530 definitive contract awarded by the Food and Drug Administration (FDA), a civilian agency, to Genentech Inc., a foreign-owned for-profit organization, to conduct basic and applied research and development to support regulatory science and innovation. The contract is a result of the FDA's Fiscal Year 2025 Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science, which is an agency-wide effort to advance scientific knowledge in specific...
- The U.S. Food and Drug Administration (FDA) awarded a $3,090,714.59 definitive cost no fee contract to DNA Hive LLC, a small disadvantaged business, to develop a next generation medical countermeasures scientific platform for regulatory evaluation and preparedness under Broad Agency Announcement (BAA) #FY25C3AP3. The contract has an ultimate completion date of September 29, 2028 and was awarded on September 23, 2025. The FDA BAA solicits basic and applied research and development proposals to...
- The U.S. Food and Drug Administration (FDA) awarded a $4,400,000.00 Cost Plus Fixed Fee contract to Continuus Pharmaceuticals, Inc. to support the "ADVANCEMENT OF INTEGRATED CONTINUOUS MANUFACTURING (ICM) UNIT OPERATIONS." This definitive contract does not have a set-aside designation and is scheduled to be completed by September 29, 2019. The contract is part of the FDA's efforts to advance integrated continuous manufacturing unit operations, which is a major program focus area for...
- The U.S. Food and Drug Administration (FDA) awarded a $515,769.89 firm fixed price definitive contract to the University of St. Gallen, a Swiss educational institution, to conduct research and develop tools to strengthen post-market surveillance of FDA-regulated products. The objective is to apply advanced analytics and hybrid artificial intelligence to improve risk identification. This contract was awarded under the FDA's Fiscal Year 2025 Broad Agency Announcement (BAA) for Advanced Research...
- This $291,618 definitive contract was awarded by the Food and Drug Administration (FDA) to the Institute For Clinical Pharmacodynamics, Inc. (ICPI), a for-profit, minority-owned organization. The contract is in support of the FDA's Combatting Antibiotic Resistant Bacteria (CARB) program and will have a period of performance through September 29, 2023. Under this contract, ICPI will provide pharmacometric analysis and modeling services to the FDA to support updating clinical breakpoints for the...
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 science and innovation. The prime contractor, Cubrc, Inc., is a non-profit research and development company, and they have subcontracted a portion of the work to Epivax Inc., a woman-owned small business specializing in immunoinformatics and computational biology. This research aims to advance scientific knowledge to help the FDA accomplish its mission of protecting public health.
Name | Description | Solicitation Number | FederalAgency | Type | PostedDate |
|---|---|---|---|---|---|
Food and Drug Administration Broad Agency Announcement (BAA) for the Advanced Research and Development of Regulatory Science - Amendment 2 | FDABAA-20-00123 | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Solicitation 1/2 | 9/27/19, 4:13 PM | |
Food and Drug Administration Broad Agency Announcement (BAA) for the Advanced Research and Development of Regulatory Science - Amendment 2 | FY20_BAA_Awards | Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services | Award Notice 2/2 | 10/21/20, 5:36 PM |
ContractNumber | Description | Subcontractor | Prime Award | Dollars Obligated | Updated At |
|---|---|---|---|---|---|
08248S1S | Epivax Inc. | Definitive Contract 75F40120C00157 | $843.7k | 9/28/20 |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00003 | Close Out | ($5k) | 8/28/24 | |
| P00002 | Other Administrative Action | $0 | 12/2/21 | |
| P00001 | Other Administrative Action | $0 | 11/16/21 | |
| Not listed | Not listed | $1.2m | 9/25/20 |