Definitive Contract 75F40120C00150
- Not listed
- This is a firm fixed-price purchase order awarded by the Department of Health and Human Services Food and Drug Administration to Simulations Plus Inc., a prime contractor that specializes in drug discovery and development simulation and modeling software. The $130,000 contract is for the extension and validation of Simulations Plus' GastroPlus ocular compartmental absorption and transit model. There is no set-aside designation for this contract. Simulations Plus has received over $5 million in...
- The U.S. Food and Drug Administration (FDA) awarded a firm-fixed-price purchase order to Simulations Plus Inc., a for-profit software company specializing in pharmaceutical modeling and simulation. The contract, valued at $109,798.77, is for the purchase of 50 GastroPlus licenses, 30 IVIVCPlus module licenses, and 30 PBPK Plus licenses. The contract has no set-aside designation and is not associated with a larger contract vehicle. Simulations Plus has previously provided similar software...
- The University of Connecticut (UConn) was awarded a $1,310,263 cost-no-fee definitive contract by the Food and Drug Administration (FDA) to enhance and validate in vitro-in vivo correlation (IVIVC) methods for long-acting injectable drug products to accelerate their generic development. The contract is part of the FDA's Broad Agency Announcement for Advanced Regulatory Science, which solicits research and development proposals across various areas to modernize regulatory science and support...
- The Department of Health and Human Services Food and Drug Administration awarded a $2,877,830 firm fixed price delivery order contract to Biopharma Services USA Inc. for NASAL PHARMACOKINETIC (PK)PHARMACODYNAMIC (PD) STUDIES OF ORAL COMBINATION PRODUCTS CONTAINING OPIOID AGONISTS AND ANTAGONISTS. As a foreign owned, self-certified small disadvantaged business, Biopharma Services USA will conduct the in vivo study of generic drug products in human subjects to fulfill the FDA's major program of...
- This is a $375,965.05 firm-fixed-price purchase order awarded by the Food and Drug Administration (FDA) to Simulations Plus Inc. for GastroPlus, DDDPlus, and MembraneePlus software licenses. The contract has an ultimate completion date of August 31, 2026 and does not have a set-aside designation. Simulations Plus is a for-profit company that specializes in developing pharmaceutical modeling and simulation software, including tools for physiologically-based pharmacokinetic (PBPK) modeling, drug...
- This is a new task order awarded under an existing Indefinite Delivery Indefinite Quantity (IDIQ) contract (HHSF223201610004I) with the Department of Health and Human Services Food and Drug Administration (FDA). The task order, valued at $2,470,791.00, is for a Pharmacokinetic (PK) study of opioid drug products following oral ingestion of chewed products. The study falls under the FDA's In Vivo Study of Generic Drug Products in Human Subjects program. The contract is a Firm Fixed Price...
- 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 Department of Health and Human Services, Food and Drug Administration awarded a fixed-price purchase order contract to Certara USA Inc., doing business as Tripos (De), for an annual Phoenix Quantum software subscription. The contract, with a potential value of $216,547.78, provides the FDA's Office of Clinical Pharmacology with the necessary modeling and simulation tools to analyze and verify sponsor submissions, including Investigational New Drug, New Drug, Biologics Licensing, and...
- The Department of Health and Human Services' Food and Drug Administration awarded a Firm Fixed Price Definitive Contract to Uppsala Universitet, an educational institution, for the evaluation and development of model-based bioequivalence analysis strategies. The $574,726.00 contract, which does not have a set-aside designation, was awarded on April 10, 2017 with a completion date of September 1, 2020. The contractor specializes in scientific and research services related to the development and...
- The University of Southern California Department of Contracts and Grants Division, doing business as USC, has been awarded a $246,617 definitive cost-no-fee contract by the Department of Health and Human Services Food and Drug Administration (HHS FDA) to conduct a study on modified susceptibility testing protocols for predicting the in vivo efficacy of polymyxins. Performance will take place in Silver Spring, Maryland over a period of approximately 18 months concluding in March 2024. The...
The University of Health Sciences and Pharmacy in St. Louis was awarded a $1.16 million cost-no-fee definitive contract by the Department of Health and Human Services' Food and Drug Administration to develop an in vitro/in silico model to accelerate generic drug product development for the oral cavity route of administration. This contract was awarded under the FDA's Broad Agency Announcement for the Advanced Research and Development of Regulatory Science, which seeks proposals to support regulatory science and innovation across nine key areas. The prime contractor will establish a biowaiver approach for conventional clinical trials using an extended in silico modeling and simulation platform. Simulations Plus Inc. was selected as a major subcontractor to incorporate oral cavity drug dissolution profiles into its GastroPlus modeling software to generate predicted in vivo dissolution and pharmacokinetic simulations to increase predictability for product variants. This will advance the FDA's regulatory review of generic drug products intended for oral cavity administration.
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 |
|---|---|---|---|---|---|
824101S | Simulations Plus Inc. | Definitive Contract 75F40120C00150 | $229.0k | 9/30/20 |
Mod # | Description | ReasonForModification | Federal Obligation | Date |
|---|---|---|---|---|
| P00005 | Supplemental Agreement for work within scope | $0 | 12/13/23 | |
| P00004 | Other Administrative Action | $0 | 3/8/23 | |
| P00003 | Other Administrative Action | $0 | 7/20/22 | |
| P00002 | Supplemental Agreement for work within scope | $0 | 11/5/21 | |
| P00001 | Novation Agreement | $0 | 3/4/21 |