This is a federal contract award from the Food and Drug Administration (FDA) to the Albany College of Pharmacy and Health Sciences (ACPHS), a private non-profit educational institution. The $199,380.68 definitive contract, titled "A Community Based Study of Adverse Effects of NSAIDs on the Kidney and Risk Mitigation to Reduce Preventable Harm," was awarded on September 11, 2015 with a completion date of September 14, 2018. The contract is a cost-no-fee type and was not set aside for...
This is a $1,054,186.47 delivery order contract awarded by the Office of the Assistant Secretary for Preparedness and Response (ASPR), a civilian agency, to The Texas A&M University System for the Centers for Innovation in Advanced Development and Manufacturing program. The contract involves technology transfer and cGMP (current Good Manufacturing Practice) manufacture of an adenovirus type 5 (Ad5) vectored anthrax vaccine. No set-aside was used. The prime contractor, Texas A&M...
This is a $408,692 firm fixed-price definitive contract awarded by the Office of the Assistant Secretary for Preparedness and Response, a civilian federal agency, to Univercells SA, a for-profit organization located in Belgium. The contract is for research and development of mRNA vaccine production using Univercells' NFINITYTM platform, under Advance Opportunity Inquiry (AOI) #21 "Vaccine on Demand: R&D for mRNA Production Reinvented." The contract has an ultimate completion date...
This $1,997,031 firm fixed-price federal contract was awarded by the Food and Drug Administration (FDA) to New York Medical College (NYMC), a private non-profit educational institution, to characterize the clinical presentation of COVID-19 vaccine-associated myocarditis (C-VAM) and contrast it with the cardiac complications of SARS-CoV-2 infection that the vaccines seek to prevent. The goal is to inform best practices for surveillance and monitoring of C-VAM, including in asymptomatic cases....
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 $65,806,649.98 cost-plus-fixed-fee contract awarded by the Office of the Assistant Secretary for Preparedness and Response, a civilian agency, to Biofactura Inc. for preclinical and manufacturing development activities. The contract includes cell line development, process development, non-clinical efficacy and safety studies, manufacturing, and clinical activities. The contract was awarded on September 26, 2019 with an ultimate completion date of March 30, 2029. The contract has no...
This is a $37,000 firm fixed price purchase order contract awarded by the National Institute of Allergy and Infectious Diseases (NIAID), a civilian agency within the U.S. Department of Health and Human Services (HHS), to Protein Sciences Corp, a for-profit manufacturer, to provide purified recombinant proteins. The contract has no set-aside designation. Protein Sciences Corp has received multiple federal contract awards from HHS's Office of the Assistant Secretary for Preparedness and Response...
The Department of Health and Human Services (HHS) Food and Drug Administration (FDA) awarded a $505,858.00 Definitive Contract to Uppsala Universitet, an educational institution and state-controlled institution of higher learning, for the "Development of Model-Informed Bioequivalence Evaluation Strategies for Long-Acting Injectable Products." The contract is a Firm Fixed Price agreement without a set-aside designation. Uppsala Universitet will provide scientific and research...
This is a cost-plus-fixed-fee definitive contract awarded by the National Institute of Allergy and Infectious Diseases (NIAID), a civilian agency within the U.S. Department of Health and Human Services. The contract, with a ceiling value of $86,670,401.90, is for biomedical (advanced) products and services. The prime contractor is Janssen Vaccines & Prevention B.V., a foreign-owned for-profit organization. The contract does not have a set-aside designation and has an ultimate completion date...
This contract was awarded by the Department of Health and Human Services' National Institutes of Health National Institute of Allergy and Infectious Diseases to the Icahn School of Medicine at Mount Sinai, a private medical school in New York City. The contract is for the development of vaccine candidates for biodefense, antimicrobial resistant infections, and emerging infectious diseases, with a potential value of $22,709,915.00. It is a definitive, cost-no-fee contract with a completion date...