The National Institute of Allergy and Infectious Diseases (NIAID) is re-competing an existing contract for synthesis of therapeutic agents for treatment of infectious diseases.
Most experimental agents require chemical resynthesis, pharmaceutical analysis, and dosage formulation to ensure they are of sufficient quantity and quality to permit evaluation in clinical trials in humans. This solicitation will support the synthesis of therapeutic agents in small and large scale amounts, some according to current Good Manufacturing Practice (cGMP) regulations of the Food and Drug Administration (FDA).
The synthesis contract was initiated in 1989 and last awarded in 2008 to Starks Associates, Inc. (HHSN272200800011C). This solicitation provides for the recompetition of the current contract that will expire on February 15, 2015.
In the last 5 years, an average of 25-30 compounds has been synthesized per year. Compounds assigned for synthesis include heterocycles (typically containing nitrogen, oxygen, and sulfur), carbocycles, carbohydrates, nucleosides and peptides. The majority of synthesized compounds have been used for enzymatic, in vitro, and in vivo studies. Small quantities of metabolites have been synthesized for use in a mechanism of action and metabolism studies and larger, bulk quantities of compounds have been synthesized for animal studies and clinical trials.
The contract will be awarded for a one year base period of performance. In addition, six one-year options will be included for the extension of the term of the contract. The total period of performance resulting from the base period plus all potential term Options is 7 years.
The scope of this effort is small scale synthesis of compounds in quantities required for testing in either in vitro or in animals, and large scale synthesis of compounds for early Phase I clinical studies. Some compounds will require synthesis in compliance with cGMP regulations. This contract will provide resources for the synthesis of promising compounds for the treatment of HIV, TB and other infectious diseases of relevance to the research agenda of NIAID.
Further details are available under Solicitation Number: NIAID-DAIDS-NIHAI2013177.