Accessibility Information

Users of assistive technologies such as screen readers should use the following link to activate Accessibility Mode before continuing: Learn more and Activate accessibility mode.

A -- Synthesis of Therapeutic Agents for Treatment of Infectious Diseases

Solicitation Number: NIH-NIAID-DAIDS-08-19
Agency: Department of Health and Human Services
Office: National Institutes of Health
Location: National Institute of Allergy and Infectious Diseases
  • Print

Note:

There have been modifications to this notice. You are currently viewing the original synopsis. To view the most recent modification/amendment, click here
:
NIH-NIAID-DAIDS-08-19
:
Presolicitation
:
Added: May 8, 2007
The Division of Acquired Immunodeficiency Syndrome (DAIDS), NIAID, NIH, supports research to identify therapeutic agents for the prevention and treatment of infections with the human immunodeficiency virus (HIV) and co-infections with pportunistic pathogens, including Mycobacterium tuberculosis. DAIDS-sponsored researchers are actively engaged in investigating the basic biology of the targeted pathogens, identifying novel therapeutic approaches to treat diseases caused by these infectious agents, and testing therapeutic agents in vitro and in animal models. Prior to evaluation in clinical trials, most experimental agents require chemical resynthesis, pharmaceutical analysis, and dosage formulation to ensure products are of sufficient quantity and quality to permit proper testing in humans. DAIDS currently uses contracts to fulfill its needs for these services. This solicitation will support the DAIDS drug development effort by accomplishing 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). This solicitation provides for the recompetition of a contract (N01-AI-05402) that was awarded to Starks Associates, Inc. for synthesis of potential therapeutic agents for treatment of infectious diseases. Over 250 different compounds of interest to DAIDS have been synthesized to date. 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 by DAIDS-supported contracts for enzymatic, in vitro, and in vivo studies. Small quantities of metabolites have been synthesized for use in mechanism of action and metabolism studies and larger, bulk quantities of compounds have been synthesized for animal studies and clinical trials. The scope of this effort is small scale synthesis of compounds in quantities required for testing in either in vitro screens or 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, tuberculosis, hepatitis and other infectious diseases of relevance to the research agenda of NIAID. The major tasks to be carried out are as follows: 1) Initial transition; 2) Synthesize compounds (small scale); 3) Synthesize compounds (large scale); 4) Acquire compounds for efficacy testing; 5) Ship compounds to NIAID; 6) Provide facilities, equipment, and other resources; 7) Information Security; and 8) Final transition. This is a 100% SMALL BUSINESS SET-ASIDE, NAICS 541710 with a size standard of 500 employees. It is anticipated that one (1) cost reimbursement, completion type contract will be awarded for a period of seven (7) years beginning on or about February 16, 2008. It is estimated that six (6) full time equivalents (FTE) will be required on a yearly basis. Any responsible offeror may submit a proposal which will be considered by the Government. This RFP will be available electronically on/about May 23, 2007, and may be accessed through the NIAID Office of Acquisitions (OA) Home Page at http://www.niaid.nih.gov/contract and through the FedBizOpps http://www.fedbizopps.gov/. This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile transmissions will be accepted. See Government-Wide Numbered Note 26.
:
Department of Health and Human Services, National Institutes of Health, National Institute of Allergy and Infectious Diseases, Office of Acquisitions 6700 B Rockledge Room 3214 MSC7612, Bethesda, MD, 20892-7612, UNITED STATES
:
Anita Hughes, Contract Specialist, Phone 301-451-3694, Fax 301-480-4675, Email anhughes@niaid.nih.gov - Eileen Webster-Cissel , Branch Chief, Phone 301-496-0349, Fax 301-480-4675, Email webstere@mail.nih.gov