Preclinical Services for HIV Therapeutics

Provide the extramural scientific community with research materials and preclinical product development support for candidate products that emerge from investigator-initiated research studies or from collaborations with private sector or academic partners. The scope of work encompasses activities that range from basic research and initial product discovery to activities required for clinical trials and/or product licensure. These services may also be used to support product discovery and development leading to Investigational New Drug Application (IND), Investigational Device Exemption (IDE), and/or New Drug Application (NDA) filings with the Food and Drug Administration (FDA). NIAID will primarily use these contracts to fill critical development and resource gaps more rapidly and efficiently and advance promising products into clinical testing. Although the focus of these contracts will be development of therapeutic products for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Mycobacterium tuberculosis (MTB) complex, as well as repository services, at the discretion of NIAID, these contracts may also be used to advance vaccines, antivirals, and preventive strategies for these and other infectious diseases.

Task Orders will be issued in the following areas:

Task Area A: In Vitro Testing and Screening Resource for Therapeutics
Task Area B: Synthesis of Therapeutic Agents for Treatment of Infectious Diseases
Task Area C: Small Animal Models for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), and Hepatitis C Virus (HCV)
Task Area D: Small Animal Models of Mycobacterium Infection
Task Area E: Formulation Development and Manufacture of Clinical Dosage Forms
Task Area F: Preclinical Pharmacology and Toxicology Services
Task Area G: Reagent Program for HIV and other Infectious Diseases