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Currently Funded Resources

The following DAIDS-sponsored contract resources are available to aid sponsors with promising therapeutic agents in addressing specific needs in their drug development plan leading towards filing an investigational new drug (IND) application. Activities can be conducted as needed in compliance with FDA's current GLP recommendations.

• Pharmacokinetics

  Evaluations can be conducted in rodents, dogs, and nonhuman primates and can include:



• Quantitation of drug and metabolite levels in plasma
• Determinations of bioavailability and other pharmacokinetic parameters
• Studies in pregnant and neonatal animals


• Toxicology

  Evaluations can be conducted in rodents, rabbits, dogs, and nonhuman primates and can include:
  

• Dose range finding and maximum tolerated dose (MTD) determinations
• Evaluation of systemic toxicity following single or multiple administrations
• Immunotoxicity determinations
• Vaginal irritation evaluations of potential microbicides
• Evaluation of specific target organ toxicity (e.g., renal, hepatic, nervous system)
• Genotoxicity determinations (e.g., Ames test, mouse lymphoma assay)

For further information please contact Dr. Michael Ussery (phone: 301-402-0134; email: mussery@niaid.nih.gov). The SRI International web site provides an overview of the contractor's full toxicology capabilities, only a subset of which are available to investigators via DAIDS support.

Grant Mechanisms

The following describes grant-based funding opportunities for investigators in the areas of animal pharmacokinetic and toxicity studies:

• The NIH Grants and Contracts home page provides links to general information regarding NIH and SBIR/STTR grant mechanisms and to the NIH Guide for Grants and Contracts.
• The NIAID Council News - Extramural Information Center home page provides links to specific programs sponsored by The National Institute of Allergy and Infectious Diseases to which investigators can submit applications.
• The National Cooperative Drug Discovery Group for Opportunistic Infections (NCDDG-OI) grant program supports consortia of academia, industry, and government investigators working collaboratively on targeted discovery and preclinical development of new OI drugs and therapeutic strategies.

  Please contact Dr. Barbara Laughon (phone: 301-402-2304; email: blaughon@niaid.nih.gov for additional information regarding the NCDDG-OI program.

• The Novel HIV Therapies: Integrated Preclinical/Clinical Program (IPCP) supports (1) the discovery and preclinical development of new anti-HIV drugs and therapeutic concepts; and (2) the translation of innovative preclinical findings to the clinic via small clinical studies. This grant program funds consortia of investigators from academia and the private sector, working collaboratively on the development of a defined therapeutic concept identified and proposed by the collaborative group. This mechanism is particularly appropriate for highly experimental therapeutic strategies that are new or otherwise not yet ready for large clinical trials.

  Please contact Dr. Sandra Bridges (phone: 301-496-8197; email: sbridges@niaid.nih.gov for additional information regarding the IPCP.