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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 and GMP recommendations.

• Chemical Resynthesis


• Potential drug candidates can be resynthesized in quantities ranging from 0.1 to 1000 g using synthetic schemes provided by the drug sponsor
• Analogs, metabolites, and reference standards can be synthesized


• Analytical Chemistry


• Chemical structure and compound purity can be verified
• Analytical methods to quantitate drug in formulations or biological samples can be developed and validated
• Drug stability determinations and other preformulation studies (e.g., solubility, pH rate profiles) can be conducted
• Evaluation of pharmaceutical dosage forms following USP requirements can be made


• Formulation Development


• Dosage formulations can include sterile products, tablets, capsules, topical preparations, and non-conventional products such as semi-solid or sustained release preparations
• Formulations can be developed to enhance drug solubility, improve bioavailability, enhance drug stability, target tissue delivery, and treat specific patient populations
• Stability and release properties of formulations can be evaluated in vitro


• Manufacture Of Clinical Dosage Forms


• Both pilot- and production-scale batches of pharmaceutical dosage forms can manufactured, packaged, labeled, and shipped
• Bulk drug substances and manufactured products are evaluated following USP requirements in compliance with GMP recommendations for quality control and assurance
• Long-term stability studies of the manufactured products can be conducted

For further information please contact Dr. Michael Ussery (phone: 301-402-0134; email: mussery@niaid.nih.gov).

Grant Mechanisms

The following describes grant-based funding opportunities for investigators in the areas of chemistry, formulation, and manufacturing:

• 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 on the IPCP.