DAIDS Services Program to Accelerate Drug Development

The Division of AIDS (DAIDS) maintains contracts that can potentially provide limited pre-clinical resources and services to investigators who are working on the development of therapeutics targeting HIV and HIV-associated co-infections, including hepatitis B virus (HBV), hepatitis C virus (HCV) and Tuberculosis (TB).  The focus of the program is to facilitate the advancement of promising drug candidates from bench to clinic and fill critical program and resources gaps in an investigator’s drug development efforts as they advance their product toward regulatory submissions and clinical trials.

Areas of Focus

  • DAIDS is especially interested in the development of next-generation therapies for HIV and HIV-associated co-infections with improved safety and ease of use including sustained release therapeutics, novel HIV targets & inhibitors, and novel immune-based therapies. 
  • Projects in both the early and late stages of preclinical development are suitable for support under this program. 
  • Experimental therapeutics may include small organic molecules, polymers, or biologics (e.g., peptides, oligonucleotides, antibodies), as well as cellular and genetic drug products (e.g., CAR-T cells).

Support Services

Available services are offered in the following areas: 

A) In Vitro Testing and Screening of HIV Compounds

  • High throughput screening of compound libraries in cell-based or biochemical assays
  • Testing in human peripheral blood mononuclear cells (PBMCs) and/or continuous cell lines to confirm the activity of anti-HIV therapeutic agents
  • Hit-to-Lead progression studies 
  • HIV drug resistance testing 

B) Synthesis of Therapeutic Agents 

  • Chemical synthesis of small molecule lead compounds for use in additional drug development studies.  Requested product must be of known chemical structure and have already been successfully synthesized. Synthesis of new analogs is not supported.
  • Investigators provide the synthetic schemes to be followed; NIAID contractors will modify or optimize problematic steps as necessary.
  • Complexity and cost will limit potential scale-up efforts, but synthesis of up to 1 kilogram of a simple small molecule often can be accommodated.
  • Drug substances can be synthesized under GMP guidelines. 
  • Investigators must have preliminary data to support the continued development of the product.

C) Evaluations in Small Animal Models for HIV, HBV, HCV and TB

  • Pharmacokinetic (PK), safety, and efficacy studies to characterize products, inform dose selection, optimize formulations, and/or obtain other information necessary to advance or support product testing in subsequent large animal or human studies (supported under different mechanisms). 
  • Assessment of mainly therapeutics, but also vaccines, other prophylactic methods, and diagnostics for use against HIV, HBV, HCV and TB in small animal models.
  • When applicable, other activities (e.g., immunology, histopathology, in situ hybridization, whole body and tissue imaging, etc.) may be supported.

D) Formulation Development and Manufacture of Clinical Dosage Forms

  • Development of alternative dosage forms (strength, physical form, route of administration) and new formulations to improve drug properties.
  • Development and validations of analytical assays. 
  • Drug product manufacturing and stability studies in compliance with GMP guidelines. 

E) Preclinical Pharmacology and Toxicology

  •  Pharmacokinetic studies in animal species.
  • Good Laboratory Practice (GLP) compliant toxicology and safety pharmacology studies.
  • In vitro Absorption, Distribution, Metabolism, Elimination, Toxicity (ADMET) studies.
  • Development of new toxicology models and test systems, such as 3-dimensional culture, hollow-fiber cell culture, or organ-on-a-chip technology.

Oversight & Contact Information

DAIDS Preclinical Therapeutic Development Committee (DPTDC) 

Funding

Investigators seeking these services receive no funding from NIAID, but instead receive products or information generated by NIAID-funded contractors on their behalf. These services are provided at no cost to the investigator. 

Eligibility Requirements

Investigators seeking access to DAIDS resources must be conducting research for treatment of HIV and HIV-associated co-infections (HBV, HCV or TB) and have a defined drug development program.  Services requested are expected to be narrowly focused to fill gaps in areas of need.  Investigators are not required to have current NIH funding to apply.  It is expected that resources other than those supported by DAIDS preclinical services will be sought or in place to complete the drug development program.  Requested services may not overlap with efforts already funded through the Department of Health and Human Services.

These DAIDS services are not intended for Investigators seeking to develop untested ideas or ideas based on extrapolation of data obtained with structurally—or functionally—similar products. NIAID supports these latter types of activities via one of its grant mechanisms.

By accepting the data package for review, DAIDS does not guarantee funds will be available for services. The provision of services to an investigator depends on several factors, including technical merit, relative program priority, and available funds.

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