Develop HIV Therapeutic Products Using NIAID Preclinical Services

Take note if you are an investigator working on drug development to treat HIV and HIV-associated co-infections hepatitis B virus (HBV), hepatitis C virus (HCV), and tuberculosis (TB): our new funding opportunity announcement (FOA) Resources Access for Preclinical Integrated Drug Development (RAPIDD) Program (X01, Clinical Trial Not Allowed) invites you to apply for access to NIAID Division of AIDS (DAIDS) preclinical services.

An Atypical Activity Code

This FOA uses the Resource Access Award (X01) mechanism, which is significantly different from a research project grant. The DAIDS RAPIDD program offers gap-filling services to reduce barriers in drug development. Applicants do not submit a Research Plan, and NIAID will not provide an award budget. Instead, investigators submit three- to five-page applications requesting and justifying access to a discrete set of preclinical services provided by NIAID contractors at no cost to the applicants.

NIAID staff, rather than peer reviewers, will review the applications and then work with meritorious requesters to confirm projects, timelines, confidentiality, and intellectual property arrangements. Priority considerations will be given to programs that target DAIDS high-priority research areas, such as developing less toxic and longer lasting drugs for HIV and HIV-associated co-infections, novel HIV targets and inhibitors, and novel immune-based therapies.

Available Preclinical Services

The RAPIDD program offers gap-filling services in the following areas:

1. 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 to optimize lead anti-HIV therapeutic candidates and analogs
• HIV drug resistance testing

2. Evaluations in Small Animal Models for HIV, HBV, HCV, and Mtb

• Supported studies include 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). Xenograft models will use postnatal human cells and tissue. For studies in small animal models, Mycobacterium species are limited to Mycobacterium tuberculosis (Mtb).
• Assessment of mainly therapeutics, but also vaccines, other prophylactic methods, and diagnostics for use against HIV, HBV, HCV, and Mtb in small animal models
• Clinical manifestations, body weight, complete blood counts, and serum chemistries to determine the health of the animals during the study
• Assays and assay components to support animal model improvement and in vivo product evaluation
• When applicable, other activities (e.g., immunology, histopathology, in situ hybridization, whole body and tissue imaging) may be supported as well

3. Formulation Development and Manufacture of Clinical Dosage Forms for HIV and HIV-Associated Co-Infections HBV, HCV, and TB

• Development of alternative dosage forms (strength, physical form, route of administration)
• Development of new formulations to improve drug properties
• Development and validations of analytical assays to determine the identity, strength, quality, and purity of drug products, and stability indicating assays
• Drug product manufacturing in compliance with current good manufacturing practice
• Stability studies

4. Preclinical Pharmacology and Toxicology for HIV and HIV-Associated Co-Infections HBV, HCV, and TB

• Pharmacology studies in animal species
• Good laboratory practice-compliant toxicology and safety pharmacology studies
• Genotoxicity and off-target toxicity evaluations of drug candidates
• In vitro Absorption, Distribution, Metabolism, Elimination, Toxicity studies of lead compounds
• Development of new toxicology models and test systems, such as three-dimensional culture, hollow-fiber cell culture, or organ-on-a-chip technology

Typically, services for areas A, C, and D will not exceed 12 months. Services for area B may extend to 24 months.

Applicants may request services from multiple areas, to include any service within areas A, B, C, or D; however, each area requires a separate application submission with a strong justification.

Broad Eligibility

Applicants are not required to have current NIH funding to apply. We expect investigators to seek or put in place resources other than those supported by the RAPIDD Program to establish a comprehensive drug development program. Requested services may not overlap with efforts already funded by HHS or NIH.

Projects in both the early and late stages of preclinical development are suitable for the RAPIDD program. Experimental therapeutics may include small organic molecules, polymers, or biologics (e.g., peptides, oligonucleotides, antibodies), and cellular and genetic drug products (e.g., CAR-T cells).

NIAID Contacts and Due Dates

We strongly recommend you discuss your research situation with NIAID staff before applying. Each of the preclinical service areas above has a corresponding scientific/research contact at NIAID:

• Area A—Dr. Betty Poon at poonb@niaid.nih.gov or 240-669-5024
• Area B—Dr. Brigitte Sanders at sandersbe@niaid.nih.gov or 240-627-3209
• Areas C and D—Dr. Marina Protopopova at marina.protopopova@nih.gov or 301-761-7653

The FOA has two annual due dates: September 1 and January 17 at 5 p.m. local time of the applicant organization.