# NIAID Preclinical Development Support - Production of HIV-1 M Group Conserved Element DNAs

> **NIH NIH N01** · ADVANCED BIOSCIENCE LABORATORIES, INC. · 2020 · $151,691

## Abstract

This contract will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. Activities include but are not limited to small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. 
-Process Development and Production of candidate HIV vaccines, microbicides or non-vaccine HIV prevention modalities
-Safety, Immunogenicity and Spectrum of Activity Testing of candidate HIV vaccines, microbicides or non-vaccine HIV prevention modalities consistent with relevant FDA guidelines
-Regulatory Documentation-obtain and compile non-clinical data, Investigator's Brochure, and/or final product trail protocol appropriate for submission to CBER or CDER, FDA (for an IND application) or other non-US regulatory authorities.

## Key facts

- **NIH application ID:** 10145545
- **Project number:** 272201100021I-P00006-27200015-1
- **Recipient organization:** ADVANCED BIOSCIENCE LABORATORIES, INC.
- **Principal Investigator:** TIMOTHY FOUTS
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $151,691
- **Award type:** —
- **Project period:** 2013-08-23 → 2023-03-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10145545

## Citation

> US National Institutes of Health, RePORTER application 10145545, NIAID Preclinical Development Support - Production of HIV-1 M Group Conserved Element DNAs (272201100021I-P00006-27200015-1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10145545. Licensed CC0.

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