Preclinical Services for HIV Therapeutics

The National Institute of Allergy and Infectious Diseases awarded a master IDIQ on October 15, 2020, for preclinical development services supporting candidate therapeutics for HIV, hepatitis B and C, and tuberculosis, with orders permitted through October 14, 2027. The vehicle carries an unrestricted competitive structure with a shared ceiling of $107.3 million and has obligated $22.6 million of $24.2 million in combined task-order potential value across 46 awards as of September 30, 2025.

Ordering activity peaked in 2021 with 18 task orders, then declined sharply to 2 orders in 2022, 6 in 2023, 4 in 2024, and 1 in 2025. The vehicle's early momentum has not sustained. Roughly 14 months of ordering authority remain as of today.

Task orders span seven task areas specified in the original solicitation: in vitro testing, chemical synthesis, small animal efficacy models, formulation development, preclinical pharmacology and toxicology, and a reagent repository. Recent awards reflect this breadth—orders include in vitro HIV screening and assay development, compound synthesis batches for subsequent testing, pharmacokinetics studies in rodents for tuberculosis agents and HIV candidates, and long-term operation of the HIV Reagent Program repository. Pricing is mixed across cost-plus-fixed-fee and cost-no-fee structures.

Prime contractor concentration is notable but not dominant. American Type Culture Collection holds one order valued at $10.7 million, dominating the portfolio by value. Among active research contractors, Starks Associates (5 orders, $3.7 million), Research Triangle Institute (5 orders, $2.1 million), and Colorado State University (4 orders, $1.8 million) lead by order count and value. Southern Research Institute, University of Texas Medical Branch at Galveston, and a wider field of academic and research institutions round out the awardee base. The top five primes account for 82 percent of combined potential value; task orders are not heavily concentrated among two or three firms.

All 46 task orders are unrestricted competitive awards. No set-asides have been exercised, despite the originating solicitation designating Task Area B (synthesis) as set-aside for small business under NAICS code 541715. Single customer: all orders fund NIAID programs. Task-order values range from small management orders (quality assurance planning tasks under $30,000) to substantive research and development efforts ($1.2 million to $1.5 million range for multi-year animal efficacy and pharmacokinetics work). The guarantees and minimum amounts issued at vehicle award in 2020 carried zero obligation, serving as contract vehicles only.

Provide the extramural scientific community with research materials and preclinical product development support for candidate products that emerge from investigator-initiated research studies or from collaborations with private sector or academic partners. The scope of work encompasses activities that range from basic research and initial product discovery to activities required for clinical trials and/or product licensure. These services may also be used to support product discovery and development leading to Investigational New Drug Application (IND), Investigational Device Exemption (IDE), and/or New Drug Application (NDA) filings with the Food and Drug Administration (FDA). NIAID will primarily use these contracts to fill critical development and resource gaps more rapidly and efficiently and advance promising products into clinical testing. Although the focus of these contracts will be development of therapeutic products for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), and Mycobacterium tuberculosis (MTB) complex, as well as repository services, at the discretion of NIAID, these contracts may also be used to advance vaccines, antivirals, and preventive strategies for these and other infectious diseases.