The Biomedical Advanced Research and Development Authority (BARDA) recently published a Presolicitation Notice for a project titled ‘BARDA Chemical Animal Model Development” [beta.SAM.gov | Search]. The Notice announces BARDA’s intention to publish an RFP for the same project on or around February 14, 2021. The RFP seeks proposals related to testing services, not product development. The RFP will have more details but it will seek proposals from labs that can develop and use animal models to evaluate the effectiveness of Medical Countermeasures (MCMs) that are supported by BARDA and possibly other Federal agencies. Labs that are capable of controlled exposures with pulmonary agents (cyanides or opioids) and vesicants/nerve agents (mustard gas) can respond but they must provide evidence that they performed at least one study meeting the FDA Good Laboratory Practices (GLP) guidelines in the past three years. This is a sign that BARDA is getting back to work on things that are not exclusively related to COVID and we will watch for more solicitations.
The objective of the RFP is to identify labs that can perform studies necessary to support the approval or licensure of MCMs using the FDA Animal Rule. This regulatory path is used when efficacy testing in humans of not feasible or ethical and so far it was used for five novel NDAs/BLAs. Developing effectiveness data sufficient for approval may require two or more animal models- one that uses correlates or surrogates shared with humans and another to provide test groups large enough to establish statistical significance if that is possible. About ten years ago BARDA first established the so-called Animal Model Network through a similar solicitation and continues to use the same contract mechanism, indefinite-delivery, indefinite quantity (IDIQ). We can expect multiple awards to be made through this RFP that will simply get labs into the network. Members of that network will then receive RFPs for specific work that will be performed as a Task Order (TO) amendment to the IDIQ contract. The network is renewed through a new RFP every five years, this being the second solicitation after the original.