MCDC Seeks Industry Input on Prophylaxis in Advanced Development for Military Biological Threat Protection

The Medical CBRN Defense Consortium (MCDC), through Advanced Technology International (ATI), has issued a Request for Information (RFI) on behalf of the Capability Program Executive for Chemical, Biological, Radiological, and Nuclear Defense (CPE CBRND) for “Prophylaxis in Advanced Development.” This notice is intended strictly for information gathering and planning and does not constitute a Request for Proposal (RFP) or a commitment to issue one later. Still, it offers a meaningful early signal of where the government may be heading: toward the development of next-generation medical countermeasures that can protect warfighters from emerging biological threats. According to the RFI, the future program is expected to focus on prophylactic solutions that provide reliable, mission-enabling protection against both endemic and weaponized pathogens across the conflict continuum.

At a high level, the government is using this RFI to conduct market research for the Prophylaxis in Advanced Development (PAD) program, which is expected to launch in Fiscal Year 2028. CPE CBRND states that it is looking for collaboration with industry partners developing advanced prophylactic candidates in two areas: vaccines and chemoprophylactics. For vaccines, the government is interested in novel, durable candidates capable of providing long-lasting immunity in operationally relevant environments. For chemoprophylactics, the RFI emphasizes field-stable formulations and practical routes of administration, including oral, inhalation, intranasal, injectable, sublingual, and dermal patch delivery, with an eye toward reliable pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP) in contested or resource-limited settings.

The RFI makes clear that the government is most interested in mature candidates, with preference given to those that have completed Phase II development. It also provides target product profile characteristics for both advanced vaccines and field-ready chemoprophylaxis products. For vaccines, desired features include durable protection of at least 12 months without a booster, reactogenicity comparable to the annual influenza vaccine, an injectable liquid stable formulation, and familiarity with regulatory pathways such as Fast Track, Biologics License Application (BLA), and the Animal Rule. For chemoprophylaxis products, desired features include rapid onset of action, favorable safety in healthy adults, minimal drug-drug interaction risk, no cold-chain requirement, simple administration, and regulatory experience aligned with pathways such as a New Drug Application (NDA), Fast Track, emergency use authorization, and the Animal Rule.

From a response standpoint, the government is asking for a white paper of no more than three pages and a separate one-page quad chart. The quad chart must address the project objective and product benefit, a high-level development schedule with major goals and timelines, a rough order of magnitude cost, and any relevant intellectual property, patent, commercial market, or data rights information. The RFI further states that the government will place the greatest emphasis on Technical Approach and Product Maturity and Regulatory and Clinical Status. Respondents are asked to describe product type, intended use, target biological agents, mechanism of action, Technology Readiness Level (TRL) using the Public Health Emergency Medical Countermeasures Enterprise scale, efficacy data, U.S. Food and Drug Administration (FDA) engagement, clinical trial history, manufacturing capacity, scale-up strategy, supply chain considerations, company experience, and teaming strategy.