The Portfolio Management Executive for Chemical, Biological, Radiological and Nuclear Defense (PME CBRND), through its Accelerated Defense Pharmaceuticals (ADP) program, has issued a Request for Information (RFI) on Prophylactic Platform Technologies for Medical Countermeasures. The government seeks input from commercial and academic product developers with platforms that could accelerate protection against priority chemical, biological, radiological, and nuclear (CBRN) threats.
The focus is on existing prophylactic candidates built on proven platforms with established clinical safety profiles and/or strong preclinical immunogenicity, safety, and efficacy data. The objective is to advance candidates through Phase 1 or Phase 2 clinical trials. Novel candidates may also be considered when built on proven manufacturing platforms.
This is market research, not a funding solicitation or request for proposals. Responses will inform government planning and do not guarantee a future solicitation or award.
What Technologies Are of Interest?
The RFI identifies four focus areas:
Proven prophylactic platforms: Nucleic acid, viral vector, recombinant protein, nanoparticle, and other mature technologies that can be rapidly retargeted and manufactured against emerging threats.
Broad-spectrum countermeasures: Prophylactic solutions offering cross-protection against two or more agent classes, engineered variants, or emerging biological or chemical threats.
Biological response modifiers and adjuvants: Immune modulators, adjuvants, and host-directed factors that improve immunogenicity, protective efficacy, durability, or dose-sparing.
Alternative administration methods: Microneedle patches, intranasal formulations, sublingual or oral delivery, and inhaled aerosol or dry-powder systems.
Companies whose candidates cross-reference or use established Food and Drug Administration (FDA) Master Files for platform technology are specifically encouraged to respond.
Which CBRN Threats Are Prioritized?
Appendix 1 identifies targets across five categories:
Viral threats: Ebola, Sudan, Bundibugyo, and Marburg viruses; Crimean-Congo hemorrhagic fever; Nipah and Hendra; Western, Eastern, and Venezuelan encephalitis viruses; hantaviruses; Lassa and Junin; and La Crosse and Jamestown Canyon viruses.
Bacterial threats: Antimicrobial-resistant E. coli, Staphylococcus aureus, and Pseudomonas aeruginosa; Q fever; plague; anthrax; tularemia; and Burkholderia mallei and Burkholderia pseudomallei.
Toxins: Ricin, T2 mycotoxin, marine toxins, botulinum toxins A–G, and staphylococcal enterotoxin B.
Chemical threats: Fentanyl derivatives and other pharmaceutical-based agents, traditional nerve agents, and sulfur mustard.
Radiation threats: Ionizing, non-ionizing, and nuclear radiation.
The accompanying draft objectives call for candidates targeting at least one listed threat, with broad-spectrum protection preferred.
What Would the Development Program Cover?
The draft Statement of Objectives describes Vaccine Acceleration by Modular Progression (VAMP), a potential effort organized around five development modules:
Candidate design and formulation.
Animal studies, including toxicity and efficacy testing.
Current Good Manufacturing Practice (cGMP) manufacturing for human use.
Regulatory interactions and submissions.
Phase 1 or Phase 2 human clinical studies.
The draft anticipates up to four years of performance, with Go/No-Go checkpoints across nonclinical, clinical, manufacturing, and regulatory activities. Both traditional intramuscular delivery and alternative administration approaches are included. Candidates would be developed with eventual FDA licensure in mind, although FDA approval is not an expected endpoint under VAMP. These are draft objectives for a potential future effort, not an active award competition.
What Should Responses Include?
The government requests a capability description addressing five areas:
Technical approach and product maturity: Platform, mechanism of action, target threats, delivery route, formulation stability, readiness levels, and supporting efficacy and safety data.
Regulatory and clinical status: FDA interactions, regulatory milestones, and completed, ongoing, or planned Phase 1 or Phase 2 trials.
Manufacturing and supply chain: cGMP capacity, fill-finish capabilities, release assays, surge capacity, supplier dependencies, and storage requirements.
Advanced development roadmap: Proposed partners, critical-path milestones, timelines, and rough order of magnitude costs for nonclinical, clinical, manufacturing, and regulatory activities.
Company profile and teaming strategy: Relevant experience, federal past performance, and proposed collaborations, licensing arrangements, or subcontracting models.
How to Respond
Submit capability descriptions by email to Scott I. Hoffman, Agreements Officer, at [email protected] and Alexander Z. Mayatte, Agreements Specialist, at [email protected]. Responses are limited to four pages, excluding an optional cover page.
EverGlade is a national advisory firm helping innovators navigate the federal funding ecosystem. We support companies across the funding lifecycle, from early-stage strategy through proposal development, negotiations, and post-award execution, ensuring you win the award and deliver the program.
For additional information on where your capabilities could plug into this market research, schedule a conversation with our team.
