JPEO-CBRND EB NEW APPROACH METHODS (NAMS) RFI

Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, Enabling Biotechnologies (JPEO-CBRND-EB) Request for Information (RFI) for New Approach Methods (NAMs)

W911SR-26-RFI-NAMs

Description

THIS IS A REQUEST FOR INFORMATION (RFI) ONLY –   This RFI is issued solely for information and planning purposes – it does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future.  Solicitations are not available at this time.  Requests for a solicitation will not receive a response.  This notice does not constitute a commitment by the United States Government to contract for any supply or service whatsoever.  All information submitted in response to this announcement is voluntary; the United States Government will not pay for information requested nor will it compensate any respondent for any cost incurred in developing information provided to the United States Government.  Not responding to this RFI does not preclude participation in any future RFP, if any is issued.  It is the responsibility of the potential offerors to monitor sam.gov for additional information pertaining to this requirement.

Background

The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, Enabling Biotechnologies (JPEO-CBRND-EB), develops, manufactures and delivers safe and effective Medical Countermeasures (MCMs) for preparedness, prevention, protection, response, and recovery from CBRN threats.  This mission supports rapid response capabilities including discovery, optimization and manufacturing to rapidly equip the warfighter with the best available protective measures.

The Chemical and Biological Incident Preparedness and Response (CBIPR) Program within JPEO-CBRND-EB seeks to identify and foster initiatives that safely and efficiently accelerate drug development, including those that reduce cost or accelerate the timing of in-vivo testing. New Approach Methodologies (NAM) have been proposed to augment and/ or replace animal-based non-clinical testing in drug development while providing more predictive results for human safety and efficacy.[1]  NAMs utilize computational modeling, artificial intelligence and machine learning along with ex-vivo, organoid, organ-on-a-chip, microphysiological systems (MPS) and other in-vitro systems to augment, reduce or replace certain testing that is currently only available through the use of animal models. NAMs have the potential to drastically accelerate the time to field MCMs to CBRN threats, at reduced cost.

JPEO-CBRND-EB is seeking information on NAMs that provide information on specific CBRN threats and MCM development use cases such as: replacement of key pharmacologic and toxicologic tests now conducted in animals, NAM capabilities that inform or enable first-in-human dose projections through pharmacokinetic, artificial intelligence and machine learning capabilities to accelerate toxicology studies and other in-vivo studies, pharmacodynamic and inter-species projections, and recapitulation of biothreat or nerve agent pathologies or disease states in NAM systems. The target Technology Readiness Level (TRL) for responses to this RFI are 3-6, though others may be reviewed with sufficient supporting information at reviewer discretion.

Requested information

To enable future capabilities utilizing NAMs within the CBRN MCM development space, JPEO-CBRND-EB is seeking the following information (including but not limited to):

A. INFORMATION ON NEW APPROACH METHODOLOGIES FOR CBRN USE CASES

Areas of interest include and are not limited to:

1. Recapitulation of in-vivo CBRN threat exposure, disease states and pathologies
2. NAM approaches to support or replace key nonclinical toxicology, pharmacology or efficacy studies used to support MCM development
3. NAM approaches that inform human estimated dose
4. Use of artificial intelligence and machine learning capabilities to augment or improve NAMs, accelerate toxicology studies, or other in-vivo studies

The following information is requested:

1. Describe the model system, test or capability (including in-silico models), its workings, and how it is intended to reproduce key features of CBRN threat exposure, biological responses, or MCM dose, efficacy and toxicology.
2. Illustrate the intended use for the capability in the MCM development process, including what key decision points in the drug development process that the technology supports.
3. Provide descriptions of specific non-clinical studies that the test or capability might support or replace. 
4. Provide details on the accuracy and precision of predictions and the applicability to both individual and population level in-vivo phenomena.
5. Indicate whether the test or capability is intended for use in a research and development setting or for use in a regulated environment or to support regulatory requirements.
6. Describe the experimental inputs or data pipeline that is needed to use the capability or train any predictive models used.
7. Detail the required critical reagents and supplies, including biological materials, cell lines, sourcing sustainability and shelf life.
8. Provide information about the speed and throughput of the test or device.
9. Expand on the differentiating features of the test, capability or model relative to what is currently commercially available.

B. TECHNOLOGY READINESS AND INTELLECTUAL PROPERTY

TECHNOLOGY READINESS ASSESSMENT

1. Define the current technology readiness level (TRL).[2]  This RFI targets products that minimally have established with proof of concepts and experimentally demonstrated.
2. Indicate whether the NAM is offered commercially, and if not, summarize proposed pathway and needs  to create a minimum viable product.
3. Summarize the transferability of the technology to customer or government labs, including training, facility requirements and expected maintenance requirements.

INTELLECTUAL PROPERTY

1. Provide a summary of intellectual property owned by the offeror on the proposed technology.

TECHNOLOGY TRANSFER

1. Describe the readiness and willingness of the offeror to license, install, or otherwise transfer the technology to either a US government facility or another 3rd party.
2. Describe how the offeror supports training, installation and other aspects of transfer of the capability or technology to a customer or third party. 

C. DEVELOPER PROFILE AND CAPABILITIES

PROFILE

1. Provide a profile of your company or organization including approximate size by employees and location(s).

MANUFACTURING AND FABRICATION CAPABILITIES

1. Describe the current state of fabrication, manufacturing and distribution capabilities for required components and finished system(s).
2. Describe gaps in the above that require further development to field the technology.

COMPUTATIONAL MODELING AND HIGH-THROUGHPUT DATA PIPELINE CAPABILITIES

1. Detail unique computational or high-performance computing capabilities that your company has developed or that accompanies the NAM technology or capability.
2. Discuss your company’s capability of generating data pipeline(s) that may be required to train or parameterize models implemented with the technology.

SERVICE OFFERINGS AND TEST DEVELOPMENT

1. Detail fee-for-service offerings pertaining to in-vitro, in-vivo or any testing related to the NAM technology.
2. Detail any contract research offerings that your company provides for test development and/or customization for specific applications.

Interested parties are requested to respond to this RFI in the form of a presentation or white paper (not to exceed 5 pages).  Supporting or promotional documents (not to exceed 3) are allowed as attachments.

The response date for this market research is November 28, 2025.  All responses to this RFI may be submitted via e-mail to Elizabeth Smith, Deputy Director – Advanced Technology Products (ATP), at elizabeth.l.smith165.civ@army.mil.

[1] The Food and Drug Administration (https://www.fda.gov/science-research/about-science-research-fda/fdas-predictive-toxicology-roadmap, ) and National Institutes of Health (https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies) have announced initiatives supporting the development, qualification, and eventual utilization of NAMs in the development and evaluation of drug candidates.

[2] See https://www.cto.mil/wp-content/uploads/2023/07/TRA-Guide-Jun2023.pdf for more information.