W911SR-26-9-NAMS RPP.pdf

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Army Contracting Command Aberdeen Proving Ground

Edgewood Contracting Division, Fort Detrick Request for Project Proposal

W911SR-26-9-NAMS

Agency: Department of the Army Office: Army Contracting Command, Edgewood Contracting Division Location: Fort Detrick, MD, USA Program Office: Capability Program Executive Office for CBRN Defense, Joint Project Management Office for CBRN Emerging Technologies RPP Number: W911SR-26-9-NAMS Date Issued: June 1, 2026 Proposals Due: 1500 hours, June 12, 2026

1. Through this Request for Project Proposal (RPP), the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense’s (CPE CBRND) Joint Product Lead for CBRN Emerging Technologies (JPL CBRN ET) seeks to advance New Approach Methodology (NAM) capabilities that reduce reliance on traditional animal models, de-risk Medical Countermeasure (MCM) development against CBRN threats and shorten MCM development timelines as described in the attached Statement of Objectives (SOO). In accordance with Section VIII.A.11 of announcement CBRND BAA 22-01, the Government is hereby requesting formal submission of preproposals to execute a formal agreement under 10 USC 4022, Other Transaction Authority (OTA) for the prototype project described below.

Upon receipt of a preproposal submitted in response to this RPP, the next steps are as follows:

- The Government will evaluate the preproposal.

- Discussions among the parties, whether verbally or in writing, will occur as appropriate.

- The Government may request a full proposal from the offeror.

- Additional discussions will occur as necessary.

- Award(s) may be made after evaluation and selection of a successful submission. (Note:

Awards are dependent upon the availability of funds.)

2. This RPP is issued to request project proposals in compliance with USC 4022 and is being issued for planning purposes only. It is not to be construed as a commitment by the Government to award an agreement, nor will the Government pay for the information solicited.

3. The JPL CBRN ET is tasked with developing, manufacturing, and delivering safe and effective medical countermeasures capabilities against CBRN threats for deployed U.S. Forces.

This effort intends to result in NAM capabilities that will reduce in vivo dependencies and enable faster fielding of MCMs to warfighters. Agreement under the authority of 10 USC 4022, with the expectation that quantities necessary for production, including fielding and testing new capabilities, may be non-competitively procured from awarded to the successful performer(s) of a prototype project in a follow-on production contract or other transaction agreement.

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4. The Government will review/evaluate the submitted preproposals and if there is Government interest, the Agreements Officer may issue a request for full proposal (RFFP) in response to this RPP. The Government may award an agreement based on the submission or may require submission of additional details. The award of Prototype agreements shall be for the development of prototypes that are directly relevant to enhancing the mission effectiveness of personnel of the Department of Defense and the supporting platforms, systems, components, or materials proposed to be acquired or developed by the Department of Defense, or to improvement of platforms, systems, components, or materials in use by the Armed Forces. A prototype project can generally be described as a preliminary pilot, test, evaluation, demonstration, or agile development activity used to evaluate the technical or manufacturing feasibility or military utility of a particular technology, process, concept, end item, effect, or other discrete feature. Only a warranted Agreements Officer may obligate the U.S. Government to the expenditure of funds for awards under this Announcement.

5. Evaluation will be performed by JPL CBRN ET personnel, other Federal Agency Representatives, or combinations thereof to enable the selection of the best preproposal submission, and/or subsequent full proposal submission. After evaluation and selection, an award will be made to the successful offeror(s). Subsequent awards depend upon the availability of funds and fulfillment of requirements and priorities determined to exist at the time of award.

In some cases, funding priorities may change as certain scientific tasks are addressed and new mission assignments arise. Award may also be dependent upon demonstration by the offeror that they have adequately addressed the requirements.

6. The U.S. Government does not fund preparation of proposals or support work efforts or tasks that are inferred from discussions with technical project officers. The Offeror will not be reimbursed for any costs incurred prior to the effective date of the agreement. There are certain post-employment restrictions on former Federal officers and employees as defined in 18 USC 207 and FAR 3.104-3(d). If an offeror believes a post-employment restriction or conflict of interest exists, notification should be sent to the Agreements Officer prior to initiating efforts on a full proposal.

7. The Freedom of Information Act (FOIA) (5 USC 552) provides a statutory basis for public access to official U.S. Government records. “Records” are defined to include documentation received by the U.S. Government in connection with the transaction of public business. Certain types of information submitted to the Government in a process having the potential for award of an OT may be exempt from disclosure requirements of FOIA for a period of five (5) years from the date the Government receives the information. The types of information listed above may continue to be exempted, in whole or in part, from disclosure after the expiration of the five (5) year period if it falls within an exemption to the FOIA such as trade secrets and commercial or financial information obtained from a person that is privileged or confidential. It is the Offeror’s responsibility to adequately mark any submitted information in accordance with the FOIA.

8. The Government is prohibited from soliciting and awarding actions to awardees that have engaged or are suspected to have engaged in criminal, fraudulent, or seriously improper conduct.

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9. Prospective awardees shall complete electronic annual representations and certifications at https://sam.gov. By submission of an offer, the Offeror acknowledges the requirement that prospective awardees MUST be registered in the System for Award Management (SAM) database prior to award and through final payment of any contract resulting from this RPP.

Offerors that are not registered should consider applying for registration immediately upon receipt of this solicitation. To remain registered in the SAM database after the initial registration, the Offeror is required to review and update, on an annual basis from the date of initial registration (or subsequent updates), its information in the SAM database to ensure it is current, accurate and complete.

10. Data submitted that cannot be disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall be marked appropriately on the title page and/or specific data sheets.

11. Questions regarding this announcement may be submitted by email to usarmy.detrick.dod- CPE CBRND.mbx.baa@army.mil AND hunter.t.robinson4.civ@army.mil AND bianca.g.batista.civ@army.mil prior to 5 business days of the closing date.

12. The Government may award a follow-on production contract or Other Transaction (OT) for any OT awarded under this BAA if: (1) that participant in the OT, or a recognized successor in interest to the OT, successfully completed the entire prototype project provided for in the OT, as modified; and (2) the OT provides for the award of a follow-on production contract or OT to the participant, or a recognized successor in interest to the OT.

13. Proposals, Brochures, or other descriptions of general organizational or individual capabilities will not be accepted as a preproposal. An email will acknowledge receipt of a proposal. Generally, the Project Manager of the submitting organization should receive a decision letter or email upon completion of the evaluation and determination.

14. Administration: The Government will retain comments and information received in response to this RPP. Do not use Government security classification markings. All written responses must be received by the due date. Submission should be identified with a Subject Line of the Responding Organization and RPP Title. Material that is advertisement only in nature is not desired. Late submissions will not be considered.

15. Requirements: See attached Statement of Objectives (SOO).

16. Submissions: Preproposals shall be submitted in accordance with CBRND-BAA-22-01 Section VIII “Other Transaction Agreements” Subsection 11 “Submission Procedures” to below listed mailboxes only.

usarmy.detrick.dod-CPE CBRND.mbx.baa@army.mil AND hunter.t.robinson4.civ@army.mil AND bianca.g.batista.civ@army.mil

Submissions must include sufficient detail to warrant a decision or otherwise will not be considered. Submissions cover page must identify appropriate POC’s in addition to company address and UEI and CAGE codes. If the offeror is not listed in SAM.gov, then the extent of https://sam.gov/ mailto:CPECBRND.mbx.baa@army.mil mailto:hunter.t.robinson4.civ@army.mil mailto:bianca.g.batista.civ@army.mil mailto:usarmy.detrick.dod-CPECBRND.mbx.baa@army.mil mailto:hunter.t.robinson4.civ@army.mil mailto:bianca.g.batista.civ@army.mil

Page 4 of 4 Page 4 of 4 their submission package to SAM should be documented. Cover page, ROM, and WBS will not be considered in the total page count. Any additional pages exceeding 15 pages will not be considered.

Submissions must be delivered by the date and time expressed in announcement or will not be considered.

17. Evaluation Factors: Proposals received as a result of the BAA will be evaluated per CBRND- BAA-22-01 Section VII.C “Evaluation Factors For Prototype Agreements”.

18. Selection for Award: See CBRND-BAA-22-01 Section VIII “Selection For Award Of Prototype Agreements.”

New Alternative Models (NAMs) Statement of Objectives (SOO)

Description of Project

The Joint Project Lead - Chemical, Biological, Radiological and Nuclear Enabling Technologies (JPL-CBRN-ET), is a component of the Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE-CBRND), has a mission to develop, de-risk, and operationalize innovative technologies for the rapid development, manufacture, and deployment of medical countermeasures against chemical, biological, radiological, and nuclear threats to the Warfighter. Within JPL-CBRN-ET, Advanced Technology Platforms (ATP) develops MCMs or platforms that enable medical countermeasure (MCM) development in response to emerging threats for the Department of War (DoW).

JPL-CBRN-ET-ATP manages the Chemical and Biological Incident Preparedness and Response- Model Development (CBIPR-MODEL) program, which fosters initiatives to accelerate MCM development through supply chain support and evaluates New Approach Methodology (NAMs) to reduce the enterprise's long-term reliance on animal models and further mitigate the supply chain risks. NAMs will 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 (AI) and machine learning (ML) along with ex vivo, organoid, organ-on-a-chip (OOC), 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.

JPL-CBRN-ET-ATP is seeking proposals for NAMs that provide actionable data on CBRN threat agent pathology or CBRN medical countermeasure development. Some specific goals include 1) reducing reliance on animal models, 2) de-risk MCM development against CBRN threats, and 3) reducing timelines of MCM development. Example approaches include the prediction of immunogenicity of biologics in humans, replacement of key pharmacologic and toxicologic tests now conducted in animals, and testbed capabilities that would allow assessments of MCMs in parallel to ongoing or historic MCM development programs. Bespoke NAMs for targeted MCM development are deprioritized in this request for proposals (RFP) as ATP desires a platform approach where the NAM technology is capable of broad threat agnostic development for MCMs

1 The Food and Drug Administration (https://www.fda.gov/science-research/about-science-research-fda/fdas-predictive-toxicology-roadmap, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-use-new-approach-methodologies-drug-development) 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.

https://www.fda.gov/science-research/about-science-research-fda/fdas-predictive-toxicology-roadmap https://www.fda.gov/science-research/about-science-research-fda/fdas-predictive-toxicology-roadmap https://www.fda.gov/science-research/about-science-research-fda/fdas-predictive-toxicology-roadmap https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-use-new-approach-methodologies-drug-development https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-use-new-approach-methodologies-drug-development https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-considerations-use-new-approach-methodologies-drug-development https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies

Project Objectives

JPL-CBRN-ET-ATP is requesting proposals in any, or all, of four main Topic Areas below.

Proposals can be at any level of development, however for all four Topic Areas, comparison of NAM results to animal or human data should either be previously demonstrated or outlined in the proposal to assess the predictive value of the NAM system or method. Evidence of interactions with the Food and Drug Administration (FDA) is preferred but not required. Non-cell or non-tissue-based assays and computational methods may accompany the NAM offering or be developed in parallel to provide complementary information. Risk assessment is a key area of interest, whether organ-specific or systemic, to inform MCM development prior to nonclinical or clinical trials. Collaboration between Offerors or subcontracting of key services and activities is permissible to achieve objectives.

I. Immunogenicity and Toxicology Testing Single or multisystem NAM technologies which can evaluate desired and undesired immune response in humans or animals exposed to small-scale laboratory batch material is desired. These technologies can be used to assess the success of humanization efforts (e.g., monoclonal antibodies) or de-risk the introduction of novel sequence motifs into MCMs. NAMs are desired that predict both T-cell and B-cell responses to exposure to MCM candidates from sequence or experimental approaches, as well as provide predictions of anti-drug antibody and other major immunological responses.

Other areas of interest include prediction of off-target effects and the potential toxicity of biologic MCMs. NAM applications may also focus on recapitulation of immunological or other adverse responses, disease states or pathologies after exposure to biological (pathogen, toxin) or chemical threat. Example readouts include biomarker response (e.g., interferon response, cytokine release, etc.), physiological changes, and disease course in multiple organs (e.g., viral load studies, apoptosis, etc.).

In either application, offerors are encouraged to build confidence in NAMs using “head-to-head” comparison with in vivo data. Together, the near-term goal is to evaluate toxicology using NAMs to inform or even replace single/repeat dose toxicity studies. In the long term, NAMs will be advanced enough for MCM development Sponsors to incorporate these technologies into their Investigational New Drug (IND) submissions to the FDA.

II. Aerosol exposure/MCM Efficacy in Lung In-vivo aerosol exposure studies to CBRN threat agents provide an understanding of disease under realistic conditions and help to refine human MCM dose/response relationships. NAMs that model physiological events occurring after respiratory exposure, including MCM efficacy and disease course, are desired to better understand in vivo outcomes and potentially reduce or replace the use of animals in such studies. Individual component or multicompartment systems are desired that appropriately recapitulate MCM efficacy in the context of aerosolized pathogen exposed to the upper airways and lungs. Ideally, comparisons should be made to animal studies (e.g., using pseudotype viruses to assess replication and viral loading in animal vs NAM studies). Note, this SOO deemphasizes models that only model or monitor lung deposition of particulates since numerous systems are commercially available in that technology space.

III. Testbed Capabilities JPL-CBRN-ET-ATP has interest in general testing services that utilize qualified, if not validated, NAM capabilities (i.e., approximated Technology Readiness Level (TRL) ≥7) to test safety and efficacy of MCMs in ongoing development campaigns. Qualification activities necessary to adapt NAMs for use in JPL-CBRN-ET-ATP relevant applications are expected, unless the testing platform and NAM are already demonstrated as fit-for-purpose.

Details on the intended applications, characterization and data outputs of the NAM or NAM systems should be provided (e.g., qualification or validation metrics, enrollment in the FDA Innovative Science and Technology Approaches for New Drugs (ISTAND) program, etc.). Test material will be shipped to the service provider for testing. Data may be compared to biosamples obtained from nonclinical or clinical studies where this material was also administered. For example, quantitative/statistical analysis of NAM data to historical models or samples is desired to support possible use in FDA submissions such as part of IND packages, where appropriate.

Offerors should additionally specify whether the service offering may include bioassay development and testing to further enable comparisons between in vitro and in vivo results.

IV. Pharmacokinetic Prediction Applications JPL-CBRN-ET-ATP is also interested in organ-representative or multisystem NAMs which model bioavailability and pharmacokinetics of MCMs after dosing and impacts on disease course to estimate MCM efficacy. For example, JPL-CBRN-ET-ATP is interested in technologies that predict the pharmacokinetics (PK) of circulating antibodies including those with neonatal Fc (crystallizable fragment) receptor (FcRn) modified Fc regions. NAMs can base PK predictions on sequence or small-scale laboratory batches of test material. As with all other Topic Areas, in vivo-in vitro (IVIVC) comparisons should demonstrate applicability and rigor of predictivity of the NAMs. Long term goals will include additional PK NAM technologies that can predict PK for different MCM modalities (e.g., not just antibodies).

Proposal Requirements

Submit a whitepaper up to 5 pages and up to two supporting documents (no more than 10 additional pages, for 15 pages total including all documents) containing the following elements.

A subset of proposals will be selected for in-person presentation of a more detailed proposal, proposed statement of work, and Cost.

1. Responses to this RFP must specify which Topic Area(s) their technology addresses.

Responses to multiple Topic Areas can be provided within the same whitepaper.

2. Describe the model system, test or capability (including computational models), its workings, and how it is intended to reproduce key features of CBRN threat exposure, biological responses, efficacy and toxicology with or without introduction of MCMs.

3. 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.

4. Provide information on the technology itself such as required critical reagents including biological materials, cell lines, sustainability of supplies, shelf life, throughput, readouts, reproducibility, extent of qualification or validation, etc.

5. Summarize the intellectual property (IP) rights of the technology, data rights, and licensing considerations if applicable. Note that JPL-CBRN-ET-ATP generally is expecting unlimited rights to data derived from these studies, with no claims to background IP. Justify any claims to less than unlimited rights if applicable.

6. Define the technology readiness level (TRL)2. This RFP targets products that have demonstrated at least proof-of-concept and have been experimentally demonstrated in multiple studies.

7. Identify specific nonclinical or clinical studies the capability may support or replace.

Include description of key decision points in disease characterization or drug development that are supported by the technology. Explain how the proposed technology will reduce, replace, or alleviate the need for animal testing in medical countermeasure development activities. Provide an estimate in how the incorporation of this technology could derisk and reduce time to help accelerate overall MCM development timelines.

Rough order of magnitude cost for proposed work. Special Requirements

Travel No travel is anticipated under this contract.

Government Furnished Property Any products or other biological and pharmaceutical related material shipped, received and tested remains property of the United States Government. All property shall be documented and maintained in accordance with the terms and conditions of the contract to include the PWS. All property shall be secured in accordance with the requirements specified herein, and no property without express permission from the AOR shall have access to this product.

Other Government Contracts The Offeror shall address other Government contracts that relate to the proposed development effort, including those with agencies outside the DoW. This avoids duplicity in effort and allows cross-Government coordination.

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

https://www.cto.mil/wp-content/uploads/2023/07/TRA-Guide-Jun2023.pdf

Security and Classified Data Any information/data generated under this agreement will be designated Unclassified (U) and is subject to the safeguarding and reporting requirements of the base Other Transaction Agreement Article XVII. Data generated under this contract are considered DoW Controlled Unclassified Information (CUI) and fall under ITAR 120.10 whose export is restricted by the Arms Export Control Act (Title 22, U.S.C. Sec 2778, et seq.) Violations of United States export laws are subject to severe criminal penalties.

Data Rights Data rights will be negotiated. The DoW desires, to the fullest extent possible, unlimited rights to data generated with DoW funding for data furnished to or developed for the Government under an Agreement.