Beacon SOO DRAFT.pdf

Statement of Objectives (SOO) for Beacon

1.0 PROJECT TITLE

Beacon – Medical Countermeasure (MCM) Candidate Integration and Subcontractor Management

2.0 BACKGROUND/DESCRIPTION

The Capability Program Executive for Chemical, Biological, Radiological and Nuclear Defense (CPE CBRN Defense), through the Beacon program, is accelerating identification and screening of chemical threat medical countermeasure (MCM) candidates through a data-driven approach. Beacon will conduct targeted non-clinical, clinical, and Chemical, Manufacturing, and Controls (CMC) testing of MCM candidates to reduce the risk of failure in advanced development. Beacon will also perform studies targeting operationally relevant parameters to demonstrate effectiveness in a simulated operational environment.

Beacon will establish and maintain a robust pipeline, seamlessly transitioning successful candidates to continued advanced development. Beacon benefits the warfighter by proactively maintaining a resilient and innovative MCM portfolio, ensuring access to effective medical countermeasures and mitigating the risk of delays in fielding critical capabilities. Under this program, the Government will be solely responsible for:

• Identifying and selecting all MCM candidates for evaluation

• Defining the specific nonclinical, clinical, and CMC testing to be performed

The awardee's primary role will be to obtain Government-identified MCM candidates and execute the Government's defined testing plan by rapidly awarding and managing subcontracts with testing performers. The awardee will be responsible for overseeing study execution, managing cost and schedule, identifying programmatic risks, and ensuring the on-time delivery of all required data packages to the Government.

3.0 SCOPE

The scope of this effort is to identify a single contractor to provide expert program management and subcontract administration in support of the Beacon program's mission.

The contractor shall be responsible for the efficient execution of Government-defined testing plans for Government-selected MCM candidates.

4.0 PROGRAM OBJECTIVES

4.1 Program Management Objectives

• Program Manager Expertise: The awardee's proposed Program Manager shall have demonstrated experience managing complex government contracts, preferably within the medical or drug development field. The proposed individual is designated as Key Personnel for this effort and, upon selection, may not be substituted without the prior written consent of the Contracting Officer.

• Planning and Execution: On a monthly basis, the awardee shall develop and maintain a detailed Integrated Master Schedule (IMS) for the entire program, inclusive of all subcontractor activities. The IMS must detail timelines, milestones, deliverables, and critical path activities.

• Reporting and Communication: The awardee shall establish effective communication channels and a regular meeting rhythm with the Government. This shall include, at a minimum, leading biweekly Programmatic meetings to discuss cost, schedule, and risks, as well as separate biweekly technical meetings to review study progress and data. These meetings will serve as the primary forum for the Government to assess progress against program objectives and to communicate any necessary adjustments or required improvements. For these meeting series, the awardee shall be responsible for generating and distributing agendas, preparing and presenting status updates via presentation slides, and delivering detailed meeting minutes for Government’s approval. The awardee shall also provide monthly, quarterly, and annual reports covering technical, schedule, and cost performance.

The awardee shall also develop, maintain, and report a detailed program Spend Plan. At the conclusion of the program, the awardee will deliver a detailed final report that includes all Government-specified data elements and summarizes the program’s outcomes, challenges, and successes.

• Risk Management: The awardee shall develop and submit a Risk Management Plan for Government approval. Upon approval, the awardee shall implement and maintain the plan throughout the period of performance. This plan will identify, assess, and mitigate program risks.

• Government Oversight and Access: The Government reserves the right to conduct on-site audits, inspections, and observations at the awardee's and any subcontractor's facilities with reasonable notification. This right includes, but is not limited to, facility inspections, on-site data audits to ensure data integrity and quality, and the observance of critical program events, such as key experiments or animal challenge studies. The awardee shall be responsible for facilitating this access for Government personnel and their designated representatives across all performance locations.

4.2 Candidate Selection Objectives

• Candidate Selection and Review: Under the Beacon program, the Government is responsible for managing and facilitating the solicitation, review, and down-selection of new MCM candidates. The awardee's primary role is to manage and execute the subsequent technical testing for these Government-selected candidates. To support this Government-led process, the awardee shall facilitate the collection of standardized data packages from subcontractors and ensure all required data is available for the Government's technical evaluation. The Government retains final authority over the down-selection process and may direct the testing of specific candidates at any time to meet programmatic goals.

4.3 Candidate Testing Objectives

• The awardee shall manage and ensure the successful execution of the following technical activities through its network of subcontractors:

o MCM Candidate and Materials Procurement: Manage the procurement of MCM candidates, test agents, and all necessary animals and materials for non-clinical, clinical, and CMC studies. This includes the responsibility for ensuring agent Quality Control (QC) testing is performed upon receipt to verify the identity, purity, and concentration of all chemical warfare agents prior to their use in any study.

o Non-Clinical and Clinical Testing: Oversee a range of studies including, but not limited to, in vitro and in vivo efficacy studies, proof-of-concept studies, and safety/toxicology studies. Where applicable, efficacy studies shall test MCM candidates against a minimum of three nerve agents, selected by the Government based on the proposed intended use and/or previous candidate data. Ensure performers utilize adequate animal models (at least two, where applicable) for product development under the U.S. Food and Drug Administration (FDA) Animal Rule. The studies shall be designed to support regulatory submissions. The awardee shall be responsible for overseeing the development of detailed study protocols for Government approval prior to the initiation of any work.

o Chemical, Manufacturing, and Controls: Manage the development of validated, scalable manufacturing processes for promising MCM candidates.

The awardee must ensure formulation requirements are met and will oversee stability testing programs.

o Operational Relevancy Studies: The awardee shall oversee the execution of nonclinical studies, as directed by the Government, to determine the operational impact of MCM treatment in a nerve agent-contaminated environment.

These studies will evaluate the ability of an MCM candidate to preserve or restore key functions post-exposure. Evaluated tasks must be relevant to Warfighter duties and may include motor skills, cognitive function (e.g., memory, learning), goal-oriented behaviors, or other such studies deemed necessary to determine operational relevance.

The awardee and/or the awardee’s subcontractor shall be responsible for defining the quantitative metrics for these evaluations and the analytical methods for interpreting the results.

The interpretation of results must correlate the behavioral outcomes to mission-relevant tasks. The final study reports must clearly articulate how the preservation of a specific function by an MCM could translate to improved Warfighter performance, safety, or mission success in an operational setting.

4.4 Regulatory Objectives

• Regulatory Sponsor: The awardee must indicate a willingness to collaborate with Government-identified drug developers who will serve as the Regulatory Sponsor and/or be willing to collaborate with drug developer-selected Regulatory Sponsor.

• Regulatory Strategy and Compliance: For each MCM candidate, the awardee shall obtain and maintain a comprehensive Regulatory Strategy. This strategy will outline the specific non-clinical, clinical, and CMC pathway required for FDA approval1. The awardee will ensure all subcontracted work complies with applicable regulations, including FDA Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), and animal welfare regulations (Animal Care and Use Review Office [ACURO]/ Office of Research and Regulatory Compliance [ORRC]).

• Targeted Product Profile: The awardee shall obtain and maintain a Target Product Profile (TPP) for each MCM candidate. The TPP shall define the key characteristics of the product from a regulatory, clinical, and operational perspective and will be used to guide development and decision-making throughout the product lifecycle. At a minimum, the TPP must define the target criteria for:

o Efficacy (e.g., survival percentage, reduction in symptoms) o Route of Administration (e.g., intramuscular, oral) o Shelf-life and Stability Requirements o Duration of Protection from a single dose o Booster requirements, if any o Time to effectiveness after administration

• Letter(s) of Authorization: Obtain letter of authorization from candidate sponsor.

1 Candidates will not be FDA approved under Beacon but should be developed with this end goal in mind.

• FDA Engagement: Support all communications with the FDA. This includes meetings, briefing packages, and facilitating Government participation.

• Submissions: Oversee the preparation, review, and submission of regulatory packages, including Investigational New Drug (IND) applications. Ensure final data reports are formatted for FDA submission (e.g., Standard for Exchange of Non-clinical Data [SEND] format).

• Government Review and Approval: The Government reserves the right to review and approve all formal regulatory submissions, briefing packages, and significant correspondence prior to their submission to the FDA.

4.5. Data Generation and Management

• Intellectual Property, Data Management, and Security: It shall be explicitly understood that the original owner of an MCM candidate retains all background intellectual property rights and ownership of their compound. The awardee shall be responsible for establishing the necessary legal framework to support this, including the execution of Non-Disclosure Agreements (NDAs) from candidate owners to permit the Government-funded work. The awardee shall manage foreground intellectual property and data rights generated under this effort in accordance with the terms of the agreement. The awardee shall also implement a comprehensive Data Management Plan and ensure the security of all project data, including Controlled Unclassified Information (CUI) and potential Secret Information.

• Data Generation and Management: Ensure the generation of all required technical data from studies. The awardee shall manage the direct and timely entry of all study data into the Government-specified data repository (e.g., Metis) by the MCM candidate owner. All data shall be quality-controlled to ensure reproducibility.

• Use of Artificial Intelligence: The awardee shall acknowledge that the Government's evaluation process utilizes the Metis tool, which employs artificial intelligence (AI) to analyze and assess candidate data.

5.0 DATA DELIVERABLE(S)

The following is a summary of deliverables described throughout the SOO. Additional detailed deliverables will be outlined in the Statement of Work (SOW).

• IMS

• Meeting Agendas, Slides, and Minutes

• Monthly, Quarterly, and Annual Reports

• Spend Plan

• Final Report

• Resource Management Plan

• Study Protocols

• Study Reports including Government-specified Data

• Regulatory Strategy

• TPP

• Letter(s) of Authorization

• FDA Communications, Correspondence, Briefing Packages, and IND Applications

• Data Management Plan

6.0 PROTOTYPE DELIVERABLE(S)

The prototypes for this effort are the data packages and assessments for Government-identified MCM candidates that demonstrate technical feasibility and military utility.

7.0 PERIOD AND PLACE OF PERFORMANCE

The anticipated Period of Performance for this effort is estimated to be 60 months (5 years) from the date of award. Specific dates are to be negotiated. The primary place of performance will be the awardee's facilities, with significant work performed at various subcontractor facilities.

8.0 AGREEMENTS OFFICER REPRESENTATIVE (AOR)

Name: Amy Sands

Telephone: 520-706-0082

E-mail: amy.l.sands4.civ@army.mil

Agency Name/Division/Section & Office Symbol: CPE CBRN Defense/JPM CBRN Medical/ SAAL-CBD-MED-CDP