The BioStabilization System (BoSS) program (ARPA-H-SOL-26-136) is soliciting Solution Summaries from technical performer teams for innovative bioprocessing technologies. Submissions, limited to four pages plus cover, citations, and key personnel, must be in English with a 12-point font. The summary requires a cover letter detailing organizational information, technical and administrative points of contact, total estimated cost, and places of performance. It must clearly describe proposed technical approaches (TA1 and TA2), their integration, and how they address technical areas with minimal jargon. The proposal should identify outcomes, problems solved, and demonstrate innovation, disruptive potential, and significant advancement beyond existing technologies, supported by quantitative metrics. Additionally, it must outline proposed work, including deliverables, milestones, technical approaches, supporting data, and risk mitigation strategies. Team organization, capabilities, and a detailed Basis of Estimate (BOE) covering labor, materials, equipment, and other costs are also required.

The BioStabilization System (BoSS) ARPA-H-SOL-26-136 document outlines the requirements for Independent Verification and Validation (IV&V) Partner Solution Summaries. It details the cover page format, including organizational information, contact details, total estimated costs, and places of performance. The summary emphasizes a four-page limit for the main content, excluding the cover page, citations, and key personnel tables with bio-sketches. Submissions must be in English with a minimum 12-point font. Key sections include a Concept Summary requiring a clear identification of qualifications and capabilities, a Proposed Work section detailing deliverables, alternative approaches, scientific principles, and robust IV&V methodology. The Team Organization and Capabilities section requires outlining roles, responsibilities, and a separate table for key personnel with their institutions and bio-sketches. Finally, a Basis of Estimate (BOE) section mandates a breakdown of timeline, federal funds, total project cost, and a detailed cost categorization including labor, materials, equipment, travel, and profit.

The BioStabilization System (BoSS) program, ARPA-H-SOL-26-136, outlines instructions for submitting Solution Pitches as part of a federal government RFP for Technical Performer Teams. Proposers must use specific templates from SAM.gov for the slide deck, cost proposal narrative, cost proposal spreadsheet, and bio-sketches of key personnel. Submissions are made through the ARPA-H Solution Submission Portal. It is crucial to follow all instructions, as incomplete submissions will not be considered, and no revisions are allowed after submission. The pitch presentations are virtual, lasting 45 minutes total, with 15 minutes for the presentation and 30 minutes for Q&A. Proposers should address questions from the slide deck template, using figures and diagrams where relevant. A link for scheduling will be provided to those with conforming submissions, emphasizing a structured and unchangeable submission process.

The BioStabilization System (BoSS) ARPA-H-SOL-26-136 document outlines instructions for submitting Solution Pitch presentations for consideration as an Independent Verification and Validation (IV&V) Partner. Proposers must use specific templates from SAM.gov for the slide deck, cost proposal narrative, and spreadsheet, along with bio-sketches of key personnel. Submissions are made through the ARPA-H Solution Submission Portal. It is crucial to review all pre-award instructions as no revisions are allowed post-submission. The virtual oral presentations are 45 minutes total, comprising a 15-minute presentation and 30 minutes for Q&A. A link will be provided for scheduling once conforming materials are submitted.

The Administrative & National Policy Requirements Document is a critical component of federal government Solution Pitch submissions, outlining mandatory administrative and policy requirements for proposals. It covers team identification, FFRDC participation, organizational and research security disclosures, novelty of work, intellectual property rights, human and animal subjects research, tax liability and felony convictions, cybersecurity, and biosecurity. Key sections mandate disclosures for foreign talent recruitment programs, foreign ownership, and research conducted in foreign countries of concern. The document also details government rights for intellectual property, requiring proposers to define expected government licenses. Adherence to formatting, submission, and disclosure guidelines is crucial for compliance and to mitigate risks associated with federally funded research.

The BoSS Solution Pitch outlines the requirements for a virtual presentation submission for the ARPA-H-SOL-26-136 solicitation. Proposers must address technical merit, including problem-solving approaches for technical areas 1 and 2, innovative solutions, challenges, and commercialization plans. The pitch also requires details on the proposer's team qualifications, leadership structure, and key personnel. Furthermore, it mandates an assessment of risks and mitigation strategies, including potential misuse. A detailed program timeline with key milestones for phases 1, 2A, 2B, and 3, along with a comprehensive cost summary across all phases, is also required. The submission process involves using the ARPA-H Solution Submission Portal, responding to feedback, and adhering to strict submission guidelines with no revisions post-submission. The virtual pitches will be 45 minutes, with 15 minutes for presentation and 30 minutes for Q&A.

The ARPA-H-SOL-26-136 solicitation outlines the requirements for the BoSS Solution Pitch, a virtual presentation for prospective partners. Submissions must be made via the ARPA-H Solution Submission Portal, addressing feedback from prior Solution Summary submissions. The pitch format includes a 15-minute presentation and 30 minutes for Q&A, with an emphasis on visual aids. Key evaluation criteria encompass technical merit, team qualifications (including leadership, key personnel, and organizational structure), identified risks and mitigation strategies, and a detailed cost summary. Technical merit requires demonstrating expertise in cell characterization, nonclinical studies, regulatory knowledge, data analysis, infrastructure, objectivity, and a track record of supporting cell characterization projects. The proposal should align with the ARPA-H mission and offer innovative solutions. Teams must also outline strengths and areas needing support as an IV&V partner. A comprehensive cost breakdown is required across various phases and categories.

This document outlines the requirements for a comprehensive cost proposal, supplementing a spreadsheet with detailed justifications and additional information. Proposers must incorporate indirect costs into labor rates or other pricing elements and substantiate large cost drivers with documentation. The proposal requires an index for supplementary materials and adherence to specific formatting. Key sections include detailed breakdowns for level of effort, materials, equipment purchases, travel, other direct costs, resource sharing, consultant costs, and team member costs. Each section requires specific information, such as itemized lists, quantities, unit prices, vendors, and basis of estimate. The document also mandates a value analysis explaining the proposed effort's return on investment for American taxpayers and its contribution to health outcomes. Proposers must provide organizational details like the Team Lead Organization, SAM.gov UEI, TIN, and CAGE code, along with contact information for technical and administrative points of contact.

The “ATTACHMENT 4: Cost Proposal Spreadsheet” outlines a standardized template for submitting detailed cost proposals for multi-party government projects. It mandates separate spreadsheets for each team member, with the lead member consolidating total project costs and others detailing their specific contributions. The template emphasizes fully burdened labor costs, excluding profit, which must be itemized separately. It also requires detailed breakdowns for materials, equipment, travel, and other direct costs across three phases, assuming a July 1, 2026, start. The document defines

The Advanced Research Projects Agency for Health (ARPA-H) has issued an Innovative Solutions Opening (ISO) for the BioStabilization Systems (BoSS) program (ARPA-H-SOL-26-136). This program seeks to revolutionize the storage and distribution of live cell-based therapies by eliminating the need for ultra-cold conditions. ARPA-H is soliciting proposals for two key roles: 'Performer teams' to develop breakthrough cell stabilization technologies and integrate them into commercially viable bioprocessing systems, and an 'Independent Validation and Verification (IV&V) partner' to supply cells and assess the performance of the developed technologies. The BoSS program is structured in three phases over 48 months, focusing on scientific feasibility, integrated capability demonstrations, and industry transition. Key metrics include production speed, scale, shelf-life at ambient temperatures, and cell viability after re-animation. The program emphasizes commercialization and regulatory engagement, requiring comprehensive plans and FDA interactions. A Proposer's Day is scheduled for January 29, 2026, with solution summaries due in February and April 2026 for Performers and IV&V partners, respectively.