Hemorrhage Countermeasure Evaluation Capabilities RFI

Request for Information (RFI)

This RFI seeks information from industry and academia regarding capabilities for providing independent verification and validation, clinical trial support, and commercialization support for hemorrhage countermeasures. DARPA is looking to identify potential partners for third-party assessments of safety and efficacy, and to assist in product transition to civilian and government markets. The agency is particularly interested in providers who can offer comprehensive knowledge across these domains for efficiency and tailored commercialization/regulatory strategies.

Respondents are asked to submit a white paper detailing their organization's experience, facilities, and approach. The paper should focus on testing and evaluating hemorrhage countermeasures and resuscitation products using synthetic or biosynthetic components. If capabilities are not in-house, respondents must outline an approach (e.g., subcontracting, additional funding) for a holistic solution.

• Organizational Capabilities and Past Performance: Core competencies, preclinical/clinical research facilities (including animal vivarium accreditation and capacity), and past performance with government agencies.

• Preclinical Evaluation Capabilities: Proposed technical approach for in vitro and in vivo studies, and Good Laboratory Practice (GLP) capabilities (or plans to achieve compliance).

• Clinical Trial Support: Experience in designing/managing Phase I & II clinical trials, and expertise in clinical regulatory affairs (IRBs, IND submissions, FDA, patient enrollment).

• Technology Commercialization and Transition Support: Experience with technical/financial due diligence, commercialization strategies, IP landscapes, and market potential for drugs, biologics, combination products, and related devices/diagnostics.

• Program Management and Key Personnel: Expertise of key personnel and a notional 3-year timeline including preclinical studies, GLP compliance, clinical trials, and FDA submission support.

• Rough Order of Magnitude (ROM) Estimate: An estimated budget by year for a notional 5-year effort, broken down by major phase (e.g., Preclinical Testing, Clinical Trials).

• Format: White paper, non-proprietary information encouraged. Technical descriptions limited to 10 pages, 12-point font, 1-inch margins.

• Submission: Electronically in PDF format to DARPA-SN-26-61@darpa.mil.

• Deadline: Responses due 15 days after posting, 4:00 PM ET.

• This RFI is for information and planning purposes only and does not constitute a solicitation for proposals.

• DARPA will not award a contract based on this RFI or pay for information requested.

• Responses are voluntary and will be treated as information only.

• No reimbursement for costs incurred in responding.

• Do not include classified information.

• Clearly label any proprietary information as "proprietary."

Request for Information (RFI)

This RFI from DARPA's Biological Technologies Office (BTO) seeks information from industry and academia regarding capabilities for providing independent verification and validation, clinical trial support, and commercialization support for hemorrhage countermeasures. The goal is to identify potential partners for third-party assessments of safety and efficacy and to assist in development strategies for transitioning these products to civilian and government markets.

Respondents are asked to submit a white paper detailing their organization's experience, facilities, and approach, focusing on testing and evaluating hemorrhage countermeasures and resuscitation products using synthetic or biosynthetic components. The white paper should address the following sections:

1. Organizational Capabilities and Past Performance: Core competencies, preclinical and clinical research facilities (including vivarium accreditation and capacity), and past performance in similar studies, especially with government agencies.
2. Preclinical Evaluation Capabilities: Technical approach for in vitro and in vivo studies, and Good Laboratory Practice (GLP) capabilities (or plans to achieve compliance).
3. Clinical Trial Support: Experience in designing and managing Phase I and Phase II clinical trials, and expertise in clinical regulatory affairs (IRBs, IND submissions, patient enrollment).
4. Technology Commercialization and Transition Support: Experience in technical and financial due diligence, commercialization strategies, IP landscapes, and market potential for drugs, biologics, and combination products.
5. Program Management and Key Personnel: Expertise of key personnel and a notional 3-year program timeline including preclinical studies, clinical trials, and FDA submission preparation.
6. Rough Order of Magnitude (ROM) Estimate: A ROM estimate for the full scope of capabilities, broken down by major phase, with an estimated budget by year for a notional 5-year effort.

• Submissions are due 15 days after posting, by 4:00 PM ET.

• White papers should be concise, limited to 10 pages, use 12-point font, and 1-inch margins.

• Submissions should be sent electronically in PDF format to DARPA-SN-26-61@darpa.mil.

• Respondents should clearly identify any proprietary information.

• This RFI is for information gathering and planning purposes only and does not constitute a solicitation for proposals.

• No contract will be awarded based on this RFI, and no payment will be made for submitted information.

• Submission is voluntary and not required to respond to future solicitations.

• DARPA will not reimburse costs incurred in responding to this RFI.

• No classified information should be included in responses.

• Respondents are advised that DARPA is under no obligation to acknowledge receipt or provide feedback.