CPP-RFI-Doc.docx

RFI No.: HT9425-25-RFI-PDM-01 Cryopreserved Platelets (CPP) for US FDA Licensure

REQUEST FOR INFORMATION

REQUEST FOR INFORMATION (RFI) NO.: HT9425-25-RFI-PDM-01

RFI ISSUE DATE: 14 January 2025

1.0 RFI TITLE: Cryopreserved Platelets (CPP) for US FDA Licensure

2.0 AGENCY: United States Army Medical Research and Development Command (USAMRDC), Fort Detrick, MD

3.0 OFFICE: United States Army Medical Materiel Development Activity (USAMMDA), Warfighter Protection and Acute Care Project Management Office (WPAC PMO) of the Program Executive Office Operational Medical Systems (PEO OPMED), Fort Detrick, MD

4.0 CONTRACTING OFFICE: United States Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD

5.0 SUBJECT: WPAC PMO seeks to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. We develop, directly through collaboration with commercial partners, medical products that enhance readiness and improve the quality of life of active-duty personnel in the operational environment. As part of the U.S. Combat Casualty Care Research Program, USAMMDA has been developing a biologic product: Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP), a frozen, biologic-platelet product. DMSO CPP are formulated to provide a platelet-derived product with a longer shelf life (2 years and potentially longer) than liquid stored platelets (LSP), which are currently licensed for storage up to 5 days at room temperature (20ºC to 24ºC) under gentle agitation.

6.0 DISCLAIMER: In accordance with Federal Acquisition Regulation (FAR) 15.201 “Exchange with industry before receipt of proposals,” and FAR 52.215-3, “Request for information or Solicitation for Planning Purposes,” this RFI is for information and planning purposes only at this time, and shall not be construed as a solicitation or as an obligation on the part of the USAMRDC, or collaborative Department of Defense (DoD) activities. This RFI is not a Request for Proposal or Invitation for Bid, nor does it restrict the Government to an ultimate acquisition approach. This notice is for information and planning purposes only and is not to be construed as a commitment by the Government. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. In keeping with the standards of FAR Part 10, the Government may request additional information from responders. The Government is not obliged to award a contract or otherwise pay for the information provided in the responses received. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Responders are advised that the Government is under no obligation to acknowledge receipt of the information received, or to provide feedback to respondents regarding any information submitted. Responders are solely responsible for all expenses associated with responding to this RFI or any follow-up information requests. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. Additionally, questions concerning the composition and requirements for a future request for proposal will not be entertained.

If a solicitation is released, a synopsis may be posted in “Contracting Opportunities” (formerly FedBizOpps [FBO]) at https://sam.gov/. It is the responsibility of any potential vendor to monitor “Contracting Opportunities” for the release of any solicitation or synopsis. NO PHONE CALLS PLEASE.

7.0 DESCRIPTION: The mission of USAMRDC is t to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. We develop, directly through collaboration with commercial partners, medical products that enhance readiness and improve the quality of life of active-duty personnel in the operational environment. As part of the U.S. Combat Casualty Care Research Program, USAMMDA has been developing a biologic product: Dimethyl Sulfoxide (DMSO) Cryopreserved Platelets (CPP), a frozen, biologic-platelet product. DMSO CPP are formulated to provide a platelet-derived product with a longer shelf life (2 years and potentially longer) than liquid stored platelets (LSP), which are currently licensed for storage up to 5 days at room temperature (20ºC to 24ºC) under gentle agitation.

In vitro studies demonstrate that compared to LSP, CPP is potentially more hemostatically active. Such characteristic is defined by irreversible changes to platelets activation, microparticle release, loss of in vitro functions including a reduced response to agonists and hypotonic stress, decrease in shape change ability, increase in thrombin generation, and a conversion to a procoagulant phenotype (PS expression) and increased numbers of microparticles. DMSO CPP are prepared from γ-irradiated [2500 centi-gray (cGy)] leukocyte-reduced apheresis platelets, stored in plasma and anticoagulant citrate dextrose solution A for up to 57 hours at room temperature (20°C to 24°C) after apheresis. The apheresis platelets are then concentrated and cryopreserved in approximately 6% DMSO at -80°C and stored at ≤-65°C.

USAMMDA’s past and current industry and academic partners have manufactured clinical-grade lots of CPP and performed Phase 1 and Phase 2 clinical studies (proof-of-concept studies) under a US Investigational New Drug (IND) application. Several Phase 1 in vivo recovery and survival studies demonstrated in vivo viability of CPP product as required by FDA’s standards. In a Phase 1/2a dose-escalation study, no thromboembolic complications resulted from the transfusion of up to 3 units of CPP into actively bleeding thrombocytopenic patients. Moreover, in no case did bleeding worsen despite patients being largely refractory to platelet transfusions.

Phase 3 activities supporting timely BLA Licensure with an operating model able to ensure adequate availability of CLPH-511/CPP to meet government procurement and civilian market needs. Enroll up to 5 additional clinical sites (up to 35 total sites) to expand recruitment of 200 additional patients.

In the CRYPTICS Phase 2/3 adaptive framework, Phase 2 accounts for MITT patients 1-200 and Phase 3 accounts for MITT patients 201 and beyond. The CRYPTICS SAP defines the maximum trial size for Phase 3 as 200 MITT patients, thus bringing the total Phase 2 and 3 MITT patients to n=400.

7.1 Technical Aims

7.1 Design and development of a CPP manufacturing process that is compliant with FDA regulations and applicable guidance for current good manufacturing practices; to include manufacture of products as necessary, to complete the objective.

7.2 Design, development, and validation of processes (inclusive of any necessary materials, equipment, and tests/assays) to enable storage and shipment of CPP for U.S. Military use.

7.3 Performance of all necessary non-clinical (in-vitro) studies and clinical trials (conducted in accordance with Good Clinical Practices).

7.4 Sponsorship and execution of all activities commensurate with serving as the Investigational New Drug (IND) application # 14047 holder and regulatory sponsor in accordance with 21 Code of Federal Regulations 312 subpart D, including all regulatory submissions and continuation through submission of the Biological License Application.

7.5 Development and maintenance of various management, risk, project, and quality plans/reports (as necessary) to provide documented evidence that the development effort is being effectively managed in accordance with the risk profile.

7.6 Optional Task Objectives: Low-Rate Initial Production (LRIP): Production and shipment of licensed CPP (shelf-life to be determined) for U.S. Army LRIP. The Offeror shall produce, release, and ship to the Government three separate lots of CPP. The total LRIP requirement will be 1500 units broken down into three (3) one-year options of 500 units per year.

The Phase 3 period of performance is estimated to take no longer than twenty (20) months.

8.0 SUBMISSION INSTRUCTIONS: Entities interested in submitting a response must furnish a white paper, a rough order of magnitude (ROM) cost estimate, and contact information table (provided below). Interested firms are requested to submit a response that demonstrates their ability to perform the scope of work identified in this RFI. The submission shall not exceed ten (10) pages; additional sheets for cover page, table of contents, tables and charts will not be counted towards the 10-page limit.

Format specifications include: Times New Roman 12-point font, single-spaced, single-sided, 8.5 x 11-inch pages with 1-inch margins. Electronic files shall not exceed 3 MB. All submissions must be made electronically and be in one of the following formats: Microsoft Word or searchable Adobe PDF. All submissions become Government property and will not be returned.

NOTE: All ‘Proprietary’, ‘Classified’, ‘Confidential’, or ‘Sensitive’ information shall be marked as Controlled Unclassified Information (CUI) at the top and bottom of each page. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).

Submission shall include the following information:

a. Cover Page

i. Title;

ii. Organization;

iii. Responder’s contractual, technical, and administrative points of contact (names, addresses, phone numbers, and email addresses);

b. Current Technical Expertise, Knowledge and Management Capability

i. Executive Summary (i.e., synopsis of the responder’s capability to perform the tasks described herein);

ii. Discussion of capabilities/challenges/technologies;

iii. The breadth of disciplines and relevant experience pertaining to the requirement (for example: government, academia or industry experience). Please also include information regarding favorable experience working with the FDA. Additionally, please provide a list of citations and other relevant documents describing experience. Technical response, relevance of responder’s expertise that demonstrates a full understanding and experience in performing the technical aims and objectives described in paragraph 7.0; and confirmation of:

Instructions to Responders:

8.1 The Government appreciates responses from all capable and qualified sources.

8.2 The Government welcomes input and will accept questions pertaining to this RFI; however, the Government reserves the right to answer or not answer all questions pertaining to this RFI. Questions pertaining to the RFI are due by 3:00 PM Eastern on 20 January 2025. Only one set of questions per vendor will be accepted. Telephone requests will not be entertained. Answers to the questions will be provided and posted as an attachment as part of a modification on FedBizOpps.

Contact Information Table Fill in the below contact information table and submit with your response to this RFI.

Company Name

Company Address

Point of Contact

Phone Number

E-mail Address

Tax Identification Number (TIN)

CAGE Code

System for Award Management (SAM) Unique Entity ID (UEI)

Company Web Page

Company Location(s)

Company is / is not a Small Business

Company is / is not SAM Registered

Other Socio-Economic Classifications (e.g., 8(a), HUB Zone, Woman-Owned, Veteran-Owned, Service- Disabled Veteran-Owned)

If 8(a), date that the company graduates from the program

Company does / does not have a Defense Contract Audit Agency (DCAA) determined acceptable cost accounting system

9.0 SUBMISSION DUE DATE & TIME:

The subject header of the email for submission shall be: “Response to RFI for Cryopreserved Platelets (CPP).”

Interested entities shall forward submissions electronically to:

Peter Mitchell at peter.d.mitchell8.civ@health.mil

RESPONSES DUE: No later than 3:00 PM ET on 20 January 2025.

Telephonic communication will not be considered as submission nor receive a response. The Government appreciates responses from all capable and qualified sources.

(End of RFI)