Development of Personalized Bacteriophage Therapeutic for the Treatment of Bacterial Infections

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the Naval Medical Research Center (NMRC). Military relevance is a critical component of the Proposal submission. Strategic oversight for the award(s) supported by this RPP will be provided by the NMRC Naval Advanced Medical Development (NAMD) program through a Defense Health Agency Component Acquisition Executive (DHA J4) chartered (DHA) Integrated Product Team (IPT) for Bacteriophage Therapeutics.

The goal of this research is to develop and optimize all aspects of practical precision bacteriophage therapy treatment(s) through clinical development to the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA). As understood, a “precision bacteriophage therapy treatment” refers to achieving reliable efficacy of a phage therapy by treating bacterial infections with phage therapeutics that are in some way customized to the individual cases being treated. As elaborated below, aspects of a bacterial infection that might require individual customization include the genetic diversity of circulating pathogens, and the potential for phage-resistant variant subcultures to arise in the course of treatment.

Clinical questions to be addressed include determination of the ability of precision bacteriophage therapy to avoid or overcome emergence of bacterial resistance to therapeutic bacteriophages and assessment of systemic responses in human subjects following treatment with antimicrobial bacteriophage therapy. Practical questions to be addressed include assessment and improvement of the clinical feasibility of delivering a precision bacteriophage therapeutic in terms of timely and high-quality design, production, and delivery of the characterized phage therapeutic; and development and demonstration of Current Good Manufacturing Practice (cGMP) production for clinical-grade bacteriophages suitable for use as a precision bacteriophage investigational/clinical therapeutic.

Scope of Work

Attachment A: Statement of Work (SOW)

The SOW developed by the Lead MTEC member organization and included in the proposal (also submitted as a separate document) is intended to be incorporated into a binding agreement if the proposal is selected for award. If no SOW is submitted with the proposal, there may be no award. The proposed SOW shall contain a summary description of the technical methodology as well as the task description, but not in so much detail as to make the contract inflexible. Do not include any proprietary information or company-sensitive information in the SOW text.

The following is the required format for the SOW.

Statement of Work

Submitted under Request for Project Proposal (Insert current Request No.)

(Proposed Project Title)

Introduction/Background (To be provided initially by the Offeror at the time of submission. Submitted information is subject to change through negotiation if the Government selects for funding.)

Scope/Project Objective (To be provided initially by the Offeror at the time of submission. Submitted information is subject to change through negotiation if the Government selects for funding.)

This section includes a statement of what the project covers. This should include the technology area to be investigated, the objectives/goals, and major milestones for the effort.

Requirements (To be provided initially by the Offeror at the time of submission to be finalized by the Government based on negotiation of Scope/Project Objective.)

State the technology objective in the first paragraph and follow with delineated tasks required to meet the overall project goals. The work effort should be segregated into major phases, then tasks and identified in separately numbered paragraphs (similar to the numbered breakdown of these paragraphs). Early phases in which the performance definition is known shall be detailed by subtask with defined work to be performed. Planned, incrementally-funded phases will require broader, more flexible tasks that are priced up front and adjusted as required during execution and/or requested by the Government to obtain a technical solution. Tasks will need to track with established adjustable cost- or fixed-price milestones for payment schedule. Each major task included in the SOW should be priced separately in the Cost Proposal. Subtasks need not be priced separately in the Cost Proposal.

Deliverables (To be provided initially by the Offeror at the time of submission. Submitted information is subject to change through negotiation if the Government selects for funding.)

Results of the technical effort are contractually binding and shall be identified herein. Offerors are advised to read the Base Agreement carefully. Any and all hardware/software to be provided to the Government as a result of this project shall be identified. Deliverables should be submitted in PDF or MS Office format. It must be clear what information will be included in a deliverable either through a descriptive title or elaborating text.

Milestone Payment Schedule (To be provided initially by the Offeror at the time of submission. Submitted information is subject to change through negotiation if the Government selects for funding. The milestone schedule included should be in editable format (i.e., not a picture).)

The Milestone Payment Schedule should include all milestone deliverables that are intended to be delivered as part of the project, a planned submission date, the monetary value for that deliverable and any cost share, if applicable. For fixed-price agreements, when each milestone is submitted, the MTEC member will submit an invoice for the exact amount listed on the milestone payment schedule. For cost-reimbursable agreements, the MTEC member is required to assign a monetary value to each milestone. In this case, however, invoice totals are based on cost incurred and will not have to match exactly to the amounts listed on the milestone payment schedule.

The milestones and associated deliverables proposed should, in general:

• be commensurate in number to the size and duration of the project (i.e., a $5M multiyear project may have 20, while a $700K shorter term project may have only 6);
• not be structured such that multiple deliverables that might be submitted separately are included under a single milestone;
• be of sufficient monetary value to warrant generation of a deliverable and any associated invoices;
• include at a minimum Quarterly Reports which include both Technical Status and Business Status Reports (due the 20th of March, June, September, December), Annual Technical Report, Final Technical Report, and Final Business Status Report. Reports shall have no funding associated with them.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.