A02 Request for Information WRAIR.pdf

Title: CLINICAL OBSERVATIONAL STUDY OF BACTERIOPHAGE THERAPY IN SKIN AND

SOFT TISSUE INFECTIONS IN GEORGIA

Solicitation: W81XWH22Q0022

Notice Type: Request for Information (RFI)

Response Date: 7 February 2022

NAICS: 541714

Location: Tbilisi, Georgia

Scope: The Medical Research Development Command (MRDC) strategic research and development plan identifies treatments for combat wound infections and sepsis as a primary gap (Gap #203617) in military medical readiness. Conventional antibiotic therapeutics for wounds are increasingly failing to resolve infections due to widespread multidrug resistant (MDR) bacteria that have acquired resistance to most, and in some cases all, classes of antibiotics. Bacteriophages are viruses with naturally occurring antimicrobial activity that have been widely and historically used to combat bacterial infection in humans. The specific requirement for studies that seek to develop wound infection MDR bacteriophages biologics is an integral and explicit part of MIDRP’s investment strategy.

Objectives: The objectives are as follows:

Contractor shall provide the following services: study personnel will meet WRAIR’s regulatory (federal-wide assurance) requirements, e.g., CITI-trained and credentialed by WRAIR as investigators on the study protocol;

Contractor will provide frequent updates on patient enrollments, blood draws, lab results, problems/protocol deviations/subject withdrawals, and sample transfer coordination to USA Medical Research Directorate – Georgia (MRD-G)USAMRD-G; all investigators will obtain protocol-specific training for on the clinical and regulatory aspects of the protocol (e.g., the study questionnaire, inclusion/exclusion criteria, study risks/benefits, enrollment processes, and informed consent/assent documents); all investigators will have familiarity with the protocol contents, to include appendix material, questionnaires, and other protocol-specific documentation, and will be responsible for complying with the specified tasks wherein those tasks;

Contractor will conduct testing in accordance with the protocol requirements and their own institutional SOPs; will log and track samples, e.g. blood and bacterial isolates;

samples will be transferred between contractor and MRD-G; will capture a complete data set as defined in the protocol for each study participant.

1. SCOPE OF OBJECTIVE

1.1. Primary Requirements:

1.1.1. Study personnel will meet WRAIR’s regulatory (federal-wide assurance) requirements, e.g., CITI-trained and credentialed by WRAIR as investigators on the study protocol.

1.1.2. Investigators will provide frequent and bidirectional updates on patient enrollments, blood draws, lab results, problems/protocol deviations/subject withdrawals, and sample transfer coordination.

1.1.3. All investigators will have protocol-specific training for on the clinical and regulatory aspects of the protocol (e.g., the study questionnaire, inclusion/exclusion criteria, study risks/benefits, enrollment processes, and informed consent/assent documents).

1.1.4. All investigators will have familiarity with the protocol contents, to include appendix material, questionnaires, and other protocol-specific documentation, and will be responsible for complying with the specified tasks wherein those tasks.

1.1.5. Laboratorians will conduct testing in accordance with the protocol requirements and their own institutional SOPs.

1.1.6. Samples, e.g. blood and bacterial isolates, will be logged and tracked.

1.1.7. Samples will be transferred between contractor and MRD-G.

1.1.8. A complete data set as defined in the protocol will be captured for each study participant.

RFI INSTRUCTIONS:

Interested parties are asked to respond to this RFI and submit a capabilities statement that supports the focus of this RFI. Please review the place of performance requirements. Please submit written responses via email in Microsoft Office 2000 or 2007 format. All responses should be complete: in 12-point font; and not to exceed 3 pages total, including graphics, tables, and appendices.

No hardcopies shall be accepted. No written solicitation document is available at this time. Telephone requests will not be honored, and no bidders list shall be maintained.

No inquiries regarding any potential future acquisition activities shall be entertained.

Potential offerors are requested to direct all questions via email to the Point of Contact listed below. Responses are due to the Point of Contact, Mr. Nathaniel Reus at email:

nathaniel.a.reus.civ@mail.mil no later than 10:00AM ET, Friday, February 7, 2022.

mailto:nathaniel.a.reus.civ@mail.mil

CAUTION: This is an active requirement. Contractors are strictly prohibited from discussing this requirement with any member of the program office. All discussion shall be with the point of contact listed above.

DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any kinds 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. Responders are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned.