B01. RFI - Malaria Radical Cure Drug Efficacy Clinical Study - Final as of 12.03.2025.pdf

REQUEST FOR INFORMATION (RFI)

TITLE: MALARIA RADICAL CURE DRUG EFFICACY CLINICAL STUDY

AGENCY: Walter Reed Army Institute of Research (WRAIR), Armed Forces Research Institute of Medical Sciences (AFRIMS)

LOCATION: While the Contractor will be providing support to a Government location outside of the Continental United States (OCONUS), the Contractor’s services shall all take place at the Contractor’s facilities within the Continental United States (CONUS).

North American Industry Classification System (NAICS) Code: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

DISCLAIMER: This RFI is issued solely for market research information and planning purposes and does not constitute a solicitation. 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 respondents. Respondents are solely responsible for all expenses associated with responding to this RFI or any follow-up information request. All information received in response to this RFI or any follow-up information request that is marked Proprietary will be handled accordingly. Responses to the RFI will not be returned. At this time, questions concerning the composition and requirements for a future request for proposal will not be entertained.

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.

DESCRIPTION: WRAIR-AFRIMS has a requirement to conduct and support clinical studies on the safety and efficacy of radical cure therapies against relapsing malaria caused by Plasmodium vivax in conjunction with the WRAIR-AFRIMS. This effort includes one clinical study to measure the efficacy of the tafenoquine in treating malaria in an endemic area in Thailand (Clinical Study One) and a second one to measure the safety and pharmacokinetics of tafenoquine in healthy adults to be carried out in the U.S. (Clinical Study Two). The Contractor shall perform pre-study preparation and pre-study activities including Institutional Review Board. (Phase One). The Contractor shall perform clinical study execution, study reporting, and all major study activities such as recruitment, enrollment, drug administration, safety monitoring, urine and blood sample collection, and study reporting (Phase Two). The contractor with a subject matter expertise (SME) in malaria pharmacokinetics and pharmacogenomics shall analyze the data from the two studies, including assisting in sample testing, clinical data analysis, results interpretation, and manuscript preparation (Phase 3).

The Contractor shall also provide SME on malaria research and laboratory support to aid in the requirement. This support shall include data analysis, results interpretation, and scientific publication on the efficacy, pharmacokinetics, and pharmacogenomics of the anti-malarial drug tafenoquine based on analysis of samples collected in both clinical studies. This is anticipated to be a four-year requirement that is expected to be completed in phases as the research progresses through the developmental phases. Phase 1 is estimated to take approximately 1 year, phase 2 is estimated to take approximately 2 years, and phase 3 is estimated to take approximately 1 year.

SUBMISSION INSTRUCTIONS: Responses from all capable and qualified sources are encouraged to respond to this request. All information regarding capabilities statements or any other proprietary information relative to this RFI shall be marked appropriately.

Please note that responses are due no later than 11:00 AM ET on 10 December 2025. The method of submission is via email. The point of contact for this action is the Contract Specialist, Ashley N. Atkins at email:

ashley.n.atkins.civ@health.mil. The Contracting Officer for this action is Jennifer C. Jackson at email:

jennifer.c.jackson18.civ@health.mil

Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE CALLS PLEASE. It is the responsibility of any potential offeror to monitor this site for the release of any solicitation or synopsis.

Responses shall be submitted via e-mail only. The font shall be Times New Roman, font size 12, single space. All submissions become Government property and will not be returned.

REQUIRED INFORMATION: Fill in the table below when responding to this RFI.

Question Response

RFI Number Company Name Company Address Point of Contact Phone Number E-mail Address Tax Identification Number (TIN) CAGE Code DUNS Number 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