A03 Request for Information.pdf

Request for Information (RFI)

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Center for Infectious Disease Research (CIDR), Viral Diseases Branch (VDB)

Subject: Novel Antimalarial Drug Targets

This Request for Information (RFI)/Sources Sought (SS) Notice is for market research information and planning purposes only, and shall not be construed as a solicitation or as an obligation on the part of WRAIR, CIDR, VDB, or the Defense Health Agency (DHA) US Army Medical Research Acquisition Activity (USAMRAA).

This market research is seeking sources only that have knowledge and capabilities to provide Research and Development to support the investigation of Novel Antimalarial Drug Targets through affinity-based pulldowns. Research efforts shall require chemistry expertise in compound WR936909 Structure-Activity Relationship (SAR) in order to produce probes and activity-based protein profiling.

The NAICS code for this requirement is 541714 - R&D in Biotechnology (except Nanobiotechnology).

Only capability statements and/or fact sheet will be accepted.

DISCLAIMER: This RFI is NOT a Request for Proposals (RFP) or a Request for Quotations (RFQ); This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Responses to the RFI will not be returned. 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 cannot be accepted by the Government to form a binding contract. No Contract will be awarded from this announcement. No reimbursement will be made of any costs to provide information in response to this announcement or any follow up information requests. Responders are solely responsible for all expense associated with responding to this RFI. Availability of any formal solicitation will be announced under a separate announcement.

All information received in response to this RFI will be treated as business confidential information. Submitters should properly mark their responses if the information is confidential. All information received in response to this RFI that is marked Proprietary will be handled accordingly.

At this time, questions concerning the composition and requirements for a future RFP will not be entertained.

RFI Response and due date: 19 May 2025 2pm Eastern Standard Time (EST)

Background: The purpose of this requirement is to is to provide R&D to support the investigation of novel antimalarial drug targets through affinity-based pulldowns.

Research efforts shall require chemistry expertise in compound WR936909 Structure- Activity Relationship (SAR) in order to produce probes and activity-based protein profiling. This shall include synthesis of WR936909 and structural analogs; design and chemical synthesis of WR936909-conjugated affinity probes; proteomic analysis of WR936909-treated Plasmodium cultures by Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS); and evaluation of Plasmodium stage-specific expression of protein target using in silico approaches. In addition to the labor required to complete the R&D activities, the Contractor shall also provide the various laboratory materials and supplies, including chemicals/reagents, solvents, general laboratory supplies, glassware, analytical support (Nuclear Magnetic Resonance (NMR), Liquid Chromatography-High Resolution Mass Spectrometry (LC-MS/HRMS), and High Performance Liquid Chromatography (HPLC)), compound shipping, Combiflash supplies, liquid nitrogen/dry ice, and nitrogen/argon tanks needed to accomplish the R&D.

Instructions to Responders: Responses from capable and qualified sources are encouraged to respond to this request.

Review the attached DRAFT Statement of Work (SOW). Respondents should address how they best can fulfil the requirements set forth in section 6 of the SOW in their capabilities statement. Capability Statements or any other proprietary information relative to this RFI should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats:

Microsoft Word or Adobe PDF and shall not exceed 3 pages (Cover page excluded from page count).

2. Cover Page

• Title

• Organization

• Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)

• Topic area(s) addressed

• Respondents shall be able to perform under the NAICS code of 541714.

3. Please note that the response shall provide sufficient technical data to determine how you fully meet the requirements as specified in the DRAFT SOW.

Please note that responses are due no later than 19 May 2025 2 pm EST. The requested information shall be submitted via email. The point of contact for this action is Jaclyn Svincek, Contract Specialist Jaclyn.p.svincek.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

DRAFT

SOW

STATEMENT OF WORK (SOW)

Contents

1. INTRODUCTION 1

2. PURPOSE AND BACKGROUND 1

3. SCOPE 2

4. PERIOD OF PERFORMANCE 2

5. WORK SCHEDULE AND LOCATION 2

6. PERFORMANCE REQUIREMENTS 2

7. DELIVERABLES 3

8. COMPLIANCE DOCUMENTS 4

9. OTHER TERMS, CONDITIONS, AND PROVISIONS 6

10. ATTACHMENTS 6

STATEMENT OF WORK (SOW)

Title: Novel Antimalarial Drug Targets Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR), Center for Infectious Disease Research (CIDR), Viral Diseases Branch (VDB) Date: April 28, 2025

1. INTRODUCTION

Since 1893, the Walter Reed Army Institute of Research (WRAIR) has been a leader in solving the most significant threats to soldier readiness and lethality such as disease and battle injury.

WRAIR’s broad research capabilities afford soldiers the best medical protection and support possible before, during, and after deployment by addressing both longstanding and emerging threats. Though WRAIR’s research is focused on soldier health, its products have important civilian applications responsible for saving countless lives around the world.

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense (DoD) requirements and to deliver life-saving products including knowledge, technology, and medical material that sustain the combat effectiveness of the warfighter. The WRAIR headquarters is dedicated to Senator Daniel E. Inouye and is located in Silver Spring, MD. The WRAIR is the largest biomedical research facility currently serving the DoD. WRAIR’s Research and Development (R&D) activities reach around the world to include Georgia, Thailand, and Kenya.

WRAIR’s vision is to be the premier DoD biomedical research organization that executes constantly relevant, integrated basic research and advanced technology that protects, projects, and sustains the warfighter today, invents global medical solutions for the future, and keeps the warfighter on point for the Nation. The WRAIR hosts three Centers: Center for Military Psychiatry and Neuroscience (CMPN), Center for Infectious Disease Research (CIDR), and Center for Enabling Capabilities (CEC) with efforts ranging from blast induced neurotrauma to infectious disease vaccine development.

2. PURPOSE AND BACKGROUND

It is the nature of modern military operations that soldiers must be prepared to be stationed abroad for extended periods of time, sometimes with short notice, and in regions where they have little to no inborn immunity to endemic disease threats. In order for the fighting force to remain intact, ready, and lethal, they require safe and effective medical countermeasures.

WRAIR's CIDR combines scientific expertise with product development capabilities to address the full range of diseases of national security importance to the United States (U.S.) military.

CIDR scientists, along with their collaborators, surveil the incidence and evolution of existing and emerging pathogens around the world to inform combatant commanders of endemic threats to their soldiers. This data can be used to inform and direct product discovery and development efforts.

The Viral Diseases Branch (VDB) under CIDR has a mission of identifying, surveilling, and characterizing the viral diseases that threaten soldier readiness and translating that knowledge into development and delivery of safe and effective countermeasures to prevent degradation of the U.S. armed forces lethality globally. Within VDB, the Integrated Pathogen Therapeutics Department (IPT) conducts drug discovery, evaluates drug efficacy and mechanisms of action, and advances promising candidates through formal preclinical and clinical development. IPT focuses on infectious diseases of military relevance, including viral pathogens and malaria.

3. SCOPE

This goal of this requirement is to provide R&D to support the investigation of novel antimalarial drug targets through affinity-based pulldowns. Research efforts shall require chemistry expertise in compound WR936909 Structure-Activity Relationship (SAR) in order to produce probes and activity-based protein profiling. This shall include synthesis of WR936909 and structural analogs; design and chemical synthesis of WR936909-conjugated affinity probes;

proteomic analysis of WR936909-treated Plasmodium cultures by Liquid Chromatography- Tandem Mass Spectrometry (LC-MS/MS); and evaluation of Plasmodium stage-specific expression of protein target using in silico approaches. In addition to the labor required to complete the R&D activities, the Contractor shall also provide the various laboratory materials and supplies, including chemicals/reagents, solvents, general laboratory supplies, glassware, analytical support (Nuclear Magnetic Resonance (NMR), Liquid Chromatography-High Resolution Mass Spectrometry (LC-MS/HRMS), and High Performance Liquid Chromatography (HPLC)), compound shipping, Combiflash supplies, liquid nitrogen/dry ice, and nitrogen/argon tanks needed to accomplish the R&D.

4. PERIOD OF PERFORMANCE (PoP)

This non-commercial R&D requirement is expected to be a two-year study with a straight two-year Period of Performance (PoP) beginning September 30, 2025, and ending September 29, 2027.

5. WORK SCHEDULE AND LOCATION

The work to be performed under this contract shall be performed off-site at Contractor facilities that may be located anywhere in the Continental United States (CONUS).

6. PERFORMANCE REQUIREMENTS

6.1 Objectives: The objective of this requirement is to perform research, design, and chemical synthesis of WR936909 analogues in order to produce probes and activity-based protein profiling. This is anticipated to be a two-year study that is expected to be completed in phases as the research progresses through the following developmental stages:

Stage One Simple probes

- Produce biotin probes by coupling of the free NH and/or OH group of WR936909 and its analogues with various biotin crosslinkers for use in assays.

Stage Two Complex probes

- Produce diaziridine probes by introducing a diazirine moiety (for

Ultraviolet (UV)-mediated cross-linking via a reactive carbene intermediate) with a clickable alkyne (for click chemistry to add either a fluorescent probe or biotin) for use in assays.

Stage Three Refinement/redesign

- Aid in affinity pulldowns to analyze data.

- Adjust probes and/or binding.

Optional Contract Line Item Numbers (CLINs) will be utilized to incrementally fund R&D as work progresses through the above stages. Optional support will be exercised via contract modification to facilitate the phased approach necessary for the timely and efficient execution of objectives and tasks described in this SOW.

6.2 Specified Tasks:

6.2.1 Perform chemical synthesis of WR936909 and structural analogs, including their probes. Produce a minimum of three WR936909 analogues and their probes for use in assays within the first 12 months of the PoP (A.001 - Probes).

6.2.2 Design and conduct chemical synthesis of WR936909-conjugated affinity probes (A.001 - Probes).

6.2.3 Perform Proteomic analysis of WR936909-treated Plasmodium cultures by LC- MS/MS (A.002 – LC-MS/MS Documentation).

6.2.4 Evaluate Plasmodium stage-specific expression of protein target using in silico approaches (A.003 – In-silico Documentation).

6.2.5 Develop SAR database to consolidate all biological and chemical information for drug design (A.004 – SAR Database).

6.2.6 Oversee project flow between the different research components of the iterative optimization process, including decisions regarding selection and advancement of lead compounds. Perform identification and purity assessment of the target compounds (A.005 – Compound Documentation).

7. DELIVERABLES

The Contractor shall complete and submit deliverables in accordance with the table below.

DELIVERABLES TABLE

SOW

Ref. Number Title/Description Due

6.2.1;

6.2.2

A.001 Probes Minimum of three probes within the first 12 months of the PoP

6.2.3 A.002 LC-MS/MS Documentation Upon request

6.2.4 A.003 In-silico Documentation Upon request

6.2.5 A.004 SAR Database Prior to end of PoP

6.2.6 A.005 Compound Documentation Upon request

7.3 A.006 CDRL Due annually

8.4 A.007 Occupational Safety and

Health Administration

(OSHA) 300A

Due by February 1 of each year

9.1 A.008 Invoices Submitted monthly or annually as

applicable via Wide Area Work Flow (WAWF)

9.4.1 A.009 Training Certifications Due within 30 days after contract award, annually thereafter

7.1 Inspection and Acceptance. The Contracting Officer’s Representative (COR) is delegated oversight of specific technical and functional responsiblities and is responsible for inspection and acceptance of all incoming shipments, documents, and support. Certification by the Government of satisfactory support provided is contingent upon the Contractor performing in accordance with the performance standards contained in the SOW and all terms and conditions of this order, including all modifications.

7.2 Contract Management

7.2.1 Government Management. The COR for this contract will be appointed by the Contracting Officer (CO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the CO has the authority to enact changes to this award.

COR Information

Name: Susan Leed Phone Number: 301-319-3036 Email: susan.e.leed.civ@health.mil

7.2.2 Contractor Organization. The Contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to mailto:susan.e.leed.civ@health.mil the requirement. The Contractor shall ensure that all Contractor personnel are advised of their chain of command and who they should contact if they have questions.

7.3 Contract Data Requirements Lists (CDRLs) and Data Rights. Rights to all technical data (including, but not limited to documents and materials) and computer software (including, but not limited to source code) produced under this contract are governed by Defense Federal Acquisition Regulation Supplement (DFARS) clauses 252.227-7013, 252.227-7014, 252.227- 7015, and 252.227-7019. Documents and materials produced under this contract may not be used or sold by the Contractor without written permission from the CO. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights (A.006 – CDRL).

8. COMPLIANCE DOCUMENTS

8.1 General Compliance

8.1.1 Federal Law. The support provided under this contract shall be conducted in accordance with all Federal, DoD, Defense Health Agency (DHA), and United States Army Medical Research and Development Command (USAMRDC) laws, command laws, regulations, policies, and procedures.

8.1.2 Applicable Publications

• The Army Physical Security Program (Army Regulation (AR) 190-13)

• U.S. Army Corps of Engineers Safety and Health Requirements Manual 385-1-1

• Medical Logistics Policies (AR 40-61)

• Antiterrorism Force Protection: Security of Personnel, Information, and Critical

Resources (AR 525-13)

• Operations Security (AR 530-1)

• Insider Threat Program (DHA-Administrative Instruction (AI) 097)

• Testing and Calibration Laboratories (International Organization for Standardization

(ISO) 17025)

8.2 Personally Identifiable Information (PII) and Protected Health Information (PHI)

The Contractor shall comply with the DHA Procedures, Guides, and Information (PGI) 224 – Protection of Privacy and Freedom of Information. The Contractor may access PII in the course performing the tasks of this contract, and as such, the Contractor shall comply with the document entitled “Personally Identifiable Information (PII), Protected Health Information (PHI) and Federal Information Requirements.”

The Contractor shall establish appropriate administrative, technical, and physical safeguards to protect any and all Government data. The Contractor shall also ensure the confidentiality, integrity, and availability of Government data in compliance with all applicable laws and regulations, including data breach reporting and response requirements, in accordance with DFARS Subpart 224.1 (Protection of Individual Privacy), which incorporates by reference Department of Defense Instruction (DoDI) 5400.11, DoD Privacy and Civil Liberties Programs;

DoD 5400.11-R, Department of Defense Privacy Program; and Department of Defense Manual (DoDM) 5400.11, DoD Privacy and Civil Liberties Programs: Breach Preparedness and Response Plan. The Contractor shall also comply with federal laws relating to freedom of information and records management. The Contractor shall comply with all requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (Pub. L. 104-191), as implemented by the HIPAA Privacy and Security Rules codified at 45 Code of Federal Regulations (CFR) Parts 160 and 164, and as further implemented within the Military Health System (MHS) by DoD 6025.18-R, "DoD Health Information Privacy Regulation" and DoD 8580.02-R, “DoD Health Information Security Regulation.” Information Technology (IT) that collects, maintains, uses, or disseminates PII must be managed in a manner that protects privacy, in accordance with all privacy laws and regulations.

8.3 Information Technology (IT) Compliance: RESERVED.

8.4 Safety Laws and Regulations. The Contractor shall maintain a safe workplace and comply with occupational health and safety rules and regulations, to include OSHA number 1904.32, and maintain an OSHA 300A log for all reportables. The Contractor shall provide a quarterly report of all mishaps, regardless of class or reportability. In addition, the Contractor shall deliver the annual OSHA 300A report by February 1 of each year (A.007 - OSHA 300A).

9. OTHER TERMS, CONDITIONS, AND PROVISIONS

9.1 Invoices. The Contractor shall submit invoices to WAWF with sufficient documentation to provide certification of invoice. The Contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment.

Invoices submitted for payment, which do not contain CLIN and the Accounting Classification Reference Number (ACRN) information, will be rejected. The WAWF – Receipt and Acceptance application is the required method of submission (A.008 - Invoices).

9.2 Access to Government Facilities: RESERVED.

9.3 Service Contract Reporting (SCR): RESERVED.

9.4 Training

9.4.1 Threat Awareness Reporting Program (TARP). Per DHA-AI 097, Insider Threat Program, Contractor employees with security clearances shall receive annual Insider Threat Awareness training within 30 days of initial employment, and refresher training annually either through instructor-led or computer-based (A.009 – Training Certifications).

10. ATTACHMENTS

Attachment 1 - Acronyms List

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition ACRN Accounting Classification Reference Number AI Administrative Instruction AR Army Regulation ATO Antiterrorism Officer CDRL Contract Data Requirements List CEC Center for Enabling Capabilities CFR Code of Federal Regulations CIDR Center for Infectious Disease Research CLIN Contract Line Item Number CMPN Center for Military Psychiatry and Neuroscience CO Contracting Officer CONUS Continental Unites States COR Contracting Officer’s Representative DFARS Defense Federal Acquisition Regulation Supplement DHA Defense Health Agency DoD Department of Defense DoDI Department of Defense Instruction DoDM Department of Defense Manual FAR Federal Acquisition Regulation HIPAA Health Insurance Portability and Accountability Act HPLC High Performance Liquid Chromatography IPT Integrated Pathogen Therapeutics Department ISO International Organization for Standardization IT Information Technology

LC-

MS/HRMS Liquid Chromatography-High Resolution Mass Spectrometry LC-MS/MS Liquid Chromatography-Tandem Mass Spectrometry MHS Military Health System NMR Nuclear Magnetic Resonance OSHA Occupational Safety and Health Administration PGI Procedures, Guides, and Information PHI Protected Health Information PII Personal Identification Information PoP Period of Performance R&D Research and Development SAR Structure-Activity Relationship SCR Service Contract Report SOW Statement of Work TARP Threat Awareness Reporting Program USAMRDC United States Army Medical Research and Development Command

U.S. United States UV Ultraviolet VDB Viral Diseases Branch WAWF Wide Area Work Flow WRAIR Walter Reed Army Institute of Research