Funding Opportunity: 25-07-Pharmacogenomics "Pharmacogenomics (PGx) Testing for Military Readiness Pilot"

Purpose

This solicitation, issued by the MTEC Consortium Manager (CM), Advanced Technology International (ATI), represents a Request for Project Proposals (RPP) for MTEC in support of the Defense Health Agency (DHA). Military relevance is a critical component of the Enhanced White Paper submission. Strategic oversight for the award(s) supported by this RPP will be provided by DHA Research & Engineering Directorate.

This RPP is focused on establishing a pilot program to demonstrate the enhanced use of pharmacogenomics (PGx) in the Military Health System (MHS) to aid in the treatment for specific medical conditions and improve healthcare delivery and outcomes.

Funding Availability: The U.S. Government (USG) currently has available a total of approximately $2.15 million (M) for this effort, for direct and indirect costs.

Number of anticipated awards: MTEC expects to make a single award to a qualified Offeror to accomplish the scope of work.

Period of performance: The Period of Performance (PoP) is not to exceed 36 months.

To view the full-length version of this RPP, please download using the link on this page.

Scope of Work

Background

DHA Research & Engineering Directorate is requesting proposals for a PGx pilot program to aid and improve military readiness and clinical care for military personnel in response to the FY24 DoD Appropriations Act. The pilot program will develop and demonstrat the standards and processes that will result in MHS protocols for routine PGx testing in applicable military cohorts and report PGx testing results that can provide actionable information to MHS providers for medical treatment of the Active-Duty population. The pilot will leverage the Electronic Health Record (EHR) patient information and patient outcomes to determine and report optimal healthcare delivery.

Results from this program will demonstrate the feasibility of utilizing PGx as an impactful and cost-effective solution to improve the personalization, safety, and efficacy of medication for Active-Duty service members (ADSM).
The intent of the PGx pilot program is to demonstrate the impact PGx can have on the ADSMs by preventing adverse drug reactions, optimizing drug dosing, and reducing the use of non-effective medications, as well as demonstrating the cost benefit, quality, and outcomes of treatment.

The PGx pilot program scope will include development of appropriate PGx processes (e.g. enrollment) relevant to military populations at DoD site(s), tracking outcomes after medical treatment, and performing analyses to determine treatment efficacy based on PGx testing.

Technical Requirements

Proposed solutions are expected to include (but are not limited to) the following characteristics and activities:

1. Collaborate with Military Treatment Facilities (already identified by the Government Sponsor) to identify approaches and/or strategies to maximize the use and/or integration of precision medicine in clinical care for ADSMs.
   
   Note: The sites identified by the Government are those that currently have PGx capabilities. The specific site information will be shared with the Offeror selected for award.
   This does not preclude Offerors from proposing an additional MTF site(s) within the Enhanced White Paper. However, a letter of support should be provided for any Offeror-identified/proposed site(s). See Section 4.2. below for information related to Letter(s) of Support.
   
2. Establish a process for the integration of PGx into clinical care. This will include development of an Application Programming Interface within the MHS EHR within the DoD secured server under strict data and national security requirements in accordance with National Institute of Standards and Technology 8582 and DFARS 239.7602-2(a).
3. Identify, establish, and execute programmatic tasks of the pilot program. These may include, but are not limited to:
   1. Document pilot processes for Clinical PGx and tele-PGx platform within the MHS through the EHR, for PGx consultation, education, and fluency across the MHS community.
   2. Conduct data collection, and data analysis, to include the measurement of effectiveness of PGx processes.
   3. Measure treatment efficacy with respect to:
      1. reductions in adverse drug reactions and use of non-effective medications;
      2. treatment outcomes;
      3. informing long-term medication management for improvements in clinical health conditions; and
      4. cost related to testing, treatment, and ADSM return to duty
   4. Ensure the use of all appropriate Clinical Pharmacogenetics Implementation Consortium guidelines, where appropriate.
   5. Develop progress and final reports with recommendations based on data analysis

Requirements for the Proposed Team:

The following are the anticipated requirements to consider when forming a team and are considered necessary to ensure the successful development of the project.

1. The team should include clinical pharmacists trained in PGx, especially those with practical experience in implementing PGx with therapeutic conditions in one or more of the following medical conditions prioritized in the MHS: behavioral health, pain management, cardiology, infectious diseases, gastrointestinal disorders, and sleep disorders, etc. Other clinical conditions may be proposed as appropriate.
2. Members of the team shall be able to satisfy requirements to receive access to government furnished equipment (i.e., computer) and obtain a government common access card (see Section 3.10 for additional information). Final requirements and the decision to issue government furnished equipment is to be determined by DHA data access approval authority. This is anticipated in order to access electronic health records (de-identified) to determine the health outcomes from pharmacogenomics testing.
3. The vendor/contractor MUST be willing and able to partner with Defense Health Agency clinical subject matter experts (to be specified post award) to ensure timely approval and access to DoD populations and medical data, to fulfill data security requirements, and maximize translation of findings to the MHS.
4. The Offeror shall include travel to four sites (determined in coordination with the Government Sponsor) for access to the PGx capability.

Proposers Conference

MTEC intends to host a Proposers Conference that will be conducted via virtual webinar on June 2, 2025, at 12:00pm (Noon) EST. The intent of the Proposers Conference is to provide an administrative overview of this RPP process to award and present further insight into the Technical Requirements outlined in Section 3 of this RPP.

To register for this conference, please use this link: https://ati.zoomgov.com/webinar/register/WN_SZXJ8HqiRGiRPOVnHy2jlw

Points of Contact

For inquiries, please direct your correspondence to the following contacts:

• Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Manager, mtec-contracts@ati.org
  
• Technical and membership questions should be directed to the MTEC Chief Science Officer, Dr. Lauren Palestrini, Ph.D., lauren.palestrini@mtec-sc.org
  
• All other questions should be directed to the MTEC Program Manager, Mr. Evan Kellinger, mtec-sc@ati.org