Development of Treatments for COVID-19

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Army Medical Research and Development Command (USAMRDC)’s Military Infectious Diseases Research Program (MIDRP). Military relevance is a critical component of Enhanced White Paper submission. Strategic and tactical oversight for the award(s) supported by this RPP will be provided by the MIDRP.

The goal of this RPP is to develop prototypes aimed to treat COVID-19 with the following focus area:

• Focus Area: Therapeutic(s) that can treat COVID-19. Treatments with potential application to the prevention of COVID-19 infection are desired. Therapeutics that can be administered in a non-hospital environment are desired.

Note: Pending successful completion of this effort, the Government may issue a noncompetitive follow-on production contract or transaction pursuant to 10 USC 2371b section f.

Scope of Work

The goal of this RPP is to develop prototype countermeasures for the treatment of COVID-19.

• The expected Technology Readiness Level (TRL) at start of the Period of Performance (PoP) is 3/4 and at the end of the PoP is TRL6.
• The Offeror is expected to have at the onset a candidate therapeutic with non-clinical data (in vitro, tox, pre-clinical data, etc.) suggesting safety and/or efficacy.
• The Offeror should have demonstrated manufacturing feasibility of the candidate therapeutic.
• Offerors who have had at least one meeting with the U.S. Food and Drug Administration (FDA) to discuss the regulatory strategy for their candidate(s) are preferred.
• Repurposing commercially-available, approved products or products in clinical development for related indications with demonstrated safety in humans are preferred.
• Partnering with U.S. Department of Defense (DoD) investigators on pre-clinical testing in animal models is encouraged, where appropriate. Note: Relationships with DoD laboratories must be brought forth as part of the Enhanced White Paper. MTEC members can access points-of-contact at Army laboratories on the members-only website.

The expected deliverable at the end of the PoP is a final technical report to support a Go/No-Go decision for the product to enter Phase II trials for the treatment of COVID-19 including the following:

A. Pre-Clinical Development Activities Including:

1. Background and scientific summary of the drug or biologic, including pharmacokinetics, pharmacodynamics (PK/PD), bioavailability/equivalence, immunogenicity, mechanism of action, and side effects.
2. Summary, protocols, and reports for: in-vitro and/or in-vivo pre-clinical safety toxicology animal studies, validation, and qualification of assays.

B. Clinical Development Activities:

1. Summary and results of any/all clinical studies completed.

C. Future Clinical Development Plan and Regulatory Strategy

1. Goals and objectives for the clinical program including a list of planned clinical studies including target population, design, primary and secondary safety and efficacy endpoints, clinical protocols, and clinical trial agreements
2. Regulatory strategy including the regulatory pathway; target product profile or equivalent and a description of how the clinical plan will support the regulatory strategy; and scheduled milestones and decision making (Go/No-Go); and any associated risks. A Gantt chart for product development should also be included.

D. Manufacturing Development Activities and Plan

1. Description of the manufacturing process, quality control, and quality assurance plans.

E. FDA Interactions

1. A list, summary, and documentation of interactions with the FDA in the form of meeting minutes.

Points of Contact

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