Appendix 2 Draft Description Statement of Objectives

APPENDIX 2

PROJECT DESCRIPTION/STATEMENT OF OBJECTIVES

PROJECT TITLE

Vaccine Acceleration by Modular Progression (VAMP) - Prophylactic Platform Technology Medical Countermeasures (MCMs) Against Chemical, Biological, Radiological, and Nuclear (CBRN) Threats

BACKGROUND/DESCRIPTION

The Portfolio Management Executive for Chemical, Biological, Radiological, and Nuclear Defense (PME CBRND), Joint Program Manager – CBRN Medical (JPM-M) Accelerated Defense Pharmaceuticals (ADP) Product Office, is requesting from product developers the design, manufacture, non-clinical and clinical testing of advanced platform technology for prophylaxis against one or more specific CBRN threats of concern. The Government is interested in approaches that will support the development of prophylactic platform technology using traditional or nontraditional administration as well as immune modulating approaches. The VAMP program evaluates platform technologies against disease/injury caused by CBRN threats in appropriate animal models and human clinical trials for safety, immune response, and effectiveness while using data-driven decision and processes to bridge capability gaps for the warfighter. The goal of the program is to expedite the development of these prophylactic MCMs through a Phase I or Phase II clinical trial. To achieve this, the VAMP program utilizes a modular approach incorporating Go/No-Go checkpoints at each applicable non-clinical, clinical, CMC and regulatory phases to facilitate generation of an Investigational New Drug Application, end of Phase 1, or end of Phase 2 data packages supporting further advancement as warranted. As part of the current MCM environment to protect against CBRN threat agents listed in Appendix 1, the Government is interested in furthering the development of prototype candidates using either traditional (intramuscular injection) or alternative routes of administration (i.e., microneedles, intranasal, etc., and defined below as non-traditional administration). In addition, MCMs that can enhance and modulate the immune system (biological response modifiers) expand the Government’s toolbox of MCMs while building the warfighter’s bio-armor. To be eligible for funding, Offerors shall have a demonstrated, successful history of designing, manufacturing, and clinical testing of prophylactic MCM platform as well as experience working with the U.S. Food and Drug Administration (FDA). Additionally, Offerors will have expertise in all aspects of platform manufacturing under current Good Manufacturing Practices (cGMP) and