DoD Peer Reviewed Medical Research Program Technology/Therapeutic Development Award

archived

This award is intended to support for the translation of promising preclinical findings into products for clinical applications in at least one of the congressionally-directed FY09 PRMRP topic areas. These products should be responsive to the health care needs of the Armed Forces, their family members, and/or the U.S. Veteran population. All applications must specifically and clearly address the military relevance of the proposed research. Collaboration with military researchers and clinicians is encouraged. The product(s) to be developed may be pharmacologic agents (drugs or biologicals), devices, or clinical guidance. The Principal Investigator (PI) must provide a transition plan (including potential funding and resources) showing how the product will progress to clinical trials and/or delivery to the military or civilian market after the completion of the PRMRP award. Examples of the types of research that may be supported include, but are not limited to: • Collection and analysis of data for developing and validating clinical guidance • Testing new therapeutic modalities (agents, delivery systems, chemical modification of lead compounds) using established or validated novel preclinical systems • Designing and implementing full-scale, pilot Good Manufacturing Practice (GMP) production of therapeutics and/or delivery systems for use in advanced preclinical and initial clinical trials • Developing pharmacologic agents through adsorption, distribution, metabolism, excretion, and toxicity (ADMET) phase • Developing pharmacologic agents to Investigational New Drug (IND) stage for initiation of Phase I clinical trials • Developing prototype devices for diagnosis or treatment to Investigational Device Exemption (IDE) stage for initiation of Phase I clinical trials • Optimizing diagnostic or treatment devices for field deployment

High