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Medical Technology Enterprise Consortium (MTEC) -- Development of Personalized Bacteriophage Therapeutic for the treatment of Bacterial Infections
The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) entitled, “Development of Personalized Bacteriophage Therapeutic for the treatment of Bacterial Infections.” The goal of this research is to develop and optimize all aspects of practical precision bacteriophage therapy treatment(s) through clinical development to the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA).
As understood, a “precision bacteriophage therapy treatment” refers to achieving reliable efficacy of a phage therapy by treating bacterial infections with phage therapeutics that are in some way customized to the individual cases being treated. As elaborated below, aspects of a bacterial infection that might require individual customization include the genetic diversity of circulating pathogens, and the potential for phage-resistant variant subcultures to arise in the course of treatment.
Clinical questions to be addressed include determination of the ability of precision bacteriophage therapy to avoid or overcome emergence of bacterial resistance to therapeutic bacteriophages and assessment of systemic responses in human subjects following treatment with antimicrobial bacteriophage therapy. Practical questions to be addressed include assessment and improvement of the clinical feasibility of delivering a precision bacteriophage therapeutic, in terms of timely and high-quality design, production, and delivery of the characterized phage therapeutic; and development and demonstration of Current Good Manufacturing Practice (cGMP) production for clinical-grade bacteriophages suitable for use as a precision bacteriophage investigational / clinical therapeutic.
Proposal Due Date: Feb. 25, 2019, Noon Eastern Time
Offerors must be MTEC Members in good standing.