REVIVE Webinar Series:
Antibacterial drugs: clinical development for non-developers
Part 2: Development of antibacterial drugs targeting specific pathogens
David Shlaes, Anti-infectives consulting, retired
Ian Friedland, Clinical consultant, Friedland Strategic Consulting, LLC
Sumathi Nambiar, Director, Division of Anti-Infective Products, Office of Antimicrobial Products, CDER, FDA
Mair Powell, Senior Clinical Assessor, Licensing Division, Medicines and Healthcare products Regulatory Agency (UK)
The overall goal of this series of webinars is to provide, for the non-clinical developer, an understanding of the risks of development for various kinds of antibacterial products. Our first webinar was devoted to more traditional approaches (Tiers A and B), best suited for more broad-spectrum products, where the risks are lower. In this webinar, we will discuss the development of products that target a single species of bacteria where the risks may be higher. While development of therapies for infections caused by a single bacterial species that is identified relatively frequently at a given body site of infection (e.g. Staphylococcus aureus (or even MRSA) in acute bacterial skin and skin structure infections) makes for readily feasible trials, this is not the case for infrequently occurring infections such as those caused by P. aeruginosa or A. baumannii. Under these circumstances, a clinical development program can be very challenging. This webinar will give an overview of the practical challenges associated with developing a therapy for a low frequency event for which treatment must be initiated urgently.