CARB-XED, GARDP, ASM, and ESCMID hosted Antibiotic Bootcamps at ASM-ESCMID conference on antibiotic R&D
The Global Antibiotic Research and Development Partnership (GARDP) and CARB-X hosted Antibiotic Bootcamps #1, #2, and #3 at the ASM-ESCMID conference September 5 – 8, 2017 in Boston, MA. Nearly 350 people registered for the full meetings with high attendance at each Bootcamp.
Bootcamp #1 included: “What makes a good hit? A good lead? How to determine structure/activity relationship (SAR) and why you should develop target product profiles (TPP) (and they should not be ‘dynamic’)” by authorities in the field, led by Lynn Silver.
Bootcamp #2 covered the challenges of Chemistry, Manufacturing and Controls (CMC), especially now that regulatory paths can be reduced by at least half with the GAIN Act, Orphan and Breakthrough designations and the recent Unmet Need guidelines – it can be a challenge for the CMC piece to keep up. Did you know that you can have CMC-focused engagement with FDA early on with the Office of Pharmaceutical Quality? Yes you can – and FDA invites you to do so. Amongst the presenters were Tim Keutzer and Evan Hecker of Powered By CARB-X company Spero Therapeutics.
Bootcamp #3 focused on the mysteries of antimicrobial susceptibility testing with practical, implementable suggestions and (painful) lessons learned about surveillance, microbiology clinical trial data and breakpoint NDA requirements from Kevin Krause of Powered By CARB-X company Achaogen. Just one example: whole genome sequencing (WGS) is now the standard for molecular characterization (vs PCR). But data interpretation methods are still in development, which can make evaluation of data challenging.