On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology assessment (HTA) landscape.
The speakers (Marco Cavaleri, PhD, Head of Anti-Infectives and Vaccines, EMA; Sumati Nambiar, MD, Director, Division of Anti-infective Products, FDA; and Colm Leonard, MD, Consultant Clinical Adviser, National Institute for Health and Care Excellence) have kindly agreed to make their presentations available and you can download them here as a 1.5MB .zip file. You’ll want to review the talks yourself, but let me point out these highlights:
MANY thanks to our colleagues at these agencies both for being so available to the community and for their steady, multi-year efforts to find a pragmatic path forward that balances Unmet Need with risk. We are truly having conversations now that were not possible even 5 years ago!
Best wishes, --jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Chief Strategy Officer, CARB-X | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog-index.html
Upcoming meetings of interest to the AMR community: