BARDA’s DRIVe goes live; FDA workshop (27 Jun!) on inhaled antibiotics

Dear All: I don’t mean to inundate your inbox (this is my 3rd email this week!), but these two things have just hit my inbox and one of them has very tight timing:

First, I previously wrote about job opportunities with BARDA’s new DRIVe initiative. With the goal of revolutionizing the way we prevent, detect, and respond to major health security threats, the initiative was described in public at BIO and has now gone live at https://drive.hhs.gov/. Initial programs will focus on (a) sepsis and (b) early detection of infection.

Second, I’ve just seen a Federal Register notice about an FDA workshop to be held 27 June 2018 from 8:30 a.m. to 4:30 p.m (yes, 19 days from now) on inhaled antibacterial drugs for Cystic Fibrosis (CF) and Non-Cystic Fibrosis Bronchiectasis (NCFB). Especially given the negative outcomes in the two recent efforts to develop an inhaled drug for NCFB, this is a welcome discussion. The planned discussions look very interesting :

  • Trial design challenges
  • Trial endpoints
  • Trial populations, duration of therapy, duration of microbiologic testing and followup
  • Device considerations

So many good meetings and discussions are planned … it’s excellent to see all this effort underway! All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog/

Upcoming meetings of interest to the AMR community:

Share

AI-based drug discovery: Chemical vs. drugs (Part 4)

Dear All, We had fun in Feb 2020 discussing whether an antibacterial compound discovered using machine learning was a drug or just a chemical. Building on that conversation, the lab that wrote the original report has a new paper about identification of a narrow-spectrum compound with activity vs. Acinetobacter baumannii. Here are the links you’ll

WHO-UNEP-FAO-OIE Youth Engagement Working Group on AMR: Apply now!

“Education is the most powerful weapon we can use to change the world…” — Nelson Mandela Dear All, Regular readers will know my interest in developing the ecosystem of people who will work to address AMR over time (e.g., this interview with the founder of the Future Leaders Against AMR, my strong support for the

Reports calling for Pull: US GAO, Global AMR R&D Hub

Dear All, Two important reports for your awareness this afternoon. First, the Global AMR R&D hub have responded to a request from the G7 Finance and Health Ministers to provide an update to their 2022 progress report in advance of upcoming G7 meetings. As background, recall that the Finance Ministers in 2021 (during the UK G7

High Watermark for Pull Incentives (and more): Reflections on an amazing week!

Dear All, As a follow up to the glorious cacophony of the events occurring right at the end of April, Kevin Outterson and I made time to discuss all that has happened. The PASTEUR Act reintroduced, the AMR House Subcommittee hearing, the European Commission proposals, the CARB-X Annual Report, FDA approval of the first microbiome-based therapeutic …

Scroll to Top