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:

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