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

Fireside Chat with BARDA’s Branch Chief for Antimicrobials

Note: Be sure to take advantage of the BARDA Industry Day(s) event that occurs Monday-Tuesday of this coming week … see newsletter and forward calendar for details. Dear All, In what could be called Part 2 of Excellent 2023 ASM/ESCMID Talks (read the newsletter on Jen Cohen’s talk on how manufacturing underpins both access and

Japan Pulls for Pandemic Preparedness: Nikkei FT Conference

Dear All, As we discussed in the 5 Nov 2023 “Pulling for Pandemic Preparedness” newsletter, AMR is a global threat: resistance in one part of the world can suddenly appear in your hospital. As an example of that sort of threat, Jason Gale’s 30 Oct 2023 newsletter entitled “Untreatable Typhoid Should Make You Worry About Poop”

Pulling for Pandemic Preparedness

Dear All, This evening I’d like to bring together several relatively recent reports and note how all of them focus in one way or another on Pulling for Pandemic Preparedness … perhaps we can call this the Rule of 3 Ps. And as an aside, I’ll note that I learned the Rule of 4 Ps

PACE: A new £30m fund for AMR innovation

Dear All, Exciting additional news merits two newsletters in one day! I’ll keep it brief and quote directly from the website: “Innovate UK, LifeArc, and Medicines Discovery Catapult (MDC) have joined forces to create PACE (Pathways to Antimicrobial Clinical Efficacy), a £30 million initiative supporting early-stage innovation against antimicrobial resistance (AMR) to save lives. PACE has today (19 October 2023) announced

Scroll to Top