Dear All (detailed and wonkish note alert … lots of thinking out loud … get some coffee and settle in!), I wrote previously (link) about FDA’s planned workshop on animal models to support antibacterial development and I was able to listen to the workshop via webcast. As brief context (and please be sure to look
Dear All, And now for a change from our usually scheduled content! As you might expect, major agencies in the US (FDA, BARDA, NIAID) and Europe (EMA, EC, national agencies) are actively supporting the global R&D response to COVID-19. In addition, global consortia are appearing and BioCentury has provided both a newsletter on this as well
Dear All: Two new events on the near-term horizon. First, FDA has announced an Antimicrobial Drugs Advisory Committee for 11 Jan 2018 (and materials from the meeting can now be found here). Per the FR notice, this AMDAC will cover Aradigm’s inhaled ciprofloxacin for non-CF bronchiectasis and is almost certainly a discussion of the results Aradigm’s ORBIT-3
Dear All (wonkish alert … the first 3 segments are non-wonkish but the last 2 are in the wonkish zone … titrate your plasma caffeine level appropriately), Part 1: FDA has recently released a draft guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population (link). This timely guidance builds on related guidance documents
Dear All: Two updates today. First, our colleagues at London School of Economics have just published a review of antibiotic innovation incentives that includes a detailed review of some of the currently available sources of funding (Simpkin VL et al., Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps. J Antibiot, 1 Nov 2017). As
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,
Dear All: FDA has today released an initial draft of its guidance on LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs). You may recall that the August 2017 Guidance on Unmet Need said such a document was underway … and now we have it. In brief, it is as expected to my eye: the proposed LPAD product needs to treat
Dear All: As requested by Congress as part of the 21st Century Cures Act, the US FDA has now released for public comment a table of surrogate endpoints that can be considered for use by developers: The public docket soliciting comments is here. The web page providing an overview of surrogate endpoints and biomarkers is here. The surrogate
Dear All: First up, NIAID has released a BAA (Broad Agency Announcement) regarding up to $15.5m in funds for awards in two research areas. Here is a brief description … see below my signature for more details. To my eye, this looks like a very broad and inclusive call for proposals. Area 1: Development of Therapeutic Products for
Dear All, Two important new research calls are now out. First, FDA is offering research funding of up to $1m to support creation of rabbit models of ventilator-associated bacterial pneumonia (VAP or VABP, depending on your preferred abbreviation) due to carbapenem-resistant strains of A. baumannii and P. aeruginosa. The call for proposals is via FDA Broad Agency Announcement (FDABAA-20-00123N, link), an ongoing