Dear All: To start the new year, I’ve learned that Pew has updated their pipeline analysis. First released in Feb 2014, it has been steadily updated ever since. This newest analysis has a data cut-off of Sep 2017 and covers both traditional antibiotics as well as non-traditional products. All the links you need are just below my signature,
4 Mar 2020 update: I recently confirmed with Barry O’Keefe (see his email below) that (i) the program is up and running with 326,000 fractions currently available and (ii) the library is available to researchers world-wide. Please contact Barry if you want to take advantage of this program! Dear All: I learned very recently
Dear All: You are doubtless now familiar with all the reasons why we need pull incentives for AMR-related products (as background, see this blog). We don’t yet have anything beyond the US GAIN act and it alone will not suffice. In the US, there are discussions this week in the House of Representatives on reauthorizing PAHPA, the
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: (18 June addendum: the materials from the meeting are now posted!) First, planning continues apace for the 14 June Duke-Margolis workshop on non-traditional products. There is now a link for registration, confirmation that the event is going to be webcast, and a draft agenda. Mark your calendar now to attend either in person or via the webcast! Second, I would like to
Dear All: This one appears to have been released on 7 Mar but it just crossed my desk today. In brief, IDSA has assembled 13 patient stories into a well-written and illustrated .pdf. The centerpiece of the paper is this graphical history of AMR shown below. Well done to IDSA for pulling these stories together
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: I wrote previously about the Duke-Margolis workshop done in collaboration with FDA on the challenges of developing non-traditional antimicrobial products. We’re now back from that workshop and I can report that it was excellent. We covered an array of strategies for non-traditional products and heard an exceptional series of company case vignettes. I’ll say that
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: IDSA and Research!America have worked together to conduct a broadly representative opinion poll in the United States regarding AMR. The project was supported by Pfizer and surveyed 1,004 adults in the US during October 2018. Key results: Less encouraging but probably an improvement from the past, 1/3rd of respondents thought antibiotics were effective