Dear All: Three things today — see list below. And if you’ve not heard, it looks like REVAMP (the US pull incentive) is not going to make it into legislation. Frustrating! We’ll have to keep trying on this. Best wishes for the summer, –jr ASM Microbe 2019 has put out a call for session proposals. Deadline is 3 Aug
Dear All: I previously wrote about the nascent REVAMP legislation that would create a Pull incentive in the US market. With everybody back from the July 4th holiday, the goal for this week is to get REVAMP into position to be offered as an amendment at the House Energy & Commerce Committee’s PAHPA mark-up (expected next week).
Dear All: ISHAM 2018, the meeting of the International Society for Human and Animal Mycology, is now happening in Amsterdam. I was given an opportunity to talk today on antifungal R&D and I thought I would share the slides with the broader community. It was really interesting to think about the parallels between antibacterials and
Dear All: Incredibly exciting news! Due to the bipartisan efforts of Representatives John Shimkus (R-IL) and Tony Cardenas (D-CA), the Re-Valuing Anti-Microbial Products (REVAMP) Act of 2018 is now being introduced. This is the Pull incentive that we’ve been looking for in the US! The very short summary is that REVAMP (a) creates a new “priority antimicrobial product” category, (b) grants
Dear All: New things continue to appear at a furious pace! Here are 3 excellent opportunities to listen and learn. Even if you can’t be there in person, the first is a webinar and the other two are (in my experience) very likely to be webcast: On 26 June, there will be a webinar sponsored
Dear All: Following hard on the heels of yesterday’s note about the 14 June 2018 Duke-Margolis workshop on development of non-traditional products, we now have a notice regarding a 21-22 Aug FDA workshop on that same topic! The meeting will be on FDA’s White Oak Campus from 8.30a-4.30p (21 Aug) and 8.30a-noon (22 Aug). From the notice: “The purpose
Dear All: Also appearing today are two valuable opportunities to comment on key global strategy documents. I do hope each of you can make time to look at these materials and consider sending in your thoughts — it really does make a difference when central leadership groups hear from a broad array of stakeholders! First, EMA has
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: 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,