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
Dear All: FYI, see below an announcement of an 8-day intensive course in Paris in November 2017: “ICARe is designed for early career scientists – assistant professors, new industry scientists, MDs, and postdoctoral research associates – as well as members from developing areas contending with the practical challenge of managing the antibiotic resistance problem with
Dear All: This is your heads-up about next week’s World Antibiotic Awareness Week. Themed “Learn how to handle antibiotics with care,” this is the third in a series of annual WHO-driven World Antibiotic Awareness Weeks (prior ones are in this archive). I’ll confess that I had overlooked this event until I was reminded about it just
Dear All: Just hitting my inbox today is this report from OHE. The paper reviews in detail the incentive proposals in the 2016 O’Neill Report on incentives from the UK AMR Review commissioned by UK government and the 2017 GUARD Report entitled “A Call for Concerted Action on Antibiotics Research and Development” commissioned by the German government. This well-written and detailed paper is a welcome
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: I wrote twice last week with materials from the 5-8 Sep ASM-ESCMID conference (EMA-FDA-NICE updates and the CARB-X + GARDP Bootcamps. But there’s more … in parallel, we last week also had the final DRIVE-AB conference in Brussels! In the absence of a Star Trek transporter it was not possible to attend both, but I did
This note was updated on 12 Jan 2018 to provide links to the videos from the bootcamp sessions. Dear All: GARDP + CARB-X have this week hosted Antibiotic Bootcamps #1, #2, and #3 at the ASM-ESCMID conference on antibiotic R&D. There were nearly 350 people registered for the full meeting with good attendance at each Bootcamp.