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
8 June 2018 No Comments
Meetings
14 June Duke-Margolis workshop + A taxonomy for non-traditional (non-Fleming) antimicrobials
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
14 May 2018 No Comments
14 June Duke-Margolis workshop on non-traditional products: Post-meeting materials
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
18 June 2018 No Comments
NIAID workshop: What is a robust PK-PD package?
Dear All: The ~150 of us who gathered in Washington yesterday and today for the NIAID’s PK-PD workshop enjoyed a very rich conversation. It’s really
15 June 2017 No Comments
Incentives for antibiotics: Summary of DRIVE-AB / Slides from the 6-8 Sep 2017 ASM-ESCMID meeting
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 …
11 September 2017 No Comments
FDA workshop on non-traditional antibacterials (21-22 Aug 2018)
Please be sure to look closely at the events calendar: Q&A with Scott Gottlieb, Lipinski on Lipinski, and more! Dear All: FDA’s 21-22 Aug 2018
23 August 2018 No Comments
TATFAR’s 2018 meeting: Live streaming of 7 Mar opening session
Dear All: On 7-9 Mar 2018, the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) will meet in Atlanta, GA to discuss: Improving antibiotic use in
22 February 2018 No Comments
Potpourri: QIDP Q&A, BEAM Alliance paper and meeting, Duke-Margolis workshop on inclusion/exclusion criteria
Dear All: And then there are days when the floodgates open and things just appear! The amount of stuff afoot is amazing… QIDP Q&A: FDA has
29 January 2018 No Comments
(Another!) FDA trial design workshop: Complex innovative designs
Dear All: Adding to the 19 Mar 2018 (Designs for Rare Diseases) and 16 Apr 2018 (Inclusion/Exclusion criteria) workshops already announced (see list below), FDA
24 February 2018 No Comments
Duke-Margolis & FDA: Workshop on stats & methods for rare diseases
Dear All: Duke-Margolis and FDA have now announced a 19 Mar 2018 workshop entitled Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Drug Development (FR notice). Here’s the
14 February 2018 No Comments