Dear All, First up today is a very interesting new workshop from FDA on 1-2 Sep entitled “Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.” In brief: “The Complex Innovative Trial Design Pilot Meeting Program (CID Program) facilitates and advances the use of complex and innovative trial designs that have the potential
Dear All, This webinar merits a standalone newsletter! If you are thinking (or working on) phage, then please mark your calendar for an FDA (CBER; Center for Biologics Evaluation and Research) workshop entitled: Science and Regulation of Bacteriophage Therapy: August 30, 2021—September 1, 2021 The purpose of the public workshop is to exchange information with the
Dear All: Below my signature, find details of 4 new meetings and (collectively) 4 active or upcoming grant opportunities. One of the grants has a 6 Sep deadline, so look quickly! At the very bottom of the email you will find an integrated summary of all upcoming meetings … there is a lot going on!
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
Dear All: I listened with interest to the 19 July 2017 FDA Workshop entitled “Development of New Tuberculosis Treatment Regimens– Scientific and Clinical Trial Design Considerations.” Most of the materials from the meeting are available online (see link below my signature). I was interested in this workshop both because I want to see new TB
Dear All: There is a newly announced FDA workshop on 13 Sep on using real-world evidence. Here is the link and I’ve also reproduced the key background text below my signature. This is of interest to the antibacterial community as our reliance on non-inferiority trials for the majority of our data means that we are often going to want
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 humans and animals, Preventing infections and their spread, and Strengthening the drug pipeline. The opening session (8.30-10.00a EST on 7 Mar) will be available for viewing via live-streaming. What is TATFAR? Created
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 teaser from the web: “Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will
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 has now announced a 20 Mar 2018 workshop on complex innovative designs (CID) in clinical drug trials. From the Federal Register notice, we are told that the workshop seeks to (1) facilitate
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 released a draft Q&A guidance document on QIDP. Dated January 2018 (and posted as of 30 Jan 2018 via this FR notice, this guidance covers such topics as required information, whether QIDP is
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