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 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

14 May 2018 No Comments

Treating CNS infections: An NIH/DoD workshop on strategies for crossing the blood-brain barrier

Dear All: Sponsored by NIH (NIAID, NINDS, NHLBI, NCATS) and DoD (DTRA), a 2-day workshop on CNS infections and ways to penetrate the blood-brain barrier has just been announced for 21-22 Aug 2018. Full details are found online at http://www.cvent.com/d/wgq9j7. The preliminary agenda online looks fascinating and shows planned discussions of viral encephalitis (e.g., West Nile),

9 May 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 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

24 February 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 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

22 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 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

14 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 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

29 January 2018 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 … 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

11 September 2017 No Comments

New meetings & grants, with a focus on Vietnam, China, and the UK

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!

2 September 2017 No Comments

Using Real-World Evidence: FDA Workshop on 13 Sep 2017

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

29 July 2017 No Comments

Workshop on TB drugs: Lessons for the antibacterial community

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

22 July 2017 No Comments

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