Meetings

FDA workshop: Revising the process for importance-ranking of human antimicrobials to guide their use in animals

Dear All, FDA have announced that they will hold a virtual public workshop on 16 Nov 2020 (9.30a-4.00p EST) entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” Go here for the FR notice, here for extended details, including registration, and here for

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UK Antibiotic Subscription Pilot: Updates from a webinar

Dear All (and with thanks to Kevin Outterson for co-authoring), We’ve written and talked before from various perspectives about the groundbreaking UK NHS England-, NHS Improvement-, and NICE-sponsored antibiotic subscription pilot project: 10 Feb 2021: Fabulous 5-minute video explainer on the economics of antibiotics by Andrew Jack of Financial Times Superb discussions of Push/Pull, the role

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FDA workshop: Insights on inhaled antifungals and antibacterials

Dear All (wonkish alert … coffee up!), FDA held a workshop on 25 Sep 2020 on development of inhaled antifungal (AF) therapies with a focus on (i) therapies for allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitization (SAFS), (ii) prophylaxis in lung transplantation, and (iii) adjunct therapy in invasive fungal lung infections (link to

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18-19 Nov 2019 FDA-IDSA-NIH-Pew Workshop: Enhancing Antibacterial Trials in the US

Dear All, Long note alert: Set aside at least 30 minutes for this one … there’s a lot of important material here. Last week’s workshop entitled “Enhancing the Clinical Trial Enterprise for Antibacterial Drug Development in the United States” was an unusual and unusually instructive meeting. You can go here for the meeting materials but as there are

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FDA workshop on complex innovative trial designs / WHO consultancy

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

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COVID-19 and bacterial infections / New webinars and meeting updates

Dear All: Three brief items for you today.  First up: Perhaps like many of you, I’ve been wondering whether or not COVID-19 and bacterial resistance would begin to cross paths in some fashion. I can’t think of a reason why COVID-19 would directly cause resistance, but use of antibiotics becomes pretty common after you’ve been

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(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

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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),

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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

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