R&D Insight

Benefit-Risk analyses: Gassman et al. (NEJM) + FDA

Dear All: An article by Gassman, Nguyen, and Joffe in today’s NEJM entitled “FDA regulation of prescription drugs” caught my eye because of its emphasis on structured benefit-risk (B-R) analyses as a core part of regulatory thinking. See links below along with the core paper from the FDA’s website on benefit-risk (oddly, the NEJM paper is not

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Ways to talk about AMR / Powerful new insights into messages that do (and do NOT) work

Dear All: Verbatim comments from interviews with 12,000 people in Germany, India, Japan, Kenya, the UK, the USA and Thailand: India: “[Antimicrobial resistance] is quite normal, no big thing, like malaria. It’s on a personal level, if you take antibiotics, your resistance will be on [the] lower side. If you are fit, your body resistance is more.” Germany: “Air pollution

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Funding, Filing, and Finance: Most current update of this lecture

Dear All: I had the opportunity today to share an updated version of my “Funding, Filing, and Finance” talk with the attendees of Superbugs & Superdrugs in London. Topics covered were: Funding: What are the global initiatives? Where can you find information on how you could apply? Filing: What are the must-read background documents for developers? What

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Approaches to antifungal R&D: A lecture from ISHAM

Dear All: ISHAM 2018, the meeting of the International Society for Human and Animal Mycology, is now happening in Amsterdam. I was given an opportunity to talk today on antifungal R&D and I thought I would share the slides with the broader community. It was really interesting to think about the parallels between antibacterials and

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The hunt for oral antibiotics: Beyond Lipinski’s Rule of Five

Dear All: Given our collective interest in finding oral antibiotics, a recent article in J Med Chem on the evolution of our understanding of Lipinski’s Rule of 5 (Ro5) prompts me today to share it along with a recent webinar and links to both Lipinski’s original paper as well as his 2016 commentary:  The original

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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 workshop on the development of non-traditional antibacterial agents was an excellent discussion of core challenges in this area. The agenda plus all the meeting materials (including the public comment slides and

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ECCMID Symposium: Expediting antibacterial development: core lessons and key tools for a rocky road

Dear All: GARDP and CARB-Xed co-sponorsored yesterday an ECCMID symposium entitled “Expediting antibacterial development: core lessons and key tools for a rocky road.” A detailed tour of the many lessons we’ve learned in recent years, the program was (follow the links to download the talks): Marco Cavaleri (EMA): EU regulatory tools for expedited antibacterial development programmes EMA has

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4-7 Sep 2018: ESCMID-ASM Conference #3 on AMR (initial flyer)

Dear All: Now available is the initial flyer for next year’s ESCMID-ASM Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This third meeting will be 4-7 Sep 2018 in Lisbon and will follow the prior (and excellent!) meetings #1 (Vienna, 2016) and #2 (Boston, 2017). Although you can’t register for it yet (and I’ll let you know as soon

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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

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CARB-X is seeking additional accelerators to expand support for its pipeline

Dear All: It is exciting to see that CARB-X today announced that it is seeking to partner with up to 6 additional accelerator organizations to expand its drug development and business support for its growing pipeline of early development antibacterial research projects. The Powered by CARB-X portfolio currently has 22 active projects in its pipeline, with more project announcements

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