R&D Insight

All-in cost of a new antibiotic from discovery to 10 years on market

Dear All (and with thanks to Kevin Krause for co-authoring this newsletter), The elements that contribute to the all-in cost of an antibiotic have been reviewed in two prior newsletters: 6 Mar 2020 (focused on cost of R&D to approval): What does an antibiotic cost to develop? What is it worth? How to afford it? 7 Jan

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Sunday 10 Jan: UCSF-Stanford regulatory conference with FDA

Dear All, New on the meetings calendar today is the 10 Jan 2021 UCSF-Stanford Innovations in Regulatory Science Summit. Per the meeting website: “It is a gathering of leaders in the academia, industry and regulatory sectors to discuss the role of regulatory science in medical product development.   “The 2021 Summit will have a major focus on

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JPIAMR call: 25m Euro for interventions to reduce/prevent AMR

Dear All, JPIAMR is today launching an international call entitled “One Health interventions to prevent or reduce the development and transmission of AMR.” The call, with financial support from the European Commission, includes 30 funding organisations from 21 JPIAMR member countries and has a total estimated call budget of 24.9 million Euro. Here’s the description of

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FDA offers 2 fellowships and 3 RFPs! Endpoints, breakpoints, PROs & more!

Dear All, Our colleagues at FDA are planning some serious AMR-related research during 2021-22 with the following fellowships and RFPs. Extended details are available via the links — you can also find brief summaries below my signature or via FDA’s research webpage. Wow! FDA Fellowship #1: A study of ordinal endpoints for antibiotic trials using

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Jan-Feb meetings; CDC releases Healthcare Epidemiology RFP

Dear All: Happy New Year! I hope everyone was able to take a least a brief break over the holidays. Two things for today. First, there are two meetings in January and one in February that have just popped onto my radar. See the meetings calendar for a pair of Keystone Symposia on the microbiome,

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Treating resistant Gram-negatives: IDSA provides pragmatic expert advice

Dear All, IDSA (Infectious Diseases Society of America) have today released an eagerly awaited new guidance document on treating infections due to resistant Gram-negative bacteria (link). The thing that makes this document unusual is that it is an expert guidance rather than a formal guideline. Although there is value in formal guidelines that carefully review

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