Y2021

Amended Indian PPL slide / SUPERBUGS Act / Novo REPAIR Global Call

Dear All, Three bits of news you can use… First, when I wrote yesterday about the new Indian Priority Pathogen List (PPL), I said that it was similar to the WHO PPL list except for the addition of Staphylococcus epidermidis (and speculated that this relates to the role of S. epidermidis in neonatal sepsis). Well, it

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Where’s the innovation? / Indian Priority Pathogen List / DTR video explainer

Dear All, Three things briefly this evening: First, the observation about the limited degree of innovation across products in Phases 1-3 in the recent newsletter about the Pew Pipeline review (only 1 in 4 are novel classes or novel mechanisms; none are potentially active against Gram-negative ESKAPE pathogens or WHO critical threat pathogens) generated queries along

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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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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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