Dear All, FDA, NIAID and CDC have announced a public workshop on development considerations of antimicrobial drugs for the treatment of gonorrhea. The workshop will cover both nonclinical (preclinical) and clinical trial design considerations: Animal models Clinical pharmacology considerations Trial design considerations for gonorrhea, such as enrollment strategies, choice of comparators and site of infection.
Dear All, WHO have today updated their 2019 clinical/preclinical pipeline review by releasing their 2020 analyses of both the clinical and pre-clinical antibacterial product pipelines (the new 2020 report, the press release). Their 2020 review of antibacterial products in Phase 1 and beyond covers both traditional (n = 43) and non-traditional products (n = 27)
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
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
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,