Dear All, For those of you who enjoy listening to learn, here are some updates to recent newsletters that you might enjoy: 9 Jan 2021 (newsletter): “All-In Cost of a New Antibiotic From Discovery to 10 Years on Market“ As you’ll recall, the key point is that the all-in cost is ~$1.7b per new molecule after
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, 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
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, Breaking news! Prior newsletters (initial and follow-up) have discussed the UK’s innovative antibiotic subscription pilot (aka, “Netflix for antibiotics”). In brief, the UK intends to identify two innovative antibiotics suitable for being purchased via a delinked model in which the payment to the innovator is a fixed annual fee rather than a per-use
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,
Dear All, Just out is a Broad Agency Announcement (BAA 75D301-21-R-71738) from CDC with a 13 Jan 2021 deadline for white papers. The webpage for the BAA is here and you’ll need to look at the .pdf of the solicitation to understand all the possibilities. The AMR-related research areas include calls for proposals that would: Improve identification of bacteria
Dear All, Howard Bauchner, the editor-in-chief of JAMA, regularly does 30-minute Q&A podcasts. Today’s Q&A was with Tony Fauci and is a superb review of current state of play. Yes, he is ready to get the vaccine and is going to be vaccinated in public! Go here to listen. For more, below my signature you
Dear All, The US Department of Defense (DoD) is offering funds through the Small Business Innovation Research (SBIR) program for a “Novel Antibiotic for the Treatment of Multidrug-Resistant Pseudomonas Aeruginosa Infections.” Antibody, phage, and vaccine approaches are out of scope and the business must be located in the United States. To find the funding offer, navigate
Dear All, And now for a change from our usually scheduled content! As you might expect, major agencies in the US (FDA, BARDA, NIAID) and Europe (EMA, EC, national agencies) are actively supporting the global R&D response to COVID-19. In addition, global consortia are appearing and BioCentury has provided both a newsletter on this as well
