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: 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 (wonkish alert … coffee up!), FDA held a workshop on 25 Sep 2020 on development of inhaled antifungal (AF) therapies with a focus on (i) therapies for allergic bronchopulmonary aspergillosis (ABPA) and severe asthma with fungal sensitization (SAFS), (ii) prophylaxis in lung transplantation, and (iii) adjunct therapy in invasive fungal lung infections (link to
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, 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, We learned today during the BEAM AMR conference (link) that EMA released a call on 7 June 202 for comments on their draft Network Strategy to 2025 that considers how “the European medicines agencies’ network can continue to enable the supply of safe and effective medicines that meet patients’ needs in the face of challenges
Dear All, Today we have a bit of a potpourri for WAAW (World Antibiotic Awareness Week). Lots of good stuff… In the new meetings category, we have two meetings for investors seeking social impact: 23 Nov 2020 (online, 6-7p CET): Webinar sponsored by Access to Medicine Foundation (ATM) entitled “The Materiality of Superbugs: Investor Action
Note: If you have trouble downloading the files referenced by this newsletter, please use the copy of the newsletter posted at https://13.43.35.2/. Dear All, Following the precept “Don’t repeat old mistakes — always make new ones,” a foundational goal of the CARB-X program was to provide open access to R&D data from terminated projects. As
Dear All, Today we have two hopeful signs from our younger colleagues about the future of AMR! First Global AMR Youth SummitThe World Health Students’ Alliance (WHSA) has announced a 3-day virtual event (20-22 Nov 2020, see details below) where “youth around the world come together to discuss, learn, and get empowered about various AMR-related