Please be sure to look closely at the events calendar: Q&A with Scott Gottlieb, Lipinski on Lipinski, and more! Dear All: FDA’s 21-22 Aug 2018 workshop on the development of non-traditional antibacterial agents was an excellent discussion of core challenges in this area. The agenda plus all the meeting materials (including the public comment slides and
Dear All: ISHAM 2018, the meeting of the International Society for Human and Animal Mycology, is now happening in Amsterdam. I was given an opportunity to talk today on antifungal R&D and I thought I would share the slides with the broader community. It was really interesting to think about the parallels between antibacterials and
Dear All: Given our collective interest in finding oral antibiotics, a recent article in J Med Chem on the evolution of our understanding of Lipinski’s Rule of 5 (Ro5) prompts me today to share it along with a recent webinar and links to both Lipinski’s original paper as well as his 2016 commentary: The original
Dear All: GARDP and CARB-Xed co-sponorsored yesterday an ECCMID symposium entitled “Expediting antibacterial development: core lessons and key tools for a rocky road.” A detailed tour of the many lessons we’ve learned in recent years, the program was (follow the links to download the talks): Marco Cavaleri (EMA): EU regulatory tools for expedited antibacterial development programmes EMA has
Dear All: Now available is the initial flyer for next year’s ESCMID-ASM Conference on Drug Development to Meet the Challenge of Antimicrobial Resistance. This third meeting will be 4-7 Sep 2018 in Lisbon and will follow the prior (and excellent!) meetings #1 (Vienna, 2016) and #2 (Boston, 2017). Although you can’t register for it yet (and I’ll let you know as soon
Dear All: On 7-9 Mar 2018, the Transatlantic Task Force on Antimicrobial Resistance (TATFAR) will meet in Atlanta, GA to discuss: Improving antibiotic use in humans and animals, Preventing infections and their spread, and Strengthening the drug pipeline. The opening session (8.30-10.00a EST on 7 Mar) will be available for viewing via live-streaming. What is TATFAR? Created
Dear All: It is exciting to see that CARB-X today announced that it is seeking to partner with up to 6 additional accelerator organizations to expand its drug development and business support for its growing pipeline of early development antibacterial research projects. The Powered by CARB-X portfolio currently has 22 active projects in its pipeline, with more project announcements
Dear All: Several updates today, all on the theme of good things to know or share! First, EMA, FDA, and PMDA are continuing to meet and have released a summary of their third tripartite meeting. The key message is alignment: alignment on trial designs for key indications, alignment on pediatric programs, and alignment on single global development programs! This is
Dear All: The wait is over — CARB-X has today released a call for new applications! The call has an interesting 2-round structure and you’ll need to study carefully both the press release and the supplemental details document to understand where your program would fit. Here’s my summary: Round 1: Submission window for Expressions of Interest: 22-29 March 2018 Scope: Restricted
Dear All: And then there are days when the floodgates open and things just appear! The amount of stuff afoot is amazing… QIDP Q&A: FDA has released a draft Q&A guidance document on QIDP. Dated January 2018 (and posted as of 30 Jan 2018 via this FR notice, this guidance covers such topics as required information, whether QIDP is