Dear All: The idea of using real-world evidence (RWE) as a way to support development of novel agents (including antibiotics!) has always intrigued. As you may recall, the 21st Century Cures Act (Cures Act) gave FDA a mandate to evaluate the potential use of RWE to support drug approval. There was a workshop on this on
Dear All, Apologies for the delay, but I’ve held off on this note until the majority of the presentations from the 3-6 Sep 2019 ASM-ESCMID meeting (Boston) were online. You can now access the program, most of the presentations, and the meeting abstracts here. It was a wonderful meeting with over 400 attendees. And, please be sure
Dear All: Below my signature, find details of 4 new meetings and (collectively) 4 active or upcoming grant opportunities. One of the grants has a 6 Sep deadline, so look quickly! At the very bottom of the email you will find an integrated summary of all upcoming meetings … there is a lot going on!
REDear All: I just heard to today that FDA is holding a public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease” on 8 April 2019 from 8.30a-5.00p. Register here. Per their website, “the purpose of the public workshop is to discuss the clinical trial design considerations, including endpoints, related to the
Dear All: FDA held a workshop (go here for workshop agenda and materials) on 8 Apr 2019 on “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease.” I attended by webcast and worked with an on-the-spot attendee (David Melnick of Spero Therapeutics) to develop this summary. The workshop started with a review of the underlying
Dear All: Apologies for the back-to-back emails, but this one just came across the transom. In brief, FDA will hold a public meeting on Friday 12 Jul 2019 (9a-3p EDT, FDA White Oak Campus) at which FDA is soliciting public comment on the 2018 LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs) guidance. You can register
Dear All: There are days when I have the feeling of drinking from a fire hose … and this is one of them! Multiple interesting new events have crossed my radar in the past 48 hours with topics that span AMR Awareness (two events in Geneva next week!), CNS infections (Rockville, MD), an EMA info-day
Dear All, Please mark your calendar now to be in the Washington, DC area on 18-19 Nov 2019 for a 2-day workshop at FDA’s White Oak Campus focused on enhancing the clinical trial enterprise for antibacterial drug development. Jointly co-sponsored by FDA, IDSA, NIAID, and Pew Trusts, this meeting will have a particular focus on (a)
Dear All: Sponsored by NIH (NIAID, NINDS, NHLBI, NCATS) and DoD (DTRA), a 2-day workshop on CNS infections and ways to penetrate the blood-brain barrier has just been announced for 21-22 Aug 2018. Full details are found online at http://www.cvent.com/d/wgq9j7. The preliminary agenda online looks fascinating and shows planned discussions of viral encephalitis (e.g., West Nile),
Dear All: There is a newly announced FDA workshop on 13 Sep on using real-world evidence. Here is the link and I’ve also reproduced the key background text below my signature. This is of interest to the antibacterial community as our reliance on non-inferiority trials for the majority of our data means that we are often going to want