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: 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: 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
Dear All: I knew that the idea of an online and frequently updated website for FDA-recognized Susceptibility Test Interpretive Criteria (STIC) was brewing based on the 21st Century Cures Act … and now it has happened! Check this out: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm410971.htm There is also a short URL link that remaps to the longer URL just above: https://www.fda.gov/STIC
Dear All: Adding to the 19 Mar 2018 (Designs for Rare Diseases) and 16 Apr 2018 (Inclusion/Exclusion criteria) workshops already announced (see list below), FDA has now announced a 20 Mar 2018 workshop on complex innovative designs (CID) in clinical drug trials. From the Federal Register notice, we are told that the workshop seeks to (1) facilitate
Dear All: Duke-Margolis and FDA have now announced a 19 Mar 2018 workshop entitled Utilizing Innovative Statistical Methods and Trial Designs in Rare Disease Drug Development (FR notice). Here’s the teaser from the web: “Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, this public event will
Dear All: On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology assessment (HTA) landscape. The speakers (Marco Cavaleri, PhD, Head of Anti-Infectives and Vaccines, EMA; Sumati Nambiar, MD, Director, Division of Anti-infective Products, FDA; and Colm Leonard, MD, Consultant Clinical Adviser,
Dear All: Just announced today (press release, website), Novo Holdings has created a $165m impact fund that seeks to support novel therapies from Lead Optimization (LO) through Phase 1. The fund specifically targets “first-in-class therapies, covering small molecules, biologics, and new modalities.” Similar to the focus of CARB-X, REPAIR (Replenishing and Enabling the Pipeline for Anti-Infective Resistance) will focus on priority pathogens from the
Dear All: OK … enough with bad news, at least for today. In today’s edition of XKCD (link), we learn about resistance to apples and the need to use good apple stewardship. Image reproduced with permission from https://xkcd.com/2161/ If you don’t read XKCD, you should! All best wishes, –jr John H. Rex, MD | Chief Medical
Dear All, Long note alert! There are two deep and deeply connected topics to share today. Refresh your coffee and settle in… Today’s first topic: Adding to the recent reviews of the clinical stage pipeline for both traditional products (link to the Sep 2019 Pew Charitable Trusts summary), and non-traditional products (link to an Aug 2019 newsletter summarizing