Dear All: Per an email received today, there will be an FDA Grand Rounds webcast on 14 Sep 2017 (noon-1p EST) in which FDA unveils a new paradigm for evaluating the cardiac safety of new drugs entitled the Comprehensive in vitro Proarrhythmia Assay (CiPA) initiative. Here is the link to the FDA webpage where you can get further details
Dear All: It is great to see that the UK Department of Health (DH) and the Chinese Ministry of Science and Technology (MoST) have today announced the size, scope and eligibility for the UK-China AMR Collaboration that was initially announced in 2016. DH will to invest up to £10 million in UK businesses and MoSt will provide to 60 million
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
Dear All: As we head into the Easter and Passover weekend, three new calls for proposals have emerged! Perhaps one of these is for you? The US CDC has released a Broad Agency Announcement (FY2018-OADS-BAA) seeking proposals for projects across a range of areas (diagnostics, transmission, microbiome disruption, resistance genes in the environment, and stewardship). Initial proposals
Dear All: Just in case you missed the 30 March annoucement, see at right a snapshot of the first 11 Powered by CARB-X funded companies. Initial funding is $24m, with potentially a further $24m if the companies hit their milestones. With the funds provided by the companies themselves, the total potential investment is $75m. This is just the start:
Dear All: OK, I’ll say that I’m sending this around because the title was so intriguing and reminded me of the debates we’ve had about why fever is not part of endpoint definition for clinical trials of new drugs. But, this article (see weblink & abstract below) is an excellent, in-depth survey of how salicylic acid and
Dear All (long note alert … there’s a lot of material below my signature): Just published today is an IDSA White Paper entitled “Developing Antimicrobial Drugs for Resistant Pathogens, Narrow-spectrum Indications, and Unmet Needs.” The paper is accompanied by an editorial by George Drusano. As the papers are free to download (links below). The white paper reviews the
Dear All: I listened with interest to the 19 July 2017 FDA Workshop entitled “Development of New Tuberculosis Treatment Regimens– Scientific and Clinical Trial Design Considerations.” Most of the materials from the meeting are available online (see link below my signature). I was interested in this workshop both because I want to see new TB
Dear All: Among various paradoxes that surround antibiotic development, the challenge for health technology assessment (HTA) is often implied but to my knowledge has as yet only infrequently been formally discussed. As one step towards filling this gap, the London-based Office of Health Economics (OHE) released a paper a few days ago that provides a detailed
Dear All: After a multi-year gestation period (my notes on this project go back to 2012!!), a comment on the FDA draft HABP/VABP guidance document has now been submitted by the FNIH (Foundation for the NIH) Biomarkers Consortium HABP/VABP Project Team and posted online. Links to the docket and document are below my signature. The