Potpourri: QIDP Q&A, BEAM Alliance paper and meeting, Duke-Margolis workshop on inclusion/exclusion criteria

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 limited to just things that treat or whether things that treat, diagnose, or prevent qualify (yes, all are OK), and more. 

The BEAM Alliance has been busy! First (and somehow I missed this), BEAM (Biotech companies in Europe combating AntiMicrobial Resistance) released a well-written multi-company authored position paper back in Nov 2017 on the need for AMR-related incentives to consider the needs of SMEs. This paper sits nicely alongside the materials I reviewed in my recent “Push! Pull! Push! Pull! Davos Highlights” newsletter. To further support their efforts to build the European biotech ecosystem, BEAM is organizing a 1-day AMR-focused meeting in Berlin on 2 Mar 2018. Good work, Team BEAM!

Duke-Margolis is hosting a 1-day workshop on inclusion and exclusion criteria in clinical trials on 16 April 2018 as part of a cooperative agreement with FDA (corresponding FR notice): “The purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.” This looks to me to be very general in nature — there is nothing in the material online that speaks specifically to AMR. Nonetheless, I am sharing it given some of the debates we’ve had about inclusion & exclusion (especially, for example, prior antibiotics). If you any of you happen to attend, please drop me a note should there be material of relevance for the community.

And that’s all for today! Best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://13.43.35.2/blog/

Upcoming meetings of interest to the AMR community:

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