R&D Insight Archives • Page 25 of 35 • AMR.Solutions

ECCMID Symposium: Expediting antibacterial development: core lessons and key tools for a rocky road

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

23 April 2018 No Comments

4-7 Sep 2018: ESCMID-ASM Conference #3 on AMR (initial flyer)

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

9 November 2017 No Comments

TATFAR’s 2018 meeting: Live streaming of 7 Mar opening session

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

22 February 2018 No Comments

CARB-X is seeking additional accelerators to expand support for its pipeline

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

23 January 2018 No Comments

EMA-FDA-PMDA action + Podcasts (CDD, Pew) + NEJM on non-inferiority

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

21 November 2017 No Comments

CARB-X Application Round #3 goes live!

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

20 February 2018 No Comments

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

29 January 2018 No Comments

Debut of FDA Susceptibility Test Interpretive Criteria (STIC) website

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

13 December 2017 No Comments

(Another!) FDA trial design workshop: Complex innovative designs

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

24 February 2018 No Comments

Duke-Margolis & FDA: Workshop on stats & methods for rare diseases

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

14 February 2018 No Comments

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