R&D Insight Archives • Page 21 of 34 • AMR.Solutions

14 June Duke-Margolis workshop + A taxonomy for non-traditional (non-Fleming) antimicrobials

Dear All: (18 June addendum: the materials from the meeting are now posted!) First, planning continues apace for the 14 June Duke-Margolis workshop on non-traditional products. There is now a link for registration, confirmation that the event is going to be webcast, and a draft agenda. Mark your calendar now to attend either in person or via the webcast! Second, I would like to

14 May 2018 No Comments

IDSA’s Faces of Antimicrobial Resistance (FAOR) report

Dear All: This one appears to have been released on 7 Mar but it just crossed my desk today. In brief, IDSA has assembled 13 patient stories into a well-written and illustrated .pdf. The centerpiece of the paper is this graphical history of AMR shown below. Well done to IDSA for pulling these stories together

22 March 2017 No Comments

FDA-approved surrogate endpoints for developers

Dear All: As requested by Congress as part of the 21st Century Cures Act, the US FDA has now released for public comment a table of surrogate endpoints that can be considered for use by developers: The public docket soliciting comments is here. The web page providing an overview of surrogate endpoints and biomarkers is here. The surrogate

2 November 2018 No Comments

14 June Duke-Margolis workshop on non-traditional products: Post-meeting materials

Dear All: I wrote previously about the Duke-Margolis workshop done in collaboration with FDA on the challenges of developing non-traditional antimicrobial products. We’re now back from that workshop and I can report that it was excellent. We covered an array of strategies for non-traditional products and heard an exceptional series of company case vignettes. I’ll say that

18 June 2018 No Comments

FDA LPAD guidance + Comments on incentives in Commissioner Gottlieb’s accompanying press release!

Dear All: FDA has today released an initial draft of its guidance on LPAD (Limited Population Pathway for Antibacterial and Antifungal Drugs). You may recall that the August 2017 Guidance on Unmet Need said such a document was underway … and now we have it. In brief, it is as expected to my eye: the proposed LPAD product needs to treat

12 June 2018 No Comments

Public opinion poll (US): 70%+ agree need for government intervention addressing AMR, including support for AMR R&D

Dear All: IDSA and Research!America have worked together to conduct a broadly representative opinion poll in the United States regarding AMR. The project was supported by Pfizer and surveyed 1,004 adults in the US during October 2018. Key results: Less encouraging but probably an improvement from the past, 1/3rd of respondents thought antibiotics were effective

17 November 2018 No Comments

International Course on Antibiotics and Resistance ICARe, 11-19 Nov 2017

Dear All: FYI, see below an announcement of an 8-day intensive course in Paris in November 2017: “ICARe is designed for early career scientists – assistant professors, new industry scientists, MDs, and postdoctoral research associates – as well as members from developing areas contending with the practical challenge of managing the antibiotic resistance problem with

22 March 2017 No Comments

13-19 Nov 2017: Handle (antibiotics) with Care! — World Antibiotic Awareness Week

Dear All: This is your heads-up about next week’s World Antibiotic Awareness Week. Themed “Learn how to handle antibiotics with care,” this is the third in a series of annual WHO-driven World Antibiotic Awareness Weeks (prior ones are in this archive). I’ll confess that I had overlooked this event until I was reminded about it just

8 November 2017 No Comments

Two things: WHO’s looking GLASS + FDA’s advances with PDUFA VI

Dear All: Two things today. Unrelated, but both relevant! WHO’s GLASS: WHO’s Global Antimicrobial Resistance Surveillance System (GLASS) was created during October 2015 and seeks to obtain coordinated and consistent global estimates on resistance rates. In a major report released on 29 Jan 2018, GLASS now provides provides official national AMR data for the period 2016-17 from 40 countries

6 February 2018 No Comments

New OHE report on incentives for antibiotics

Dear All: Just hitting my inbox today is this report from OHE. The paper reviews in detail the incentive proposals in the 2016 O’Neill Report on incentives from the UK AMR Review commissioned by UK government and the 2017 GUARD Report entitled “A Call for Concerted Action on Antibiotics Research and Development” commissioned by the German government. This well-written and detailed paper is a welcome

16 May 2017 No Comments

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