R&D Insight Archives • Page 4 of 31 • AMR.Solutions

Vaccines for AMR / A major review of R&D opportunities

Dear All: Just released is a substantial report commissioned by Wellcome Trust entitled “Vaccines to tackle drug-resistant infections: An evaluation of R&D opportunities.” The full .pdf is here. The associated website is worth exploring. In particular, there is an interactive tool that allows you to explore the parameters used to calculate relative priorities. As you probably already know, vaccines are an important

9 October 2018 No Comments

The hunt for oral antibiotics: Beyond Lipinski’s Rule of Five

Dear All: Given our collective interest in finding oral antibiotics, a recent article in J Med Chem on the evolution of our understanding of Lipinski’s Rule of 5 (Ro5) prompts me today to share it along with a recent webinar and links to both Lipinski’s original paper as well as his 2016 commentary: The original

8 October 2018 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

NICE-ABPI Masterclass: Using non-randomised data to estimate treatment effects in NICE submissions

For those based in Boston, please look closely at the future meetings list: a 7 Dec 2018 BAARN meeting date has been announced. Dear All: On 21 Nov 2018, the Decision Support Unit (DSU) of UK NICE and the ABPI are sponsoring a one-day workshop entitled “NICE/DSU/ABPI Masterclass: Using non-randomised data to estimate treatment effects

20 September 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

Pew’s SPARK goes live / FDA on Master Protocols and Adaptive Designs / CDC’s Fungal Awareness Week

Dear All: Potpourri! Four things of note… First, Pew’s SPARK (Shared Platform for Antibiotic Research and Knowledge) has now gone live. Seeking to address a core issue in Pew’s Scientific Roadmap for Antibiotic Discovery, SPARK is a cloud-based sharing tool for data on how molecules enter and stay inside of Gram-negative bacteria. To learn more, mark your calendar

2 October 2018 No Comments

UK Antibiotic Subscription Pilot implies Pull Incentive of up to $4b across the G20

Note that there is a follow-up newsletter that covers a post-webinar FAQ. After reading this newsletter as introduction, please go here for the follow-up newsletter. Dear All (and with thanks to Kevin Outterson for co-authoring this newsletter), Prior newsletters have covered the antibiotic evaluation procurement pilot being run by NICE and NHS England (go here for the

29 March 2020 No Comments

7 Nov 2017 FDA VRBPAC: Clinical development plan for a S. aureus vaccine (Part 1 of 3)

Addendum: This is the first in a 3-newsletters series on this topic. Go here and here for the next two newsletters. Finally, the results of the STRIVE trial have been published as Hassanzadeh et al. in Clinical Infectious Diseases, ciad218, https://doi.org/10.1093/cid/ciad218. Dear All: I just learned that FDA’s Vaccines and Related Biological Products Committee (VRBPAC) will meet at

19 October 2017 No Comments

7 Nov 2017 FDA VRBPAC: Pfizer’s S. aureus vaccine — do results in one population generalize? (Part 2 of 3)

Addendum: This is the second in a 3-newsletters series on this topic. Go here for the first newsletter and here for the final newsletter. Finally, the results of the STRIVE trial have been published as Hassanzadeh et al. in Clinical Infectious Diseases, ciad218, https://doi.org/10.1093/cid/ciad218. Dear All: I wrote on 19 Oct 2017 about the meeting on 7 Nov 2017

5 November 2017 No Comments

Summary of funding initiatives (Simpkin et al.) + E9(R1) Statistical methods update (FDA)

Dear All: Two updates today. First, our colleagues at London School of Economics have just published a review of antibiotic innovation incentives that includes a detailed review of some of the currently available sources of funding (Simpkin VL et al., Incentivising innovation in antibiotic drug discovery and development: progress, challenges and next steps. J Antibiot, 1 Nov 2017). As

1 November 2017 No Comments

AMR.Solutions

R&D Insight