R&D Insight Archives • Page 25 of 36 • AMR.Solutions

New economic models for antibiotics: Are we there yet? No, but we ARE on the road

Dear All, The Duke-Margolis team hosted an excellent full-day workshop on 16 Jan 2020. Entitled “Exploring Opportunities to Reform Antimicrobial Payment and Post-Market Incentives” and chaired by Mark McClellan, the workshop’s outstanding cast of presenters and discussants provided a thorough discussion of both the need for new payment models and and the many ongoing activities focused

20 January 2020 No Comments

Japan’s antibacterial R&D landscape / Japan calls for Pull incentives

Dear All: Late last year, I had the opportunity to hear a presentation on antibiotic R&D in Japan by Norio Ohmagari. Based in Tokyo at the National Center for Global Health and Medicine Hospital (link), Norio is Director of its (i) AMR Clinical Reference Center, (ii) Disease Control and Prevention Center, and (iii) WHO Collaborating

11 January 2020 No Comments

NIAID to fund a Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB)

Dear All, Warm up your chemistry set! NIAID has just released a pre-solicitation notice of their intent to request applications for a new NIAID contract intended to establish an innovative Chemistry Center for Combating Antibiotic-Resistant Bacteria (CC4CARB). NIAID anticipates awarding a single CC4CARB contract funding 28,000 direct labor hours per year for up to 5 years. The core

3 January 2020 No Comments

2020 US Federal Funding Bill boosts support for AMR

Dear All, On Friday, 20 Dec 2020, legislation was signed to fund the US government through Sep 2020. Relevant to AMR: The bill provides a $50 million increase in funding to NIAID for antimicrobial resistance. NIAID will also have to report to Congress on the success rate for these particular grants. The bill provides funding for

22 December 2019 No Comments

Two research calls: FDA (rabbit VAP models) and JPIAMR (aquatic pollutants)

Dear All, Two important new research calls are now out. First, FDA is offering research funding of up to $1m to support creation of rabbit models of ventilator-associated bacterial pneumonia (VAP or VABP, depending on your preferred abbreviation) due to carbapenem-resistant strains of A. baumannii and P. aeruginosa. The call for proposals is via FDA Broad Agency Announcement (FDABAA-20-00123N, link), an ongoing

22 December 2019 No Comments

NIAID/DMID seeks contract proposals for AMR / 9 Apr 2020 deadline

Dear All, As part of a NIAID Omnibus Broad Agency Announcement (BAA) posted on 31 Dec 2019, NIAID’s Division of Microbiology and Infectious Diseases (DMID, link) has three research areas (RAs) soliciting contract proposals for preclinical and clinical development of vaccines, therapeutic, and diagnostics for microbial pathogens. The entire BAA can be found here. The three RAs

7 January 2020 No Comments

Melinta, Part 2 / Bankruptcy is not the end / Post-approval costs for an antibiotic

Dear All, I realized after sending the note about Melinta’s bankruptcy that I’d failed to be clear on what comes next for the company. (If you missed it, you can go here for a copy of that prior note.) In brief, a 27 Dec 2019 press release (link) states that the bankruptcy filing exchanges $140 million of secured claims

7 January 2020 No Comments

Benefit-Risk analyses: Gassman et al. (NEJM) + FDA

Dear All: An article by Gassman, Nguyen, and Joffe in today’s NEJM entitled “FDA regulation of prescription drugs” caught my eye because of its emphasis on structured benefit-risk (B-R) analyses as a core part of regulatory thinking. See links below along with the core paper from the FDA’s website on benefit-risk (oddly, the NEJM paper is not

16 February 2017 No Comments

Ways to talk about AMR / Powerful new insights into messages that do (and do NOT) work

Dear All: Verbatim comments from interviews with 12,000 people in Germany, India, Japan, Kenya, the UK, the USA and Thailand: India: “[Antimicrobial resistance] is quite normal, no big thing, like malaria. It’s on a personal level, if you take antibiotics, your resistance will be on [the] lower side. If you are fit, your body resistance is more.” Germany: “Air pollution

30 October 2019 No Comments

Funding, Filing, and Finance: Most current update of this lecture

Dear All: I had the opportunity today to share an updated version of my “Funding, Filing, and Finance” talk with the attendees of Superbugs & Superdrugs in London. Topics covered were: Funding: What are the global initiatives? Where can you find information on how you could apply? Filing: What are the must-read background documents for developers? What

19 March 2019 No Comments

AMR.Solutions

R&D Insight