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
Dear All: On Wednesday 6 Sep at the ASM-ESCMID Conference on Antibacterial Development, we heard 3 superb back-to-back talks on the evolving regulatory and health technology assessment (HTA) landscape. The speakers (Marco Cavaleri, PhD, Head of Anti-Infectives and Vaccines, EMA; Sumati Nambiar, MD, Director, Division of Anti-infective Products, FDA; and Colm Leonard, MD, Consultant Clinical Adviser,
Dear All: We had hints back in January that this was coming (see this post), but now it is really happening! In brief, UK’s NHS will test the world’s first subscription-style payment model in which payments delinked from volume are used to incentivise pharmaceutical companies to develop new drugs for resistant infections. Below my signature, I’ve
Dear All: Dated 19 Dec 2018 and marked as released for public consultation on 14 Jan 2019, EMA has posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I have not yet had a chance to study in detail and will
Dear All: I wrote previously that EMA posted an extensively updated and consolidated version of their previously separate Guideline (CPMP/EWP/558/95 Rev.2) and Addendum (EMA/CHMP/351889/2013) documents into a single draft antibacterial guidance document. I’ve now had a chance to read it in detail and thought I would share my thoughts as a way to provoke discussion. As a reminder, the
Dear All: I’ve written a lot about the need for pull incentives, preferably delinked (some papers to read, comments by TATFAR, highlights from Davos 2018, and the UK commits to trying delinkage). Now, I am delighted to report that a really serious effort is underway in the US to make something happen during the 116th Congress. The essential document can be
Dear All: Two links to share today. First, we have a report to the UK House of Commons by their Health and Social Care Committee. This is a well-written summary of the core problem, the economic challenge for pharma, and the varied issues around resistance in human health, animal health, and the environment. Relevant to this community, we
Dear All: Recently announced is a new EU Joint Action on Antimicrobial Resistance (AMR) & Health-Care Associated Infections (HCAI). Its acronym is EU-JAMRAI and the website is https://eu-jamrai.eu/. Joint actions are a common tool for coordinating implementation activities across Europe. EU-JAMRAI actually started in September 2017 and will run for three years but it is really
Dear All: Also appearing today are two valuable opportunities to comment on key global strategy documents. I do hope each of you can make time to look at these materials and consider sending in your thoughts — it really does make a difference when central leadership groups hear from a broad array of stakeholders! First, EMA has
Dear All: Wow! It’s happened! As reported this morning in The Times and The Guardian among others, the UK will announce at Davos that it is committing to a 20-year vision and initial 5-year plan to combat AMR. The plan includes actions to reduce infection rates, to reduce antibiotic use, and most importantly for this audience to find a path to delinked