Dear All (with thanks to Kevin Outterson for leading this note), HUGE news today: Senator Michael F. Bennet and Senator Todd Young have introduced an updated PASTEUR Act that (if enacted) would create a predictable path to rewarding new #FireExtinguishersOfMedicine for their value to society via a subscription contract (valued at $750m to $3b) that prepays
Dear All, The US Department of Defense (DoD) is offering funds through the Small Business Innovation Research (SBIR) program for a “Novel Antibiotic for the Treatment of Multidrug-Resistant Pseudomonas Aeruginosa Infections.” Antibody, phage, and vaccine approaches are out of scope and the business must be located in the United States. To find the funding offer, navigate
Dear All, I think the importance of this is self-explanatory (go here for the .pdf information pack): “The Department of Health and Social Care is seeking to make 6 appointments to the Advisory Committee on Antimicrobial Prescribing, Resistance and Healthcare Associated Infections (ARPHAI). ARPHAI is a UK-wide, independent, non-executive advisory committee, which provides practical and scientific advice
Dear All, See below my signature: A 6-month consultancy with WHO to support the the SECURE initiative, a program to assist countries in accessing and sustainably managing new and existing antibiotics needed to cope with antimicrobial resistance (AMR). There’s not much online (yet) about SECURE: the best description I can find is in the Terms of Reference
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
Dear All, Kevin Outterson and I recently shared our analysis of the NICE/NHS England pilot of an antibiotic procurement subscription model (link to that newsletter). The NICE/NHS team have now released a post-webinar FAQ document. Here is the link to the document … and I’ve also added the link to the initial webpage (cited just above) discussing
Dear All, This email was just today received from the team leading the NHS England antibiotic procurement project (go here for a prior newsletter describing the project): Dear Stakeholders, In November 2019, we held a stakeholder webinar to share our response to the comments raised in targeted engagement and to outline proposals for the procurement process.
Dear All, And now for a change from our usually scheduled content! As you might expect, major agencies in the US (FDA, BARDA, NIAID) and Europe (EMA, EC, national agencies) are actively supporting the global R&D response to COVID-19. In addition, global consortia are appearing and BioCentury has provided both a newsletter on this as well
Dear All: The attached EU Parliament resolution on Access to Medicines was released today. Broadly, it calls for greater transparency in price setting for medicines and for harmonization of HTA processes. Along the way, AMR gets a couple of specific mentions as does the Adaptive Pathway concept that provides some of the logic behind registering antibiotics with
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