Dear All, First up today is a very interesting new workshop from FDA on 1-2 Sep entitled “Advancing the Development of Pediatric Therapeutics (ADEPT 7) Complex Innovative Trial Design.” In brief: “The Complex Innovative Trial Design Pilot Meeting Program (CID Program) facilitates and advances the use of complex and innovative trial designs that have the potential
Dear All, Two brief items today: First, a survey on OneHealth research priorities from WHO/FAO/OIE: “The Tripartite collaboration between World Health Organization (WHO), Food and Agricultural Organization of the United Nations (FAO), and World Organization for Animal Health (OIE)) is joining efforts to develop a One Health priority research agenda on antimicrobial resistance (AMR). “This
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
Dear All, Quick note today as I am both exhausted and exhilarated by having listened to the all-day FDA Advisory committee on the Pfizer/BioNTech COVID vaccine: There is more to learn (the timelines are unlike anything you’ve ever seen before and include a Phase 1-2-3 trial design!!), but the efficacy is impressive and the risk/benefit
Dear All, WHO have been thinking about the threat of resistant fungi as well as resistant bacteria. An initial discussion by a small working group on approaches to priority fungal pathogens (April 2020, here’s the link to the report) concluded that Candida auris; azole-resistant Candida spp., azole-resistant Aspergillus fumigatus, Cryptococcus neoformans (& C. gattii), Pneumocystis jirovecii, Mucorales, and potentially Histoplasmosis were
Dear All, The Drug-Resistant Infections team at Wellcome Trust (link to their homepage) has launched a survey collecting data on current prescribing practices in low-, middle-, and high-income countries. The survey takes about 15 minutes and seeks answers to these questions: Does the WHO Pathogen Priority List (PPL, link), published in 2015, accurately reflect current pathogen
Dear All: As you will hopefully recall from November 2019, Theuretzbacher et al. published a review of the preclinical pipeline that summarized data on 407 companies active in the preclinical R&D space during the window Sep 2016 through 1 May 2019. Go here for the newsletter about that paper and go here for my master summary
Dear All, As you know, WHO has been driving a series of clinical and preclinical pipeline reviews (go here for my current master list of pipeline reviews, including links to the 2017 and 2019 WHO reviews). In support of the next iteration of this review process, WHO have now posted (go here) a Geneva-based consultancy
Dear All, Two fascinating job opportunities have appeared. Even if you’re not looking for a job, the job descriptions tell you a lot about things going on below the surface: A role at the Associate or Full Professor level in Singapore The National University of Singapore is looking to appoint a Director for an innovative
Dear All, WHO today published a Request for Proposals (RFP) for a consultant to develop an online e-learning course on antimicrobial stewardship! There is a mention of the request on the WHO AMR homepage (link) which in turn takes you to the extended details in this Terms of Reference document (link). In brief, the project