NIMble innovation—a networked model for public antibiotic trials

Abstract

Antibiotic research and development is at an inflection point. Faced with ongoing problems with commercial innovation, we argue for a networked public approach to support and coordinate existing research and development initiatives by sustainably moving promising compounds through clinical trials. We propose a global public infrastructure of institutes tasked with (1) conducting all trial stages up to market authorisation, including small-scale compound production; (2) negotiating licensing agreements for global production and distribution by industry partners; and (3) using public purchasing agreements or subscription models to ensure commercially viable drug production at equitable prices. We invite stakeholders to consider our Networked Institute Model's benefits for unblocking the public and private antibiotic pipeline.

On the momentum toward vaccine self-sufficiency in the BRICS: an integrative review of the role of pharmaceutical entrepreneurship and innovation

“…Another innovative technology introduced into the drug manufacturing processes in the BRICS is continuous manufacturing optimization technologies ( 26 , 30 , 47 ). For example, microfluidic droplet generators are emerging Microstructured elements that optimize and tailor the drug manufacturing process equipment down to an ideal scale.…”

Sale of UK’s Vaccine Manufacturing and Innovation Centre

“…Situated at the intersection of public and private research and providing a vital bridging function for both, the centre offers a cost effective way to retain and adapt staff and skills to meet current and future threats. Its ability to rapidly produce enough promising products for phase II and III clinical trials without lengthy negotiations with external investors and manufacturers could greatly accelerate vaccine development in the UK and serve as a model for public infrastructure investment in other global health challenges such as antibiotic innovation 9…”

“…Its ability to rapidly produce enough promising products for phase II and III clinical trials without lengthy negotiations with external investors and manufacturers could greatly accelerate vaccine development in the UK and serve as a model for public infrastructure investment in other global health challenges such as antibiotic innovation. 9 Worryingly, statements by the Department of Business, Energy and Industrial Strategy (BEIS), which oversaw the substantial public investment in the VMIC, indicate that the UK government is distancing itself from the centre and its sale, with little explanation or transparency. 1 10 Meanwhile, bidders-which include Oxford Biomedica, Fuji Film, and the Lonza Group-are relative unknowns in vaccine development.…”

The UK Antimicrobial Resistance Strategy 2013–18: A Qualitative Study of International and Domestic Policy and Action Related to Livestock and the Food Chain

“…Though still patchy and not always conclusive, evidence is growing about the increase in resistance and the links between use of antimicrobials in animal and plant health and potential effects in human health (Dutil et al, 2010;Capita and Alonso-Calleja, 2013;Hollis and Ahmed, 2014;Liu et al, 2016;Meis et al, 2016;Yoon et al, 2018). In response, governments and organizations around the world are developing policies to optimize the use of antibiotics, for example, through improving diagnoses, reducing the use of broad-spectrum antimicrobials, and limiting the use of the most important antimicrobials [ (Shallcross et al, 2015;Laxminarayan et al, 2016;Mueller and Ostergren, 2016;Podolsky, 2018;Glover et al, 2021;Overton, 2021; see also EMA, 2019) for the European Medicines Agency (EMA) updated categorization of antibiotics].…”