Open Source Drug Discovery in Practice: A Case Study

Background: Open source drug discovery offers potential for developing new and inexpensive drugs to combat diseases that disproportionally affect the poor. The concept borrows two principle aspects from open source computing (i.e., collaboration and open access) and applies them to pharmaceutical innovation. By opening a project to external contributors, its research capacity may increase significantly. To date there are only a handful of open source R&D projects focusing on neglected diseases. We wanted to learn from these first movers, their successes and failures, in order to generate a better understanding of how a much-discussed theoretical concept works in practice and may be implemented. Methodology/Principal Findings: A descriptive case study was performed, evaluating two specific R&D projects focused on neglected diseases. CSIR Team India Consortium's Open Source Drug Discovery project (CSIR OSDD) and The Synaptic Leap's Schistosomiasis project (TSLS). Data were gathered from four sources: interviews of participating members (n = 14), a survey of potential members (n = 61), an analysis of the websites and a literature review. Both cases have made significant achievements; however, they have done so in very different ways. CSIR OSDD encourages international collaboration, but its process facilitates contributions from mostly Indian researchers and students. Its processes are formal with each task being reviewed by a mentor (almost always offline) before a result is made public. TSLS, on the other hand, has attracted contributors internationally, albeit significantly fewer than CSIR OSDD. Both have obtained funding used to pay for access to facilities, physical resources and, at times, labor costs. TSLS releases its results into the public domain, whereas CSIR OSDD asserts ownership over its results. Conclusions/Significance: Technically TSLS is an open source project, whereas CSIR OSDD is a crowdsourced project. However, both have enabled high quality research at low cost. The critical success factors appear to be clearly defined entry points, transparency and funding to cover core material costs

A case study on Staphylococcus aureus bacteraemia: available treatment options, antibiotic R&D and responsible antibiotic-use strategies

Abstract Objectives This case study addresses: (i) antibiotic treatment options for Staphylococcus aureus bacteraemia (SAB), for both empirical and targeted therapy; (ii) the current status of and priorities for the antibiotic pipeline to ensure access of effective antibiotics for SAB; and (iii) strategies for responsible antibiotic use relevant to the clinical management of SAB. Methods Evidence to address the aims was extracted from the following information sources: (i) EUCAST and CLSI recommendations, summaries of product characteristics (SPCs), antibiotic treatment guidelines and the textbook Kucers' The Use of Antibiotics; (ii) the www.clinicaltrial.gov database; and (iii) quality indicators for responsible antibiotic use. Results Current monotherapy treatment options for SAB include only three drug classes (β-lactams, glycopeptides and lipopeptides), of which two also cover MRSA bacteraemia (glycopeptides and lipopeptides). The analysis of the antibiotic pipeline and ongoing clinical trials revealed that several new antibiotics with S. aureus (including MRSA) coverage were developed in the past decade (2009–19). However, none belonged to a new antibiotic class or had superior effectiveness and their added clinical value for SAB remains to be proven. Responsible antibiotic use for the treatment of SAB was illustrated using 11 quality indicators. Conclusions Awareness of the problem of a limited antibiotic arsenal, together with incentives (e.g. push incentives), is needed to steer the R&D landscape towards the development of novel and effective antibiotics for treating SAB. In the meantime, responsible antibiotic use guided by quality indicators should preserve the effectiveness of currently available antibiotics for treating SAB

Promoting resilience in medicine supply chains:An exploration of the role of contracting

Research on supply chain resilience identifies strategies and underlying capabilities for responding to disruptions, including sourcing strategies. However, we still know little about how contracting decisions, specifically, influence resilience. We explore the role of contracting through a qualitive case study of medicine procurement in the English National Health Service. We find that tendering and contracting practices tend to promote resilience based on redundancy, rather than on adaptive capabilities to cope with unforeseen disruptions. We extend prior research by positioning contracting interventions into the emerging discourse over the engineering and ecological perspectives on supply chain resilience

The effect of generic market entry on antibiotic prescriptions in the United States

Acknowledgements C.K. and C.Å. were funded by the DRIVE-AB Consortium. DRIVE-AB is supported by the IMI Joint Undertaking under the DRIVE-AB grant agreement number 115618, the resources of which are composed of financial contributions from the European Union’s Seventh Framework Programme and the European Federation of Pharmaceutical Industries and Associations companies’ in-kind contribution. C.K. and C.Å. were partly supported by the Research Council of Norway through the Global Health and Vaccination Programme (GLOBVAC), project number 234608. K.O. is supported by NOA 06-IDSET160030 from the Biomedical Advanced Research and Development Authority (BARDA) under the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services, and the CARB-X award from the Wellcome Trust, but the views expressed herein are not necessarily those of CARB-X or any CARB-X funder. J.H. works for Health Services Research Unit, University of Aberdeen, and is core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates. R.L. was supported by 16IPA16092427 from the US Centers for Disease Control and Prevention. The funder provided support in the form of salaries for authors, according to the statement above, but did not have any additional role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.Peer reviewedPublisher PD

Introduction and Geographic Availability of New Antibiotics Approved Between 1999 and 2014

Despite the urgent need for new, effective antibiotics, few antibiotics of value have entered the market during the past decades. Therefore, incentives have been developed to stimulate antibiotic R&D. For these incentives to be effective, geographic availability for recently approved antibiotics needs to be better understood. In this study, we analyze geographic availability and market introduction of antibiotics approved between 1999 and 2014

Supply chain risk management strategies in normal and abnormal times:Policymakers’ role in reducing generic medicine shortages

Purpose – This paper links supply chain risk management to medicine supply chains to explore the role ofpolicymakers in employing supply chain risk management strategies (SCRMS) to reduce generic medicineshortages.Design/methodology/approach – Using secondary data supplemented with primary data, the authors mapand compare seven countries’ SCRMS for handling shortage risks in their paracetamol supply chains beforeand during the first two waves of the COVID-19 pandemic.Findings – Consistent with recent research, the study finds that policymakers had implemented few SCRMSspecifically for responding to disruptions caused by COVID-19. However, shortages were largely avoided sincemultiple strategies for coping with business-as-usual disruptions had been implemented prior to the pandemic.The authors did find that SCRMS implemented during COVID-19 were not always aligned with thoseimplemented pre-pandemic. The authors also found that policymakers played both direct and indirect roles.Research limitations/implications – Combining longitudinal secondary data with interviews sheds lighton how, regardless of the level of preparedness during normal times, SCRMS can be leveraged to avertshortages in abnormal times. However, the problem is highly complex, which warrants further research.Practical implications – Supply chain professionals and policymakers in the healthcare sector can use thefindings when developing preparedness and response plans.Social implications – The insights developed can help policymakers improve the availability of high-volumegeneric medicines in (ab)normal times.Originality/value – The authors contribute to prior SCRM research in two ways. First, the authorsoperationalize SCRMS in the medicine supply chain context in (ab)normal times, thereby opening avenues forfuture research on SCRM in this context. Second, the authors develop insights on the role policymakers playand how they directly implement and indirectly influence the adoption of SCRMS. Based on the study findings,the authors develop a framework that captures the diverse roles of policymakers in SCRM

Common characteristics of open source software development and applicability for drug discovery: a systematic review

<p>Abstract</p> <p>Background</p> <p>Innovation through an open source model has proven to be successful for software development. This success has led many to speculate if open source can be applied to other industries with similar success. We attempt to provide an understanding of open source software development characteristics for researchers, business leaders and government officials who may be interested in utilizing open source innovation in other contexts and with an emphasis on drug discovery.</p> <p>Methods</p> <p>A systematic review was performed by searching relevant, multidisciplinary databases to extract empirical research regarding the common characteristics and barriers of initiating and maintaining an open source software development project.</p> <p>Results</p> <p>Common characteristics to open source software development pertinent to open source drug discovery were extracted. The characteristics were then grouped into the areas of participant attraction, management of volunteers, control mechanisms, legal framework and physical constraints. Lastly, their applicability to drug discovery was examined.</p> <p>Conclusions</p> <p>We believe that the open source model is viable for drug discovery, although it is unlikely that it will exactly follow the form used in software development. Hybrids will likely develop that suit the unique characteristics of drug discovery. We suggest potential motivations for organizations to join an open source drug discovery project. We also examine specific differences between software and medicines, specifically how the need for laboratories and physical goods will impact the model as well as the effect of patents.</p

Antibiotic research and development: business as usual?

This article contends that poor economic incentives are an important reason for the lack of new drugs and explains how the DRIVE-AB intends to change the landscape by harnessing the expertise, motivation and diversity of its partner

A one health framework to estimate the cost of antimicrobial resistance

Abstract Objectives/purpose The costs attributable to antimicrobial resistance (AMR) remain theoretical and largely unspecified. Current figures fail to capture the full health and economic burden caused by AMR across human, animal, and environmental health; historically many studies have considered only direct costs associated with human infection from a hospital perspective, primarily from high-income countries. The Global Antimicrobial Resistance Platform for ONE-Burden Estimates (GAP-ON€) network has developed a framework to help guide AMR costing exercises in any part of the world as a first step towards more comprehensive analyses for comparing AMR interventions at the local level as well as more harmonized analyses for quantifying the full economic burden attributable to AMR at the global level. Methods GAP-ON€ (funded under the JPIAMR 8th call (Virtual Research Institute) is composed of 19 international networks and institutions active in the field of AMR. For this project, the Network operated by means of Delphi rounds, teleconferences and face-to-face meetings. The resulting costing framework takes a bottom-up approach to incorporate all relevant costs imposed by an AMR bacterial microbe in a patient, in an animal, or in the environment up through to the societal level. Results The framework itemizes the epidemiological data as well as the direct and indirect cost components needed to build a realistic cost picture for AMR. While the framework lists a large number of relevant pathogens for which this framework could be used to explore the costs, the framework is sufficiently generic to facilitate the costing of other resistant pathogens, including those of other aetiologies. Conclusion In order to conduct cost-effectiveness analyses to choose amongst different AMR-related interventions at local level, the costing of AMR should be done according to local epidemiological priorities and local health service norms. Yet the use of a common framework across settings allows for the results of such studies to contribute to cumulative estimates that can serve as the basis of broader policy decisions at the international level such as how to steer R&D funding and how to prioritize AMR amongst other issues. Indeed, it is only by building a realistic cost picture that we can make informed decisions on how best to tackle major health threats