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Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations.

ABSTRACT: Background:Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most discovery and early phase development for antibiotics and other drugs. This paper attempts to gather a better understanding of SMEs' targets, costs, and durations related to discovery and early phase development of antibacterial therapies. Methods:DRIVE-AB, a project focused on developing new economic incentives to stimulate antibacterial innovation, held a European stakeholder meeting in February 2015. All SMEs invited to this meeting (n?=?44) were subsequently sent a survey to gather more data regarding their areas of activity, completed and expected development costs and timelines, and business models. Results:Twenty-five companies responded to the survey. Respondents were primarily small companies each focusing on developing 1 to 3 new antibiotics, focused on pathogens of public health importance. Most have not yet completed any clinical trials. They have reported ranges of discovery and development out-of-pocket costs that appear to be less expensive than other studies of general pharmaceutical research and development (R&D) costs. The duration ranges reported for completing each phase of R&D are highly variable when compared to previously published general pharmaceutical innovation average durations. However, our sample population is small and may not be fully representative of all relevant antibiotic SMEs. Conclusions:The data collected by this study provide important insights and estimates about R&D in European SMEs focusing on antibiotics, which can be combined with other data to design incentives to stimulate antibacterial innovation. The variation implies that costs and durations are difficult to generalize due to the unique characteristics of each antibiotic project and depend on individual business strategies and circumstances.

SUBMITTER: Ardal C

PROVIDER: S-EPMC5885303 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations.

Årdal Christine C Baraldi Enrico E Theuretzbacher Ursula U Outterson Kevin K Plahte Jens J Ciabuschi Francesco F Røttingen John-Arne JA

Journal of pharmaceutical policy and practice 20180405

<h4>Background</h4>Antibiotic innovation has dwindled to dangerously low levels in the past 30 years. Since resistance continues to evolve, this innovation deficit can have perilous consequences on patients. A number of new incentives have been suggested to stimulate greater antibacterial drug innovation. To design effective solutions, a greater understanding is needed of actual antibiotic discovery and development costs and timelines. Small and medium-sized enterprises (SMEs) undertake most dis ...[more]

PMID: 29632669

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Project description:BackgroundOccupational health interventions for leaders are underrepresented in small and medium-sized enterprises (SMEs). When creating and developing effective occupational health interventions, identification of the specific needs of the target group is regarded as an essential step before planning an intervention. Therefore, the aim of this study was (1) to examine the subjectively experienced work-related stressors of leaders in small and medium-sized IT and technological services enterprises, (2) to explore coping behaviors leaders use to deal with the experienced work-related stressors, (3) to investigate resources supporting the coping process and (4) to identify potentially self-perceived consequences resulting from the experienced stressors.MethodsTen semi-structured interviews with leaders in small and medium-sized IT and technological services enterprises were conducted. The interviews were transcribed and analyzed with content-structuring qualitative content analysis in accordance to Kuckartz.ResultsLeaders in small and medium-sized IT and technological services enterprises experience various stressors caused by work organization as well as industry-related stressors and other work-related stressors. To address the experienced stressors, leaders apply problem focused coping behaviors (e.g. performing changes on structural and personal level), emotional focused coping behaviors (e.g. balancing activities, cognitive restructuring) as well as the utilization of social support. Helpful resources for the coping process include organizational, social and personal resources. As a result of the experienced work-related stressors, interviewees stated to experience different health impairments, negative effects on work quality as well as neglect of leisure activities and lack of time for family and friends.ConclusionThe identified experienced work-related stressors, applied coping behaviors, utilized resources and emerging consequences underpin the urgent need for the development and performance of health-oriented leadership interventions for leaders in small and medium- sized IT and technological services. The results of this study can be used when designing a target-oriented intervention for the examined target group.

Dataset Information

Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations.

Publications

Insights into early stage of antibiotic development in small- and medium-sized enterprises: a survey of targets, costs, and durations.

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