Why is it hard to terminate failing projects in pharmaceutical R&amp;D?

Peck, Richard; Lendrem, Dennis; Grant, Iain; Lendrem, B. Clare; Isaacs, John D.

doi:10.1038/nrd4725

Cited by 50 publications

(29 citation statements)

References 5 publications

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“…Some reported models focus on use of non-clinical or translational data to improve predictions of safety (Bowes et al, 2012) or efficacy (Dolgos et al, 2016). Others focus on target-centric approaches, particularly for new biological entities (Swinney and Anthony, 2011), more rapid paths to clinical proof-of-concept (Owens et al, 2015), or attempts to identify candidates for early termination, i.e., before the most expensive late-stage clinical development starts (Peck et al, 2015), or more systematic portfolio review to systematically challenge development candidates (Cook et al, 2014). Of note, risk mitigation is not only an important topic for the pharmaceutical industry but also in academic drug discovery (Dahlin et al, 2015).…”

Section: Introductionmentioning

confidence: 99%

Opportunities and Challenges for Drug Development: Public–Private Partnerships, Adaptive Designs and Big Data

Yildirim

Gottwald

Schüler³

et al. 2016

Front. Pharmacol.

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Drug development faces the double challenge of increasing costs and increasing pressure on pricing. To avoid that lack of perceived commercial perspective will leave existing medical needs unmet, pharmaceutical companies and many other stakeholders are discussing ways to improve the efficiency of drug Research and Development. Based on an international symposium organized by the Medical School of the University of Duisburg-Essen (Germany) and held in January 2016, we discuss the opportunities and challenges of three specific areas, i.e., public–private partnerships, adaptive designs and big data. Public–private partnerships come in many different forms with regard to scope, duration and type and number of participants. They range from project-specific collaborations to strategic alliances to large multi-party consortia. Each of them offers specific opportunities and faces distinct challenges. Among types of collaboration, investigator-initiated studies are becoming increasingly popular but have legal, ethical, and financial implications. Adaptive trial designs are also increasingly discussed. However, adaptive should not be used as euphemism for the repurposing of a failed trial; rather it requires carefully planning and specification before a trial starts. Adaptive licensing can be a counter-part of adaptive trial design. The use of Big Data is another opportunity to leverage existing information into knowledge useable for drug discovery and development. Respecting limitations of informed consent and privacy is a key challenge in the use of Big Data. Speakers and participants at the symposium were convinced that appropriate use of the above new options may indeed help to increase the efficiency of future drug development.

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Section: Introductionmentioning

confidence: 99%

Opportunities and Challenges for Drug Development: Public–Private Partnerships, Adaptive Designs and Big Data

Yildirim

Gottwald

Schüler³

et al. 2016

Front. Pharmacol.

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“…In this paper we argue that the termination of innovation projects (although the projects themselves can be considered as failures) is a laudable management practice and an effective detection of such failures is necessary to avoid waste of time and high costs in continuing projects. Thus, firms can prevent overspending on innovation, which the literature found to be correlated with innovation project termination [6], [17]- [19]. In sum, this paper advocates for termination of a project as a valuable learning opportunity and a proper way of handling less promising innovation projects.…”

Section: Introductionmentioning

confidence: 85%

Pulling the Plug? Investigating Firm-Level Drivers of Innovation Project Termination

Vaculik

Lorenz

Roijakkers

et al. 2019

IEEE Trans. Eng. Manage.

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Firms need to innovate and develop dynamic capabilities to create a sustainable competitive advantage. Due to this pressure, firms in high-tech industries invest a high percentage of their revenues in innovation. Despite the vast number of innovation success stories, only one in five innovation projects reach the market. It is important to understand the drivers of project termination as many firms make sizable investments in innovation and these drivers may have a significant impact on their innovation performance. Therefore, earlier recognition of unfeasible projects would avoid continued investment and release resources that could be invested in more profitable projects. This paper investigates firm-level factors influencing the termination of innovation projects based on a sample of 4,385 firms in the Czech Republic and Germany. We find that firm size, R&D activities, organisational agility, and the level of internationalisation are positively associated with innovation project termination. Surprisingly, marketing innovation is also positively associated with project termination. Our results contribute to an improved understanding of why some firms are better at identifying unsuccessful projects (earlier) than others. Identifying generalizable factors provides complementary insights into project-level factors of project termination that can have a remarkable impact on the profitability and survival of firms.

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“…In a recent article, Richard Peck et al . made a strong case that promoting “truth‐seeking” rather than “progression‐seeking” behavior would increase R&D success by learning more in early clinical development. Peck et al .…”

Section: Commentarymentioning

confidence: 99%

Take Care of the Fast‐in‐Human Study

Hoogdalem¹

2017

Clinical Translational Sci

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Why is it hard to terminate failing projects in pharmaceutical R&D?

Abstract: 'Quick-kill' strategies in pharmaceutical research and development aim to reduce late-stage attrition by bringing project termination decisions forward, to an earlier point in the process. How can the barriers to implementing such strategies be overcome?

Cited by 50 publications

References 5 publications

Opportunities and Challenges for Drug Development: Public–Private Partnerships, Adaptive Designs and Big Data

Opportunities and Challenges for Drug Development: Public–Private Partnerships, Adaptive Designs and Big Data

Pulling the Plug? Investigating Firm-Level Drivers of Innovation Project Termination

Take Care of the Fast‐in‐Human Study

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