Improving R&amp;D productivity

Śmietana, Katarzyna; Ekstrom, L.B.; Jeffery, Barbara; Møller, Martin

doi:10.1038/nrd4650

Cited by 28 publications

(15 citation statements)

References 2 publications

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“…Drug discovery and development is an extremely challenging, lengthy and expensive endeavour with an unsustainable success rate12. Understanding the ligandability of a target protein remains a central challenge for early small molecule drug discovery programmes3.…”

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confidence: 99%

Prioritizing multiple therapeutic targets in parallel using automated DNA-encoded library screening

et al. 2017

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The identification and prioritization of chemically tractable therapeutic targets is a significant challenge in the discovery of new medicines. We have developed a novel method that rapidly screens multiple proteins in parallel using DNA-encoded library technology (ELT). Initial efforts were focused on the efficient discovery of antibacterial leads against 119 targets from Acinetobacter baumannii and Staphylococcus aureus. The success of this effort led to the hypothesis that the relative number of ELT binders alone could be used to assess the ligandability of large sets of proteins. This concept was further explored by screening 42 targets from Mycobacterium tuberculosis. Active chemical series for six targets from our initial effort as well as three chemotypes for DHFR from M. tuberculosis are reported. The findings demonstrate that parallel ELT selections can be used to assess ligandability and highlight opportunities for successful lead and tool discovery.

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confidence: 99%

Prioritizing multiple therapeutic targets in parallel using automated DNA-encoded library screening

et al. 2017

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“…The benefits of making quality choices have the potential of influencing all stakeholders, and interestingly decision making has recently been linked to improving R&D productivity within pharmaceutical companies. 12 This study investigated and identified the diversity of current agency and company practices and perspectives regarding making quality decisions as well as measuring of the quality of the decision making.…”

Section: Discussionmentioning

confidence: 99%

Quality of Regulatory Decision-Making Practices: Issues Facing Companies and Agencies

Bujar

McAuslane

Salek

et al. 2016

Ther Innov Regul Sci

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The findings of this study support the need to further characterize and assess the practices and behaviors of individuals and organizations. Furthermore, the barriers, mainly relating to the influence of biases, should be addressed by developing the general principles of a formal quality decision framework and identifying quality decision-making practices in order to ensure that structured decisions are made throughout the life cycle of medicines.

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“…It would also be of value to involve other organisations, including smaller companies or agencies from emerging markets with less established systems, to determine how QDMPs are built into those organisations, compared with larger companies and agencies. 23 This could in turn help improve the productivity of companies and ensure agencies are not only undertaking a good-quality review or appraisal but are also making sure their decisions are consistent and transparent.…”

Section: Next Steps For Improving the Practices Of Individuals And Ormentioning

confidence: 99%

A Process for Evaluating Quality Decision-Making Practices During the Development, Review and Reimbursement of Medicines

Bujar

McAuslane

Walker

et al. 2020

Int J Health Policy Manag

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Background: The development of a medicine is not only underpinned by good science but also by Quality DecisionMaking Practices (QDMPs). Indeed, it is important to ensure that all organisations involved in the lifecycle of medicines are aligning their practices in decision-making to the QDMPs to ensure quality, transparent and consistent decisionmaking processes. Methods: The aim of this study was to evaluate the practicality of QoDoS (Quality of Decision-Making Orientation Scheme) in assessing the incorporation of ten QDMPs during the development, review and reimbursement of medicines, illustrated by case studies with a pharmaceutical company, a regulatory authority and a health technology assessment (HTA) agency. Individuals from each organisation completed the 47-item QoDoS questionnaire. Results: The results demonstrate the applicability of QoDoS in identifying favourable and unfavourable practices and in assessing the consistency and transparency of the QDMPs within each organisation, as well as across the different stakeholders. Furthermore, the study established the value of the methodology in raising awareness of the biases and best practices in decision-making, as well as having a basis for discussion for differences within and across stakeholders to promote consistency and alignment in decision-making. Finally, the QoDoS demonstrated the need for improvement across a number of decision-making practices for the 3 organisations such as the evaluation of alternatives and of the decision impact. Conclusion: The QoDoS can be used to benchmark organisations’ decision-making practices to provide a basis for discussion to ultimately encourage a level of trust across and within organisations and helping to identify areas for improvement.

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Improving R&D productivity

Cited by 28 publications

References 2 publications

Prioritizing multiple therapeutic targets in parallel using automated DNA-encoded library screening

Prioritizing multiple therapeutic targets in parallel using automated DNA-encoded library screening

Quality of Regulatory Decision-Making Practices: Issues Facing Companies and Agencies

A Process for Evaluating Quality Decision-Making Practices During the Development, Review and Reimbursement of Medicines

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