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. 2024 Sep;38(5):343-353.
doi: 10.1007/s40290-024-00533-y. Epub 2024 Aug 9.

P.O.L.A.R. Star: A New Framework Developed and Applied by One Mid-Sized Pharmaceutical Company to Drive Digital Transformation in R&D

Riccardo Mariani  1 , Maria Carmela De Vuono  2 , Elena Businaro  2 , Silvia Ivaldi  2 , Tina Dell'Armi  3 , Michele Gallo  3 , Diego Ardigò  2
Affiliations

P.O.L.A.R. Star: A New Framework Developed and Applied by One Mid-Sized Pharmaceutical Company to Drive Digital Transformation in R&D

Riccardo Mariani et al. Pharmaceut Med. 2024 Sep.

Abstract

Digital transformation has become a cornerstone of innovation in pharmaceutical research and development (R&D). Pharmaceutical companies now have an imperative to embrace transformation, including mid-sized and small-sized companies despite resource limitations that do not allow economies of scale compared with larger organizations. This article describes the journey undertaken by Chiesi to develop an efficient framework to drive digital transformation along its R&D value chain with the objective of building and refreshing a clear roadmap and relevant priorities, together with identifying and enabling new digital capabilities and skills within R&D, defining tools and processes that will guide Chiesi activities in the space up to mid-long term. This work has led so far to five main achievements, which align with the steps in the framework: a strategically aligned roadmap with key focus areas for digital transformation and a dedicated team to lead the effort; a common language for data across the R&D value chain; an internal mindset that's open to innovation and participation in key external networks and consortia; a set of quick-win use cases for the new framework; and a defined set of Key Performance Indicators (KPIs) and monitoring tools for digital transformation. The work presented here demonstrates that R&D digital transformation should represent an ongoing process to enable cross-functional collaboration and integration within complex corporate environments that face an ever-growing volume of diverse data, to efficiently support business needs, and to ensure a positive impact on patient care.

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Conflict of interest statement

Riccardo Mariani, Maria Carmela De Vuono, Elena Businaro, Diego Ardigò are employed by Chiesi Farmaceutici SpA; Silvia Ivaldi was employed by Chiesi Farmaceutici SpA; Tina Dell’Armi and Michele Gallo are employed by EVERSANA INTOUCH Healthware.

Figures

Fig. 1
Fig. 1
Key digital focus areas along R&D value chain. RWD real-world data
Fig. 2
Fig. 2
Main clusters of data across Chiesi R&D value chain. GxP good practices
Fig. 3
Fig. 3
Methodological approach adopted for the development of Chiesi Digital R&D ontology-based data model
Fig. 4
Fig. 4
Chiesi Digital R&D OWL Ontology
Fig. 5
Fig. 5
Use cases evaluation criteria. FAIR Findability, Accessibility, Interoperability, Reusability
See this image and copyright information in PMC

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