The right implementation of an end-to-end digital laboratory platform for generics pharmaceutical development is the topic to be developed at the PLA2021 Europe by our keynote speaker Jernej Grmas, Project Manager at the Sandoz Development Center Slovenia, a Novartis Company.
Product Development labs have historically been challenged with a combination of paper-based process, disconnected electronic systems and silos of hard to access data.
This presentation describes the digital transformation process to address similar challenges across the R&D labs in the Sandoz global Product Development network, including the configuration and implementation of Flow, a complete Digital Lab Platform from AgiLab, to manage end-to-end creation and processing of scientific data for Analytical and Formulation Development for all four Sandoz PD sites and Clinical Bioanalytics; Sandoz Biopharmaceuticals.
In this journey, which formally became project in 2017, Jernej will take us through the complete journey of the project.
He’ll debrief and explain clearly all the key steps and milestones. Like a Good Practice Guide of Digital Project , Jernej and his team have initiated the journey with the analysis of the as-is state, setting the scope and expectations for the to-be state.
Once the team was formed and committed, their final User requirements was an exhaustive series of questions about functionalities, IT requirements and trainings. They called 7 vendors for Request for Information (RFI) process, benchmarking candidates with smart and objective assessment system.
Following the ideal process, that call for demo the final candidates and decided also to go for Proof of Concepts with both of them.
Once the best candidates fitting the most to their needs was confirmed, they executed a fully blown IT project with configuration and implementation with the aim to finish in 2022. Success and failure factors, together with key learnings throughout the journey will be described.
last but not least, change management and the impact of people acceptance was seriously considered and approach with proactive frequent workshop will all people implied at Sandoz .
A very pragmatical presentation and a real case of digital project not to be missed at the #PLA2021Europe
Jernej Grmaš is a Project Manager at Sandoz Development Center Ljubljana, a division of Novartis group developing generic pharmaceutical products. After graduation, he joined Sandoz in 2008 as a scientist in Analytical Development, becoming involved in the development of nasal spray products, a topic on which he completed his PhD study at University of Ljubljana in 2019.
In 2013, he joined the Project Management team. Leading different project teams enabled him to develop management skills and provide insights into the complete development process to see manual and time-consuming activities which are constraining agile generic development. In 2017, he became responsible for leading global Sandoz Product Development team for development and implementation of Flow, a Digital Lab platform.
In parallel to his current Project Manager role he remains connected to science, further developing the field of nasal spray products within Sandoz.
Sandoz is a division of Novartis group, developing generic pharmaceutical products. Our Purpose at Sandoz is to pioneer access for patients. By delivering on our Purpose day to day, we contribute to society’s ability to support growing healthcare needs.
The ambition of Sandoz Product Development is to be a well-tuned development engine that drives growth for Sandoz. It aims to help Sandoz be the ﬁrst-to-market at the earliest possible opportunity, and last out.
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