-Rita Lencastre, Head of Laboratory Advisory, NNIT
With the right digital toolbox, scientists and lab technicians in the life sciences industry can streamline workflows and accelerate business process improvements. NNIT can help identify the right systems, improve adoption of existing tools, and implement new digital solutions.
Laboratories are crucial in the life sciences value chain for ensuring the safety, efficacy, and quality of pharmaceutical products. From the initial development of drug substances and formulations to supporting manufacturing operations and ensuring the final product's quality, lab scientists and technicians conduct thousands of tests and experiments, generating vast amounts of data.
Data generated during research and development is vital for product development, market entry, and demonstrating product efficacy, safety, and regulatory compliance. This data also holds potential value for improving product yield or developing new products. However, this data often ends up in unstructured formats such as paper or electronic notebooks, slideshow presentations, PDFs, and spreadsheets, making it difficult to find, access, read, interpret, and reuse.
This results in inefficient processes and extra effort needed to accomplish tasks like generating documentation or analyzing research results. For example, a research team might need to find and extract data from several lab systems, export it to a spreadsheet or presentation, and discuss it over a video conference call.
– Most pharmaceutical companies aim to accelerate their Time-to-Market for new products or improve efficiency by reusing data. To achieve these benefits, both data and metadata must be captured and shared. Transforming data into insights when generated is crucial, but being able to reuse it in the future without the immediate team's implicit knowledge is a game changer, says Rita Lencastre, Head of Laboratory Advisory at NNIT.
Disconnected strategies and unmanaged tools hinder data sharing and reusability
When life sciences organizations fail to utilize data across the organization, it is often due to disconnected digitalization and data strategies, and leadership's failure to prioritize value-chain alignment. Misalignment between Research labs, Chemistry, Manufacturing & Control (CMC) labs, Manufacturing Science and Technology (MSAT) labs, and Manufacturing units hampers collaboration and data reusability throughout the product development lifecycle.
Rita Lencastre explains that while different business areas such as Research, CMC, or Manufacturing have separate agendas and digital toolboxes, a holistic data-centric approach is necessary to prevent data from being trapped in fragmented systems. The tools that make sense in early product and process development differ from those needed later, but data must be structured and contextualized for future insights.
For example, earlier in the pipeline, the CMC lab performs experiments to evaluate manufacturing process parameters and product quality. Later, MSAT labs may need to perform new experiments to assess the impact of manufacturing deviations on product quality and patient safety. Previously generated CMC datasets could expedite these investigations. However, for this to happen, MSAT scientists must be able to find, assess, and reuse existing data, which many life science companies struggle with today.
– Lab teams often work on isolated tasks, sending results to the next step in the value chain and then disconnecting. We need to transform this one-way pipeline into loops where data can be shared in multiple directions, says Rita Lencastre Fernandes.
Data must be accessible across the value chain
Digitalization and better data utilization require engagement and collaboration from all relevant parts of the organization. Attention should be given to the different ways data can be used by various stakeholders and how to enable this reuse.
Capturing, structuring, and making data available through digital solutions is not just a technology project. It involves improving or rethinking ways of working, establishing shared processes, and governance for data sets. This requires input from users in different labs and stakeholders, as well as overcoming organizational inertia and reluctance to prioritize changes across functions.
– This change must be part of executing a business strategy. Leadership must engage with technical stakeholders and drive the efforts to implement a data strategy and governance. They must also support the identification and use of IT/digital solutions. Success in establishing a connected digital toolbox requires consistent, disciplined work, enforced, and incentivized by management, explains Rita Lencastre.
A key element is ensuring that data is readily available as FAIR (Findable, Accessible, Interoperable, Reusable) datasets. FAIR data ensures that both data and related metadata are collected, stored, and made available for reuse by humans and machines.
Building the right technology landscape – connecting the digital tools.
Once the strategy and governance are in place, you need proper digital tools to support them. Each business function must identify its preferred tools to enable their daily work while ensuring integration with enterprise solutions to avoid data silos.
For early, non-regulated production for research purposes, the Benchling platform may be a good choice. This cloud-based R&D platform is designed for the life sciences sector, integrating electronic laboratory notebook (ELN) capabilities with molecular biology tools. It centralizes data management and streamlines laboratory workflows, enhancing productivity and collaboration.
Further along the value chain, clinical supplies and commercial manufacturing are usually managed via a Manufacturing Execution System (MES) or similar system. The Laboratory Information Management System (LIMS) acts as the main execution platform for analytical development or quality control laboratories across the entire pipeline.
Let NNIT help you master your digital toolbox
At NNIT, we can help you defining your digital toolbox and integrate it with enterprise solutions, digitalizing your lab workflows and liberate your data.
Few life sciences organizations can master the combination of strategic insight, domain knowledge, technology expertise, and available manpower needed for cross-organizational digitalization of lab work and data. Achieving these objectives often requires an experienced partner.
At NNIT, we can offer a wide range of Laboratory Transformation Services, including:
Strategy & guidance.
- Digital Toolbox Identification: solution fit-gap assessment, technical architecture.
- Requirement specification and solution vendor selection.
- Solution implementation including technical implementation, organizational change management and operational readiness support.
- Compliance and validation.
- Application services.
We leverage our extensive knowledge of IT and Lab Automation landscapes to guide pharmaceutical industry clients through challenging transitions, ensuring smooth adaptation to new processes and technologies.
