Modern drug discovery and development workflows incorporate a growing range of automated, high-throughput technologies that can generate data on a truly impressive scale. Innovation in next-generation sequencing, mass spectrometry and synthetic biology are also helping to accelerate the delivery of personalised treatments by allowing scientists to probe human diseases in unprecedented levels of detail. However, while these advanced technologies are unlocking a wealth of therapeutic opportunities, the growing volume and complexity of the data produced poses significant challenges to the pharmaceutical industry, in terms of information management.
Here, we look at the challenge of controlling pharmaceutical data, and how cloud-based laboratory informatics platforms are providing businesses with an extensible solution.
The challenge of controlling multi-dimensional pharmaceutical data
The pharmaceutical landscape has changed considerably over the past two decades. Where once much of the drug discovery and development pipeline was conducted in-house, today, outsourcing and collaboration have become increasingly popular approaches. As such, the data produced by modern drug development strategies must often be securely shared and accessed by teams across the world.
With global outsourcing more widespread and drug development increasingly international in nature, regulatory bodies are putting emphasis on the accuracy, completeness and consistency of pharmaceutical data. Given this growing regulatory focus, the platforms used for data management should not only make information securely accessible by those who need it, they must also support full accountability and traceability of actions across the whole pipeline.
However, for large numbers of pharmaceutical companies, the reality of controlling data is far from this ideal. While many laboratories have transitioned from the paper-based workflows of the past to digital solutions, such as electronic laboratory notebooks (ELNs) and laboratory information management systems (LIMS), these tools are not always implemented in the most joined-up manner. Often, separate digital tools end up being employed by separate teams, departments or facilities, with little consideration as to how they will support collaborative working. So, rather than bringing teams together to support efficient working practices, these fragmented informatics platforms can create data silos that effectively lock data in specific platforms.
This problem can have serious implications for drug development pipelines, making it more challenging to share data between people and reducing operational efficiency. Using separate systems can foster inconsistencies between the way teams organise their data, requiring information to be standardised before it can be shared. Furthermore, these poorly integrated systems do not provide decision-makers with a comprehensive overview of the whole pharmaceutical pipeline, potentially resulting in decisions that aren’t based on up-to-date insight. What’s more, as datasets grow larger and the volume of information handled by drug developers increases, these issues become more acute.
Given the challenges associated with controlling large amounts of complex data using fragmented data management systems, pharmaceutical companies require more extensible solutions. For many, the answer is cloud-based laboratory informatics platforms.
Making data-sharing simple and convenient
Cloud-based laboratory informatics platforms allow pharmaceutical companies to create an integrated digital ecosystem for all of their data. By connecting instruments, workflows and people through a single system, these platforms make data from across the pipeline securely accessible and searchable. Moreover, because these platforms are housed in the cloud, they are not restricted by the capacity of in-house IT infrastructure, and offer businesses the scalability and flexibility they need to accommodate the growing volume and complexity of multi-dimensional pharmaceutical data.
One of the biggest advantages of cloud-based platforms is the way in which they make securely sharing data simple and convenient. By organising information centrally, rather than in multiple disparate systems, cloud-based platforms eliminate the friction associated with bringing together datasets from multiple sources. And because all authorised individuals can access this information through the cloud using a single software platform, data can be easily and securely shared with colleagues or collaborators. Sharing data with colleagues or collaborators via cloud-based platforms is much more secure than via email, and can be accessed in original format and file type.
Cloud-based platforms allow pharmaceutical companies to apply the same data management practices right across their workflows. In doing so, they harmonise the collection and analysis of data. This not only helps to enhance the quality and consistency of pipeline information by applying standardised working practices, it also supports faster decision-making, as teams have access to the same information in a consistent format. With standardised workflows and data management tools through the cloud, organisations can benefit from more efficient working practices, potentially accelerating drug development timelines.
Bringing an organisation’s data into a single integrated cloud-based platform also makes it easier to maintain a complete audit trail of actions with which to demonstrate regulatory compliance. Fragmented data management platforms can make recalling events for review purposes time- and resource-intensive, as separate systems can require users to perform the same activities multiple times. Using a single overarching platform that allows authorised individuals to search against all user interactions made in the system gives organisations a complete overview of activity. As a result, businesses are better placed to identify unusual or non-compliant behaviour wherever it occurs, helping to maintain the highest standards of data integrity.
Challenge of controlling pharmaceutical data
Technological advances over the past decade have rapidly expanded the volume and complexity of pharmaceutical data, and all signs suggest this trend is likely to continue. The digital transformation is revolutionising laboratory connectivity; even equipment such as refrigerators and pipettes are now capable of providing information on environmental and operating conditions. Automation is now ubiquitous in pharmaceutical workflows, supporting the collection of data at ever greater speeds. Even if pharmaceutical companies haven’t fully embraced these technologies by now, it’s just a matter of time before these tools become the norm. For businesses, this means that the data management solutions they adopt must not only meet today’s data handling requirements, but also be well-equipped to meet the needs of tomorrow’s data pipeline too.
Platforms built on cloud-based architecture are highly flexible and scalable, allowing pharmaceutical companies to expand their capabilities on their own terms. Some cloud-based platforms, such as the Thermo Fisher Platform for Science software, for example, are based on a modular framework that allows businesses to add specialised ‘apps’ according to their individual needs. This allows LIMS and ELN solutions to be incorporated into the system as and when required. Moreover, because these informatics systems are developed, tested and maintained by independent providers using a cloud-based architecture, new features can be added without the need for extensive changes to internal IT infrastructure.
Of course, to get the most from ongoing advances in technology, the data management tools pharmaceutical companies adopt must be capable of supporting new technologies and techniques as they become available. Many of the latest cloud-based platforms are designed to be compatible with instruments from multiple vendors, ensuring complete connectivity, regardless of their existing or future system set-up. By focusing on the long-term use, robust cloud-based platforms provide customers with a clear roadmap for future growth, supporting expansion as and when they are ready to take these next steps.
Meeting the needs of tomorrow’s drug development pipeline
The modern pharmaceutical landscape requires businesses to share data effectively with colleagues and partners, while maintaining the highest levels of data integrity. However, continued growth in the volume and complexity of pharmaceutical data means the solutions used to control this information must be sufficiently scalable to support future business expansion. Cloud-based laboratory informatics platforms offer an extensible solution to this challenge, providing the flexible framework businesses need to manage increasingly multi-dimensional data in a regulatory compliant manner, while allowing them to securely share data throughout the pharmaceutical pipeline.