The digital lab in pharma refers to the digitalization of laboratory operationsand the digitization of data processes to enhance quality control efforts, enable continuous workflows and improve process efficiency.
Historically, pharma labs have used paper notebooks and control sheets to keep track of experimental data, observations and results. This method proved challenging for maintaining an experiment’s integrity and value as data from paper-based systems are not easily shareable, searchable, standardized or accessible.
Paper is now slowly being replaced with digital technologies enabling the real-time control of lab procedures, speeding up quality control and making labs far more efficient.
“Scientists can make decisions efficiently based on the output from analytics, digitalized laboratory informatics systems and connected devices. These elements combined with the support of people will ensure research results are achieved much faster.”
How digital solutions stem the tide of data velocity?
Pharma companies looking to scale their digital transformation strategies in the lab must find efficient ways to overcome the sheer volume, velocity and verity of data generated from the digital systems implemented.
“Up to 70 percent of research is currently not reproducible, often due to the inability to find the original research data, or because the experimental conditions are inconsistently or inadequately catalogued,” said Dr. Haydon Boehm, Head of Commercial Marketing - Connected Lab at Merck Group, in a Pharma IQ panel discussion alongside two digital lab experts from Merck.
To navigate legacy applications and maximize data insights in the lab today, Dennis Della Corte, Chief Science Officer at ZONTAL, said in his session at SmartLab Digital 2021: “Making data findable, accessible, interoperable, and reusable (FAIR) will help pharma companies eradicate data silos with high maintenance costs, enhance data interoperability and integration, improve compliance and data integrity practices and drive new data driven solutions for continuous innovation and business transformation.”
In addition, with the pharma industry battling with the pressures from the Covid-19 pandemic, frictionless access to scientific data, full data transparency and eradicating manual processes from the lab will help scale scientific research and get products to patients in need faster.
Felipe Albrecht, Bioinformatics and Computer Scientist at Roche, said in a discussion on workflow automation in the lab: “Gaining greater visibility into large volumes of data is a challenge but data transparency can really power faster research possibilities, especially as the industry changes at such a rapid pace.
“To gain greater visibility of data, pharma companies need to work in partnership with the technology they want implemented and with the people and scientists that work in the lab. You can have the best IT systems in the world but if the people do not support the technology or cannot use the systems, the digital lab will become useless.”
As Albrecht has noted, scientific, operational and clinical data can deliver meaningful positive impacts for both patients and pharma companies if there is a balanced relationship between the technology and the people. “Digital systems are only as good as the information people feed into them,” empathized in the Pharma IQ report, How effective data management can drive R&D labs of the future.
SmartLab Digital 2021: Ensuring sustainable lab operations during and after Covid-19 (Source: Pharma IQ)
How to encourage the move to the digital lab of the future?
Leverage clean data intelligence for quick and easy access to information on the go by utilizing FAIR data principles in the R&D process.
Adopt risk-based validation practices to ensure manufacturing protocols address data quality and reliability.
Foster a data culture by collaborating with internal and external partners to extend knowledge and data networks.
Add lab intelligence to existing electronic data with data analysis algorithms.
This can be achieved by following three stages in the image below on the voyage to achieving digital transformation:
Stages on the journey to the digital lab. (Source: Accenture)
Value creation and opportunities with digital labs
In a recent survey, 41 percent of Pharma IQ’s audience listed workflow efficiency and product quality as a top priority they would like to improve on in 2021. With emerging technologies such as advanced analytics, robotics and automation providing pharma leaders with the potential to revolutionize digital lab environments, respondents of the survey also commented that these digital initiatives are likely to lead the way in ensuring better quality and compliance. This can be through reducing manual errors and variability, as well as allowing for faster and effective resolutions of problems.
Workflow efficiency, product quality and improving products in-house could upend current business models for pharma. (Source: Pharma IQ)
Furthermore, digitalization enables labs to prevent, report, manage and respond to data breaches with the right skills, tools and processes.
Charles Fracchia, CEO at BioBright and VP of Data at Dotmatics, commented in a Pharma IQ report on data integrity and data security: “[Digital labs offer] an unprecedented opportunity to expand the industry’s digitization efforts and enable a novel kind of analytics in a machine-learning age of biology.
“Analytics technology can now provide researchers and scientists with trustworthy, high-quality and secure data to enable innovative, data-driven biological discoveries. This also allows [the industry] to relax the requirements around very burdensome workflow-driven decisions that do not incorporate real-time or historical data.”
Overall, digital labs can lead to more efficient data exchanges, use of laboratory resources, reagents, consumables, laboratory supplies and asset utilization.
Breaking down the barriers to the digital lab of the future with AI
After defining the trends and technologies that characterize the makings of the digital lab, it is nearly impossible to shy away from the revolution of AI in scientific research and its utility in the lab space. AI has become a crucial tool for reviewing data efficiently and accurately, uncovering patterns, improving analyses and streamlining operations.
“By training deep learning algorithms, researchers can conduct tests at a previously-unimaginable scale, even before physically administering the vaccine candidate to test patients,” Sisk remarked. “These AI algorithms can be used to identify and sample antibodies to fight infectious diseases with drastic improvements in speed and cost. Advanced analytics and data visualization of human response to the potential vaccines can then be used to assist with rapid testing, allowing for more intricate analysis and lower error rates.”
In a debate session at SmartLab Digital 2021where two pharma experts argued for the most significant technology trend aiding strategies for the digital lab of the future, Mathew Divine Senior Data Scientist at Boehringer Ingelheim, noted: “Augmentation technologies provide scientists with instant knowledge at their fingertips. If you take the example of standard operating procedures (SOPs) for instance, which are required by law to have displayed in all pharma laboratories, quality and compliance challenges become easy to fix with an augmented AI-assistant. You can receive safety data sheets or SOPs for how to perform a laboratory process or experiment safely and effectively within minutes, removing quality control bottlenecks and increasing speed of delivery to market.”
For more real-word examples of how AI is changing the pharma field, watch the debate between Janssen and Boehringer Ingelheim during their session at SmartLab Digital 2021 below.
SmartLab Digital 2021: Lab of the future strategy, Automation vs. Augmentation (Source: Pharma IQ)
What are some tips for finding business value with the digital lab?
In recognizing the impact of digitalization on lab environments, it is essential to ask whether the real purpose of the transition helps or hinders the team in the lab.
As such, the digital systems that are implemented need to create value. Unjulie Bhanot, Solution Owner, Biopharma Development at IDBS, said in an exclusive interview with Pharma IQ: “Change management plays a huge part in organizations coming around to the idea of why they need to digitize and understanding how data brings them value. It takes buy in from the top-down in an organization and a real understanding of the benefits digital technologies will bring.
“In order for pharma to achieve total digital transformation or digital excellence, pharma companies need to implement a digitization strategy from product conception in R&D, all the way to a product being in the market and in the clinic. By having a complete understanding of the entire pharma supply chain decision-makers will know where to place digital technologies that best support their operations.”
Pharma’s digitalization journey will doubtlessly relent due to the advancement of technology, and with AI, machine learning and data analytics all becoming commonplace. However, by setting appropriate goals, choosing the right technologies and scaling up quickly, pharma companies will be able to become leaders in quality control and process efficiency and reap the benefits in the form of speed-to-market, regulatory trust and higher return on investments.