Pietro Forgione, General ManagerA 2022 McKinsey survey that analysed digital and AI quotient scores across industries, using a 100-point scale, showed that even the most digitally advanced pharma organisations were 30 or more points behind the digital leaders who have scores hitting 80 points or more. It’s clear that there will be a profound impact of closing this gap on patient outcomes, but this requires a digital strategy that is hyper-focused on accelerating high-quality drug development lifecycle.
If the monumental endeavour of developing novel, efficacious therapies wasn’t enough to focus on, the pharma industry is faced with constant market pressures. The U.S. Inflation Reduction Act and increasing competition driven by rising patent expirations are creating a perfect storm of downward pricing pressure. In a world where it takes 12-15 years and 2 billion dollars to bring a new drug to market, it’s clear that those who can deliver a new paradigm of digital empowerment will emerge as the market leaders.
For over 30 years, IDBS has been at the forefront of bridging this digital gap, empowering pharmaceutical companies by collaborating with scientists to deliver innovative digital workflow solutions that accelerate critical milestones across the lifecycle. Distilling this long history of deep domain experience, IDBS has developed a new Polar platform to integrate the workflows, data and insight that transform how work is done.
By placing the power of AI and advanced analytics into the hands of every scientist and process engineer, Polar augments laboratory workflows with the power of in-silico findings. This creates a virtuous circle of workflows and development pathways being accelerated by embedded insights, creating more and better-quality data that drives deeper and more informed insights. By connecting the dots of workflow, data and insight, it becomes clear how pharmaceutical companies can begin shifting from expensive and time-consuming empirical work to a new world of accelerated in-silico outcomes.
Changing the Playing Field
Historically, the pharmaceutical industry relied on numerous specialised systems, each designed for a specific application, resulting in siloed information. While software-based solutions were introduced to enhance various stages of the drug development and manufacturing process, they often operate in isolation, making it challenging to gain a comprehensive view of the entire drug lifecycle. Users typically gain clarity on only a fragment of the process, preventing the holistic oversight necessary to reduce the time and costs of bringing a drug to market.
Despite advancements, including modern laboratories and automated manufacturing, many pharmaceutical organisations still need to use disconnected R&D and production methodologies. This disjointed data ecosystem leads to fragmented and often lost data throughout the product lifecycle.
IDBS’ extensive experience has enabled it to guide customers through their digital maturity journeys effectively. In recent years, the company’s focus has evolved from simply understanding scientific workflows to emphasising the contextualisation of data generated throughout the drug development lifecycle. Its solutions can collect data from various sources, such as analytical instruments, bioprocessing equipment and product lifecycle management tools. Using advanced analytics capabilities and machine learning algorithms, IDBS helps monitor processes, identify patterns, predict outcomes and suggest improvements. By combining product and process data, the company enables pharmas to gain a more comprehensive understanding of their operations, from which to learn and optimise processes. This ultimately leads to better products, more efficient development cycles and a competitive position in the market.
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Our Polar Insight engine is plugged into the data backbone so that we can deliver the insights and output of the AI model directly back to the scientists and process engineers to help them accelerate critical scientific outcomes
IDBS’ approach highlights how embedding scientific knowledge at the point of data capture can accelerate time to insight. By closing the loop between insight and workflows executed in the lab, every scientist can exploit the power of AI and advanced analytics to accelerate development and milestones across the lifecycle.
Connecting Empirical Work to AI Insights
IDBS' flagship product, Polar, is a powerful cloud-based software platform for biopharma professionals seeking to accelerate their time to market. It collects, manages, analyses and allows users to share product and process data, enabling actionable insights and regulatory compliance throughout the drug development process.
The intuitive workflow solution supports bioanalysis and extends through to bioprocesses, from cell line development to the commercial production of biologics. Polar also facilitates process transfer to manufacturing, ensuring efficient workflow management and high-quality data capture.
Central to its functionality is the data backbone, which meticulously organises process and product genealogies, quality attributes and process parameters. This comprehensive data repository serves as the foundation for advanced analytics and AI model deployment through Polar Insight, which empowers users with wellcontextualised data sets and actionable intelligence derived from high-quality data. This maintains data integrity, unlike solutions that retrospectively contextualise data from instruments and data lakes, often leading to costly, time-consuming and error-prone processes.
In a world where disjointed tools in the development ecosystem, the rise of automation and robotics and extensive collaboration can result in data being lost, misrepresented, or incomplete, IDBS stands out. Its solutions span from early R&D through preclinical and clinical process development to manufacturing. Backing this holistic proficiency is IDBS’ PIMS solution, which effectively performs continuous process verification and covers critical junctures of regulatory documentation submission. Placing consistent compliance and strong data foundations at its forefront, IDBS’ portfolio ensures structure and context at the point of execution, capturing complete data—whether pass, fail, terminated, or any other status.
With experimental data structured and contextualised in the data backbone, aligned to ALCOA++ and FAIR data principles, the information captured in Polar is primed for use within Polar Insight’s advanced analytics.
“Polar Insight’s data science capabilities remove data cleansing bottlenecks and put decision-enabling advanced analytics in the scientists’ hands. Democratising access to process insight enables biopharma organisations to efficiently focus resources on the critical areas for quality and performance to accelerate process development, regulatory filings and technology transfer,” says Forgione.
This is crucial as it enables the timely monitoring of process performance, allows proactive troubleshooting or course corrections, reduces the chances of losing precious time and materials, optimises operations and drives data-informed decision-making.
Recognising that customers have high ambitions of AI/ML applications that can benefit their business, IDBS' in-built capabilities allow users to truly harness the game-changing potential of data. Users can use historical data to predict future process execution, shorten timelines by predicting future behaviours with better accuracy and reduce time, material and resource wastage.
"Our Polar Insight engine is plugged into the data backbone so that we can deliver the insights and output of the AI model directly back to the scientists and process engineers to help them accelerate critical scientific outcomes," states Forgione.
Combining Expertise-Backed Informatics and Process Data Management
Running a bioreactor involves an extensive workflow that involves creating media batches, managing cell lines for inoculation, taking samples, running analytics and interpreting results. Quickly identifying and addressing issues is paramount, and it can be easily achieved if all the elements are interconnected and contextualised within a system.
Consider a scenario where Polar detects declining cell viability in a client’s bioreactor—a potentially costly issue, given the time and resources involved. With well-contextualised data driving accelerated analytics, the process could be halted early, allowing for a thorough root cause analysis. The investigation might trace the problem to a specific component in a media batch used in the bioreactor, illustrating the critical importance of well-contextualised data in delivering rapid insights. This anecdote underscores Polar's potential to provide timely and actionable information, preventing significant setbacks in the biopharma development process.
This principle applies on a broader scale to process development and drug commercialisation phases, such as investigational new drug (IND) applications and technology transfer.
Our platform creates a flywheel effect by seamlessly integrating scientific workflow with advanced data analytics in a way that reinforces and accelerates each step of the lifecycle
By providing a more controlled process and quicker access to critical data, IDBS enables companies to achieve accelerated development timelines, demonstrating the transformative impact of well-integrated digital ecosystems in the biopharmaceutical industry.
The Next Generation of Life-Changing Therapies
IDBS is proud to be part of Danaher, a leading global life sciences and diagnostics innovator committed to accelerating the power of science and technology to improve human health. This partnership benefits both companies and places them at the forefront of the industry thanks to the expertise they share across different lifecycle stages.
Powered by a team with substantial experience, long tenures and deep insights into scientific processes, IDBS' expertise extends beyond simply storing data and creating visualisations. It involves a fundamental understanding of the science behind meaningful connections, a distinct skill set the company has successfully cultivated.
In the next 12 to 18 months, IDBS will focus on streamlining workflows, enhancing data capture and expanding its ever-growing data backbone. Significant investments are being made to improve each element of the Polar Insight engine, adding more models and capabilities as apps within the framework.
Polar's flexibility allows for configuration without extensive coding, making it adaptable to scientific processes and product development workflows in various domains. IDBS’ underlying concepts and capabilities extend their utility beyond human health to different sectors, including agriculture, food and beverage, energy and consumer goods. Within these sectors, where data points and diverse stakeholders make it hard to gain a comprehensive view of a product’s lifecycle, IDBS’ approach to digitalising workflows and capturing contextual data is a game-changer.
IDBS continues to expand its capabilities and impact while proving that expertise-backed informatics and cutting-edge data management can restructure an industry, making it an invaluable partner in the quest to improve human health.
