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Digital Data Management Is a ‘Must’ in the Life Sciences

Most companies have learned a lot during the pandemic, both about what works for the business in these challenging times and what doesn’t. One lesson that’s emerged across disciplines is that the companies most successful at weathering the storm have used digital data management. For Life Sciences organizations, this has been a “must” for keeping research pipelines in motion during the pandemic. But in the grander scheme of things, digital data management is also what enables a more efficient and cost-effective path to the end goal: novel therapeutics that change and save patients’ lives.

For these organizations above almost all others, there is enormous complexity in data management, and therefore a high degree of uncertainty. But innovation itself is complex—and it is the key to success, not just for the company, but for patients. It is virtually impossible to meet the hefty data requirements of research and development (R&D) today without implementing a digital data management system. One might argue it is the key factor in determining whether therapeutics come to market in a timely and safe manner.

If you look at search engine data over the years, it shows that the search term “digital strategy” was surpassed several years ago by “digital transformation.” This reflects the growing realization that digital transformation is not just about technology—it’s about having a robust, digital business model. While most technologies provide possibilities for efficiency gains, it’s clear that if digital initiatives don’t adapt to include business processes, then “going digital” will only magnify existing problems and execute them more efficiently.

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Digital transformation strategy is therefore the key: it involves shifting a siloed or functionally divided enterprise into an agile data science-enabled powerhouse. Digital data management has numerous benefits, including reduction in human error, enhanced data sharing among teams, time and cost savings, and compliance and communication with regulatory agencies. For some companies, it can also mean fully eliminating paper from business processes, empowering staff to work remotely, or automating processes and systems to elevate the organization to new levels of productivity and efficiency.

An excellent case study of how digital data management can have significant real-world benefits is in the US-based biotech company Moderna. It recently catapulted into the public eye when it developed with unprecedented speed one of the Covid-19 vaccine frontrunners. The company’s vision had always been to deliver on the promise of mRNA in therapeutics, with the end-goal of developing a generation of truly transformative medicines. They have long considered themselves a digital biotech company, with “digital” the foundational component of their identity and goals. And that vision has paid off.

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Moderna’s strong digital transformation strategy, a key goal having been to reduce complexity in scientific and business operations. The company was particularly focused on two areas within scientific development: research engine digitization and early development engine digitization. Staff implemented, among other digital tools, a cloud-based electronic lab notebook system, IDBS’ E-Workbook Cloud, that has enabled them to streamline and track experiments in a standardized way, with multiple mRNA R&D programs running in parallel. As the company has said, mRNA research naturally lends itself to digitization since mRNA has many software-like features itself. This inherent quality along with Moderna’s digitization strategy has made the company’s data management smarter across numerous dimensions and enhanced its ability to move from mRNA concept to research to clinical development.

The proof in the pudding was the unprecedented speed with which the company developed a vaccine against the novel coronavirus, only 63 days after the virus’ genetic sequence had been published. This agility may be due to existing data from Moderna’s work on Middle Eastern Respiratory Syndrome coronavirus, MERS-COV as the company’s digitized data management would enable it to immediately leverage the data and adapt it to SARS-CoV-2, the virus that causes Covid-19. Moderna was one of the first two companies to submit Covid-19 vaccine data to the Food and Drug Administration (FDA) for emergency use authorization (EUA).

Another great example is Chugai Pharma, a Japanese company that wanted to move away from paper for several reasons. The use of paper notebooks created significant problems for researchers, including indecipherable notes, transcription errors, cumbersome manual searches of past data, and time-consuming printing and manual pasting into paper notebooks. The company was also concerned about the risk of natural disasters on paper-based records; finally, as an environmentally conscious company, Chugai was looking to reduce paper dependency and the number of storage areas required to house documents.

Chugai talked with their strategic partners, including Switzerland-based Roche, who was already using a cloud-based electronic notebook system and ultimately implemented such a digital system themselves, using a slow and staged approach. They began the rollout of the E-Workbook Cloud with a six-month pilot program in their pharmacology groups, collecting data on the transition to measure success and allowing other departments to switch over at their convenience and as their research allowed.

The digital platform has now been embedded throughout Chugai and has led to measurable benefits across its research groups. Pharmacology scientists have seen gains between 20-30% in productivity; analytical groups enjoyed a 30% improvement in efficiency, based on the superior quality and quantity of information captured digitally over paper methods. Pre-formulation groups are seeing productivity gains of up to 50%.

Companies are embracing and enjoying the advantages of digital data management more and more. There are additional benefits beyond what can be described here—like communication with regulatory bodies. The European Medicines Agency (EMA) and the FDA now expect to access companies’ data in real-time, particularly for the rolling reviews that enable fast-tracked drug candidates. A digital data management system can provide a fast and secure method to do this. Making the switch to a digital management system in a life sciences company may take some work, but it will save a host of problems and costs, improve workflow in measurable ways, and get new medicines to the patients who need them.

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