Digitalization pyramid: How stakeholder interests can lead to a data-driven business

What is Digitization?

Digitalization has been defined by Gartner as, “the use of digital technologies to change a business model and provide new revenue and value-producing opportunities; it is the process of moving to a digital business.”

Digital businesses have never been so important to the effectiveness of creating business continuity than in the current global health pandemic. With local grocers, hospitals and traditional manufacturing suffering from the worst economic circumstances in a decade, digital businesses like Amazon, Teladoc Health, and Zoom are registering stock evaluations.

A recent report by Accenture demonstrates that only digitally mature companies are resilient enough to maintain full operations in this and future crisis. For example, Google’s Deepmind has recently contributed to scientific efforts to combat Covid-19 by using its artificial intelligence application to release virtual structure predications of several under-studied proteins associated with SARS-Cov-2.

With increasing healthcare offerings supported by Accenture and Mayo clinic, Google Cloud is setting a powerful new paradigm for how life science companies are using technology to detect, diagnose and treat diseases. In an effort to meet the increased demands of the market, life science organizations are starting to turn to these new digital health solutions, however, the definition of digitalization, its imminent impact and the associated urgency often remain misunderstood and underappreciated by the relevant stakeholders in life science companies. These stakeholders are focused on their current business needs, and while they can see some benefit in technology, their real-life problems and stressful schedules prevent them from identifying what initiatives are best to scale up and what digital success will look like in the future.

This blog is intended to help life science organizations understand how digitalization is achieved and the benefits it will bring to their part of the organization.

The first thing to realize is that we are all trying to do our best. Even though friction between different organizations and their respective goals seem inevitable, there is a common destination to be reached. This destination is a newly transformed business that results from synchronized innovation in all respective organizational units, focused on solving the current stakeholders needs.

In simple terms, if every part of the organization addresses their current challenges and embraces novel technological opportunities, their progress can merge into a unified whole. Regrettably, this is not apparent to all stakeholders, due to an effect a German idiom coins: The forest being disguised by trees.

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Let us look at some of the common challenges of stakeholders in life science businesses that could be solved by today’s technology. As examples, we will put ourselves into the shoes of a laboratory head, a quality control (QC) manager, a regulatory affairs representative and a collaboration manager. We will see that extrapolating only a few steps will merge all stakeholder’s interests in the same final outcome: the foundation of a digital business.

Laboratory head

With Eroom’s law working against them, laboratory heads are mainly interested in finding better, safer and more cost-effective drugs. In order to make good decisions, they need to be able to find and access all relevant information related to a specific project.

In most companies, it is currently not possible to retrieve all digital information for a specific product through a simple search. Therefore, much effort is being spent on breaking up data silos and providing basic search and retrieval function to laboratories. Once this problem is solved, the desire will arise to not only find specific data sets, but also to interrelate them with other projects in the company.

The idea to increase efficiency by making better decisions on which drugs to promote and which projects to stop will result in greater quality and higher throughput. This can only be achieved if data is harmonized and transformed into information by adding descriptive metadata.

A main bottleneck of integrating information are the incompatible data formats that digital information is often stored in. Leveraging data standards like Allotrope will enable future reuse of data. A set of well-curated, long-term usable information packages is the foundation of any digital business. The path of the lab head will inevitably lead to this stage.

QC and compliance manager

QC managers have one major concern in a world of rapidly advancing technologies that regulatory officials will require access to legacy data a company cannot provide.

Warning letters are detrimental to any life science company and need to be avoided. The main reason for warning letters issued over the last few years is missing data integrity. While paper prints and file backup solutions have sufficed in the past, current audits require frequent access to reintegrable data. It is, therefore, an eminent challenge for QC managers to put into place archiving solutions that keep data in a fully compliant storage.

Once the problem of storing measurements has been solved, however, a new challenge can be foreseen. How can the process that leads to a specific released batch be made visible and how can a drill down into the data genealogy be made possible?

The ability to reconstruct a human readable process description and all relevant descriptive information on the fly will become the next object of desire. Standardized data models and process descriptions integrated into the data storage solution will form the basis of what can be coined a streamlined audit.

No more mountain archive explorations or calling people out from retirement will be necessary. All information will be available with the push of a button.

Consider the system necessary to achieve this; it has to collect, harmonize, store and reprocess digital information. Similar to the lab head, this system forms the foundation of a digital business as the logical destination for the QC manager.

Regulatory affairs manager

A crucial task to bring a product to market is proving the safety and effectiveness of a drug to regulatory authorities. Wagon loads of documentation has to be prepared, in agreement with minute specifications that vary between countries.

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Today, a plethora of data management systems needs to be consulted to retrieve all the information necessary to produce the desired submission documents. Unfortunately, these systems do not communicate well with each other and require much manual effort to operate.

It is, therefore, a high priority item for all regulatory affairs managers to increase efficiency and reduce errors using automation of manual efforts in data digitalization and transfer between systems.

A key component to ensure the integrity of data is through implementing master data systems that hold definitions of contextual metadata to be assigned to individual information packages. Every data package created needs to be tagged with a set of mandatory and optional metadata.

If such automation is fully deployed the resulting data packages will be connected on their metadata level. This means that a foundation is laid for completely automatic creation of submission material. It is clear to see that the need for automation, coupled with connecting data, can result in substantial time savings during the submission process, which equals millions of dollars per day for a blockbuster drug.

While the desired outcome is very different from the one of the lab head and QC manager, the enabling technology has many parallels and again provides the basis of a digital business.

Collaboration manager

A collaboration manager has the responsibility to ensure that contract research organizations (CRO) and contract manufacturing organizations (CMO) receive and deliver information of the highest quality. While it has been an established practice to subcontract parts of the drug discovery and development pipeline to third party companies, never before has the need for digital exchange of data been greater.

With the previously described needs for standardized and well curated data from all other units in the organization, the collaboration manager needs to make sure that the CROs and CMOs submit data according to required standards. A secure data transfer is only the first part of the pipeline, because even more important are automatic quality checks to guarantee data integrity and compliance. While these abilities are currently under development in many companies, it can be conjectured that the next big leap will be an automatic monitoring and performance scoring of CROs and CMOs.

Such a metric, completely data driven, will enable life science companies to go beyond trust and identify the best partners in the industry. The gained transparency will result in cost savings and higher product quality. Furthermore, the system necessary to accomplish this data exchange, quality checking and performance scoring will have to rely heavily on standardized and contextualized data packages. As in our previous examples, this will be the foundation for a data-driven, digital business.

In conclusion, every life science company has to successfully go through the process of digitalization or risks being overtaken. While many stakeholders do not grasp the full picture, their individual interests will lead them to contribute to the foundation of a data-driven business.

If management encourages a synchronized effort to build a system capable of transforming the organization, all stakeholders will instantly gain valuable business benefits. At ZONTAL, we believe that technology holds the key to unprecedented productivity. Together with our top 20 pharma partners, we have developed ZONTAL – a space to guide digital transformation and bring immediate business benefits to important stakeholders. Join us for our educational webinar on May 28 to learn how we can transform the industry together.