When I hear biotech and pharma executives talk about their company’s “data estate,” I know the Microsoft and Amazon people have been meeting with them. I also think of the little British man who ran the estate on Magnum PI. His shtick was to be intimidating because his ferocious Dobermans listened to him. With just the right nod to his dogs, they would viciously attack the perpetrator.
Data as the Foundation of Digital Strategy
In the past, executives looked at their IT strategy and their business apps as the ultimate foundational component. The prevailing thinking was, “How do I get all of my data into one place that is secure and enables all the workloads I think I’ll need to execute our strategies?” Increasingly, innovative biotech and pharma business executives are looking at their digital strategy in the context of “digital disruption.” They see their data as the foundational component. In this perspective, their business applications (ERP, CRM, eQMS, LIMS, CTMS, etc.) function as heavy players on top of the data. But they’re not the only players.
Two things happened.
First, companies realized that while they gained connected operating processes and efficiencies from these mainly “off-the-shelf” business apps, the data was hard to get out to expose and leverage.
Second, the shift to cloud computing unleashed all of these available services that would enable new digital strategies. (Think of a library of pre-built software routines that can run on top of the data.) These services can be even more powerful than Dobermans. They can disrupt and change an entire industry, resulting in big losers and big (and sometimes new and emerging) winners.
As a result, the dominant cloud providers have taken steps to expose the data of their business apps into an underlying overall data model that is accessible to these available cloud services. Amazon calls its model the “data lake,” and Microsoft now calls its model the “dataverse.” Wow, Keanu Reeves, red pill or blue?
Making the Most of Your Dataverse
What can you do with this? A lot. You can:
- Extend workloads to happen over mobile devices and web apps that previously could not
- Combine data generated in your core business with data from outside sources to create products and add new digital experiences and relationships for your patients, providers, and customers
- Run predictive learning models against your combined data to make recommendations or even automatically take actions
- Use augmented reality devices to create operational efficiencies or new patient or customer experiences
- Jump your current supply chain distribution channel and go straight to end patients, providers, or customers with mobile apps or portals where they can order your services and products and maintain an ongoing digital relationship with you
- Enforce regulations in your field team’s interactions with care providers, leveraging your data and devices
- Run AI algorithms against your critical vendor delivery data combined with outside data to predict delivery performance
- Run AI algorithms correlating your biological source material and actual batch fermentation past data to predict the yield of expensive in-process materials you plan to produce
- Create no code and low code apps, dashboards, and notification engines without developers, to do all kinds of things
Oh, and if you aren’t doing these things, someone else is about to in a way that fundamentally re-orders your industry and the successful business models that exist in it. That is digital disruption, and it’s a great time or a terrible nightmare, depending on whether you are the disruptor or the disrupted.
However, as an FDA-regulated biotech or pharma company, care must be taken to ensure that any of these scenarios operate with GxP and PHI compliance where required. Suppose you extend delivery and handling of your drugs into an app that tracks devices inside the package (think Pfizer vaccine) with a mobile component and portals to handle delivery, excursion management of damaged lots, and acceptance by the verified recipient. In that case, those transactions have to capture the associated Part 11 audit trail data and be able to reassemble the audit history for an FDA audit. This includes before data value, after data value, timestamp, who changed it, etc.)
Some of those actions may require dual signature authorization. For example, “These lots went out of temperature tolerances for this number of hours, they were retested, and now we want to change their status back to available, re-establishing expiry dates.” If your digital portal enables direct-to-patient orders and shipping, with a recommending provider relationship who receives referral fees and handles the patient insurance payment, that patient data must be protected according to PHI.
Enabled by these cloud platforms, biotech and pharma are beginning digital transformation as an industry. In the same way other industries have experienced, there will be winners and losers. It is an exciting time and not for the faint of heart. But a smart digital strategy pays attention to digital and operating compliance while executing these strategies in order to emerge on the winning side of change.
Ready to make the most of your data estate?
Are you prepared to tackle data lake analytics in new and innovative ways that drive real value to your operation? The team at Merit is ready to help. Book a call and let’s get started.