The storming & performing era of pharmaceutical cloud deployment

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The move to digitalisation and the migration to the cloud have been happening gradually within the pharmaceutical sector. Immature digital cultures, lack of in-house data skills, or poorly defined digital strategies have combined to hold businesses back  and historically, misperceptions of the cloud have played into this. Manufacturers that have established legacy systems  are often unduly concerned about the security risks of moving to the cloud. There has been a hesitancy to invest in new cloud infrastructure, even though the likely long-term savings offered by the switch to cloud far outweigh its short-term costs.

More recently, however, ambitious pharmaceutical companies are now in the ‘storming and performing’ era of cloud adoption, accepting this is the direction they will need to pursue in the age of digital transformation and Pharma 4.0.

The move from on-premise , local software installation , to cloud, where data is stored and accessed from a global network of servers, is now becoming more commonplace. At the inception, many manufacturers have chosen to adopt a hybrid cloud approach, which  refers to a mixed computing, storage, and services environment made up of on-premises infrastructure, private cloud services and a public cloud.

In a sense, the trends of digital transformation and Pharma 4.0 go hand in hand and together have laid the foundations for the move to the cloud. The ongoing need to drive speed to market and to be ready for demand spikes has been put into sharper focus by the COVID-19 pandemic. The rapid roll-out of vaccines has set a tough precedent for pharmaceutical manufacturers to match – and companies are feeling the pressure to deliver products to market even faster.  Pharma 4.0, the digitalised operations model of a pharmaceutical business, is a natural evolution of this process. However, Pharma 4.0 also encompasses other trends including big data, AI, collaborative robotics and, perhaps most important, distributed cloud-based architectures.

That move to the cloud is a critical element of the Pharma 4.0 process, helping to deliver enhanced operational efficiencies to manufacturers and accelerate the whole process of drug development.

In line with this, we are seeing pharmaceutical manufacturers today adopting hybrid cloud infrastructure as an urgent priority to reduce the burden on IT, drive costs down, deliver enhanced efficiencies and improve data accessibility and analysis to inform better decision-making.

 

Creating a pharmaceutical cloud

While some lack the resources or the expertise to drive change, many are beginning to set up data lakes as the starting point of a wider migration away from exclusively on-premise models.

This migration has long been in gestation but is now starting to gather pace. Thanks to the Internet of Things, the breadth of connected equipment and systems available to pharmaceutical companies has been massively growing.

Two of the main reasons there is a push to implement cloud strategies is to satisfy the aforementioned requirement to get medicines to market faster and to minimize supply chain disruptions. Another factor is the growing amount of data that accompanies a drug manufacturing project. For instance, the complexity of modalities being developed for therapeutics has resulted in more variables to measure, which equates to larger data files and a greater volume of data. In turn, as the sources of data increase, so does the number of individual data silos, often residing at multiple locations. What can complicate things further is a disparity in data science expertise across sites, which keeps a company in reactive instead of proactive mode.

Pharmaceutical companies are therefore increasingly looking to pull data into the cloud from multiple sources, including manufacturing, lab systems, ERP solutions and financial solutions. Aggregating those data offers these businesses the opportunity to mine their data, creating an integrated overview of how the whole business is performing and affording better decision-making. Cloud solutions can augment validated on-premise solutions and data can be extracted to feed machine learning. Cloud can also support the implementation of advanced digital solutions in remote locations where there is limited IT support. For all these reasons the volume of data pharmaceutical companies bring into the cloud is likely to increase over time.

With the benefits that cloud affords, many pharmaceutical companies have moved from the ‘norming and forming’ phase of cloud implementation to the ‘storming and performing’ stage, where the concept is proven and they are thinking through more applications and use cases. However, many questions remain.

What sort of data from manufacturing, labs or financial systems should be in the cloud, for instance and what should reside at plant level? What kind of cloud-based applications should they use? But for many, the most important question is what is the data strategy pharmaceutical companies should follow right now, in the pursuit of greater accessibility to data for sharing, analysis and ultimately reducing the IT burden?

 

Putting a plan in place

The biggest question, however, should be: how can companies take full advantage of the cloud now, in the context of well-planned digital strategies? In simple terms, the first step is identifying the pain points; building strategy, aligning with the company’s business initiatives and securing buy-in. The second step is to determine KPIs, plan and implement pilots, then assess and scale.

New cloud-based approaches using AI and predictive capabilities are already delivering important gains in the efficiency and time-to-market of batch releases, for example, resolving the bottlenecks around reviewing of data. Electronic record-keeping and the reduction of human error mean organisations benefit from increased data integrity.

 

Step by step

Process predictions is one area that pharmaceutical companies often focus on to get the ball rolling, especially if there are indications that quality or reliability are at risk. Implementing predictive technologies is often the first step pharmaceuticals companies take on their move to the cloud because it is lower risk. The results raised by predictive technologies around likely equipment failures further down the line are early flags that, if acted upon, will prevent problems occurring at a later date and help the organisation minimize unplanned downtime.

In our example of a batch release process, manual review of paper-based systems is highly manual and error-prone.

With relevant data collected and integrated seamlessly, the workflow can be made more efficient because checks and controls can be handled electronically by automated systems, both on-premise and ultimately in the cloud where there is even greater accessibility to data. That means products can be confidently released in a timely manner. Also, removing the need for people to spend their time on laborious manual checks, frees them up to perform higher-valued tasks within the organisation.

 

Reaping the rewards

Most pharmaceutical companies will benefit from significant cost savings by moving to the cloud.  The cost of building and scaling an on-premise IT set-up can be exorbitant, especially for smaller companies. Typically, to run a production, development and a test system on-premise, organisations will need computers, servers and cables, in addition to networking. There are likely to be significant IT maintenance costs to factor in on top of that. By moving to the cloud, pharmaceutical companies can offload much of this cost.

Critically, having data available in the cloud drives efficiencies. In the development process, firms can start to circumvent the time-consuming process of having to shuffle papers, churn through reports and spreadsheets and so forth.  By driving greater efficiency in that process, and across the wider supply chain, pharmaceutical businesses can shorten time to market.

The cloud can also help companies predict more effectively and therefore become more reliable in terms of process and assets.  The ability to remove manufacturing downtime and to release assets creates a more reliable supply chain and therefore helps to provide a guarantee to the end customer that the product will be on the shelf as soon as it is needed.

Starting out on the journey to the cloud is becoming an urgent imperative for pharmaceutical companies today. They don’t have to do everything in one go – a step- by-step approach can pay rich dividends – but by getting underway they can stop merely gathering data and instead start using it to drive business advantage and competitive edge.