Digital: Cloud Storage‘Storming and Forming’ Cloud DeploymentPharmaceutical companies that have started to embrace digitalisation and cloud storage are examining the many areas where these technologies can benefit their increasingly data-rich businesses Kelly Doering at AspenTechThe move to digitalisation and the migration to the cloud have been happening gradually in the pharma sector. Immature digital cultures, lack of in-house data skills, or poorly defined digital strategies have combined to hold businesses back. Historically, misperceptions about the cloud have supported this view. Manufacturers with established, legacy systems are often unduly concerned about the security risks of moving to the cloud. There has been hesitancy to invest in new cloud infrastructure, even though the likely long-term savings far outweigh its short-term costs.

More recently, however, ambitious pharma companies are embedding themselves in the ‘storming and performing’ era of cloud adoption, accepting that this is the direction they will need to pursue in the age of digital transformation and Pharma 4.0.
Hybrid Approach The move from on-premises, local software installation to cloud, where data is stored and accessed from a global network of servers, is becoming more common. At the inception, many manufacturers have chosen to adopt a hybrid cloud approach. This is 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 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 rollout of vaccines has set a tough precedent for pharma 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 pharma 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, pharma manufacturers are seeing adoption of hybrid cloud infrastructure as a 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 companies are beginning to set up data lakes as the starting point of a wider migration away from exclusively on-premises 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 is growing greatly.

Some of the main reasons to implement cloud strategies are to satisfy the requirement to get medicines to market faster and to minimise supply chain disruptions. Another factor is the need to manage the increasing amounts of data that accompany 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 do the numbers of individual data silos, which often reside at multiple locations. A further complication is a disparity in data science expertise across sites, which can keep a company in a reactive, instead of a proactive, mode.

Increasingly, pharma companies are looking to pull data into the cloud from multiple sources, including manufacturing, lab systems, ERP solutions and financial solutions. Aggregating those data offers them 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-premises solutions and data can be extracted to feed ML. 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 pharma companies bring into the cloud is likely to increase over time.
With the benefits that cloud affords, many pharma 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. For instance, what sort of data from manufacturing, labs or financial systems should be in the cloud and what should reside at plant level? Or what kind of cloud-based applications should they use? But, for many, the most important question is: What data strategy to 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 companies can take full advantage of the cloud now, in the context of well planned, digital strategies. In simple terms, the first step is to identify 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, by resolving the bottlenecks around reviewing data. Electronic record keeping and the reduction in human errors mean organisations benefit from increased data integrity.
Step-by-Step Approach One area that pharma companies often focus on initially is process prediction technology, especially if there are indications that quality, or reliability, is at risk. Implementing this is often the first step to the cloud, because it is lower risk. The results raised by predictive technologies, around likely equipment failures down the line, are early flags that, if acted upon, prevent problems occurring later and help minimise unplanned downtime.

In the 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. This is because checks and controls can be handled electronically by automated systems, both on-premises and, ultimately, in the cloud, where there is even greater accessibility to data. That means products can be released confidently and in a timely manner. Also, removing the need for people to spend time on laborious manual checks frees them to perform more valuable tasks.
Reaping the Rewards Most companies gain significant cost savings by moving to the cloud. The cost of building and scaling an onpremises IT setup can be exorbitant, especially for smaller companies. Typically, to run a production, development and test system on-premises, organisations need computers, servers and cables, in addition to networking. There are likely to be significant IT maintenance costs on top of that. Moving to the cloud offloads much of this cost.

Critically, having data available in the cloud drives efficiencies. In the development process, firms can circumvent the time-consuming process of having to shuffle papers, churn through reports and spreadsheets, and so on. Greater efficiency here, and across the wider supply chain, 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 when it is needed.

Starting the journey to the cloud is an urgent imperative for pharma companies today. They do not have to do everything in one go; a step-by-step approach can pay rich dividends. They can stop merely gathering data and begin using it to drive business and competitive advantages.
Kelly Doering is Senior Director, Industry Marketing, Pharma, at AspenTech. She leads the marketing team for the Pharmaceuticals Business Unit at AspenTech and has held numerous roles in product management, technical marketing, and business development since 2007. She completed a postdoctoral fellowship at Boston Children's Hospital and holds an MS and PhD in Nutritional Sciences & Molecular Biology from the University of Connecticut, US, and a BS in Health Sciences and Natural Sciences from Worcester State University, US.
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