Eroom's law is the acknowledgement that the cost of developing a new drug roughly doubles every nine years. Drug development is becoming slower and more expensive over time, meaning an ever-dwindling number of new drugs emerge from the market every year.
The pharmaceutical industry is crumbling under the weight of this issue. An industry that can most benefit from new, innovative products, is unable to take advantage of all the possibility our technologically evolving society has to offer. Instead, pharmaceutical companies are struggling to support the burden of inefficient development processes and crippling expenses.
This diagnosis will prove fatal to the industry if nothing is done to transform the status quo. New efficiencies through cloud technology must be utilized to increase the agility needed to stay competitive in our digital era.
Research and Development (R&D) is a complex area, made even more complicated by the industry regulations and security requirements at this stage of the product lifecycle. R&D requires the recording, storage, processing, and analysis of massive amounts of clinical data. To cope with this major influx of data, a more efficient and cost-effective application management construct must be implemented.
Application platform technology in the cloud can enable streamlined R&D by unifying fragmented processes and siloed data. With cloud applications, organizations can provide transparency throughout R&D, allowing for seamless information sharing. Cloud can also enable integration across development sites around the world, and facilitate automatic system updates to maintain compliance for evolving regulatory needs.
Further, data security can be achieved with a hybrid of cloud and on-premises implementations. Organizations have the ability to protect their most sensitive data within their existing firewalls while extending more flexible developmental activities into the cloud. Certain cloud platforms have additional security and compliance measures that can instill complete confidence in the transformed development process.
Clinical Trials are another stage in the product lifecycle that could benefit from digital transformation enabled by the cloud. Clinical Trials can be highly disconnected, making them difficult to navigate. The biggest challenge is to improve communications and share information, both within, and across trial instances and systems. To enhance efficiency in this stage of the product lifecycle, it is essential to provide an easy mode of collaboration between patients, investigators, regulators, and service providers.
Implementing a cloud solution in the clinical trial stage of development can improve the quality and increase the consistency of data sharing among key members of the trial process. This, in turn, can speed the timeline of the clinical trial, by getting results to those who need them quickly and easily.
Cloud technology also improves communication across geographic regions, making collaboration globally accessible. These efficiencies in communication ultimately contribute to a streamlined process, reducing time-to-market, and remaining transparent and compliant throughout.
Labeling is a third stage in the medicinal product lifecycle that could benefit from cloud adoption. Ensuring the safe and effective use of a drug is the ultimate goal, making the labeling process one of the most crucial aspects of pharmaceutical delivery. There are many obstacles and considerations to pay mind to in this process, such as regulatory compliance and regional labeling differentiations. The safety of patients is at stake.
To control the chaos of managing labeling requirements, varying regional labeling requirements, and audit demands, it is imperative to achieve a consolidated and standardized process. Here is where cloud technology can be transformational.
Cloud solutions can manage all variations of labeling content, whether it is print, packaging, or digital content, in various languages, and under a spectrum of regulations. This gives organizations the ability to run regional applications around the globe faster, with implementation and integration capabilities across multiple sources. Easier data integration and accessibility makes maintaining compliance easier, and the whole labeling process more streamlined.
There is immense potential that comes with Cloud adoption for the life sciences industry. The Cloud can help at each stage of the product lifecycle; here are the top three benefits the cloud can bring:
1. Cost Reduction
One of the most pressing issues plaguing the life sciences industry, the increasingly high costs of drug development, can be eased with cloud implementation. Cloud users have recorded a noticeable cost savings from using cloud-based software and infrastructure. Leveraging cloud can require less development infrastructure investment and testing resources. This helps moderate monetary investment in initial development environments and execution, as well as subsequently controlling costs for support and maintenance of applications.
"With typical IT organizations spending over 30% of their budget on infrastructure (primarily data centers and data networks), shifting some or all of this work to the cloud can save organizations anywhere from 10-20% of their annual IT budget, savings that can either be returned to the firm or reinvested in growth and innovation." *
2. Improved Efficiency
The cloud can help enable automation for repeatable business processes, getting drugs to market that much more efficiently.
Implementing an automation platform in the cloud also improves the ability to collaborate among departments, suppliers, regulators, and distributors. An open channel of communication promotes faster decision making and a more streamlined drug development process.
This transparency also allows employers to gather data on the capacity and availability of materials and other employee needs. Having awareness of, and feedback from processes in real-time makes operations more efficient and gives decision makers a more informed perspective.
3. Scalability and Flexibility
Pharma can require very large server storage investments and expensive network technology to host the massive amounts of data gathered throughout the drug development process.
Cloud computing offers a much more flexible environment for data storage and sharing. Organizations have the ability to scale up from tens to hundreds of servers to perform complex programs and return to baseline levels once the program is completed.
"Cloud services have a high degree of cost variability, so expenses can quickly go down if demand for services is reduced."**
When an organization wants to expand into new trials, products, markets, and/or regions they need a core IT infrastructure that can scale to their decentralized needs. Cloud technology offers standardization or personalization where needed.
Life Sciences organizations are constantly faced with the challenge to rapidly adjust their infrastructures to new standards and adjust the scale of certain requirements to better tend to their operational needs. On-premise applications aren't easy to efficiently structure, expand and scale to various activities and processes. But if altering processes to meet requirements are not achieved in a timely manner, a company can be in danger of not meeting compliance standards and falling behind competitors.
With cloud technology, organizations can deploy scalable IT solutions that are easily adjustable to meet any requirements that arise. Cloud offers the assurance that needed resources will always be available for quick implementation. This capability not only lends to maintaining compliance, but also contributes to improving speed to market.
"By 2019, over 75% of life science R&D IT organizations will adopt cloud-first applicationdeployment strategies."
- Gartner, Accelerate Digital Capabilities by Migrating Validated Life Sciences Applications to the Cloud, 01 August 2017
Organizations have already started making the move to Cloud. At Appian's recent Pharma User Group meeting, many customers discussed their Cloud implementation journeys. From slow and fragmented processes, overwhelming compliance standards, and ever-changing regulations to seamless integrations across departments and regions, providing enhanced performance and ultimately improving patient outcomes. Every Cloud implementation discussed mentioned expedited time-to-market, and efficient drug development cycles.
This Cloud-based efficiency doesn't end with drug labeling. Cloud is also disrupting the Healthcare industry, benefiting Healthcare providers in the drug distribution process. For a broader look at how Cloud is disrupting the drug lifecycle, from conception to clinician, check out this eBook:
Appian is the unified platform for change. We accelerate customers’ businesses by discovering, designing, and automating their most important processes. The Appian Low-Code Platform combines the key capabilities needed to get work done faster, Process Mining + Workflow + Automation, in a unified low-code platform. Appian is open, enterprise-grade, and trusted by industry leaders.