Cynthia A.Challener, Ph.D, Scientific Content Director, That's Nice LLC
Drug development is a time-consuming and costly enterprise. It takes on average more than 10 years to receive regulatory approval for new medicines, and the average cost to develop a new drug is estimated to be $2.6 billion-double that just 10 years ago, according to the Pharmaceutical Research and Manufacturers of America (PhRMA). The rising costs are in part due to the exponential increases in generated data (i.e., genetic sequencing information, results of numerous large and complex clinical trials and electronic patient records) that must be collected, managed, monitored, shared and analyzed for both discovery and regulatory compliance purposes. Despite its conservative nature, the pharmaceutical industry is turning to cloud computing and the Industrial Internet of Things (IIoT) to increase efficiencies, reduce costs, and accelerate the development of highly efficacious drugs.
Beyond Improved IT Performance
IT departments have traditionally been significant cost centers for drug manufacturers. Despite dramatic increased in computing power, the complexity of needs and the growing demands placed on current IT systems have led to increasing costs. Today’s pharma industry IT systems must deliver cost-effective solutions for managing vast quantities of disparate data while maintaining quality, regulatory compliance and flexibility. Use of infrastructure-as-a-service (IaaS), cloud-based platform-as-a-service (PaaS) and software-as-a-service (SaaS) systems eliminates the need for capital expenditures on infrastructure, freeing up dollars for investment in R&D. Ongoing costs for maintenance and personnel and the need to rely on legacy and rapidly outdated IT systems are also eliminated.
“Today’s pharma industry IT systems must deliver cost-effective solutions for managing vast quantities of disparate data while maintaining quality, regulatory compliance and flexibility”
Cloud computing also allows for rapid system configuration and ready scalability of nearly unlimited computing, storage and other infrastructure resources. Additional benefits include portability and immediate access to centralized, real-time data from any device in any location. For smaller and even some larger companies, cloud computing provides access to technologies and practices they cannot afford internally. Indeed, a survey of several emerging pharma and biotech companies identified numerous advantages of cloud computing: “reduced cost and greater R&D speed, improved efficiency, enhanced agility, superior storage and data analysis, improved change management, superior collaboration and connectivity, enhanced security, faster drug discovery, better performance, appreciable regulatory proficiency with greater scalability and flexibility of IT resources.”
With the move to evidence-based medicine, it is no longer sufficient for new drugs to be safe and effective; they must earn their position on insurance formularies with demonstrated, advantageous performance compared to existing products on the market. However, generating such data through comparative clinical trials is not practical. These large masses of information must be obtained from clinicians and patient health records. In addition to making retrieval and processing of this data possible, cloud computing can help companies find and recruit appropriate patients for drug trials. Efforts are being pursed to connect researchers with patient data in order to leverage the vast quantities of information now available regarding responses of diseases to various treatments.
Cloud-based electronic data capture systems (EDC) combined with mobile communications, social media platforms and wearable technologies are also transforming the way in which clinical trials are conducted. With the storage of protocols, assignments, and patient data in one central location for all sites in a clinical trial, cloud-based EDC software provides efficient data monitoring, analysis, trending and reporting, enhanced communication and collaboration, better budget forecasting, and significant cost savings. The modular, scalable, custom-configurable cloud-based EDC platforms available today allow selection of the tools that are needed when they are appropriate for a given study.
Basic discovery efforts are also benefitting from the vast resources enabled by cloud-based computing. Not only collaboration across multiple locations is made possible; processing of large quantities of data generated from genome sequencing, proteomics research, protein docking, modeling and simulation, and data mining, are also accelerating the early phases of drug development. Bioinformatics, statistics and adaptive trial designs can be more rapidly implemented with predictable times and costs. Furthermore, hybrid systems help maintain confidential patient information separate from data used for research purposes.
Managing the Supply Chain
As growth in the pharma industry has shifted to emerging markets where demand is greatest for low-cost, low-margin products, drug manufactures have responded by outsourcing many aspects of their businesses. In the process, companies have lost control over many aspects of the supply chain and are turning to cloud-based sourcing solutions to gain greater visibility into all parts of the value chain. Simultaneously, vendors gain access to information necessary for providing optimum performance through controlled interactions. Integration of purchasing systems, logistics and quality management systems allow real-time monitoring and data sharing with multiple vendors and preemptive resolution of potential problems.
Cloud-based computing combined with and leveraging of the IIoT and automation of manufacturing processes and process analytics, enables real-time monitoring and control for improve quality and efficiency at lower cost, plus effective production scheduling, forecasting of raw material and equipment needs and contingency planning across multiple facilities. Additional benefits include:reduced likelihood of operator errors, enhanced safety, increased product quality and consistency, and greater flexibility to respond to changing market demands. Regulatory compliance efforts, such as serialization, can also be simplified.
Supporting the Customer
Cloud computing has perhaps been most widely employed in the pharma industry to increase access by sales and marketing teams to up-to-date information. SaaS systems including mobile platforms are also affecting the relationships between sales representatives and physicians, enabling drug companies to play a more educational role and gain access to data that can be used for future drug development efforts. Accenture reports that one pharma company was able to reduce customer resource management staff and department costs each by 50 percent.
Security and Regulatory Compliance Concerns
Uncertainties about data security and regulatory compliance are the biggest hindrances to the adoption of cloud computing in the pharmaceutical industry. Companies that have implemented IaaS, PaaS and SaaS solutions in the regulated (GxP) environment take the approach that these risks can be mitigated through appropriate risk mitigation, validation and documentation strategies that consider cloud-based architectures. They are also turning to cloud-based services designed specifically for life-science companies that are offered by providers with an understanding of the regulatory compliance issues faced by the pharma industry. In fact, in many cases security at such firms is often greater than can be achieved with in-house resources. The GAMP Cloud Computing Special Interest Group (SIG) was formed in 2012 to develop guidance on the use of cloud technologies in the GxP environment in order to accelerate their adoption.