Andrew Brosnan, Senior Analyst, Health Sciences
Life sciences companies are faced with significant economic challenges that necessitate a change in their business model: the cost of developing new drugs is too high, and the current cost of healthcare is unsustainable. As a result, big pharmaceutical companies must leverage new technologies to extract greater value from their data while reducing the cost of drug development.
At this year’s Oracle OpenWorld conference, Oracle and Accenture outlined the R&D IT platform that they are developing to provide pharma companies with enhanced analytical capabilities while streamlining the industry’s drug development operations.
A complex environment and increasing trial costs necessitate change
The cost of clinical trials has been steadily increasing, and the thresholds for the commercialization of new drugs have been raised. Clinical trials are becoming more difficult to run and more complex in nature, particularly with the increasing application of personalized medicine. As many as 1,900 drug candidates at various stages of development currently require clinical testing in order to win regulatory approval for commercialization.
At the same time, for formulary placement and reimbursement of new drugs, healthcare payers are requiring greater efficacy over existing medications.
In this environment, biopharma companies need to focus on researching and identifying novel drug therapies that meet these more stringent criteria rather than on the mechanics of operating clinical trials. They are therefore outsourcing more and more trials to contract research organizations (CROs). This externalization has led to a complex environment of providers that perform all or part of clinical trials for trial sponsors.
Although standards have been established for the collection and reporting of clinical data, in reality there is considerable variation in how these standards are implemented across the provider ecosystem. Additionally, these providers service multiple trial sponsors that have diverse requirements and specifications.
As a result, the integration and aggregation of the vast amounts of trial-related data, much of which is unstructured, requires significant resources. Furthermore, each trial sponsor currently has to maintain its own internal infrastructure necessary to complete these data operations.
Oracle and Accenture’s cloud-based solution, Accenture Life Sciences Cloud (ALSC), seeks to address these pain points, which have grown out of this fragmentation of the value chain, while reducing the overall cost of implementing and maintaining the necessary IT infrastructure.
A shared cloud-based platform, inconceivable a few years ago, is now becoming a reality
At its core, ALSC leverages Oracle technology, namely Oracle’s Life Science Data Hub, Data Management Workbench, Clinical Development Analytics, Oracle Fusion Middleware, and Oracle Exadata, and it is made available through the Oracle Cloud. On top of this core platform, Accenture has layered extensive business model and process integration adapters to deliver a comprehensive service offering. The partnership provides a secure, extensible, and scalable platform that is much more rapidly provisioned and implemented than a similar on-premise implementation.
ALSC will offer greater efficiency and functionality over existing proprietary implementations by establishing a specified implementation of industry standards, increasing the reusability of aggregated data and the adoption of a “utility” model that enables co-investment in a single solution. By adopting a specified implementation of the industry data standards, different stakeholders in the drug development ecosystem will be able to exchange data more easily and efficiently.
The adoption of a utility model will negate pan-industry duplication of investment in a multitude of proprietary solutions that provide similar functionality.
The two partners are already working with a large multinational pharma company and two CROs, using the platform to aggregate and share data. The vision of the partnership is to have additional life science companies participate by co-investing in the platform, a concept known as pre-competitive collaboration, to further enhancements, such as end-to-end integrated applications in the cloud, for the benefit of all members.
Representatives from both companies said that they were in talks with other large multinational pharma manufacturers about participating in the “coalition”: seven multinational companies participated in the inaugural meeting. Other institutions would also be able to use the platform on a subscription basis, so smaller institutions can reap the benefits of the platform too.
Data aggregation has potential, but a critical mass of clients is necessary
The aggregation of diverse trial-related data, with the potential to integrate with other sources such as electronic medical records and pharmacogenomics on Oracle’s high-performance hardware, represents an opportunity to derive greater value from scientific, operational, and medical data.
New high-performance hardware technologies are enabling more robust types of analysis to be conducted. Furthermore, subscribing to the platform and thus becoming a part of an alliance could represent a competitive advantage for different stakeholders within the ecosystem, particularly CROs. Subscribing clients would be assured that trial data is provided in a specified format or one that conforms, and that there is already an established means for transmitting trial data.
However, in order for subscription to represent a competitive advantage for CROs, there needs to be a critical mass of organizations either subscribing to or participating in the platform. Although security concerns are somewhat mitigated by the fact that certain documents such as the trial protocols are needed to interpret the data sets that are being transmitted, the industry is still rather hesitant, culturally and legally, about putting sensitive data in the cloud.
Despite this, additional multinational pharma companies have expressed an interest in participating in the project, and this is encouraging.