Oracle and PwC team up on drug development solutions

Faced with a multitude of pressures, including the demise of the “blockbuster” drug model, a decline in market growth and increased therapeutic competition, the pharmaceutical industry is

By Editor on Feb 1, 2001

Faced with a multitude of pressures, including the demise of the blockbuster drug model, a decline in market growth and increased therapeutic competition, the pharmaceutical industry is searching for new ways to achieve stockholder expectations. And according to Simon Hughes, Director PwC Pharmaceuticals Industry Group, transformation of the development process is one promising avenue to reduce costs, increase efficiencies and speed time-to-market.

In fact, Hughes predicts that to meet stockholder expectations, R&D organizations must double the numbers of drug leads and the success rate of drugs entering development. They also need to add three years to peak sales of marketed drugs and increase average revenues per drug by 20 percent. The Oracle-PwC partnership therefore plans to focus on solutions that will allow companies to leverage the vast quantities of information scattered among disparate computing systems and applications to improve the decision-making process throughout the drug development lifecycle.

Looking ahead to 2005, the industry cannot continue with its current development model and survive, said Steve Arlington, Global Head of Research and Development Consulting at PwC Management Consulting. On average, it has traditionally taken 12-15 years from target identification to market launch. Over the last decade, the cost of drug development has risen to in excess of $600 million. Everyone agrees this isn'st sustainable, but until now only incremental changes in the process have been possible, despite the industry's best efforts to improve things.

However, using our approach by killing projects that don'st succeed earlier (currently only one in 10 drugs make it from test tube to market) and by reducing the size, complexity and number of trials a typical pharmaceutical company might expect to make double-digit percentage savings in the current cost and time in clinical development, Arlington continued.

Oracle and PwC have agreed to develop an open architecture, capable of handling data regardless of a company's existing technology platform and accommodating the addition of new applications and data sources as the science and technologies advance in the future. The team has promised to build a high-performance data model that is user-definable and independent of particular clinical data management software or applications.

The key to this revolution is a central data repository, which accommodates and integrates all the relevant data, irrespective of source and format, said Juan Rada, Senior Vice President, Oracle Industries EMEA (Europe, Middle East and Africa). Significant benefits accrue as this critical resource is exploited and interrogated to improve decision-making throughout the drug development lifecycle and beyond.

The team's vision includes a virtual private network, connecting the integral members of a typical development team in a reliable, always-on phone company model. Internet deployment of applications and decision support tools will be achieved through a portal model, enabling the creation of both internal and external communities to be created.

Internet technology means that this centralized information can be shared, via personalized and secure portal access, among all those involved in the drug development process, possibly even including regulators and patients, Rada said. This approach will cut through functional and organizational boundaries, and significantly reduce the wasted time and energy involved in re-cutting the data to meet the needs of different groups.

To achieve the level of flexibility and reliability required, the team has chosen to customize its solutions around a configurable hub that allows integration of a company's pre-existing and future applications through the use of individual, specialized adaptors. This approach is designed to enable process integration and optimize system validation. The partnership believes the new system will be particularly helpful following mergers, as a newly formed company attempts to integrate many different legacy systems.

According to John Murray of Oracle, the solution is being designed for both existing Oracle customers as well as companies that are not already using Oracle products. Non-Oracle customers will gain support through the provision of tools to load both clinical and non-clinical data, while existing Oracle customers will benefit from the re-use of definitions that are already in place. The solution will, however, require the use of Oracle 9i, which serves as the hub of the system.

A suite of data handling solutions will be offered, including a warehouse for data storage, as well as tools for data loading, manipulation, visualization, management and distribution. The team also is considering the development of tools for standards reports (such as point tabulations) and to enable replication of data and programs to other servers.

Because the changes occurring in the pharmaceutical development process will not occur overnight, the solution will facilitate a phased implementation approach, allowing companies to customize the process for drug development to meet their own needs and time scales. In addition, the partnership will offer implementation acceleration services, including project management, business process design, migration management, solution implementation, validation, hosting services, training and knowledge transfer, and change management assistance as product options.

Oracle and PwC hope to form alliances with three or four major pharmaceutical partners by the end of this month and anticipate rolling out the first version of the solution in the next 12-18 months.

For more information about PwC and Oracle, visit the companies's Web sites at www.pwcglobal.com and www.oracle.com.

Editor's note: The editor would like to acknowledge the contributions of Helen Oram, eyeforpharma Newsdesk writer, to this article.