Life sciences executives are turning to technology to address critical data issues for M&As, regulatory compliance, and beyond.

Dec 2005 / Jan 2006 | Clinical Data acquires Genaissance. Pfizer acquires Pharmacia. Affymetrix acquires ParAllele. In the life sciences and pharmaceutical industries, the number of mergers and acquisitions continues to rise. The challenge of meeting aggressive merger timelines while dealing with regulatory validation and business integration issues is significant.

From a broader IT perspective, life sciences companies face numerous systems management and integration challenges, including disparate data sources and types, and a plethora of data consumers and requirements. These issues can create significant cost and regulatory hurdles. Concomitant with these integration issues is the ability to provide for a common and regulatory-compliant information security infrastructure.

Defining EII
The resolution of these challenges must, by definition, be architectural but implemented within a compressed timeframe. An emerging approach is a thin reference layer -- a data services grid -- to unify fragmented source data for reporting and applications. This layer is known as enterprise information integration (EII).

An EII server presents live data from different sources as if it existed in a single place. In contrast to a data warehouse, EII appears as a “virtual” database -- transparently generating queries to multiple sources behind the scenes and combining information appropriately as it is returned. The benefits are more flexibility, unlimited detail, and always-current data. (EII is often used in conjunction with, but not as a replacement to, a data warehouse, to extend existing analysis capabilities.) These qualities make EII well suited to the broad scope, iterative approach, and short timeframes of life sciences reporting and development projects.

EII is making inroads in the pharmaceutical, banking, and other data-intensive industries. IBM offers its Information Integrator extension for DB2. Composite Software (also available from Informatica and Cognos) is an early EII pure-play vendor. And Sybase recently entered the space with its acquisition of Avaki.
EII Applications

Both upstream and downstream business processes face the challenge of information sources located in different silos. The following process areas are examples of EII-based solutions deployed or in development by leading pharmaceutical companies:

Drug discovery/upstream R&D. One biotechnology firm is investigating the use of EII to map experiment data from distinct projects into normalized formats for cross-product discovery. Because of the ad hoc nature of drug discovery, many systems and data sets are “homegrown” and vary from project to project. Clean records are important from a compliance perspective as compounds move between phases.

Marketing and sales. With investments of thousands of dollars per physician, field education, coverage, and measurement are critical to the success of any drug marketing program. One large U.S. pharmaceutical provider is implementing dashboards for its regional managers to roll up key performance indicators on each rep in his or her region -- samples, coverage ratio, pictures of new arrivals, and sell-through results. As these data elements come from different sources, the EII server provides an aggregation layer to simplify development and keep business and data modeling logic insulated from potential future changes in the user interface/presentation layer. The goal is improved visibility into each rep and better market responsiveness as a result.

Administration. In a large global pharmaceutical firm, organic growth and a series of acquisitions domestically and internationally left internal systems fragmented. To get a clear view of the organizational headcount for reporting/planning purposes, internal analysts traditionally spent a minimum of three weeks gathering information manually. With improvement in processes, data gathering, and an EII server to federate the data sources, full reports are now built automatically in a matter of minutes.

Bioinformatics. With the growing number of public genomic and proteomic databases, the need to query both internal and external repositories is a challenge with varying search capabilities, formats, and result sets. Typically this issue has been addressed by either custom coding or manually querying different systems. The custom code approach doesn’t scale well, and several pharmaceutical companies are evaluating EII as an alternative. EII can provide a unified querying layer to couple these internal and external information assets for more effective offline analysis.

Regulatory compliance. One of the best ways that EII helps support pharmaceutical companies meet regulatory compliance requirements is during the process of tracking lot numbers. EII provides additional visibility into batches of ingredients and finished goods. The information often resides in various manufacturing execution systems, as well as in inventory and warehouse management systems. EII can tap these disparate systems and give the pharmaceutical line manager or executive a single view of the whereabouts of every lot number. More importantly, the information is available on demand, in the case of a recall or a regulatory audit.
Platform Requirements

For all of the above-mentioned examples, fundamental architectural requirements apply. EII supports the independent maintenance of metadata about the sources and uses of data, providing a complete abstraction environment. (By definition, point-to-point adapters do not provide any ability to combine or simplify data.) It operates across standard data sources (relational, XML, Microsoft Office, etc.), operating systems, and access mechanisms (ODBC, JDBC, and Web Services). The approach provides capabilities for separate and granular access control and information security. It also provides extensibility to custom data sources and types, to be broadly deployable. And increasingly, the approach coexists with packaged applications such as Siebel and SAP.

As more biopharmaceutical organizations face the challenges of integrating their business systems, they are looking to technology to help make this integration a smooth process. With its ability to create a “virtual” database that transparently generates data queries to multiple sources behind the scenes, and presents the information in a way that users can best use it, EII is proving to be a strong ally to organizations whether during the transition periods of a merger or acquisition, or by helping organizations readily obtain information necessary to meet with regulatory compliance procedures, or to fragmented data sources generally.

Michael Abbott is CTO and founder of Composite Software. E-mail: mike@compositesw.com.