Sanofi-Aventis Brings Products to Market More Rapidly with SAS®

"Because Health Matters." That's the slogan of the second largest pharmaceutical group in France. With a presence in 100 countries and more than 30,000 employees worldwide, Sanofi-Aventis had consolidated annual sales of €6,488 million euros ($7,313 million) in 2001. Its strengths lie in four areas: cardiovascular/thrombosis, central nervous system, internal medicine and oncology.

With 6,300 researchers and 48 drugs under development, research is a major strategic axis for the group. Sanofi-Aventis has selected SAS, whose solutions are recognized by the United States Food and Drug Administration (FDA) to accelerate the development and marketing stages of its drugs and consequently to improve profitability.

Speeding the Development Phase
Pharmaceutical research follows a well-determined process. The initial investigation has as its objective the discovery or exploration of new substances with potential targets in terms of treatment. This stage focuses on some core aspects of research such as cardio/thrombosis or the fight against cancer and determines potential substances that over time may be developed as a future medicine. Once identified as potentially useful for a given therapeutic indication, a substance enters the development phase.

According to Didier Régent, Director of Information Systems for Sanofi-Aventis, "Of all the substances studied, only a few can later be used." Once the preclinical phase appears to be viable, clinical development involving human subjects is initiated within the regulatory context. "At this stage," says Régent, "the objective is to develop these substances as rapidly as possible until we can obtain approval for launching and marketing." A patent is valid for 20 years from the time that it is filed. The faster the developmental phase is, the longer the pharmaceutical group can actually use the patent.

SAS Helps Gain Time in Marketing
The regulatory authorities must be provided with all the results that show that the product has successfully passed these trial phases. Physicians working together with statisticians determine the various clinical models. Sanofi-Aventis looked to SAS to supply the software that would allow it to analyze the data collected in the course of clinical studies and to reduce the development phase. Didier Régent adds, "In order to obtain Launching Approval as early as possible and to increase the marketing phase, we must provide an electronic file that contains the document management and data analysis tools. SAS software integrates into all the electronic file management processes and provides us with real added value."

A Solution Recognized by the FDA
Sanofi-Aventis must generate results that integrate into a complete report that the group submits to the health authorities. This report includes all the studies including all the stages, from preclinical development to clinical development, as well as the data that yielded these results. It is therefore of utmost importance that these data are reliable and that the tools are validated so that the results comply with statistical laws.

The SAS solutions reflect the professional concerns of Sanofi-Aventis. The tools must be reliable, easy to deploy, effective and rapid. They must also meet the professional expectations of the pharmaceutical industry. According to Didier Régent, "We will continue to use SAS, because its software is appropriate and allows us to file quality documents in terms of results, methodology and associated development."

SAS also provides Sanofi-Aventis with a unique overview of its processes and allows it to evolve its approach, specifically for the non-clinical part, which the group now emphasizes.

The objective of the group is to standardize and homogenize its architecture in terms of procedures and programs and to study a centralized solution. "SAS has now been installed throughout Sanofi-Aventis in order to produce results linked to the clinical trials. We are in the process of implementing software together with SAS using an architecture developed with Websphere for preclinical or upstream research applications for the non-clinical part," says Didier Régent. This architecture is scheduled for implementation in 2003.

A global clinical database
Sanofi-Aventis has three research centers – Montpellier and Chilly-Mazarin in France and Malvern, PA in the United States – that guide the clinical studies and work with affiliates to conduct the studies in various countries. All of their data are consolidated and gathered into a global database. Didier Régent emphasizes, "We have databases that are replicated between Europe and the United States in order to eliminate problems relating to response time and followup. Now, we have an architecture that uses SAS solutions installed in the three research centers of Sanofi-Aventis. There are links between SAS and the clinical database for the statistical analysis of the data."

Copyright © SAS Institute Inc. All Rights Reserved.