Director of Global Biometrics
Rx for Global Intelligence, Solvay Pharmaceuticals enhances worldwide drug development efforts with SAS
Shortening drug development cycles is a primary goal of all pharmaceutical companies. But the need is compounded when companies lack sufficient means for sharing the data used in collaborative research efforts at locations spread around the globe.
Such was the case for Solvay Pharmaceuticals, a subsidiary corporation of the worldwide Solvay Group of chemical and pharmaceutical companies headquartered in Brussels, Belgium, but with test facilities in the Netherlands, United States, Germany and Japan. Using SAS® Drug Development, Solvay Pharmaceuticals effectively removes geographic boundaries to make information available to anyone who needs it, when they need it.
"The power to get to know your compound better on a global scale by using SAS Drug Development will translate into improved earnings through shorter time to market and decreased development costs," says Stefan Driessen, Solvay Pharmaceuticals’ director of global biometrics.
The power to get to know your compound better by using SAS will translate into improved earnings through shorter time to market and decreased development costs.
Expediting drug development
Solvay Pharmaceuticals, one of the top pharmaceutical companies in the world, focuses drug development efforts in the fields of psychiatry, gastroenterology, cardiology, male and female hormone replacement therapy, and immunology. The company invests 15 percent of sales earnings into research for new drugs.
When developing these drugs, Solvay Pharmaceuticals needs a repository to provide global, secure access to clinical information that is used by some 100 researchers around the world, working in a variety of areas, including data management, statistics, and clinical and medical review.
With SAS Drug Development, the company has found an all-in-one solution for data warehousing, analysis, reporting and exploration that transforms massive amounts of data into intelligence, which, in turn, expedites the drug development process.
Solvay Pharmaceuticals collects a huge amount of information during clinical trials, explains Rick Miller, director of clinical information management for Solvay Pharmaceuticals Inc. The data must be stored electronically while remaining easily accessible. Meanwhile, the company has to ensure it complies with stringent regulations placed on electronic data systems by the U.S. Food and Drug Administration (FDA). And Solvay Pharmaceuticals must efficiently deal with data coming in from other companies around the world, including outsourced clinical trials.
"Whether we’re doing development in Europe or in the U.S., we need to be able to combine and share data – and learn from it – so that we can submit it for regulatory approval," Miller says. "SAS gives us the ability to be a truly global organization."
Rendering time zones irrelevant
Not only does Solvay Pharmaceuticals bring together information from its own research facilities in Europe and America, but it also works with outside development companies from around the world. Solvay Pharmaceuticals must bring together common technical documents from clinical trials around the world and analyze the data regularly to make sure, for example, that no safety concerns exist. And, at the end of a study, Solvay Pharmaceuticals needs to test the product’s efficacy.
"The transfer of data back and forth, especially when studies are ongoing, is critical to making sure we get a feel early as to whether the drug is safe," Miller explains.
The sooner a drug is determined not to be a good prospect, for example, the more the company can save in terms of research costs. "And we want to get it approved in the United States as well as in Europe, Asia and all over the world," Miller says. "So we’re looking at clinical data that’s coming in regularly, and we’re sharing that data with each other around the world."
With SAS Drug Development, Solvay Pharmaceuticals researchers around the world can query and explore the same data without the drag of time differences that once slowed the sharing of knowledge and the discovery of intelligence. "Operating on a global scale can be difficult, because people need to look at the same information – often at the same time," Driessen says. "It used to take months and months to collect data from around the world, and months and months to come up with usable answers to our queries. But now, using SAS, we can do all that in a week."
Eventually, Driessen and Miller will use SAS Drug Development to combine drug studies on the fly as they are completed. That way, Solvay Pharmaceuticals will have an integrated database ready to offer plenty of insight into future studies. "You can run trials, look at the data, understand what your compound is doing and be able to make better decisions," Miller explains. "And that will make it easier to manage our portfolio of compounds and will help us get them to market faster."