“If I had a billion dollars…If I had a billion dollars…I’d launch me a new drug.”
This adaptation of the hit Barenaked Ladies single may not be entirely facetious.
Because a billion bucks – and 10 years – is approximately what it takes for pharmaceutical companies today to develop a single new drug and get it to market, according to SAS Institute Director of Health and Life Sciences Strategy, Laurie Rose. (A study by Boston-based business consultancy, Bain & Company puts the cost at $1.7 billion).
At a press briefing on April 11, the second day of the SAS Institute user conference a.k.a. SUGI in Philadelphia, Rose announced a SAS application designed to speed things along, while potentially reducing the cost and complexity of drug development.
The software that can pull this off, she said, is SAS Drug Development 3.0.
According to Rose, in its third iteration, SAS Drug Development is the consolidator par excellence. “It provides an environment for integration of clinical trial data scattered in silos across different departments on incompatible systems.”
She said life-science firms already including SAS in their organizations – and these include every Fortune Global 500 life sciences company and nearly 600 pharmaceutical firms – could use the application to accelerate the clinical trials process. “They can do this in a cost-effective, regulatory complaint manner.”
And that – Rose said – is a huge value proposition, especially in a regulatory environment that’s getting tougher by the day. Stricter US Food and Drug Administration (FDA) scrutiny, Rose said, is putting tremendous pressure on drug companies, and non-compliance can spell disaster. She alluded to last Thursday’s recall of Bextra, the controversial painkiller, and the withdrawal, in October 2004, of Vioxx, the blockbuster arthritis medication by Merck & Co.
Rose said Drug Development 3.0 features such as embedded versioning, audit trails, and electronic signatures provide irrefutable documentation of all data transformation activities. That’s what has made it a tool of choice for many global drug companies, she said.
One such firm is Solvay Pharmaceuticals headquartered in Marietta, Ga. The company uses the Drug Development to provide 100 researchers worldwide secure access to clinical information.
“Whether we’re doing development in Asia, Europe or in the U.S., we need to be able to combine and share data for regulatory approval, said Rick Miller, Solvay’s director of clinical information. He said SAS Drug Development offers this feature.
For one analyst, the consolidation capabilities of SAS Drug Development are its greatest strength.
The product “[makes] research content from locations across the organization available to trial managers, clinicians, and bio-statisticians and [embeds] tools designed for every type of users,” said Judy Hanover, senior research analyst with Framingham, Mass.-based IDC’s Life Science Insights.
SAS’ Rose also discussed her company’s own R&D and product development approach in the life-science space.
It’s an approach, she said, that responds directly to at least three trends: the advent of personalized medicine; the move by drug companies to optimize sales and market spend; and the clamour for standards in the clinical research space.
In the area of standards, she said SAS wholeheartedly supports the work of the Austin, Texas-based Clinical Data Interchange Standards Consortium (CDISC) that’s working to develop global, platform-independent data standards that enable information system interoperability for medical research and related areas. “We have members on the [CDIC] board and in its various work teams,” she said.
