The pharma has set up a biomarker discovery center in Singapore.
By Allison Proffitt
November 10, 2009 | SINGAPORE—“If you Googled ‘biomarkers’ ten years ago, I think you’d end up with all kinds of websites on extraterrestrial life. Biomarkers: life in space!” jokes Erik Sprengers, site head of the Schering-Plough Translational Medicine Research Centre (TMRC).
Today biomarkers are the mandate. “This is really the first lab of its type for Schering-Plough,” says Sprengers. The TMRC, which opened in February 2009, is headquartered in Biopolis, Singapore’s quickly-growing biomedical research park (see, “Building Buzz in Singapore,” Bio•IT World, June 2008) where Schering-Plough has two floors and 30,000 square feet.
While biomarkers have been on the pharma’s agenda for years, Sprengers says the company lacked “a lab that took the biomarkers from discovery research and developed them for diagnostic tests fit for clinical purposes. The lab we’re setting up here is very much a biomarker lab,” he explains, with target validation, patient stratification, and safety being the primary goals. The TMRC supports Schering-Plough’s global R&D programs by focusing on biomarker discovery and development. The translational research initiative is only a few years old, and Sprengers believes that conducting research translationally is a much-needed shift.
A critical problem in pharma is that R&D productivity is too low. “Pour in money and you get out too little product,” says Sprengers. “It’s not a sustainable business model all the time, so the whole industry is looking at ways to improve the attrition and to improve R&D productivity. And the big hype in the pharma industry now, is translational medicine and the translational approach.”
“In the old days, discovery research discovered new compounds and tested them in all kinds of animal models and showed some interesting effects, so it was decided to take them into man to see whether they worked or not… More often than not, the drug doesn’t work; that’s the biggest failure in the pharma industry.”
The crucial question, Sprengers says, is what to do with that failure. “Did we give the wrong dose? … Do we need an intravenous or oral preparation? Did we test it in the wrong patients? Do we abandon the compound and go on to the next one? Beyond that, do we abandon the compound then and also abandon the target?”
Translational approaches systematically address those questions, starting with target validation. “It’s not a question that was looked at, measured,” says Sprengers. “You need to make sure that your compound hits the target, that the concentration is high enough to hit the target, and hitting the target, you should also cause some downstream effect—some downstream pharmacology. In the past we didn’t measure that.”
Today at Schering-Plough, any discovery team that wants to propose a target for clinical development must submit both the target and a biomarker for target engagement as well. TMRC takes those biomarkers and compounds and develops them to robust, fit-for-purpose tests that can be used on clinical samples to give reproducible results. The clinical capabilities of TMRC will allow the lab to also do the testing of the clinical samples for the smaller series.
In House Development
Biomarker development falls into a sort of gray area for pharma between discovery and the clinic, not the kind of project easy to farm out. Says Sprengers: “Suppose I develop a novel biomarker here and I do my first into man study in my clinical unit next door. I’ll collect samples from 20 to 30 patients or so and I do the testing here and see whether it works or not and then decide if I’ll proceed. If you’re successful… over time you farm out the bulk testing to specialized vendors.” Sprengers adds that biomarkers are largely for internal decision-making. “It’s rather an exception that you take a biomarker test into your regulatory dosing,” he says. “If a biomarker tells me it doesn’t engage the target, I stop the approach. If the biomarker shows that yes, it engages the target and we see some very interesting downstream pharmacology, then I pour a little bit more money there.”
Sprengers arrived in Singapore in September 2008. From just four staff last January, he now has 20 people in the lab, and five more in the clinical unit. He hopes for 50 by the end of 2009. The lab is up and running. “We are able to deliver our first results, our first real output this year. We have signed a few collaborations. We’re on track for our first clinical study in the clinical unit. It’s early days, but we’re moving forward.”
This article also appeared in the November-December 2009 issue of Bio-IT World Magazine.
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