‘Congress’ explores state of personalized medicine

May 29, 2009 – 6:27 pm by Michael Christel

So what’s really holding up the transformation of personalized medicine from dream to reality? After all, most agree the idea of targeting new drugs to specific patients is an appealing concept both medically and commercially. Well, there are several factors to blame for the slow journey, but the biggest culprits may not necessarily be what many think. The topic was examined and debunked at this week’s Biomarker World Congress 2009 in Philadelphia, where I attended yesterday.

“The focus is on healthcare economic issues as the big barrier. While they are true, I think that’s fundamentally misdirected,” says Brian Spear, Ph.D., director, scientific affairs, global pharmaceutical research and development, Abbott Labs, who delivered an address on the business context for personalized medicine in R&D. “Similarly, we hear, once we can sequence a human genome, then we’ll know all these things. Testing technology is not the problem. The problem is we don’t have enough tests which are unequivocally beneficial. If we did, the regulatory issues would not be a problem, the reimbursement issues would not be a problem.”

Dr. Spear attributes the tough road for personalized medicine to the high level of difficulty – and related expense and time considerations – in finding robust biomarkers, demonstrating clinical validity of those markers in responder and non-responder populations, and ultimately, having the markers gain medical acceptance. As a result, Dr. Spear says, there has been reluctance by the pharmaceutical industry to invest in the discovery and validation of biomarkers, not because of the business risks involved, but rather the uncertainty of outcome.

“The people who need to allocate the resources don’t have any sense that there is going to be a benefit coming out of it,” Dr. Spear told the crowd. “It’s one of the biggest impediments that we deal with. The pharmaceutical industry exists in a world of risk. We hear it all the time – we have to be risk takers. Risk is regarded as a good thing. Personalized medicine, at this point, is right smack dab in the middle of uncertainty.”

Dr. Spear notes, however, that the chances of a biomarker program lasting through the clinic and being approved are no worse than the odds for conventional new drug projects, which are generally around 10%. He discussed potential ways to optimize personalized medicine opportunities and help shift stakeholder perception of the field from the uncertainty to the risk realm.

In a Q&A following his talk, Dr. Spear touched on the stronger utility biomarkers provide in the areas of oncology and infectious disease, noting the frequent failure of drug candidates for those diseases and the ability to analyze the infectious organism or the cancerous tumor independent of normal, thus enabling earlier-stage research of biomarkers and their effects.

There were close to 50 companies on hand in Philly, including those specializing in biomarker testing, imaging, lab services, protein analysis, data collection, and molecular diagnostics. The companies showcased their respective technologies, some doing so in group session. Here are a few highlights from the sessions I sat in on.

- Craig Stovold of Quotient Bioresearch discussed the advantages of developing multiplex assays for high-throughput biomarker analysis.  Dr. Stovold highlighted several methods, include Quotient’s Gyrolab nanotechnology platform.

- Dr. Colin Williams, a bioinformatics expert for Thomson Reuters’ healthcare and science business, talked about the overload of biomarker information clogging the cybersphere and the need for drug companies to be able to transform that information into knowledge to help make better educated go/no-go decisions. Thomson Reuters provides its own comprehensive database of biomarkers, called BIOMARKERcenter, which presently includes information on 3,000 molecular, imaging, and multiplex markers, with 32,000 unique uses. The program monitors the lifecycle of each biomarker in five stages: emerging, experimental, early studies in human, late studies in humans or observational studies, and recommended/approved.

- Peter Duncan of Definiens Inc., an 85-member image analysis company based in Munich but with offices in Morristown, N.J., discussed his company’s Cognition Network Technology. Mr. Duncan, along with two other speakers at the conference, Dr. Klaus Lindpaintner, head of medical genomics at Roche, and David Wholley, director of The Biomarkers Consortium, are among the experts featured in  “What’s Wrong with Biomarkers?,” a new whitepaper by Bio-IT World. You can register for a download of the paper here.

- Maribeth Raines of Quest Diagnostics, one of the largest central labs in the world, serving 150 million patients annually, talked about the benefits and challenges of using biomarkers in global clinical trials. According to Dr. Raines, important factors to consider are that clinical utility may require multi-site testing to meet short turnaround times; the unique testing and validation requirements such as batch testing and shipment and specimen handling; and geographical considerations, including  a country’s import/export restrictions, quality standards, and cultural influences.

- Several speakers emphasized the importance of launching a biomarker program in the early stages of development.

“You need to start early, before Phase II,” Dr. Geert Kolvenbag, global product VP, oncology, AstraZeneca Pharmaceuticals, told the audience during his presentation, “Personalized medicine: Turning promise into reality.” “For a biomarker to be used to direct drug therapy, you need to develop assays, collect samples, and test samples for biomarker status early on.”