“Every molecule companies are developing now has a biomarker strategy,” says Larry Lesko, director of the Office of Clinical Pharmacology and Biopharmaceuticals at the FDA. “The challenge is identifying the marker that will do the job.”
The pharmaceutical industry once rooted in “blockbusterology,” is not only “walking the walk” but now “talking the talk” about personalized medicine. Eli Lilly President and CEO John Lechleiter has affirmed that his company’s business model will accommodate personalized medicine. And Switzerland’s Roche paid over $3 billion for Tucson, Ariz.-based Ventana Medical Systems, a leading supplier of automated diagnostic systems to the anatomical pathology market, to give it a greater footprint in the personalized medicine world.
“The pace of adoption of personalized medicine is accelerating in such a way that it proves that we are past that tipping point,” says Carol Kovac, venture partner at Burrill & Company and co-chair of the 5th Annual Burrill Personalized Medicine meeting, which was held in November 2009. “Eight years ago when the first draft of the genome was announced, you could argue that personalized medicine was still — maybe not a dream — but a future vision. But today, we see real companies in the marketplace with real solutions.”
Kovac says personalization of therapies is not only becoming more widespread, but emerging as a best practice and a standard of care in some areas. She expects that will only increase, especially as more and more proof points come into the market.
“We are in a very rapidly accelerating phase of adoption of practical solutions in personalized medicine,” she says. “There will be road blocks along the way that could derail the momentum that has been building around personalized medicine — the most notable of which is reimbursement of genetic testing and pharmacogenomic tests. But these will be quickly addressed as coming to grips with the spiraling costs of healthcare is high on the nation’s agenda. Personalized medicine will certainly be part of the solution.”