Personalized Medicine...Big Pharma Business Models Restructure

Companies like Genentech are already working in this direction, especially with genetic research related to cancer...will the big blockbuster promotions soon be a thing of of the past since the best medication for our ills will be determined by our genes? Big Pharma has some new potential business models to explore in the near future...and on the other hand there may be some new life to failed drugs of the past....With personalized medicine, a visit to the doctor's office could reveal much more than a mere diagnosis.....BD

“One of the biggest challenges for the biotechnology and pharmaceutical companies in the 21^st century will be to develop and deliver drugs that fit the individual patient’s biology and pathophysiology,” Jan Trost Jorgensen, principal scientist at Dako, wrote in the January issue of Personalized Medicine. “These changes could mean an end to the blockbuster philosophy in ‘big pharma’ and thereby impose major changes in company structures.” In fact, Robert Schmouder, executive director of translational medicine at Novartis, has put a similar 10-year life expectancy on the blockbuster model

Many industry observers have pointed out that perhaps big pharma needs to rethink its business model since innovation has been drying up, as seen in the dwindling number of new treatments approved by the US Food and Drug Administration last year. In 2007, the FDA approved 17 new molecular entities and two biologic license applications, the lowest number recorded since 1983.

“It was a parallel development. Genentech very early on realized that it was important to have an assay to select the patients that would respond to” Herceptin, Jorgensen said. “They developed [internally] from Phase II – which is the way that drug-diagnostic co-development should be done – a clinical trial assay.”