An article published last October in Harvard Business Review, “Realizing the Promise of Personalized Medicine,” provides an outstanding analysis of the various barriers to personalized medicine and how they could be overcome. In particular, the article, which was cowritten by Mara G. Aspinall, president of Genzyme Genetics (Westborough, MA), and Richard G. Hammermesh, professor of management practice at Harvard Business School (Boston), identifies the pharmaceutical industry, its blockbuster-drug business model, and its attitude toward companion diagnostics as major barriers.

According to the authors, “large pharmaceutical companies have tended to take a dim view of drugs that are linked to diagnostics, fearing that the diagnostic component would complicate marketing to physicians and slow the identification of treatment-worthy patients by adding another step to the diagnosis process.”

In order to overcome such barriers, the authors argue that drug companies will need to take measures that support the development of the personalized medicine paradigm. Such measures include forging partnerships with IVD companies, and changing their business strategies away from the blockbuster model and more toward therapies that can be targeted through the use of companion diagnostics.

Recent developments indicate that IVD and pharmaceutical companies have already begun to adopt the strategy of forming joint collaborations. In October, for example, GE Global Research (Niskayuna, NY) and Eli Lilly and Co. (Indianapolis) signed a three-year collaborative research agreement to discover and develop IVD assays that may predict cancer treatment response to targeted therapies (see Trends & Perspectives). Celera (Rockville, MD) has also entered into a research collaboration with Merck & Company, Inc. (Whitehouse Station, NJ), to develop biomarker and pharmacogenomic tests for cancer patients.

In addition, officials at drug companies believe the pharmaceutical industry has begun to realize that times have changed, and that past ways of doing business are no longer acceptable.

“With targeted therapies, pharmaceutical companies need to develop companion diagnostic markers, not only for postlaunch—so that physicians know whether or not to put their patients on a particular drug—but also to help us streamline, reduce, and shorten our clinical trials,” says Jeremy Graff, PhD, research adviser for Eli Lilly's research laboratories. “I think the entire pharmaceutical industry is moving in this direction. The entire industry realizes the necessity of pushing targeted therapies forward in conjunction with companion diagnostics and biomarker strategies. The whole industry has to go this way. There's no other option.”

All drug companies will eventually have to change their business models, research and development strategies, and approaches to clinical trials. A major part of such changes will include greater involvement of IVD companies and the development of companion diagnostics. Such involvement will serve as a significant boon to the IVD industry because diagnostics will get the full recognition they deserve as an integral part of healthcare.

Richard Park