G. Steven Burrill has aptly summarized the potential benefits of personalized medicine: “The right drug for the right patient at the right time.” Burrill also points out the potential benefits for the developer of the medicine: smaller, quicker, and less costly clinical trials for proving efficacy in the target population, resulting in a better safety profile and a higher probability that the medicine will reach the marketplace.
Personalized medicine thus represents a new paradigm for the pharmaceutical industry. Because the costs of product development should drop significantly, attractive returns on investment will no longer require blockbuster-sized sales. The market leaders will no longer depend on a few megabillion dollar products but rather will generate many more products, each focusing on a smaller but still substantial market niche, ultimately achieving better clinical results. Pharmaceutical companies unable to compete effectively in this game-changing scenario will eventually be marginalized.
Opportunities now abound for the development of innovative therapeutics. Current drugs benefit just a limited number of patients with neurodegenerative diseases, and at present there is no cure for such diseases. With respect to cancer, standard drug treatment benefits only a minority of all cancer patients, and the one-year survival rates for various cancers are unacceptably low.
The practice of personalized medicine will indeed be game-changing, and those drug firms that don’t change their game will be the losers. Those that do will be among the winners. The question is not whether drug firms focus on innovative therapeutics but rather which firms will grasp the new paradigm and represent the new big pharma.
J. Leslie Glick, Ph.D., is an independent corporate management advisor and a former adjunct professor of technology management in the graduate school of the University of Maryland's University College. Dr. Glick, a cofounder of the Industrial Biotechnology Association, which eventually became the Biotechnology Industry Organization, also cofounded and ran three biotech companies, one of which was Genex. E-mail: [email protected]