Innovate or Perish: Managing the Enduring Technology Company in the Global Market

The Future: Personalized Medicine, Integrated Innovation, and Global Health

Paraphrasing a recent quote of Steve Burrill (Burrill & Co.), the future of the biopharmaceutical industry lies in the three “P”s: prevention, prediction, and personalization.

If there is one thing we can be sure of in the biopharmaceutical industry, it is simply that the days of the “one-size-fits-all” drug are over. While we may be a long way from the idealized vision of personalized medicine, we are perhaps further along that path than is generally recognized. Many of the tools to make it fully possible are already in place, and a surprising number of low-tech biomarkers are already embedded in clinical decisions.

Pressure from outside the industry will be a major driver to develop better markers to diagnose disease, predict outcome to treatment, and monitor response to treatment.

Some of the obvious benefits and regulatory and market forces that will drive the introduction of targeted or patient-specific treatments are listed in Exhibit 11.5.

Exhibit 11.5. Benefits and Forces That Will Accelerate Biomarker Discovery and Implementation

Patients

Avoid risks of exposure to drugs with no benefit. Increase demand (and willingness to pay) for effective medicines. Avoid false expectations of benefit. Avoid costs of drugs that will of little benefit.

FDA

Will mandate use in trials to enrich for responders. Will seek use of companion diagnostic as part of new drug approvals. Will eventually seek use in postmarketing ...