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Personalized Medicine in Perspective

We are told that personalized medicine will transform drug development and bring about the end of blockbuster drugs. If you believe the hype, this will all happen soon. More realistically, personalized medicine is at least a decade away from having any substantial impact. Blockbuster drugs are not going to disappear anytime soon.

“Personalized medicine” involves managing a patient’s healthcare with therapies based on patient-specific characteristics. It is often defined as part of genomics, although there are and will be non-genomic therapies that fit within personalized medicine. Personalized medicine is seen as individualized treatment and “the future of drug development.”

In contrast, most of our current therapeutic options are drugs and biologics intended for large cohorts of patients. This creates a focus on developing “blockbuster drugs” that will be used by hundreds of thousands and even millions of patients. It is said that the rise of personalized medicine will bring an end to “the era of blockbuster drugs.”

To understand the status of personalized medicine, it is instructive to look at the history of biotechnology. As with all great transformative achievements, latecomers might imagine that success was inevitable and progress was smooth and relatively trouble-free. The reality has been quite different.

Biotechnology began in confusion, uncertainty and opposition. In 1975, the scientific community gathered at Asilomar, CA to consider the future of biotechnology. They were operating in an environment of apprehension and believed restrictive legislation might be adopted. In part because of principles, guidelines and restrictions adopted at Asilomar, biotechnology lasted just long enough to quell the worst fears that uncontrolled experiments might change the fundamental nature of man, animals and plants.

Here is my history of how biotech developed into a force:

  • Rocky childhood (1970′s)
  • Became “the next big thing” (1980′s)
  • Finally had a significant impact (1990′s)
  • Some biotechs mature and big pharma swallows small biotechs for their knowledge, capacity and pipeline (2000′s)

Notice that there is almost 20 years between childhood and impact. Fortunately for the health of the American people, biotechnology still has plenty of room to grow.

I expect something of a similar pattern for personalized medicine. The movement is, at best, in late childhood. It is not yet the “next big thing,” except rhetorically. It will be at least 2020 before more than a handful of products are making an impact….and we can’t know whether it will be a significant impact. The death of the blockbuster is at least 10 to 15 years away and may never occur.

One expectation is that genomic information will spur “drug development by design.” This will allow the discovery of better drugs more quickly and with many fewer developmental failures. This is a much harder road than it may seem. History shows us that clinical trials can fail, sometimes quite miserably, just when everyone is most sure that the solution is logical and success guaranteed. The human body is almost always more subtle than we can discern, even with the best tools.

Deservedly, there is lots of excitement about personalized medicine. It will eventually transform drug development. However, as you read and listen, remember that:

  • excitement is not the same as impact, and
  • investment is not the same as success.

Steven

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