Personalized medicine for complex traits has different time horizons and scope of impact based on two categories: “genetic targets” and “large-effect variants”
At the Harvard-Partners Personalized Medicine Conference last week I participated in a panel discussion on complex traits. When asked about where personalized medicine for complex traits will be in the future, I answered that I envision two major categories for personalized therapies.
(1)Development of drugs based on genetic targets will lead to personalized medicine; and
(2)Large effect size variants will be detected in clinical trials or in post-approval studies and will lead to personalized medicine.
This answer, I said, was based in part on current categories of FDA pharmacogenetic labels and in part on how I see new drug discovery occurring in the future. But did the current FDA labels really support this view?
The answer is “yes”. In reviewing the 158 FDA labels (Excel spreadsheet here), my crude analysis found that 31% of labels fall into the “genetic target” category (most from oncology – 26% of total) and 65% fall into the “large effect” category (most from drug metabolism [42% of total], HLA or G6PD [15% of total]).
A subtle but important point is that I predict that category #2 (PGx markers for non-oncology “genetic targets”) will grow in the future. In other words, development of non-oncology drugs will riff-off the success of drugs developed based on somatic cell genetics in oncology. …