FDA Report Outlines Approach to Personalized Medicine

Miriam E. Tucker

October 29, 2013

In This Article

Next-Generation Sequencing Is Here

Elizabeth Mansfield, PhD, director of the Personalized Medicine Staff at CDRH, explained that current "next-generation sequencing" technology allows for rapid and inexpensive examination of the DNA sequence of a patient's cancer to help subclassify those who will respond to a particular drug.

The CDRH is now collaborating with the National Institute of Standards and Technology on a project to create genetic reference materials via an open-access database that is expected to be available within a year. Information generated from next-generation sequencing will be added over time.

"Next-generation sequencing is a tool that's coming very rapidly into the clinic. It's going to change the way we treat people, more so in oncology than in other areas in the beginning. FDA is working really hard through our personalized medicine programs and with intercenter collaborations to be able to address this technology to be sure patients have access to safe and effective diagnostics that we hope will lead to safe and effective therapies," Dr. Mansfield said.

Beyond Pharmacogenomics

Mike Pacanowski, PharmD, associate director for Genomics and Targeted Therapy at the Center for Drug Evaluation and Research, said personalized medicine also addresses individualized drug dosing and how genetic factors affect response to drugs.

Examples include KRAS mutation testing of patients with colon cancer and the recent advances in chronic hepatitis C treatment, in which targeted therapies have improved the success rates from just 10% a decade ago to 80% or more today. "I think all trends will continue in that direction," he said.

At the FDA, the development of a genomic data program and a biomarker qualification program are among the initiatives that have allowed the agency to adapt to receiving genetic sequencing data in drug applications and help ensure consistency in its review process for those products, Dr. Pacanowski said.

"Programmatic enhancements will continue.... There are a lot of factors that play into the success of personalized medicine, but I think we're on track to do that," he said.

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