December 2013


Transforming Cancer Care through Diagnostics and Personalized Medicine


On October 29, the AACR hosted a symposium titled Transforming Cancer Care through Diagnostics and Personalized Medicine in Washington, D.C., in partnership with AdvaMedDx, an organization representing over 75 leading manufacturers of diagnostics.

The symposium highlighted emerging cutting-edge technological advances that are being used to develop the next generation of molecular diagnostics in cancer as well as examined the regulatory and reimbursement challenges posed by this rapidly advancing field.

Nobel laureate Harold Varmus, M.D., Director, National Cancer Institute talked about “Why Diagnostics Matter?” in his opening keynote. He noted that molecular diagnostics are crucial to tailoring therapies based on the unique signatures of individual cancers. “Diagnostic development has to keep pace with the explosion of new personalized cancer drugs that have been approved over the past few years so that targeted treatments that are more safe and effective can be delivered to patients,” emphasized Dr. Varmus.

A special lunchtime conversation between Francis Collins, M.D., Director, National Institutes of Health (NIH) and Margaret Hamburg, M.D., Commissioner, Food and Drug Administration (FDA) was moderated by AACR President, Charles Sawyers, M.D.

Cancer therapies are increasingly paired with a diagnostic device that can determine whether a patient will respond to the drug based on their tumor’s genetic characteristics. Regulating these complex medical products and coordinating their review and oversight in a manner that efficiently incorporates current regulatory science standards while upholding patient safety presents unique challenges, said FDA Commissioner Hamburg.

Dr. Collins spoke about the coming era of whole genome sequencing which will soon eclipse our current system of examining just one or a few genes at a time to decide on a treatment course for a patient. He cautioned that whole genome sequencing presents new ethical and regulatory challenges such as defining risk and how health care providers should address incidental findings, which is genetic information discovered unintentionally.

Dr. Hamburg announced the release of a report*, which describes FDA’s unique role in helping usher in personalized medicine products. Learn more about this conference.

View the agenda for this conference.

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