Two Vanderbilt-Ingram Cancer Center (VICC) leaders have been named to a panel of the Institute of Medicine (IOM) to help shape national policies on the use of biomarkers for targeted cancer therapies.
Harold L. (Hal) Moses, M.D., Ingram Professor of Cancer Research and director emeritus of VICC, will chair the IOM’s ad hoc committee, Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies. Moses is a member of the IOM and founding chair of the group’s National Cancer Policy Forum.
Yu Shyr, Ph.D., director of the Vanderbilt Center for Quantitative Sciences and VANGARD (Vanderbilt Technologies for Advanced Genomics Analysis and Research Design), also will serve as a committee member.
New technologies have identified gene mutations in patient tumors as well as molecular biomarkers that signal key attributes of a patient’s disease.
This information can be used to guide selection of therapies most likely to benefit a particular patient.
The development of these new technologies and their use in clinical practice is a hallmark of precision medicine which seeks to match the right therapy to the right patient at the right time.
Biomarkers also have become important in the selection of targeted therapies in diseases other than cancer.
“This is a critical time to examine these issues as the FDA is moving toward exerting more oversight and regulation of biomarker tests, and input from the broader scientific community should be helpful in assuring appropriate FDA oversight,” Moses said.
Using previously published IOM reports as a starting point, the committee will examine opportunities for, and challenges to, the use of biomarker tests to select optimal therapy. The committee will formulate recommendations to accelerate progress in this field.
The committee will also address the standards of evidence used by the Centers for Medicare and Medicaid Services (CMS) and other payers to make decisions about coverage and interpretation of molecular tests and clinical decision-making.
“As a quantitative scientist on this committee, I want to make sure that there is solid data supporting the policies for biomarker tests and especially genomics-based tests,” said Shyr, Harold L. Moses Professor of Cancer Research.
The committee’s next meeting is scheduled to be held in April, with two additional meetings later in the year. The group will generate a report with specific conclusions and recommendations for the FDA, CMS, and other agencies, and the report will undergo a rigorous peer review prior to publication.
The IOM is the health arm of the National Academies, which also includes the National Academy of Sciences, National Academy of Engineering and National Research Council.