Director of the National Cancer Policy Forum
Institute of Medicine
National Academy of Sciences
Accumulating knowledge about the molecular basis of cancer has transformed drug development in recent years. The goal now is to develop drugs that can precisely target the molecular changes in a patient's tumor. This approach depends on biomarker technologies that identify the key attributes of a patient’s disease and thus can guide selection of the therapy that is most likely to benefit that particular patient.
Because of these changes, the practice of medicine also is undergoing a transformation. However, these new tools for molecularly targeted medicine pose significant challenges for the systems that regulate the development of drugs and diagnostics, as well as those that deliver and pay for health care. Careful consideration of these challenges is needed to efficiently and effectively move the field forward and to realize the full potential of these transformations. The key issues involve three major areas: regulatory oversight of test development, clinical adoption of tests, and payment processes. Failure to address these issues in a timely manner will delay the development and adoption of more effective targeted therapies that can improve patient outcomes.
Dr. Nass will lead a team at the Institute of Medicine (IOM) to examine these policy issues, develop recommendations, and produce a report on this topic, which is of great concern to all stakeholders in drug and test development and patient care-including pharmaceutical and diagnostics companies, clinical laboratories, governmental agencies, academic researchers, health care professionals, patients, and patient advocacy groups. The IOM has a long tradition of providing science-based policy advice from a national perspective. This tradition rests on the ability to convene diverse committees of experts who deliberate in an objective and independent environment, assuring rigorous analysis for the achievement of consensus recommendations.
Dr. Nass and colleagues have interviewed a broad range of experts in the field of biomarker development to seek input on the study charge and to solicit nominations for potential consensus committee members. They have also begun to lay the groundwork for the first in-person deliberations of the committee as well as an Institute of Medicine workshop that will provide input to the consensus study.
Dr. Sharyl Nass is a scholar at the National Academy of Sciences’ Institute of Medicine (IOM) and Director of the IOM’s National Cancer Policy Forum. Over the past 14 years, her work at the IOM has focused on a broad range of topics that include cancer clinical trials, developing cancer biomarkers and ‘omics-based tests to guide patient care, strategies for large-scale biomedical science, developing technologies for the early detection of breast cancer, improving breast imaging quality standards, improving quality of cancer care, the HIPAA Privacy Rule in health research, and contraceptive research and development. Her current position at the Institute of Medicine combines her dual interests in biomedical research and health science policy. She has also served as an adjunct faculty member at the University of Maryland School of Nursing, lecturing on cancer biology, detection, and treatment. With a doctorate in Cell and Tumor biology from Georgetown University and postdoctoral training at the Johns Hopkins University School of Medicine, she has authored papers on the cell and molecular biology of breast cancer. She also holds a bachelor of science degree in genetics and an MS in Endocrinology/Reproductive Physiology, both from the University of Wisconsin-Madison. In addition, she studied developmental genetics and molecular biology at the Max Planck Institute in Germany under a fellowship from the Heinrich Hertz-Stiftung Foundation. Dr. Nass was the 2007 recipient of the Cecil Award for Excellence in Health Policy Research, the 2010 recipient of a Distinguished Service Award from the National Academies, and the 2012 recipient of the IOM staff team achievement award.