Director of the National Cancer Policy Forum
Institute of Medicine
National Academy of Sciences
Advances in tumor biology have led to the development of drugs that can precisely target specific molecules in a patient's tumor, a concept referred to “personalized” or “precision” medicine. However, these changes in the practice of medicine and the emergence of new technologies for molecularly targeted medicine pose significant challenges for the systems that regulate new drugs and diagnostics, as well as those that deliver and pay for health care. The key issues involve three major areas: 1) regulatory oversight of test development, 2) clinical adoption of tests and 3) payment processes. Failure to address these issues will delay the development and clinical use of more effective therapies that can improve patient outcomes. Dr. Nass is leading 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. Careful consideration of these challenges is needed to efficiently and effectively move the field forward and to realize the full potential of these transformations.
Sharyl Nass, PhD. is a scholar at the National Academies’ Institute of Medicine where she serves as Director of the National Cancer Policy Forum and Interim Director of the Board on Health Care Services. Over the past 15 years, her work at IOM has focused on topics such as the quality of cancer care, cancer clinical trials, cancer biomarker tests, strategies for large-scale biomedical science, and technologies and quality standards for early detection of breast cancer. With a PhD. in cell biology from Georgetown University and postdoctoral training at the Johns Hopkins University School of Medicine, she has studied the cell biology of breast cancer. She also has a BS in genetics from the University of Wisconsin-Madison and has studied developmental genetics at the Max Planck Institute in Germany. Dr. Nass received the Cecil Award for Excellence in Health Policy Research (2007), a National Academies Distinguished Service Award (2010), and an IOM staff team achievement award (2012).