PRECISION BREAST CANCER MEDICINE VISIONARY CREATES AND DIRECTS MAJOR INNOVATIVE INITIATIVES TO IMPROVE BREAST HEALTH FOR INDIVIDUAL PATIENTS
M.D., M.B.A. DIRECTOR, CAROL FRANC BUCK BREAST CARE CENTER, PROFESSOR OF SURGERY AND radiology, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, Associate director, UCSF Helen Diller Family comprehensive cancer center
Laura Esserman, MD, MBA, an internationally recognized breast surgeon, breast oncology specialist and visionary in personalized medicine, is revolutionizing breast cancer screening and treatment. Since 2002 she has led the I-SPY TRIALS, a groundbreaking national public-private collaboration among NCI, FDA, more than 20 cancer research centers and major pharma and biotech companies. By combining biomarker-based personalized medicine with adaptive trial design, the goal is to significantly reduce the cost and time to bring safe and effective new drugs to market. This has now become a national model for translational research. Dr. Esserman is now working to determine whether breast cancer screening that is personalized to each woman, based on her individual risk factors, is safer and more effective than standard annual mammograms. To answer this big question, she was awarded a $14.1 million grant by the Patient-Centered Outcomes Research Institute (PCORI), and will follow 100,000 women. Participants will be drawn from another of her major initiatives, the Athena Breast Health Network, a University of California-wide breast cancer research consortium. Dr. Esserman received her undergraduate degree at Harvard University, her medical and surgical training as well as a postdoctoral fellowship in breast oncology at Stanford University. After joining the Stanford faculty, she received Hartford fellowship to attend Stanford Business School where she received her M.B.A.
Fit for Purpose: Using Biomarkers and Diagnostics to Impact and Personalize Care, Accelerate Regulatory Endpoints, and Drive Health Care Value
All diseases are heterogeneous as are the hosts that develop them. Personalized medicine does not necessarily mean that the treatment is better. We need systems to evaluate and continue to improve our ability to adapt care. A range of diagnostic tools will be critical to ushering in an era of more personalized medicine that increases health care value. These include diagnostics to : understanding disease and host biology; predict progression; measure response to therapy. The driver for use should be to drive improvement by improving outcomes (avoiding mortality), accelerating learning and approval of effective interventions, and driving health care value. Some examples will be reviewed where critical issues can be tackled using integration of diagnostics and adaptive care in trials and practice to accelerate progress. It is as important to learn who needs less intervention as it is who needs more intervention. Our goal should be to tailor treatment to biology, patient preference based on rapidly emerging evidence from clinical performance.