Session Synopsis: The advancement of the field of Precision Medicine, including the “Moonshot” to cure cancer, along with a variety of proposals to share big data are promising. But these endeavors will prove frustratingly empty unless we recognize and address the shortcomings of current diagnostic tests and the generation of “big data”. Further, money drives success and reimbursement depends on demonstrating that biomarker tests provide clear clinical value. This value proposition will lag unless we embrace standards, which exist but are not being embraced by the international community. This session will show how design-controlled development and validation of internationally harmonized biomarker assays will prove critical to achieving the promise of precision medicine.
Session Chair Profile
Ph.D., CSO, CEO & Chairman, Invivoscribe, Inc.
Jeffrey Miller, Ph.D. has two decades of experience with personalized molecular medicine®. He founded Invivoscribe® in 1995 without outside investment. The company is a highly profitable vertically integrated international network of six wholly-owned ISO13485 manufacturing and ISO15189 clinical testing companies. They are located in the U.S., Europe and Asia and operate under a single quality and regulatory system. The companies offer GMP test reagents, internationally harmonized clinical testing, and CRO services for stratification of patients for treatment and enrollment in clinical trials. Dr. Miller received his undergraduate degree in biochemistry from UCLA, and a combined Ph.D. in biochemistry & molecular biology from UCSB.
M.D., Chief Medical Officer, Genection
Dr. Patay is dedicated to improving health by integrating genomic knowledge into medical care. He has authored numerous articles in his field, presented at multiple conferences and has been featured in Bloomberg Business Week. Dr. Patay has been involved in the design and implementation of the MyAML and MyHeme products. He has been head of the Internal Medicine section at Scripps Torrey Pines, worked as an Assistant Professor at STSI, has been a founding member of the Board, and Vice President of the College of Genomic Medicine- which was established in 2010 to educate physicians and other health care professionals about genomic medicine. He graduated in economics and molecular cell biology from the UC Berkeley. Received his M.D. degree at UC San Diego, and is board certified in Internal Medicine and Pediatrics.
Importance of Design Controlled Assays in Hematopathology
Within hemapathology, the driving genetic variants have become known spurring the National Cancer “Moonshot” initiative to eliminate cancer. This endeavor can only be achieved with harmonized regulatory requirements in view of the pressures of a globalised manufacturing market for medical devices so one can deliver quality products to the marketplace.
M.D., Ph.D., Professor of Oncology, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University
Dr. Mark Levis’ broad research goals are to identify and validate novel molecular therapeutic targets in hematopoietic malignancies. His research group is interested in the identification and pre-clinical development of novel targeted therapies, and, in particular, the “translational” step of this research by using correlative studies to incorporate these novel therapies into existing treatments. Currently, Dr. Levis is actively involved in the pre-clinical and clinical development of small molecule kinase inhibitors targeting signaling pathway in acute myeloid leukemia, with a particular focus on FLT3. He completed a baccalaureate in genetics at U.C. Berkeley, and is a graduate of the Medical Scientist Training Program from U.C. San Francisco. He completed his residency training in internal medicine and a fellowship in medical oncology at Johns Hopkins University.
Acute Myeloid Leukemia: Bringing Order Out of Chaos
Acute myeloid leukemia (AML) is an aggressive hematopoietic malignancy that is molecularly heterogeneous. Survival for AML patients is improving slowly, thanks to emerging new therapies, but choosing the right therapy for each patient is only going to happen with the introduction and widespread use of precise, standardized diagnostic assays.