Session Abstract – PMWC 2018 Silicon Valley

Session Synopsis: The nascent field of Precision Medicine depends on molecular testing to help physicians identify the right treatment for the right patient at the right time. Since clinical test results help define treatment, it follows that a bad test can be every bit as dangerous as a bad drug. Further, regulatory agencies, including the FDA, have expressed an interest and willingness to help pharmaceutical companies accelerate drug approval if molecular tests clearly demonstrate clinical efficacy. As virtually all drug trials depend on the stratification and enrollment of patients drawn from multiple clinical sites, often located around the world, accelerating drug trials depends both on more careful and uniform selection and better monitoring of patients.

This session is designed to provide evidence of the ongoing value of international harmonization and standardization of tests and bioinformatics for patient testing.

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.

Speaker Profile

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.


Minimal Residual Disease in AML: Using Precision Medicine to Save Lives
The treatment of acute myeloid leukemia (AML) has become a paradigm for precision medicine. We describe the development of an assay that detects the persistence of a driver mutation, FLT3-ITD, in patients with no overt evidence of disease, allowing us to identify those patients that can benefit from targeted therapies.

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