Session Chair Profile
Ph.D., CSO, CEO & Chairman, Invivoscribe, Inc.
Jeffrey Miller, Ph.D., has worked in the field of precision medicine for more than two decades. In 1995, he founded Invivoscribe without outside investment. Invivoscribe’s team has built the company into a vertically integrated, international network of wholly-owned ISO13485 manufacturing and CLIA/CAP, ISO15189 clinical testing companies located in the U.S., Europe, and Asia, including China. They operate under a single quality and regulatory system. The companies develop and commercialize companion diagnostics, providing standardized PCR and NGS based kits and bioinformatics software from their FDA inspected cGMP manufacturing facility, and internationally available standardized clinical testing 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.
Streamlined CDx™ – A Pipeline That Accelerates Drug Approvals
Companion Diagnostics have revolutionized precision medicine as they play a pivotal role in defining the efficacy of targeted therapies. Invivoscribe’s Streamlined CDx™ program has been shown to collapse development timelines, improve and accelerate selection of patient cohorts, leading to earlier submissions and accelerated FDA, EMA and PMDA approvals of new targeted therapies.
Session Abstract – PMWC 2019 Silicon Valley
Session Synopsis: Companion diagnostics (CDx) tests provide information that is essential for the safe and effective use of a corresponding therapeutic products, such as a drug. Tumor profiling NGS tests may include CDx claims that are prescriptive for a specific therapeutic product, and are supported by analytical validity and a clinical study.