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.
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.
Ph.D., Vice President, R&D Clinical Sequencing Division, Thermo Fisher Scientific
In this role, Dr. Godsey is responsible for driving development of Thermo Fisher Scientific’s next generation of life science, transitional medicine and IVD products, including establishing a best in class companion Dx program as the centerpiece for CSDs Oncology Portfolio. Prior to that, he served as Senior Vice President of Product and Technology Development at Roche Tissue Diagnostics/Ventana Diagnostics, where he was responsible for leading the technology strategy, product development and on-market support. In this role, Dr. Godsey, built Ventana’s CDx program supporting Genentech, as well as external pharma partners such as Pfizer. Prior to Roche, Dr. Godsey led R&D Teams at Digene, Veridex, Gen-Probe and Dade-Behring. Dr. Godsey has had the privilege of launching a number of molecular Dx industry firsts, including the first FDA approved auto matched, molecular Dx asseys for blood screening, STD Screening and CTCs. Dr. Godsey also brings general management experience to any new challenge he takes on. He holds a Ph.D. in biology from St. John’s University.
How Can We Democratize And Globalize NGS For Companion Diagnostics?