The technology of companion diagnostics is going through the most significant change since the establishment of the concept of personalized medicine. The reason and the main driver of this change is the next generation sequencing and the option to check for several predictive biomarkers simultaneously. Another issue that complicates the steady progress of companion diagnostics is the current state of the reimbursement uncertainty in the area of molecular diagnostics. Our Fifth Annual Companion Diagnostics: Technology & Reimbursement conference will be featuring technological advances of companion assays both as IVD products and as laboratory developed tests. It will also address the pivotal issue of reimbursement with the emphasis on partnership between payers and assay developers.
Regulatory Review of Clinical Sequencing Assays
In November of 2013 FDA issued the first clearances of NextGen Sequencing based assays. There have additionally been a number of clinical trials approved recently that utilize NextGen Sequencing based assays for patient enrollment or stratification. In light of the expanding roles that new sequencing technologies are playing in clinical decision making, this talk will focus on critical elements that FDA considers when evaluating NextGen sequencing validation using the recent clearances/approvals as examples. There will also be a discussion of any new communications that FDA has issued in regard to the regulatory review of NextGen sequencing-based assays.
Harry Glorikian, Managing Partner, Strategy, Precision for Medicine
Jennifer Dickey, RAC, Ph.D., Office of In Vitro Diagnostics, DIHD, US Food and Drug Administration
Next Generation Sequencing in Clinical Practice: Case Reports of Clinical Utility and Reimbursement
Elaine Lyon, Ph.D., Medical Director, Molecular Genetics, ARUP
Andrea Ferreira-Gonzalez, Ph.D., Professor, Virginia Commonwealth University
Madhuri Hegde, Ph.D., FACMG, Associate Professor, Human Genetics; Executive Director, Emory Genetics Laboratory, Emory University School of Medicine
Keynote Presentation: Applications of Next-Generation Sequencing in Multiplex Companion Assays: The Age of Targeted Therapy
Kevin Krenitsky, M.D., Chief Commercial Officer, Foundation Medicine
Personalized Genomic Analyses of Human Cancer
Victor E. Velculescu, M.D., Ph.D., Professor of Oncology, Co-Director, Cancer Biology, Johns Hopkins Kimmel Cancer Center
What Does The History Of in vitro Diagnostics Tells Us About The Future Of Personalized Medicine?
Kenneth Emancipator, M.D., Director, Companion Diagnostics Merck Research Laboratories
Considerations in the Implementation of Clinical Trials with an integral Next-Generation Sequencing Assay
Barbara Conley, M.D., Associate Director, Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute
Preparing a Multi-Analyte NGS Assay for Use in Clinical Studies for Cancer
P. Mickey Williams, Ph.D., Director, Patient Characterization Center & CADC, SAIC Frederick
Talk Title to be Announced
Mark S. Boguski, M.D., Ph.D., Associate Professor of Pathology, Center for Biomedical Informatics, Harvard Medical School
Data Integration for Biomarker Driven Clinical Trials and Personalized Medicine
Jomol Mathew, Ph.D., Director, Clinical and Translational Informatics, IS, Dana-Farber Cancer Institute
Chairperson: Jorge A. Leon, Ph.D., President & CEO, Leomics Associates, Inc.
A Do-It-Yourself Guide to Partnerships between Payers and Molecular Diagnostic Companies
Lon Castle, M.D., Medical Science Liaison, Medical Affairs, CardioDx
Real Cases and Real Solutions for the Reimbursement Crisis and the Need to Meet Halfway
Jorge A. Leon, Ph.D., President & CEO, Leomics Associates, Inc.
Lee H. Newcomer, M.D., Senior Vice President, Oncology, United Healthcare (invited)
Talk Title to be Announced
David Himsworth, Director, Clinical Affairs, Luminex Corporation