MONDAY, AUGUST 20
MORNING SHORT COURSES, 9:00 am – 12:00 pm
LIQUID BIOPSY TECHNOLOGIES APPLICATIONS, REGULATIONS AND REIMBURSEMENT
John Simmons, PhD, Director, Translational Science & Diagnostics, Personal Genome Diagnostics
Hatim Husain, MD, Physician, Medical Oncology, University of California, San Diego
Živana Težak, PhD, Associate Director for Science and Technology, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH/FDA
Girish Putcha, MD, PhD, Director of Laboratory Science, MolDx, Palmetto GBA
Arlington
ABOUT THIS COURSE:
Clinical Application of Circulating Cell-Free Tumor DNA
- The scientific background on circulating cell-free tumor DNA (ctDNA)
- Analysis of ctDNA: from sample collection to data generation
- Applications of ctDNA in the clinic and in drug development R&D
- Survey of commercially available ctDNA tests
- Looking into the future: ctDNA as potential companion diagnostics
- Can we combine them: ctDNA, exosomes, and circulating tumor cells?
Adoption Trends and Promising Applications for Liquid Biopsy
- Adoption trends amidst future users
- Predominantly used cell types—CTCs, ctDNA, cfDNA and EVs
- Promising applications for liquid biopsy—current and future
- Predominant approaches to liquid biopsy: hotspot panels, single marker tests, and so on
- Technologies used to detect ctDNA and CTCs—current vs. future users
- Bottleneck to mainstream implementation of liquid biopsy
Regulatory oversight – past, present and future
- Currently existing regulation of NGS-based assays
- Regulation of NGS-based assays
- Final NGS guidances and optimizing oversight
- Next steps and bigger picture
Reimbursement Considerations for Liquid Biopsies
- Overview of the NGS-based Oncology Testing Landscape: Past, Present and Future
- Tissue vs liquid biopsies
- Somatic vs germline
- Tumor-only vs matched tumor-normal
- Past, Tumor Mutational Burden and Immunotherapy
- MSI by NGS
INSTRUCTORS:
John Simmons, PhD, Director, Translational Science & Diagnostics, Personal Genome Diagnostics
John Simmons, PhD is the Director of Translational Science and Diagnostics at PGDx. In this role, John focuses broadly on scientific strategy and biomarker discovery and diagnostics development partnerships with pharma/biotech. Previously, John was at the National Cancer Institute where his research focused on identifying novel therapeutic strategies for multiple myeloma through chemical genomic approaches with a particular focus on drug combinations. He received his undergraduate degree in Biology with honors from American University and Ph.D. in Tumor Biology from Georgetown University as part of the NIH Graduate Partnership Program. As a post-doctoral fellow, he received the Multiple Myeloma Research Foundation (MMRF) Research Fellow award to support his work in developing systems-level approaches for drug combination identification and prioritization.
Hatim Husain, MD, Physician, Medical Oncology, University of California, San Diego
Dr Husain received his undergraduate and medical degree from the Northwestern University Feinberg School of Medicine in Chicago, Illinois. He completed his internal medicine residency at the University of Southern California in Los Angeles, and an oncology fellowship at the Johns Hopkins Hospital in Baltimore, Maryland. He has published articles in peer-reviewed journals including Nature Cell Biology, Oncology, Pharmacogenetics, Annals of Oncology, Clinical Cancer Research, Pharmacogenetics and Genomics, the Journal of Neuro-Oncology, and the Journal of Clinical Oncology, among others. His research focuses on novel cancer therapeutic strategies in solid tumors, specifically lung cancer, with an emphasis on the epithelial growth factor receptor and non-invasive cancer detection strategies.
Živana Težak, PhD, Associate Director for Science and Technology, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH/FDA
Živana Težak, Ph.D., is an Associate Director for Science and Technology, Personalized Medicine Staff, in the Office of In Vitro Diagnostic Device (IVD) Evaluation and Safety (OIR), at the Center for Devices and Radiological Health, Food and Drug Administration (FDA). Prior to joining the FDA in 2004, as a scientific reviewer in microbiology, genomics and molecular biology, Dr. Težak worked in the biotechnology industry, holding research and development scientist positions in a bioinformatics and array developer company. Dr. Težak received a Ph.D. in Biochemistry/Molecular Biology from Florida State University in 1997. From 1998 to 2001 she was a research fellow at the University of Pittsburgh Medical Center and Children’s National Medical Center, Research Center for Genetic Medicine, working on neuromuscular disorders, human genetics, gene therapy and high-throughput screening technologies. Her work resulted in a number of publications in peer-reviewed journals, book chapters and proceedings. In her current position, Dr. Težak has been leading efforts to develop flexible regulatory policies for novel technology-based IVDs, such as next-generation sequencing, in order to enable their smoother translation into the clinic.
Girish Putcha, MD, PhD, Director of Laboratory Science, MolDx, Palmetto GBA
Girish Putcha is currently Director of Laboratory Science for Palmetto GBA’s MolDX program, and the founding Medical Director for Orion Genomics and TOMA Biosciences, personalized medicine companies focused in oncology. Previously, Girish was the founding Medical/Laboratory Director or Chief Medical Officer at Ariosa Diagnostics, Crescendo Bioscience, Life Technologies, and VitaPath Genetics. He also focused on venture capital investments across healthcare, from biopharmaceuticals to medical devices to diagnostics, at Panorama Capital and RiverVest Venture Partners. Prior to this, he held various positions at VeraCyte, CardioDx, and Aviir, all venture-funded personalized medicine companies. Girish received a bachelor's degree from Rice University and two master's degrees from the University of London and the Welcome Institute as a Marshall Scholar. He holds medical and doctoral degrees from Washington University School of Medicine, where he also completed a postdoctoral fellowship in molecular neuroscience. Girish completed his postgraduate medical training at the Stanford University School of Medicine, where he also served as adjunct faculty, specializing in molecular genetic pathology