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The changing landscape of diagnostic biomarkers: Revealing the future of diagnostics, from singleplex to multiplex

This webinar is brought to you by the Science/AAAS Custom Publishing Office

The changing landscape of diagnostic biomarkers: Revealing the future of diagnostics, from singleplex to multiplex

Recorded 12 June 2019


Advancing personalized medicine is increasingly becoming the goal of many drug manufacturers and would be an obvious boon for both clinicians and patients. Immunohistochemistry (IHC)-based companion and complementary diagnostics that can help identify the right patient for the right drug are playing a major role in this trend. While a single-biomarker diagnostic test is clinically appealing due to its simplicity and low cost, the additional information that the right multi-biomarker test could offer is luring many developers to pursue multiplex strategies.

In this webinar, our expert panel will discuss:

  • An overview of the multiplex technologies under consideration as potential diagnostic tools
  • The pros and cons of singleplex IHC versus multibiomarker panels for patients, clinicians, cost centers, and regulators
  • The hurdles faced by new companion diagnostics chemistries and what the regulatory pathway for their application might look like.

The panel will also answer questions from the live, online audience.

This webinar will last for approximately 60 minutes

You can also view Part 1 of this series.

Speaker bios

Sacha Gnjatic, Ph.D.

Icahn School of Medicine at Mount Sinai
New York, NY

Dr. Gnjatic received his Ph.D. in immunology from the University of Paris VII after completing a fellowship at the Institut Cochin in Paris. Following a postdoctoral fellowship at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York, he joined the Ludwig Institute for Cancer Research at MSKCC, where he eventually became an associate member and was named director of Immunological Monitoring at the Ludwig Center for Cancer Immunotherapy. In 2013, Dr. Gnjatic was appointed to his current position of associate professor of medicine at the Tisch Cancer Institute and the Precision Immunology Institute, part of the Icahn School of Medicine at Mount Sinai in New York. He also serves as associate director of the Human Immune Monitoring Core at Mount Sinai. Dr. Gnjatic’s research focuses on human antigen-specific immune responses to tumor antigens, in an attempt to define new targets for the development of cancer immunotherapies, assess the efficacy of these immunotherapies, and learn why they may fail. He also studies the mechanisms of antigen presentation to T cells, the impact of immunoregulation on tumor antigen-specific responses, and characterization of the tumor-immune microenvironment. By supporting correlative studies and biomarker discovery from peripheral blood and at the tissue site, Dr. Gnjatic’s work has established the immunological basis for testing human cancer immunotherapies in over 40 clinical trials, and has resulted in more than 150 publications in high-impact, peer-reviewed journals as well as numerous patents.

Jaime Rodriguez-Canales, M.D., FEBP

Gaithersburg, MD

Dr. Rodriguez-Canales received his M.D. degree and anatomic pathology board certification at the Pontifical Catholic University of Chile. He is also certified by the European Board of Pathology (Utrecht, The Netherlands). From 2002 to 2005 he was fellow in oncologic surgical pathology under the direction of Dr. Juan Rosai. From 2005 to 2012, he was postdoc and research fellow at the Pathogenetics Unit and Laser Capture Microdissection Core of the Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, U.S. National Institutes of Health, in Bethesda, Maryland. In 2012, he joined the University of Texas MD Anderson Cancer Center, and in 2013 was promoted to assistant professor and director of the Immunohistochemistry and Digital Pathology Lab of the Department of Translational Molecular Pathology, where he and his team focused on optimizing multiplex immunofluorescence (IF) and Vectra multispectral imaging for cancer immunoprofiling. In August 2017, Dr. Rodriguez returned to Maryland as senior pathologist at MedImmune/AstraZeneca, where he continues his work on multiplex IF for immuno-oncology, and directs an annual course on the same topic. He has coauthored over 135 peer-reviewed papers, including validation and methodology for multiplex IF in cancer immunoprofiling.

Reena Philip, Ph.D.

U.S. Food and Drug Administration
Silver Spring, MD

Dr. Philip is currently director of the Division of Molecular Genetics and Pathology in the Office of In Vitro Diagnostic Devices and Radiological Health, at the Center for Devices and Radiological Health at the U.S. Food and Drug Administration (FDA). The Division of Molecular Genetics and Pathology provides regulatory oversight of in vitro diagnostic tests in a variety of product areas, including oncology molecular tests, pathology and cytology, companion diagnostic tests, and genetic disorder molecular tests. At the FDA, Dr. Philip has been involved in many diverse activities, such as premarket clearance/approval, manufacturer assistance, postmarket regulatory compliance actions, and the development of the FDA guidance document “In Vitro Companion Diagnostic Devices.” She is also actively involved in biomarker measurement and reporting standardization/harmonization efforts in the field of oncology.

Lei Tang, Ph.D.

Roche Tissue Diagnostics
Tuscon, AZ

Dr. Tang received her Ph.D. in molecular biology and biochemistry from Indiana University. For the past 10 years she has been working for Roche Tissue Diagnostics (RTD), spending the first 8-and-a-half years in product development, with an emphasis on in vitro diagnostic assays (both in situ hybridization and immunohistochemistry). She is now a director at CDx Pharma Services, which leads the development of robust prototype assays and supports exploratory clinical testing in RTD’s CAP/CLIA laboratory. Her division has recently focused on development and optimization of multiplex immunofluorescence assays as well as image-analysis approaches. Prior to her work at RTD, Dr. Tang worked for Exagen Diagnostics developing in situ hybridization and real-time PCR-based assays.

Jackie Oberst, Ph.D.

Washington, DC

Dr. Oberst did her undergraduate training at the University of Maryland, College Park, and her Ph.D. in Tumor Biology at Georgetown University, Washington D.C. She combined her interests in science and writing by pursuing an M.A. in Journalism from the Philip Merrill College of Journalism at the University of Maryland, College Park. Dr. Oberst joined Science/AAAS in 2016 as the Assistant Editor for Custom Publishing. Before then she worked at Nature magazine, the Howard Hughes Medical Institute, The Endocrine Society, and the National Institutes of Mental Health.

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