SC22: Cellular Phenotyping Assays in Oncology Trials
Room Location: 101/102

Monday, March 11 from 8:00-11:00am


The advent of novel therapeutic modalities in oncology practice, including immune checkpoint inhibitors, chimeric antigen receptor T cells and DNA damage response inhibitors, has resulted in a renewed emphasis on monitoring cellular phenotypes (and changes thereof) as predictive or pharmacodynamic biomarkers in oncology trials. This short course will focus on aspects related to the development, validation and implementation of cellular phenotyping assays and the analysis of results thereof. Focus areas will include 1: overview of new and advanced technologies to expand and enhance ability to monitor discrete cellular populations in clinical programs (Mark Edinger), 2: data analysis techniques to detect pharmacodynamic or predictive effects of cell populations in immune checkpoint inhibitor clinical trials (Nathan Standifer) and 3: a case study of the development and validation of a cellular DNA-content assay as proof-of-mechanism, pharmacodynamic biomarker in oncology trials (Megan McCausland and Linlin Xu).

A next generation of flow cytometry practice has evolved in recent years. This evolution is based, in part, on more complete instrument characterization and standardization, refinement of panel construction, optimized processing protocols, new polymer fluorochromes, advancements in detector technology, and new acquisition and analysis algorithms. Together these developments provide the basis for an exquisite, new, and expanded set of tools for dissecting the immune response to malignant cells and the overall tumor microenvironment. These practical and technological advances in flow cytometry practice serendipitously arrived concomitantly with our burgeoning understanding of the role of the immune response in the progression or eradication of tumor. These advances now provide a significant discovery driver on how best to monitor and manipulate the immune response to produce more efficacious treatment outcomes. Highly complex flow cytometry assays (30 plus biomarkers in a single tube with greater than 500 reportable populations) are now routinely used to monitor immune response checkpoint inhibitors, cellular proliferation, activation or exhaustion, tumor infiltrating T Cells, circulating levels of chimeric antigen receptor T Cells, multi-specific antibody construct performance, drug receptor occupancy, and post treatment levels of disease. In addition, the large-scale implementation of next generation flow cytometry in the clinical trials has now become practical with the availability of affordable novel high-performance instrumentation, expanded software analytical capabilities, and cloud-based analysis tools and reporting capability.


Coming soon


Edinger_MarkMark Edinger, Director, Scientific Affairs, Flow Cytometry, Q² Solutions

Mark Edinger is the Scientific Advisor for Flow Cytometry at Q² Solutions. Mark began his career at the Cleveland Clinic where he pioneered flow cytometry there in the late 1970’s. During his 21 years there he developed many of the techniques and assays employed today for clinical practice and academic research. In 1998 Mark formally joined BD Biosciences where he founded the Technical Applications Group, and later the R&D Systems Validation Laboratory. While at BD Mark, working with scientists at Amgen, developed the whole blood phosphoprotein lysing buffer that is now used daily in labs throughout the world. Mark joined Quintiles in 2012 and since here has, working with his former colleagues at BD, put quantitative standardization of flow cytometers in place, along with other state of the art practices, making Q² flow labs the first to offer this level of instrument standardization anywhere in the world. BD and Q² presented this work at Cyto/ISAC 2014. Mark is currently implementing next generation flow cytometry globally at Q², which will be operational in 2019.

McCausland_MeganMegan McCausland, Senior Scientist, Translation Science Laboratory, Q² Solutions

Megan McCausland, a Senior Scientist in the Translational Science Laboratory at Q² Solutions, is responsible for development, validation and global implementation of multi-parameter flow cytometry assays to support clinical trials. Prior to joining Q² Solutions 5 years ago, Megan spent 13 years in academia studying the generation and maintenance of immune memory at Emory University and La Jolla Institute for Allergy and Immunology. She holds a BS in Biology from James Madison University.

Standifer_NathanNathan Standifer, PhD, Scientist II, Clinical Pharmacology and DMPK, MedImmune

Nathan Standifer received his PhD in Microbiology and Immunology from the University of Texas Health Science Center at San Antonio in San Antonio, Texas. Afterwards, he performed his post-doctoral studies in the laboratory of Gerald T Nepom MD, PhD at the Benaroya Research Institute at Virginia Mason in Seattle, Washington. As a post-doctoral fellow, Nathan’s work focused on characterizing autoreactive T cell specificities in type 1 diabetes (T1D) patients and identifying predictive biomarkers of T1D development. After completing his post-doctoral fellowship, he worked in the Clinical Immunology department at Amgen and specialized in development of clinical flow cytometry assays in trials of therapeutics for inflammation-mediated disease. Currently, Nathan is a Scientist II in the Clinical Pharmacology and DMPK department at MedImmune, the biologics development arm of AstraZeneca, at which he supervises development and implementation of flow cytometry-based biomarker assays and the analysis of resulting data in over 35 immune oncology trials. He has authored or co-authored articles in numerous journals including Proceedings of the National Academies of Science, Journal of Immunology, Clinical Immunology and Clinical Cytometry.

Xu_LinlinLinlin Xu, PhD, Scientist I, Clinical Pharmacology and DMPK, MedImmune

Linlin Xu received her PhD degree in Microbiology and Immunology from Indiana University School of Medicine. After that, she worked as a bioassay development scientist at Lakepharma.Inc. Currently she is working at MedImmune as Scientist I for clinical cellular biomarker assay development and implementation in clinical programs.

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