SC11: COMPANION DIAGNOSTICS FOR IMMUNO-ONCOLOGY
Room Location: 101/102

Sunday, March 10 | 5:30 – 8:30 pm

ABOUT THIS COURSE:

As the field of Immuno-oncology (IO) therapeutics evolves from one of monotherapy focused on PD-1 or PD-L1 targets into IO combination therapies including either 1) chemo/radio therapy or 2) novel therapeutic targets within the immune system, biomarker approaches to enrich for subjects most likely to respond to IO therapeutics have evolved also. This short course will review where we have been as a field regarding PD-L1 immunohistochemistry, microsatellite instability and DNA repair biomarkers, thinking forward to biomarkers of mutation burden which are still in development as potential companion diagnostic biomarkers.

COURSE AGENDA:

5:30 Intro to IO Diagnostic Biomarkers and PD-L1 IHC Evolution from TPS to CPS

Kenneth Emancipator, MD, Executive Medical Director and Head of Companion Diagnostics, Merck & Co.

6:15 Dinner

6:45 MSI/MMR Testing: From CRC Prognosis/Lynch Syndrome Diagnosis to Pan Tumor Immunotherapy

Mary J. Savage, Scientific Director, Merck & Co., Inc.

7:30 HRD/TMB Testing: DNA Mutation Signatures, Present and Future Promise for Patient Selection

Deepti Aurora-Garg, Director, Companion Diagnostics, Merck & Co., Inc.

8:15 Q&A

ACRONYM KEY:

IO: ImmunoOncology

TPS: Tumor Proportion Score

CPS: Combined Positive Score

MSI: Microsatellite Instability

MMR: Mismatch Repair

CRC: Colorectal Cancer

HRD: Homologous Recombination Deficiency

TMB: Tumor Mutation Burden

INSTRUCTORS:

Aurora-Garg_DeeptiDeepti Aurora-Garg, Director, Companion Diagnostics, Merck & Co., Inc.

Deepti Aurora-Garg is the Director of Companion Diagnostics at Merck and Co. since 2014. She has been instrumental in development of biomarkers and companion diagnostics in oncology and other therapeutic areas. She has been leading the companion diagnostic efforts in support of Merck’s anti-PD1 therapy Keytruda across various tumor types on immunohistochemisty and next generation sequencing platforms. Prior to joining Merck, Deepti served as Director of Product Development at Immucor, a market leader in Transfusion and Transplantation diagnostics. In her role, she was responsible for developing and commercializing molecular diagnostic assays for minor blood group antigens. She also has experience developing multiplex immunoassays for and molecular assays for infectious diseases and oncology at Genprobe and Trovagene. Through her career, she has helped develop, seek regulatory approvals and commercialize several IVD products. Deepti received her PhD in Molecular Biology and Immunology from Indiana State University and her post-doctoral training from Children’s Hospital Boston an affiliate of Harvard Medical School working with Dr. Anna Aldovini in the Department of Infectious diseases on development of vaccination strategies for HIV/AIDS.

Emancipator_KennethKenneth Emancipator, MD, Executive Medical Director and Head of Companion Diagnostics, Merck & Co.

Kenneth Emancipator received his AB degree from Harvard University and his MD from St. Louis University. He completed his medical internship at Westchester County Medical Center and his pathology residency at the State University of New York at Stony Brook. He was a Senior Staff Fellow at the National Institutes of Health and the U.S. Food and Drug Administration. Dr. Emancipator began his career in academics, having served as Director of Clinical Chemistry at Cornell University and Beth Israel Medical Center. He subsequently migrated to the medical device industry, holding positions as Director of Medical Affairs for Bayer Diagnostics, Senior Director of Medical Affairs for Siemens Healthcare Diagnostics, and Senior Director of Medical Regulatory and Clinical Affairs at Abbott Molecular. He has also worked as an independent consultant to the medical device and pharmaceutical industries before joining Merck to lead its companion diagnostics program. He is a former officer and former member of the Board of Directors of the American Society for Clinical Pathology. He is considered an expert on medical device safety and precision medicine. In his current capacity, Dr. Emancipator led the Merck team which worked with Dako to develop the PD-L1 test, which identifies those non-small cell lung cancer patients most likely to benefit from Keytruda® (pembrolizumab), and which is the first companion diagnostic in immuno-oncology to be approved by the US Food and Drug Administration. Dr. Emancipator was one of six members of the Keytruda® Team to receive the 2015 PhRMA Research and Hope Award for Biopharmaceutical Industry Research on behalf of Merck.

Savage_MaryMary J. Savage, Scientific Director, Merck & Co., Inc.

Mary graduated with a PhD in Pharmacology from Columbia University studying neuron injury and regeneration. She joined Cephalon, Inc. (now Teva Pharmaceuticals) to study Alzheimer's disease (AD) drug discovery and translational sciences research, including amyloid and secretase biology, with application to secretase inhibition, transgenic AD model development, and tau kinase inhibitor biology and drug discovery. Mary continued her study of Alzheimer’s disease at Merck, joining in 2006, where she led translational efforts on several amyloid beta-, apoE-, and tau-targeted drug discovery programs. In 2009, Mary shifted to become the lead for AD biomarker development, working with consortia including ADNI, ADNI PPSB and GBSC and leading to the application of patient enrollment biomarkers in two Phase III clinical trials of beta secretase inhibitor. In 2013, Mary joined the companion diagnostic group at Merck to develop biomarkers for Keytruda, including PD-L1 and Microsatellite Instability High (MSI-H) biomarkers. Her work has led to the US approval of PD-L1 Agilent Pharm Dx IHC assay for selection of late line Gastric cancer patients to receive Keytruda monotherapy, as well as the filing in Japan of the FALCO PCR assay for MSI-H, also for patient selection to receive Keytruda monotherapy (under review). Mary leads Merck’s efforts to develop two companion diagnostic assays in the US for MSI-H (Next Generation Sequencing), and mismatch repair deficiency (Immunohistochemistry).

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