Quantitative Immunohistochemistry for Development of Predictive Biomarkers in Oncology Clinical Trials

Life Sciences, Clinical Trials, Pharmaceutical, Biomarkers,
  • Wednesday, May 10, 2017

In oncology studies, biomarkers have been effectively used to measure tumor progression and to evaluate efficacy of therapies. Increasingly they have been utilized to stratify different patient groups and to develop personalized therapeutic strategies. Towards this goal, immunohistochemistry (IHC) has been playing an increasing role to help understand the mechanism of action by measuring molecular targets for particular cancer types. Through quantitative analysis of IHC images, effective biomarkers can be predictors of disease prognosis and immune response of various immunotherapies.

Merck has developed and validated various IHC assays and quantitative analysis strategies for identifying and measuring presence of molecular targets for various cancer types using the Definiens platform. They have evaluated the specificity, sensitivity and reproducibility of the IHC assays and demonstrated that these can be used to support oncology clinical trials reliably to evaluate patient response. Development of such patient selection biomarkers is expected to accelerate enrollment and increase response rates, leading to more effective clinical trial designs.


Belma Dogdas, PhD, Associate Principal Scientist, Merck, Inc.

Belma Dogdas is an Associate Principal Scientist in Applied Mathematics and Modeling / Global Data Science Competency Center department at Merck, NJ, USA. She leads the Image Data Analytics program and her research involves development of mathematical and computational algorithms for multi-dimensional analysis for relevant biological imaging applications. She has supported projects for developing biomarkers in various disease areas such as Oncology, Alzheimer’s, Cardiovascular, Diabetes, Infectious disease, Bone biology as well as Safety and Manufacturing studies. Prior to joining Merck, Dr. Dogdas received M.S. and Ph.D. degrees from University of Southern California, Electrical Engineering Department in 2002 and 2007 respectively. She, also, holds a B.S. degree from Bilkent University, Turkey in Electrical and Electronics Engineering Department in 2000. She is a Senior Member of the IEEE Engineering in Medicine and Biology society.

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