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Nominated by: Rafiq Islam, Executive Director, Bioanalytical Sciences, Celerion (NE, USA)
“Sumit joined Celerion as a scientist and quickly established himself as team leader for biomarkers. He develops bioanalytical strategy for biomarkers to evaluate disease heterogeneity, target-engagement, mechanism of action, etc. Using innovative thinking, Sumit solves problems that have proven difficult for decades. For example, many have had difficulty measuring free VEGF after VEGF inhibitor treatment. Sumit developed antibodies and statistical methods to confirm only free ligand was measured addressing a critical need for many biologics.
To achieve trial objectives, Sumit creatively integrates disease and drug target biology with bioanalytical science. He advanced biomarkers for NASH by using a context-of-use approach and generating clinical data comparing biomarkers to biopsy. He courageously collaborated with experts, presented at NASH conferences, and worked across teams to convey innovative science to drug developers. Sumit has led efforts to present to the bioanalytical community at AAPS and WRIB. I receive praise from leaders in drug development complementing Sumit’s innovative assays and knowledge.
Sumit contributes process improvement ideas to the nascent regulated biomarkers area. On working groups for the Global CRO Council, he serves side-by-side with executives to develop guidances. He proposed a creative concept of developing “drug development biomarker kits”, which persuaded a manufacturer to create these kits to help scientists accelerate method development.”
1Describe the main highlights of your bioanalytical work.
I lead biomarker assay development at Celerion designing biomarker assays with unique assay designs and the latest biomarker technologies. We published and presented work validating new biomarkers for non-alcoholic steatohepatitis (NASH) and designed one of the first reported accurate assays for free VEGF in the presence of VEGF biologic inhibitors. I have been fortunate to mentor and train interns, students, and scientists to expose them to the evolving field of bioanalysis and biomarkers in the context of drug development.
I also participate in working groups for the Global CRO Council (GCC) authoring White Papers promoting best practices for biomarker method development and validation and to educate the field on new technologies and assay design approaches. This work has led to 5 first author bioanalysis publications and presentations at WRIB, AAPS and Land O’ Lakes.