Publications by authors named "Sumit Kar"

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The Bi-steric, mTORC1-Selective Inhibitor, RMC-5552, in Advanced Solid Tumors: A Phase 1 Trial.
Alison M Schram, Abdul Rafeh Naqash, Eric B Haura, Jonathan W Riess, Susanna V Ulahannan, Sumit Kar

Clin Cancer Res· December 2025

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2024 White Paper on Recent Issues in Bioanalysis: Three Way-Cross Validation; Urine Clinical Analysis; Automated Methods; Regulatory Queries on Plasma Protein Binding; Automated Biospecimen Management; ELN Migration; Ultra-Sensitivity Mass Spectrometry ( - Recommendations on Advanced Strategies for Mass Spectrometry Assays, Chromatography, Sample Preparation and BMV/Regulated Bioanalysis - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV).
John Wojcik, Timothy Sikorski, Jian Wang, Yue Huang, Hiroshi Sugimoto, Sumit Kar

Bioanalysis· March 2025

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2024 White paper on recent issues in bioanalysis: Impact of LDT in US and IVDR in EU; AI/ML for High Parameter Flow Cytometry; The rise of Olink Technology; CDx for AAV Gene Therapies; Integrative Bioanalysis by Multiple Platforms; Super Sensitive ADA/NAb LBA ( - Recommendations on Advanced Strategies for Biomarkers, IVD/CDx Assays (BAV), Cell Based Assays (CBA), and Ligand-Binding Assays (LBA) - Regulatory Agencies' Input on Biomarkers, IVD/CDx, and Biomarker Assay Validation).
Nicoletta Bivi, Danielle Graham, Laura Joglekar, Kristina McGuire, Jeroen Stoop, Karl Walravens, Sumit Kar

Bioanalysis· February 2025

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2024 White Paper on Recent Issues in Bioanalysis: Evolution of Immunogenicity Assessment beyond ADA/NAb; Regulated Genomic/NGS Assays; Hypersensitivity Reactions; Minimum Noise Reduction; False Positive Range; Modernized Vaccine Approaches; NAb/TAb Correlation - Recommendations on Advanced Strategies for Molecular Assays and Immunogenicity of Gene Therapy, Cell Therapy, Vaccine; Biotherapeutics Immunogenicity Assessment & Clinical Relevance - Regulatory Agencies' Input on Immunogenicity/Technologies of Biotherapeutics, Gene, Cell & Vaccine Therapies).
Omar Tounekti, Sandra Prior, Sarah Wassmer, Joshua Xu, Adrian Wong, Sumit Kar

Bioanalysis· February 2025

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2023 White Paper on Recent Issues in Bioanalysis: EU IVDR 2017/746 Implementation/Impact, IVD/CDx/CLIA Approved Assays, High Dimensional Cytometry, Multiplexing Technologies, LBA Tissue Analysis, Vaccine Study Endpoints, Cell-Based Assays for Biomarkers, Cell Therapy and Vaccines ( - Recommendations on Development & Validation of Biomarkers, IVD, CDx, Cell-Based, Flow Cytometry, Ligand-Binding and Enzyme Assays; Advanced Critical Reagents Strategies).
Olga Kholmanskikh, Yow-Ming Wang, Sarah Hersey, Meenu Wadhwa, Katherine Block, Sumit Kar, Arvind Kinhikar, Sumit Kar, Kara Scheibner

Bioanalysis· June 2024

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2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody - Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Mike Baratta, Wenying Jian, Shawna Hengel, Surinder Kaur, Jennifer Cunliffe, Sumit Kar, Shane Karnik, Kara Scheibner

Bioanalysis· June 2024

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2023 White Paper on Recent Issues in Bioanalysis: ISR for ADA Assays, the Rise of dPCR vs qPCR, International Reference Standards for Vaccine Assays, Anti-AAV TAb Post-Dose Assessment, NanoString Validation, ELISpot as Gold Standard - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Biotherapeutics Immunogenicity & Risk Assessment; ADA/NAb Assay/Reporting Harmonization).
Johanna Mora, Rachel Palmer, Leslie Wagner, Bonnie Wu, Michael Partridge, Sumit Kar, Karl Walravens, Kara Scheibner

Bioanalysis· April 2024

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2022 White Paper on Recent Issues in Bioanalysis: Enzyme Assay Validation, BAV for Primary End Points, Vaccine Functional Assays, Cytometry in Tissue, LBA in Rare Matrices, Complex NAb Assays, Spectral Cytometry, Endogenous Analytes, Extracellular Vesicles - Recommendations on Biomarkers/CDx, Flow Cytometry, Ligand-Binding Assays Development & Validation; Emerging Technologies; Critical Reagents Deep Characterization.
Giane Sumner, Steve Keller, James Huleatt, Roland F Staack, Leslie Wagner, Arvind Kinhikar, Sumit Kar

Bioanalysis· August 2023

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2022 White Paper on Recent Issues in Bioanalysis: ICH M10 BMV Guideline & Global Harmonization; Hybrid Assays; Oligonucleotides & ADC; Non-Liquid & Rare Matrices; Regulatory Inputs ( - Recommendations on Mass Spectrometry, Chromatography and Sample Preparation, Novel Technologies, Novel Modalities, and Novel Challenges, ICH M10 BMV Guideline & Global Harmonization - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine).
Matt Szapacs, Wenying Jian, Daniel Spellman, Jennifer Cunliffe, Elizabeth Verburg, Sumit Kar

Bioanalysis· August 2023

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2022 White Paper on Recent Issues in Bioanalysis: FDA Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, LNP & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, ADA Affinity, Risk-based Approaches, NGS, qPCR, ddPCR Assays ( - Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach).
Luying Pan, Johanna Mora, Karl Walravens, Leslie Wagner, Shirley Hopper, Sumit Kar, Karen Liao

Bioanalysis· July 2023

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2021 White Paper on Recent Issues in Bioanalysis: TAb/NAb, Viral Vector CDx, Shedding Assays; CRISPR/Cas9 & CAR-T Immunogenicity; PCR & Vaccine Assay Performance; ADA Assay Comparability & Cut Point Appropriateness ( - Recommendations on Gene Therapy, Cell Therapy, Vaccine Assays; Immunogenicity of Biotherapeutics and Novel Modalities; Integrated Summary of Immunogenicity Harmonization).
Lina Loo, Shannon Harris, Mark Milton, Meena, Wibke Lembke, Sumit Kar

Bioanalysis· June 2022

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Recommendations on qPCR/ddPCR assay validation by GCC.
Mark Wissel, Martin Poirier, Christina Satterwhite, John Lin, Rafiq Islam, Sumit Kar, Shane Karnik

Bioanalysis· June 2022

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2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry ( - Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation).
Sarah Hersey, Steve Keller, Joel Mathews, Lindsay King, Abbas Bandukwala, Sumit Kar

Bioanalysis· May 2022

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Generating Ins2/miR-133aTg Mice to Model miRNA-Driven Cardioprotection of Human Diabetic Heart.
Hamid R Shahshahan, Tyler N Kambis, Sumit Kar, Santosh K Yadav, Paras K Mishra

Methods Mol Biol· April 2021

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Recommendations for the content and management of Certificates of Analysis for reference standards from the GCC for bioanalysis.
Joseph Bower, Jennifer Zimmer, Stacie McCown, Edward Tabler, Shane Karnik, Sumit Kar

Bioanalysis· April 2021

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2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( - Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation & Innovation - Regulatory Agencies' Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene & Cell Therapy and Vaccine).
Susan Spitz, Yan Zhang, Sally Fischer, Kristina McGuire, Ulrike Sommer, Sumit Kar

Bioanalysis· March 2021

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2020 White Paper on Recent Issues in Bioanalysis: Vaccine Assay Validation, qPCR Assay Validation, QC for CAR-T Flow Cytometry, NAb Assay Harmonization and ELISpot Validation ( - Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene & Cell Therapy and Vaccine Assays).
Bart Corsaro, Tong-Yuan Yang, Rocio Murphy, Ivo Sonderegger, Andrew Exley, Sumit Kar

Bioanalysis· March 2021

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Aggressive Angiomyxoma with Lymphangitis a Rare Entity - Case Report.
Safa Patrick, Sumit Kar, Nitin Gangane, Abhay Deshmukh, Priyanka Date

Indian J Dermatol· January 2021

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Puzzling Papules over Face: Clinicians Perplexity - A Case of Squamous Cell Carcinoma Impersonating MolluscumContagiosum.
Safa Patrick, Sumit Kar, Nitin Gangane, Priyanka Date

Indian Dermatol Online J· November 2020

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Rapid and robust bioanalytical assays are critical for SARS-CoV-2 therapeutic and vaccine development and beyond.
Sumit Kar, Rafiqul Islam

Bioanalysis· September 2020

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Bioanalysis Rising Star Award 2020: announcing our finalists.
Ashley E Ross, Chris Williams, Danielle Moncrieffe, Omar Barnaby, Sooraj Baijnath, Sumit Kar

Bioanalysis· June 2020

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MMP9 mediates acute hyperglycemia-induced human cardiac stem cell death by upregulating apoptosis and pyroptosis in vitro.
Santosh K Yadav, Tyler N Kambis, Sumit Kar, Song Y Park, Paras K Mishra

Cell Death Dis· March 2020

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Antimicrobial Susceptibility Trends among Pathogens Isolated from Blood: A 6-Year Retrospective Study from a Tertiary Care Hospital in East Sikkim, India.
Tsering Yangzom, Dechen Chomu Tsering, Sumit Kar, Jyotsna Kapil

J Lab Physicians· March 2020

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Exercise Training Promotes Cardiac Hydrogen Sulfide Biosynthesis and Mitigates Pyroptosis to Prevent High-Fat Diet-Induced Diabetic Cardiomyopathy.
Sumit Kar, Hamid R Shahshahan, Bryan T Hackfort, Santosh K Yadav, Roopali Yadav

Antioxidants (Basel)· December 2019

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New approaches for biomarker stability determination in regulated bioanalysis: trending, bridging and incurred samples.
Sumit Kar, Clarinda Islam

Bioanalysis· October 2019

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