Publications by authors named "Mark D Stewart"

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Enabling access to genetically modified cell therapies through flexible approaches to manufacturing and cost recovery.
Mark D Stewart, Christopher R Cabanski, Jeff D Allen, John E Connolly, Ben M Beneski

J Immunother Cancer· December 2025

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Diversity by Design: Real-World Data to Enhance Representation in Clinical Cancer Research.
Thao T Vo, Sangmi Kim, Ashley Jaksa, Benjamin Bates, Wei Zhou, Mark D Stewart

Clin Cancer Res· November 2025

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Analytical Validation of Blood-Derived Tumor Mutation Burden (bTMB) Assays: A Joint Consensus Recommendation of the BLOODPAC bTMB Analytical Validation Working Group.
Jonathan Baden, Mark Sausen, Andrew T Anfora, Kevin M D'Auria, Jennifer Dickey, Mark D Stewart

J Mol Diagn· October 2025

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Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification Program.
Grace Collins, Jeff D Allen, Hillary S Andrews, Bernat Navarro-Serer, Mark D Stewart

Ther Innov Regul Sci· October 2025

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Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for Validation.
Hillary S Andrews, Grace Collins, Bernat Navarro-Serer, Mark D Stewart, Jeff D Allen

Ther Innov Regul Sci· July 2025

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Navigating Complexity: Perspectives on Risk Assessment in the Era of New Blood-Based Tests for Early Cancer Detection.
Christina A Clarke, Breeana L Mitchell, Emma Alme, Jonathan P Beer, Tomasz M Beer, Mark D Stewart

Clin Cancer Res· June 2025

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ctDNA Clearance as an Early Indicator of Improved Clinical Outcomes in Advanced NSCLC Treated with TKI: Findings from an Aggregate Analysis of Eight Clinical Trials.
Hillary S Andrews, Nevine Zariffa, Katherine K Nishimura, Stephanie H Choi, Shibing Deng, Mark D Stewart

Clin Cancer Res· June 2025

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Artificial Intelligence and Machine Learning Innovations to Improve Design and Representativeness in Oncology Clinical Trials.
Tali Azenkot, Donna R Rivera, Mark D Stewart, Sandip P Patel

Am Soc Clin Oncol Educ Book· June 2025

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Intentional heterogeneity in autologous cell-based gene therapies: strategic considerations for first-in-human trials.
Christopher R Cabanski, EnJun Yang, Mark D Stewart, Jeff D Allen, John E Connolly

J Immunother Cancer· June 2025

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An Evaluation of Novel Oncology Approvals with a PMR/C for Assessing Data in Racial and Ethnic Populations Underrepresented in Premarket Clinical Trials.
Grace Collins, Hillary S Andrews, Brittany McKelvey, Carrigan Rice, Jeff D Allen, Mark D Stewart

Clin Cancer Res· August 2024

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Evaluation of Real-World Tumor Response Derived From Electronic Health Record Data Sources: A Feasibility Analysis in Patients With Metastatic Non-Small Cell Lung Cancer Treated With Chemotherapy.
Brittany A McKelvey, Elizabeth Garrett-Mayer, Donna R Rivera, Amy Alabaster, Hillary S Andrews, Mark D Stewart

JCO Clin Cancer Inform· August 2024

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Accelerating the development of genetically engineered cellular therapies: a framework for extrapolating data across related products.
Mark D Stewart, Michael Kalos, Vicki Coutinho, Marc Better, Jonathan Jazayeri

Cytotherapy· July 2024

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Advancing Evidence Generation for Circulating Tumor DNA: Lessons Learned from A Multi-Assay Study of Baseline Circulating Tumor DNA Levels across Cancer Types and Stages.
Brittany A McKelvey, Hillary S Andrews, Frederick L Baehner, James Chen, Carin R Espenschied, Mark D Stewart

Diagnostics (Basel)· April 2024

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An Analysis of Dosing-Related Postmarketing Requirements for Novel Oncology Drugs Approved by the U.S. Food and Drug Administration, 2012-2022.
Grace Collins, Brittany McKelvey, Hillary S Andrews, Jeff D Allen, Mark D Stewart

Clin Cancer Res· March 2024

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BLOODPAC: Collaborating to chart a path towards blood-based screening for early cancer detection.
Christina A Clarke, Kathryn Lang, Girish Putcha, Jonathan P Beer, Maude Champagne, Mark D Stewart

Clin Transl Sci· January 2023

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Liquid biopsies coming of age: biology, emerging technologies, and clinical translation- An introduction to the JITC expert opinion special review series on liquid biopsies.
Mark D Stewart, Valsamo Anagnostou

J Immunother Cancer· January 2023

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Need for aligning the definition and reporting of cytokine release syndrome (CRS) in immuno-oncology clinical trials.
Mark D Stewart, Bruce McCall, Marcelo Pasquini, Allen S Yang, Carolyn D Britten

Cytotherapy· July 2022

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Homologous Recombination Deficiency: Concepts, Definitions, and Assays.
Mark D Stewart, Diana Merino Vega, Rebecca C Arend, Jonathan F Baden, Olena Barbash

Oncologist· March 2022

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Real-world Overall Survival Using Oncology Electronic Health Record Data: Friends of Cancer Research Pilot.
Laura Lasiter, Olga Tymejczyk, Elizabeth Garrett-Mayer, Shrujal Baxi, Andrew J Belli, Mark D Stewart

Clin Pharmacol Ther· February 2022

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Exploring the Potential of External Control Arms created from Patient Level Data: A case study in non-small cell lung cancer.
Xiang Yin, Pallavi S Mishra-Kalyan, Rajeshwari Sridhara, Mark D Stewart, Elizabeth A Stuart

J Biopharm Stat· January 2022

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Continuing to Broaden Eligibility Criteria to Make Clinical Trials More Representative and Inclusive: ASCO-Friends of Cancer Research Joint Research Statement.
Edward S Kim, Thomas S Uldrick, Caroline Schenkel, Suanna S Bruinooge, R Donald Harvey, Mark D Stewart

Clin Cancer Res· May 2021

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Modernizing Clinical Trial Eligibility Criteria: Recommendations of the ASCO-Friends of Cancer Research Laboratory Reference Ranges and Testing Intervals Work Group.
Alexander I Spira, Mark D Stewart, Suzanne Jones, Elaine Chang, Anitra Fielding

Clin Cancer Res· May 2021

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Omissions of Care in Nursing Homes: A Uniform Definition for Research and Quality Improvement.
Rikki Mangrum, Mark D Stewart, David R Gifford, Yael Harris, Aaron M Ogletree

J Am Med Dir Assoc· November 2020

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A National Assessment of Diagnostic Test Use for Patients with Advanced NSCLC and Factors Influencing Physician Decision-Making.
Madison M Wempe, Mark D Stewart, Daniel Glass, Laura Lasiter, Diana Merino Vega

Am Health Drug Benefits· June 2020

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