Publications by authors named "Nathan Standifer"

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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, Nathan Standifer

Bioanalysis· February 2025

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A phase 1 study of the CD40 agonist MEDI5083 in combination with durvalumab in patients with advanced solid tumors.
Ben Tran, Mark Voskoboynik, Johanna Bendell, Martin Gutierrez, Charlotte Lemech, Nathan Standifer

Immunotherapy· September 2024

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First-in-human Phase I Trial of TPST-1120, an Inhibitor of PPARα, as Monotherapy or in Combination with Nivolumab, in Patients with Advanced Solid Tumors.
Mark Yarchoan, John D Powderly, Bruno R Bastos, Thomas B Karasic, Oxana V Crysler, Nathan Standifer

Cancer Res Commun· April 2024

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Phase 1/2 study of monalizumab plus durvalumab in patients with advanced solid tumors.
Sandip P Patel, Teresa Alonso-Gordoa, Susana Banerjee, Ding Wang, Jarushka Naidoo, Nathan E Standifer

J Immunother Cancer· February 2024

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The ATR inhibitor ceralasertib potentiates cancer checkpoint immunotherapy by regulating the tumor microenvironment.
Elizabeth L Hardaker, Emilio Sanseviero, Ankur Karmokar, Devon Taylor, Marta Milo, Nathan Standifer

Nat Commun· February 2024

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Modeling of Proliferating CD4 and CD8 T-Cell Changes to Tremelimumab Exposure in Patients with Unresectable Hepatocellular Carcinoma.
Xuyang Song, Robin Kate Kelley, Michelle Green, Nathan Standifer, KyoungSoo Lim

Clin Pharmacol Ther· October 2023

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Targeting the Inducible T-cell Costimulator (ICOS) in Patients with Relapsed/Refractory T-follicular Helper Phenotype Peripheral T-cell and Angioimmunoblastic T-cell Lymphoma.
Julio C Chavez, Francine M Foss, Basem M William, Jonathan E Brammer, Sonali M Smith, Nathan Standifer

Clin Cancer Res· May 2023

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Exposure-Response Analyses of Tremelimumab Monotherapy or in Combination with Durvalumab in Patients with Unresectable Hepatocellular Carcinoma.
Xuyang Song, Robin Kate Kelley, Anis A Khan, Nathan Standifer, Diansong Zhou

Clin Cancer Res· February 2023

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A Consideration of Fixed Dosing Versus Body Size-Based Dosing Strategies for Chimeric Antigen Receptor T-Cell Therapies.
Jimmy Zhijian He, Hechuan Wang, KyoungSoo Lim, Song Ren, Fred Rollins, Nathan Standifer

Clin Pharmacol Drug Dev· October 2022

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Circulating Immune Cell and Outcome Analysis from the Phase II Study of PD-L1 Blockade with Durvalumab for Newly Diagnosed and Recurrent Glioblastoma.
Lakshmi Nayak, Nathan Standifer, Jorg Dietrich, Jennifer L Clarke, Gavin P Dunn

Clin Cancer Res· 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, Nathan Standifer

Bioanalysis· May 2022

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Resistance to Durvalumab and Durvalumab plus Tremelimumab Is Associated with Functional Mutations in Patients with Non-Small Cell Lung Cancer and Is Reversed by STAT3 Knockdown.
Nabendu Pore, Song Wu, Nathan Standifer, Maria Jure-Kunkel, Melissa de Los Reyes

Cancer Discov· November 2021

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Safety, Efficacy, and Pharmacodynamics of Tremelimumab Plus Durvalumab for Patients With Unresectable Hepatocellular Carcinoma: Randomized Expansion of a Phase I/II Study.
Robin Kate Kelley, Bruno Sangro, William Harris, Masafumi Ikeda, Takuji Okusaka, Nathan Standifer

J Clin Oncol· September 2021

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Early changes in the circulating T cells are associated with clinical outcomes after PD-L1 blockade by durvalumab in advanced NSCLC patients.
Elliot Naidus, Jerome Bouquet, David Y Oh, Timothy J Looney, Hai Yang, Nathan E Standifer

Cancer Immunol Immunother· July 2021

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Best practices for optimization and validation of flow cytometry-based receptor occupancy assays.
Ed Hilt, Yongliang S Sun, Thomas W McCloskey, Steve Eck, Thomas McIntosh, Nathan Standifer

Cytometry B Clin Cytom· January 2021

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Safety and Clinical Activity of MEDI1873, a Novel GITR Agonist, in Advanced Solid Tumors.
Ani S Balmanoukian, Jeffrey R Infante, Raid Aljumaily, Aung Naing, Ashish V Chintakuntlawar, Nathan Standifer

Clin Cancer Res· December 2020

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Population pharmacokinetics, efficacy, and safety of moxetumomab pasudotox in patients with relapsed or refractory hairy cell leukaemia.
Denison Kuruvilla, Yen Lin Chia, Kemal Balic, Nai Shun Yao, Robert J Kreitman, Nathan Standifer

Br J Clin Pharmacol· July 2020

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Recruiting the Immune System Against Disease: Lessons for Clinical and Systems Pharmacology.
Paolo Vicini, Nathan Standifer, Timothy P Hickling

CPT Pharmacometrics Syst Pharmacol· July 2019

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Moxetumomab pasudotox in relapsed/refractory hairy cell leukemia.
Robert J Kreitman, Claire Dearden, Pier Luigi Zinzani, Julio Delgado, Lionel Karlin, Nathan Standifer

Leukemia· August 2018

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Receptor occupancy assessment by flow cytometry as a pharmacodynamic biomarker in biopharmaceutical development.
Meina Liang, Martin Schwickart, Amy K Schneider, Inna Vainshtein, Christopher Del Nagro, Nathan Standifer

Cytometry B Clin Cytom· March 2016

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Evaluation of assay interference and interpretation of CXCR4 receptor occupancy results in a preclinical study with MEDI3185, a fully human antibody to CXCR4.
Martin Schwickart, Carlos Chavez, Simon Henderson, Inna Vainshtein, Nathan Standifer

Cytometry B Clin Cytom· March 2016

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Discovery of T cell antigens by high-throughput screening of synthetic minigene libraries.
Brian D Hondowicz, Katharine V Schwedhelm, Arnold Kas, Michael A Tasch, Crystal Rawlings, Nathan E Standifer

PLoS One· May 2012

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ECM components guide IL-10 producing regulatory T-cell (TR1) induction from effector memory T-cell precursors.
Paul L Bollyky, Rebecca P Wu, Ben A Falk, James D Lord, S Alice Long, Nathan E Standifer

Proc Natl Acad Sci U S A· May 2011

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Short-term IL-1beta blockade reduces monocyte CD11b integrin expression in an IL-8 dependent fashion in patients with type 1 diabetes.
Srinath Sanda, Jenna Bollyky, Nathan Standifer, Gerald Nepom, Jessica A Hamerman

Clin Immunol· August 2010

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Maintenance of immune tolerance to a neo-self acetylcholine receptor antigen with aging: implications for late-onset autoimmunity.
Sue Stacy, Earlanda L Williams, Nathan E Standifer, Amanda Pasquali, Keith A Krolick

J Immunol· June 2010

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