Publications by authors named "Ola Saad"

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Polatuzumab vedotin in CNS lymphoma: proof-of-concept study for blood-brain barrier penetration.
Lei Gao, Avyakta Kallam, Geoffrey Shouse, John H Baird, Stacy Pak, Ola M Saad

Blood Adv· December 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, Ola M Saad

Bioanalysis· February 2025

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Correction to: Method development of a novel PK assay for antibody-conjugated drug measurement of ADCs using peptide-linker drug analyte.
Suk-Joon Hyung, Dongwei Li, Neelima Koppada, Surinder Kaur, Ola M Saad

Anal Bioanal Chem· December 2024

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Monomethyl auristatin E (MMAE), a payload for multiple antibody drug conjugates (ADCs), demonstrates differential red blood cell partitioning across human and animal species.
Victor Yip, Ola M Saad, Doug Leipold, Chunze Li, Amrita Kamath

Xenobiotica· August 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, Ola M Saad

Bioanalysis· April 2024

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The HER2-directed antibody-drug conjugate DHES0815A in advanced and/or metastatic breast cancer: preclinical characterization and phase 1 trial results.
Gail D Lewis, Guangmin Li, Jun Guo, Shang-Fan Yu, Carter T Fields, Ola Saad

Nat Commun· January 2024

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Development of a semi-automated MHC-associated peptide proteomics (MAPPs) method using streptavidin bead-based immunoaffinity capture and nano LC-MS/MS to support immunogenicity risk assessment in drug development.
M Violet Lee, Ola M Saad, Sylvia Wong, Jason LaMar, Lynn Kamen

Front Immunol· December 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, Ola Saad

Bioanalysis· August 2023

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Percutaneous Renal Biopsy in Egyptian Children: A Five-year Single-Center Experience.
Ola Abdeltawab Saad, Nahla Mohamed Elkalla, Ferial Moursi

Saudi J Kidney Dis Transpl· January 2023

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Multiplexed Quantitative Analysis of Antibody-Drug Conjugates with Labile CBI-Dimer Payloads Using Immunoaffinity LC-MS/MS.
Suk-Joon Hyung, Douglas D Leipold, Donna W Lee, Surinder Kaur, Ola M Saad

Anal Chem· January 2022

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Preclinical Characterization of the Distribution, Catabolism, and Elimination of a Polatuzumab Vedotin-Piiq (POLIVY) Antibody-Drug Conjugate in Sprague Dawley Rats.
Victor Yip, M Violet Lee, Ola M Saad, Shuguang Ma, S Cyrus Khojasteh

J Clin Med· March 2021

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Characterization of Tissue Distribution, Catabolism, and Elimination of an Anti- THIOMAB Antibody-Antibiotic Conjugate in Rats.
Hao Cai, Victor Yip, M Violet Lee, Sylvia Wong, Ola Saad

Drug Metab Dispos· November 2020

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Conjugation Site Influences Antibody-Conjugated Drug PK Assays: Case Studies for Disulfide-Linked, Self-Immolating Next-Generation Antibody Drug Conjugates.
M Violet Lee, Surinder Kaur, Ola M Saad

Anal Chem· September 2020

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Hypoxia Attenuates Trastuzumab Uptake and Trastuzumab-Emtansine (T-DM1) Cytotoxicity through Redistribution of Phosphorylated Caveolin-1.
Vineesh Indira Chandran, Ann-Sofie Månsson, Magdalena Barbachowska, Myriam Cerezo-Magaña, Björn Nodin, Ola M Saad

Mol Cancer Res· April 2020

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Preclinical and translational pharmacokinetics of a novel THIOMAB™ antibody-antibiotic conjugate against .
Rong Deng, Chenguang Zhou, Dongwei Li, Hao Cai, Siddharth Sukumaran, Ola Saad

MAbs· January 2020

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Immunogenicity of antibody-drug conjugates: observations across 8 molecules in 11 clinical trials.
Montserrat Carrasco-Triguero, Randall C Dere, Marija Milojic-Blair, Ola M Saad, Denise Nazzal

Bioanalysis· September 2019

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Preclinical pharmacokinetics and pharmacodynamics of DCLL9718A: An antibody-drug conjugate for the treatment of acute myeloid leukemia.
Douglas D Leipold, Isabel Figueroa, Shabkhaiz Masih, Brandon Latifi, Victor Yip, Ola M Saad

MAbs· June 2019

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A Phase 1, Randomized, Single-Ascending-Dose Study To Investigate the Safety, Tolerability, and Pharmacokinetics of DSTA4637S, an Anti- Thiomab Antibody-Antibiotic Conjugate, in Healthy Volunteers.
Melicent Peck, Michael E Rothenberg, Rong Deng, Nicholas Lewin-Koh, Gaohong She, Ola Saad

Antimicrob Agents Chemother· June 2019

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Method development of a novel PK assay for antibody-conjugated drug measurement of ADCs using peptide-linker drug analyte.
Suk-Joon Hyung, Dongwei Li, Neelima Koppada, Surinder Kaur, Ola M Saad

Anal Bioanal Chem· May 2019

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Antibody-Drug Conjugates Derived from Cytotoxic seco-CBI-Dimer Payloads Are Highly Efficacious in Xenograft Models and Form Protein Adducts In Vivo.
Dian Su, Jinhua Chen, Ely Cosino, Josefa Dela Cruz-Chuh, Helen Davis, Ola Saad

Bioconjug Chem· May 2019

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2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 - PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies' inputs on bioanalysis, biomarkers and immunogenicity).
Hendrik Neubert, Timothy Olah, Anita Lee, Stephanie Fraser, Robert Dodge, Ola M Saad

Bioanalysis· December 2018

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Minimal physiologically-based pharmacokinetic modeling of DSTA4637A, A novel THIOMAB™ antibody antibiotic conjugate against Staphylococcus aureus, in a mouse model.
Shun Xin Wang-Lin, Chenguang Zhou, Amrita V Kamath, Kyu Hong, Neelima Koppada, Ola M Saad

MAbs· October 2018

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Platform model describing pharmacokinetic properties of vc-MMAE antibody-drug conjugates.
Matts Kågedal, Leonid Gibiansky, Jian Xu, Xin Wang, Divya Samineni, Ola Saad

J Pharmacokinet Pharmacodyn· December 2017

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2017 White Paper: rise of hybrid LBA/LCMS immunogenicity assays (Part 2: hybrid LBA/LCMS biotherapeutics, biomarkers & immunogenicity assays and regulatory agencies' inputs).
Hendrik Neubert, An Song, Anita Lee, Cong Wei, Jeff Duggan, Ola Saad

Bioanalysis· December 2017

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Pharmacokinetics and pharmacodynamics of DSTA4637A: A novel THIOMAB™ antibody antibiotic conjugate against Staphylococcus aureus in mice.
Chenguang Zhou, Sophie Lehar, Johnny Gutierrez, Carrie M Rosenberger, Nina Ljumanovic, Ola Saad

MAbs· November 2017

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