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Comprehensive functional characterization of cancer-testis antigens defines obligate participation in multiple hallmarks of cancer

Nature communications, 2015-11, Vol.6 (1), p.8840, Article 8840

2015

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SIK2 Restricts Autophagic Flux To Support Triple-Negative Breast Cancer Survival

Molecular and cellular biology, 2016-12, Vol.36 (24), p.3048-3057

2016

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Multiple Cancer Testis Antigens Function To Support Tumor Cell Mitotic Fidelity

Molecular and Cellular Biology, 2012-10, Vol.32 (20), p.4131-4140

2012

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The Role of Public–Private Partnerships in Catalyzing the Critical Path

Clinical and translational science, 2017-11, Vol.10 (6), p.431-442

2017

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Precision Dosing: A Clinical and Public Health Imperative

JAMA : the journal of the American Medical Association, 2021-04, Vol.325 (15), p.1505

2021

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Thin-Walled Microvessels in Human Coronary Atherosclerotic Plaques Show Incomplete Endothelial Junctions

Journal of the American College of Cardiology, 2009-04, Vol.53 (17), p.1517-1527

2009

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Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments

Clinical pharmacology and therapeutics, 2021-03, Vol.109 (3), p.697-704

2021

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Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real‐World Setting

Clinical pharmacology and therapeutics, 2021-01, Vol.109 (1), p.25-28

2021

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A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration

Clinical pharmacology and therapeutics, 2021-01, Vol.109 (1), p.123-130

2021

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Summary of a Public FDA Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments

Clinical pharmacology and therapeutics, 2023-02, Vol.113 (2), p.221-225

2023

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Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins

The AAPS journal, 2023-05, Vol.25 (4), p.54-54, Article 54

2023

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FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Clinical cancer research, 2023-02, Vol.29 (3), p.508-512

2023

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Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use

Clinical pharmacology and therapeutics, 2020-10, Vol.108 (4), p.710-715

2020

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Thin-Walled Microvessels in Human Coronary Atherosclerotic Plaques Show Incomplete Endothelial Junctions : Relevance of Compromised Structural Integrity for Intraplaque Microvascular Leakage

Journal of the American College of Cardiology, 2009-04, Vol.53 (17), p.1517-1527

2009

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Proceedings of a Workshop: US Food and Drug Administration‐International Society of Pharmacometrics Model‐Informed Drug Development in Oncology

Clinical pharmacology and therapeutics, 2019-07, Vol.106 (1), p.81-83

2019

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Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation

Therapeutic innovation & regulatory science, 2020-11, Vol.54 (6), p.1363-1371

2020

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Abstract LB-207: Dissecting the functional landscape of triple-negative breast cancer

Cancer research (Chicago, Ill.), 2013-04, Vol.73 (8_Supplement), p.LB-207-LB-207

2013

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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 (PART 1A – Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunoge

Bioanalysis, 2024-05, p.1-58

2024

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Abstract A27: Dissecting the functional landscape of triple-negative breast cancer

Molecular cancer therapeutics, 2013-05, Vol.12 (5_Supplement), p.A27-A27

2013

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2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs

Bioanalysis, 2022-05, Vol.14 (9), p.505-580

2022

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2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays)

Bioanalysis, 2018-12, Vol.10 (24), p.1973-2001

2018

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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

Bioanalysis, 2022-06, Vol.14 (11), p.737-793

2022

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Abstract 975: Employing functional genomics to reveal emergent dependencies

Cancer research (Chicago, Ill.), 2012-04, Vol.72 (8_Supplement), p.975-975

2012

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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

Bioanalysis, 2024-04, Vol.16 (7), p.77-119

2024

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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

Bioanalysis, 2023-07, Vol.15 (14), p.773-814

2023

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Comprehensive functional characterization of cancer-testis antigens defines obligate participation in multiple hallmarks of cancer

SIK2 Restricts Autophagic Flux To Support Triple-Negative Breast Cancer Survival

Multiple Cancer Testis Antigens Function To Support Tumor Cell Mitotic Fidelity

The Role of Public–Private Partnerships in Catalyzing the Critical Path

Precision Dosing: A Clinical and Public Health Imperative

Thin-Walled Microvessels in Human Coronary Atherosclerotic Plaques Show Incomplete Endothelial Junctions

Elucidating the Impact of Immunogenicity Assessment Postapproval: A Targeted Analysis of Immunogenicity Postmarketing Requirements and Commitments

Proceedings of a Workshop: Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real‐World Setting

A Systematic Assessment of US Food and Drug Administration Dosing Recommendations For Drug Development Programs Amenable to Response‐Guided Titration

Summary of a Public FDA Workshop: Model Informed Drug Development Approaches for Immunogenicity Assessments

Impact of Organ Impairment on the Pharmacokinetics of Therapeutic Peptides and Proteins

FDA Approval Summary: Mobocertinib for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Role of Guidance and Policy in Enhancing the Impact of Clinical Pharmacology in Drug Development, Regulation, and Use

Thin-Walled Microvessels in Human Coronary Atherosclerotic Plaques Show Incomplete Endothelial Junctions : Relevance of Compromised Structural Integrity for Intraplaque Microvascular Leakage

Proceedings of a Workshop: US Food and Drug Administration‐International Society of Pharmacometrics Model‐Informed Drug Development in Oncology

Communicating Immunogenicity-Associated Risk in Current U.S. FDA Prescription Drug Labeling: A Systematic Evaluation

Abstract LB-207: Dissecting the functional landscape of triple-negative breast cancer

Abstract A27: Dissecting the functional landscape of triple-negative breast cancer

2021 White Paper on Recent Issues in Bioanalysis: Mass Spec of Proteins, Extracellular Vesicles, CRISPR, Chiral Assays, Oligos; Nanomedicines Bioanalysis; ICH M10 Section 7.1; Non-Liquid & Rare Matrices; Regulatory Inputs

2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 - LBA/cell-based assays: immunogenicity, biomarkers and PK assays)

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

Abstract 975: Employing functional genomics to reveal emergent dependencies

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

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

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