Mark Milton

A Prostate-Specific Membrane Antigen-Targeted Monoclonal Antibody–Chemotherapeutic Conjugate Designed for the Treatment of Prostate Cancer

Michael D. Henry, Shenghua Wen, Matthew D. Silva et al. · Cancer Research · 2004 · 155 citations

2019 White Paper on Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation (Part 3 – Recommendations on 2019 FDA Immunogenicity Guidance, Gene Therapy Bioanalytical Challenges, Strategies for Critical Reagent Management, Biomarker Assay Validation, Flow Cytometry Validation & CLSI H62)

Steven P. Piccoli, Devangi Mehta, Alessandra Vitaliti et al. · Bioanalysis · 2019 · 92 citations · Full text

The TeGenero Incident and the Duff Report Conclusions: A Series of Unfortunate Events or an Avoidable Event?

Christopher Horvath, Mark Milton · Toxicologic Pathology · 2009 · 83 citations

Pharmacotherapy, T Cells, Pharmacodynamic Modeling +23

The EMEA Guideline on First-in-Human Clinical Trials and Its Impact on Pharmaceutical Development

Mark Milton, Christopher Horvath · Toxicologic Pathology · 2009 · 72 citations

Clinical Endpoint, Emea Guideline, First-in-human Clinical Trials +22

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 ( <u>Part 3</u> –Recommendations on Immunogenicity Assay Strategies, NAb Assays, Biosimilars and FDA/EMA Immunogenicity Guidance/Guideline, Gene &amp; Cell Therapy and Vaccine Assays)

Bart Corsaro, Tong‐Yuan Yang, Rocio Murphy et al. · Bioanalysis · 2021 · 60 citations