Antibody-Drug Conjugates

Preface
Olivier and Hurvitz
Introduction: Historical perspective: What makes ADCs revolutionary
Kim Blackwell and Lynn Howie
Part I: What is an ADC
Chapter 1: Typical Antibody-Drug Conjugates
John Lambert
Part II: Engineering, Manufacturing, and Optimizing ADCs
Chapter 2: Selecting Optimal ADC Targets Using Indication-Dependent or Indication-Independent Approaches
Robert Hollingsworth and Jay Harper
Chapter 3: Antibody Drug Conjugates: An overview of the CMC and characterization process
Janet Wolfe and Phillip Ross
Chapter 4: Linker and Conjugation Technology and Improvements
Riley Ennis and Sourav Sinha
Chapter 5: Formulation and Stability
Kouhei Tsumoto, Anthony Young and Satoshi Ohtake
Chapter 6: QC Assay Development
Xiao-Hong Chen and Mate Tolnay
Chapter 7: Occupational Health and Safety Aspects of ADCs and Their Toxic Payloads
Robert Sussman and John Farris
Part III: Nonclinical Approaches
Chapter 8: Bioanalytical Strategies Enabling Successful ADC Translation
Xiaogang Han, Lindsay King and Steve Hansel
Chapter 9: Nonclinical Pharmacology and Mechanistic Modeling of Antibody-Drug Conjugates in Support of Human Clinical Trials
Brian J. Schmidt, Chin Pan, Heather E. Vezina, Huadong Sun, Douglas D. Leipold and Manish Gupta
Chapter 10: Pharmacokinetics of Antibody-Drug Conjugates
Amrita Kamath
Chapter 11: Path to Market Approval: Regulatory Perspective of ADC Nonclinical Safety Assessments
Stacey Ricci and Natalie Simpson
Part IV: Clinical Development and Current Status of ADCs
Chapter 12: Antibody-Drug Conjugates: Clinical Strategies and Applications
Heather E. Vezina, Lucy Lee, Brian J. Schmidt, Manish Gupta
Chapter 13: Antibody-Drug Conjugates (ADCs) in Clinical Development
Patricia LoRusso and Joseph McLaughlin
Chapter 14: ADCs approved for use: Trastuzumab emtansine (Kadcyla®, T-DM1) in patients with previously treated HER2-positive metastatic breast cancer
Gail Lewis Phillips, Sanne de Hass, Sandhya Girish and Ellie Guardino
Chapter 15: ADCs approved for use: Brentuximab Vedotin
Sven DeVos and Monica Mead
Chapter 16: Radioimmunotherapy
Jeffrey Wong and Savita Dandapani
Part V: Future Perspectives in ADC Development
Chapter 17: Radiolabeled Antibody-based Imaging in Clinical Oncology
Bart Hendriks and Daniel Gaddy
Chapter 18: Next Generation ADC Technologies
William C Olson and Amy Q. Han
Index