Antibody-Drug Conjugates
Fundamentals, Drug Development, and Clinical Outcomes to Target Cancer
1. Edition December 2016
560 Pages, Hardcover
Wiley & Sons Ltd
ISBN:
978-1-119-06068-0
John Wiley & Sons
Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells.
* Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies
* Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging
* Includes case studies of ADCs in oncology drug development
* Features contributions from highly-regarded experts on the frontlines of ADC research and development
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
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
Kenneth J. Olivier, Jr., PhD, is Head of Toxicology, Discovery Regulatory, Bioanalytical Assay Development, Pharmacokinetics and Discovery Project Management at Merrimack Pharmaceuticals and has over 13 years' experience in the biotechnology and pharmaceutical industries.
Sara A. Hurvitz, MD, is an Associate Professor of Medicine at the University of California, Los Angeles (UCLA); Co-Director of the Santa Monica-UCLA Outpatient Oncology Practice; Medical Director of the Clinical Research Unit of the Jonsson Comprehensive Cancer Center of UCLA; and Director of the Breast Oncology Program, Division of Hematology-Oncology, at UCLA.
Sara A. Hurvitz, MD, is an Associate Professor of Medicine at the University of California, Los Angeles (UCLA); Co-Director of the Santa Monica-UCLA Outpatient Oncology Practice; Medical Director of the Clinical Research Unit of the Jonsson Comprehensive Cancer Center of UCLA; and Director of the Breast Oncology Program, Division of Hematology-Oncology, at UCLA.
