Antibody-drug conjugates : fundamentals, drug development, and clinical outcomes to target cancer

Limit of Liability/Disclaimer of Warranty: While the publisher and author have used their best efforts in preparing this book, they make no representations or warranties with respect to the accuracy or completeness of the contents of this book and specifically disclaim any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives or written sales materials. The advice and strategies contained herein may not be suitable for your situation. You should consult with a professional where appropriate. Neither the publisher nor author shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. Typical Antibody-drug Conjugates / John Lambert -- Selecting Optimal Adc Targets Using Indication-dependent Or Indication-independent Approaches / Robert Hollingsworth And Jay Harper -- Antibody Drug Conjugates : An Overview Of The Cmc And Characterization Process / Janet Wolfe And Phillip Ross -- Linker And Conjugation Technology And Improvements / Riley Ennis And Sourav Sinha -- Formulation And Stability / Kouhei Tsumoto, Anthony Young, And Satoshi Ohtake -- Qc Assay Development / Xiao-hong Chen And Mate Tolnay -- Occupational Health And Safety Aspects Of Adcs And Their Toxic Payloads / Robert Sussman And John Farris -- Bioanalytical Strategies Enabling Successful Adc Translation / Xiaogang Han, Lindsay King, And Steve Hansel -- 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 -- Pharmacokinetics Of Antibody-drug Conjugates / Amrita Kamath -- Path To Market Approval : Regulatory Perspective Of Adc Nonclinical Safety Assessments / Stacey Ricci And Natalie Simpson -- Antibody Drug Conjugates : Clinical Strategies And Applications / Heather E. Vezina, Lucy Lee, Brian J. Schmidt, Manish Gupta -- Antibody-drug Conjugates (adcs) In Clinical Development / Patricia Lorusso And Joseph Mclaughlin -- 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 -- Adcs Approved For Use : Brentuximab Vedotin / Sven Devos And Monica Mead -- Radioimmunotherapy / Jeffrey Wong And Savita Dandapani -- Radiolabeled Antibody-based Imaging In Clinical Oncology / Bart Hendriks And Daniel Gaddy -- Antibody-drug Conjugates : The Next Evolution In The Cure For Cancer -- William C. Olson And Amy Q. Han. Edited By Kenneth J. Olivier Jr., Sara A. Hurvitz. Includes Bibliographical References And Index. Mode Of Access: World Wide Web. 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 Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg (R)), Brentuximab vedotin (Adcetris (R)), and ado-trastuzumab emtansine (Kadcyla (R)), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011).