Main description:

This book provides a comprehensive overview of the scientific, medical, regulatory, and economic considerations associated with the discovery, development, and delivery of novel therapeutics for children with cancer. Co-authored by a diverse team from academic, government, and industry backgrounds, the book describes the steps in the process from the identification of a promising therapeutic target to the evaluation of drug candidates in the various phases of clinical testing and regulatory review. Throughout, special emphasis is placed on the unique biology of pediatric malignancies and the medical and social needs of children and their families. In providing a firm grounding in the drug development process, the book will be of value to all with an interest in how medicines currently used to treat pediatric cancer were made available. This includes trainees as well as established practitioners and others participating in translational and clinical research in the academic setting.

Contents:

Chapter 1: History of Drug DevelopmentChapter 2: Target Identification/Validation and Drug Discovery

Chapter 3: The Pediatric Pre-clinical Testing Program

Chapter 4: Non-Clinical Toxicology

Chapter 5: Study Design and Biostatistics

Chapter 6: Personalized Medicine and Its Impact on Study Design

Chapter 7: Immunotherapy, including Gene and Cellular Therapy

Chapter 8: The Pharma/Biotech Model for Drug Development

Chapter 9: Economics of Cancer Therapeutics Development

Chapter 10: Clinical Trial Networks

Chapter 11: Clinical Research Organizations

Chapter 12: Role of Patients and Advocates in Cancer Therapeutics Development

Chapter 13: International Regulatory Considerations and Initiatives

Chapter 13: Ethical Considerations in Cancer Therapeutics Development for Life-threatening Diseases

Chapter 14: Future Directions