Approved: The Life Cycle of Drug Development

Drug development stands at a transformative threshold in modern medicine. Over the past three decades, biotherapeutics have redefined medical innovation, paving the way for treatments that are not only effective but also accessible. This book provides a comprehensive exploration of the intricate world of drug development, shedding light on the essential balance between efficiency, regulatory compliance, and quality to achieve both innovation and affordability.

Written by leading experts, this guide delves into the multi-faceted process of drug development, covering critical areas such as pharmacology, biomarkers, toxicology, product development, manufacturing, and clinical trialsall framed within the stringent requirements set by the FDA. Readers will find in-depth discussions on the latest technologies, statistical approaches, and quality assurance measures essential to navigating today's complex regulatory landscape.

With practical case studies, project reports, and curated article reviews, this book offers valuable insights into risk assessment and mitigation at every stage of development. It serves as an indispensable resource for students, educators, and industry professionals, aiming to foster a deeper understanding of the challenges and opportunities in drug development and to inspire the next generation of scientific innovators.

Covers the revolutionized innovations of biotherapeutics in the multi-dimensional nature of drug development Introduces concepts of drug design, including toxicology, product development, new technologies, and clinical trials Contains additional teaching material such as multiple choice tests, assignments, and visuals

Autorentext

Dr. Narendra Chirmule has over three decades of experience in drug development. He has held senior leadership positions at Biocon (Bangalore, India), Amgen (Thousand Oaks, CA) and Merck (Philadelphia, PA) . He is an expert in the area of immune responses to biologics and vaccines. Dr. Chirmule has a Ph.D. from University of Mumbai, post-doctoral training at Cornell University Medical College, New York, and teaching and research experience University of Pennsylvania.

Dr. Vihang Vivek Ghalsasi is a molecular biologist and science educator. With over nine years of industry and academic experience, including roles at Syngene International (Bangalore, India) and Shoolini University (Solan, Himachal Pradesh, India), he is also a BELS-certified copy-editor who supports researchers in scientific writing. Dr. Ghalsasi holds a PhD in molecular biology from Heidelberg University, Germany, and master's in biotechnology from Indian Institute of Technology Bombay. He is a passionate explorer, travel blogger, and science communicator.

Inhalt

Foreword 1.- Foreword 2.- Life Cycle of Drug Development.- Vaccines as prophylactics and therapeutics.- Discovery of Biologic Drugs: past, present, and future.- Cellular Therapies: from a theoretical concept to an immuno-augmented reality.- Hope Unlocked: Gene therapies with viral vectors and Gene Editing.- Process development for biologic therapeutics.- Manufacturing of biologic therapeutics.- Pharmacology of protein based therapeutics.- The role of biomarkers in clinical development and its relevance in precision medicines.- Examining the Toxicological Landscape of New Molecular Entities and Biotherapeutics.- Perspective on Clinical Trials: What Researchers need to know.- From Orphan Drugs to Inclusive Research: Bridging Global Gaps in Rare Disease Treatment.- N=1: development pipeline for rare diseases.- What Entrepreneurs Need to Know About Intellectual Property When Building a Strong Patent Portfolio.- The power of Data Analytics: manufacturing Quality & Compliance.- Quality Risk Analysis the key to failure prevention.- Regulatory Strategy.- Epilogue.- APPENDIX.