Approved: The Life Cycle of Drug Development

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.

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.