Narendra Chirmule, PhD, is the founder-director of SymphonyTech Biologics, a company focused on statistical, technical and quality aspects in drug development. Most recently, he was head of R&D at Biocon Research Labs, Bangalore, one of India's largest biotechnology companies. Under his leadership, the company received the first ever approvals of biologics by FDA and EMA in India.
The field of biotechnology has evolved over the past four decades, developing medicines which are curing diseases. But this journey of success has been tough and arduous, built upon the shoulders of major failures. Good Genes Gone Bad highlights seven such colossal failures in drug development-all of which culminated in the development of novel drugs-weaving together various analogies through the stories and thus allowing the reader to understand complex biological phenomena. These stories include treatment of medical conditions such as genetic clotting disorder (haemophilia), childhood-diarrhoea (rotavirus vaccine), preventing HIV infection, activation of the immune systems to treat cancer, gene therapy for treatment of diseases caused by gene-defects/mutations, cell therapy for treatment of leukaemias, and finally the success of Biocon's approval of the first biologic drug for breast cancer. Written by the former R&D head of Biocon, India's largest pharmaceutical company, Good Genes Gone Bad is a fascinating look at the complex world of medicine and drug development, providing the readers with a sense of magnitude of challenges and the extent of difficulty that it takes to make novel medicines.