Description
Managing the Drug Discovery Process, Second Edition thoroughly examines the current state of pharmaceutical research and development by providing experienced perspectives on biomedical research, drug hunting and innovation, including the requisite educational paths that enable students to chart a career path in this field. The book also considers the interplay of stakeholders, consumers, and drug firms with respect to a myriad of factors. Since drug research can be a high-risk, high-payoff industry, it is important to students and researchers to understand how to effectively and strategically manage both their careers and the drug discovery process.This new edition takes a closer look at the challenges and opportunities for new medicines and examines not only the current research milieu that will deliver novel therapies, but also how the latest discoveries can be deployed to ensure a robust healthcare and pharmacoeconomic future. All chapters have been revised and expanded with new discussions on remarkable advances including CRISPR and the latest gene therapies, RNA-based technologies being deployed as vaccines as well as therapeutics, checkpoint inhibitors and CAR-T approaches that cure cancer, diagnostics and medical devices, entrepreneurship, and AI. Written in an engaging manner and including memorable insights, this book is aimed at anyone interested in helping to save countless more lives through science. A valuable and compelling resource, this is a must-read for all students, educators, practitioners, and researchers at large—indeed, anyone who touches this critical sphere of global impact—in and around academia and the biotechnology/pharmaceutical industry.- Considers drug discovery in multiple R&D venues - big pharma, large biotech, start-up ventures, academia, and nonprofit research institutes - with a clear description of the degrees and training that will prepare students well for a career in this arena- Analyzes the organization of pharmaceutical R&D, taking into account human resources considerations like recruitment and configuration, management of discovery and development processes, and the coordination of internal research within, and beyond, the organization, including outsourced work- Presents a consistent, well-connected, and logical dialogue that readers will find both comprehensive and approachable- Addresses new areas such as CRISPR gene editing technologies and RNA-based drugs and vaccines, personalized medicine and ethical and moral issues, AI/machine learning and other in silico approaches, as well as completely updating all chapters
Table of Contents
Section A: Introduction and Overview1. Backgrounder—Part 12. Backgrounder—Part 2 Section B: Preprofessional Education3. Introduction: Preprofessional education4. Two-year certification and degree programs5. Four-year undergraduate degree programs6. The big decisionSection C: Graduate and Professional Education7. Graduate and postgraduate education at a crossroads8. Master's degree programs9. Doctoral and professional programs10. The big leapSection D: Research and Discovery11. Drug discovery: Standing on the shoulders of giants12. Drug discovery processes: When and where the rubber meets the road13. Drug discovery: Chaos can be your friend or your enemy14. Research and discovery: Essential partners but just a startSection E: Chemical, Biological, and Healthcare Product Development, Quality Requirements, and Regulatory Affairs15. Turning a potent agent—a chemical "drug"—into a registered product16. Chemical development: Synthetic studies and engineering including aspects of batch production and continuous processing17. Chemical development: Analytical studies18. FDA path and process: Sponsor's regulatory tasks for drug approval19. Development of biological and other healthcare productsSection F: Pharmaceutical Research and Development: Concluding Remarks20. Epilogue
