Managing the Drug Discovery Process

Managing the Drug Discovery Process, Second Edition thoroughly examines the current state of pharmaceutical research and development by providing chemistry-based perspectives on biomedical research, drug hunting and innovation. The book also considers the interplay of stakeholders, consumers and the drug firm with attendant factors, including those that are technical, legal, economic, demographic, political, social, ecological and infrastructural. This new edition takes a closer look at increasing pre-approval costs for new drugs and examines not only why these increases occur, but also how they can be overcome to ensure a robust pharmacoeconomic future. Since drug research can be a high-risk, high-payoff industry, it is important to researchers to effectively and strategically manage the drug discovery process. All chapters in this new release have been revised and expanded with new discussions on genetic and epigenetic advances, including CRISPR, exosomes, immuno-oncology approaches, including checkpoint inhibitors and CAR-T, antibiotics, entrepreneurship, and AI. Considers drug discovery in multiple R&D venues, including big pharma, large biotech, start-up ventures, academia and nonprofit research institutes 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, including gene editing technologies like CRISPR, personalized medicine, ethical and moral issues, data visualization, statistical representations, AI and machine learning INDICE: Section 1: Introduction and Overview 1. Backgrounder Section 2: Preprofessional Education 2. Introduction: Preprofessional education 3. Two-year certification and degree programs 4. Four-year undergraduate degree programs 5. The big decision Section 3: Graduate and Professional Education 6. Graduate and postgraduate education at a crossroads 7. Master's degree programs 8. Doctoral and professional programs 9. The big leap Section 4: Research and Discovery 10. Drug discovery: Chaos can be your friend or your enemy 11. Drug discovery: Standing on the shoulders of giants 281 12. Research and discovery Section 5: Chemical Development, Quality Requirements, and Regulatory Affairs 13. Turning a potent agent into a registered product 14. Chemical development: Synthetic studies and engineering aspects 15. Chemical development: Analytical studies 16. FDA path and process: Sponsor's regulatory tasks for drug approval Section 6: Pharmaceutical Research and Development 17. Epilogue

• ISBN: 978-0-12-824304-6
• Editorial: Woodhead Publishing
• Encuadernacion: Rústica
• Páginas: 586
• Fecha Publicación: 01/01/2023
• Nº Volúmenes: 1
• Idioma: Inglés