Description
Jeffrey S. Barrett, PhD is the Chief Science Officer at Aridhia Digital Research Environment promoting life science partners to collaborate, access and share secure data to deliver better patient outcomes. He has over 30 years’ experience in pharmaceutical research and development, 13 of which were spent in the industry (1990???2003) followed by over 10 years (2001???13) at the University of Pennsylvania and The Children’s Hospital of Philadelphia and then back to industry at Sanofi Pharmaceuticals (2013???17) while still serving as an adjunct faculty member at University of Pennsylvania. Preface and Introduction Chapter 1: The History of Drug Development Chapter 2: The Modern Pharmaceutical Industry: Big and Small Pharma, Biotechnology Companies, and Generic Drug Makers Chapter 3: Legal Considerations, Intellectual Property, Patents and Patent Protection Chapter 4: The Global Regulatory Landscape Chapter 5: Phases of Drug Development: Old and New Paradigms Chapter 6: Discovery / Preclinical Chapter 7: Phase I Chapter 8: Phase II Chapter 9: Phase III Chapter 10: Phase IV, Special Populations and Post Marketing Commitments Chapter 11: Role and Function of Project Teams Chapter 12: Compound Progression and Go / No Go Criteria Chapter 13: Regulatory Milestones and the Submission Process Chapter 14: Life Cycle Management Chapter 15: Formulation Development Chapter 16: Chemistry and Manufacturing (CMC) Chapter 17: Health Economics and the Healthcare Industry Chapter 18: Current State of Affairs: Attrition Rates and Evolving Corporate Strategies Chapter 19: Medical Devices Chapter 20: Distribution and the Supply Chain Chapter 21: Sales, Marketing and Advertising Chapter 22: Generic Drugs and the Generic Industry Chapter 23: The Generic Approval Process Chapter 24: Data Sharing and Collaboration Chapter 25: The Future of the Pharmaceutical Industry Glossary Chapter Self-Assessments and Quiz
