PB HLTH 1023
Welcome to The Drug Development Process: An Intensive Seminar
Get a detailed picture of all aspects of the complex and highly interrelated activities involved in bringing a pharmaceutical discovery to approval and market. Although the focus is on pharmaceuticals, seminar discussions also integrate biologics, diagnostics and devices. This course is designed for executives, disciplinary experts who wish to broaden and advance their careers, nontechnical professionals, investors, and others interested in fully understanding the biopharmaceutical industry.
Class discussions are guided by experts with years of hands-on experience with large and small pharmaceutical, biotechnology and related companies. Seminar topics include industry environment, discovery and pharmacology, chemistry manufacturing and controls (CMC), toxicology, pharmacokinetics, program management, Food and Drug Administration (FDA) inspections, biologics, assays and devices, clinical trial design and conduct, clinical trial statistics, pharmacogenomics, FDA compliance regulations, patents and intellectual property, and commercial development.
How You Can Benefit From This Course
Understand the processes that are vital to successfully bringing a biotechnology product to market. Recognize the critical roles of each company unit, and gain insight into the integrated and multifunctional nature of drug development. Interact with experts and colleagues from a wide range of disciplines in the biopharmaceutical industry. Leave with knowledge of the entire process, enabling you to understand industry terminology and work more effectively in multidisciplinary teams.
Schedule (tentative)
Day 1: 8:30 am–5:30 pmFall 2025 enrollment opens on June 16!
"I gained valuable insights into the drug development lifecycle and how manufacturers navigate regulatory frameworks. The instructors provided thoughtful guidance on my questions about formulation design and facility planning for startups."
-Morẹ́nikẹ́ Ẹniọlá Ọláòṣebìkan, CEO and founder of Kemet Group
"The course was very well designed, focused and engaging. I appreciated the interactive format that fostered dynamic discussions, deepening my understanding of the end-to-end drug development process."
-Ileana Facchini, AI Chief of Staff, Head of Strategy and Operations at Genentech
"I took this course to help with my career transition and use the information learned every day at work, where I lead teams who evaluate drug candidates for a potential acquisition."
-Evgeniya Nazarova, Senior Manager of Corporate Development at Mirum Pharmaceuticals