Drug Development

Go to Course: https://www.coursera.org/learn/drug-development

Introduction

### Course Review: Drug Development by UC San Diego #### Overview The "Drug Development" course offered by the University of California San Diego's Skaggs School of Pharmacy and Pharmaceutical Sciences is an exceptional resource for anyone looking to delve into the complexities of pharmaceutical development. Recorded on campus at UCSD, this course is distinguished by its blend of academic insight and industry expertise, featuring lectures from faculty members and seasoned professionals in the field. Whether you are a student pursuing a career in pharmacy, a healthcare professional, or simply curious about the drug development process, this course provides a comprehensive understanding of the various stages involved. #### Course Syllabus Breakdown 1. **Welcome!** - The course begins with a warm introduction that sets the stage for what students can expect. This welcome module helps establish a supportive learning environment. 2. **Regulatory Considerations When Filing an Investigational New Drug Application - Susan Trieu, Pharm.D.** - Dr. Trieu offers invaluable insights gained from over 12 years in regulatory affairs. Her expertise is crucial for understanding the regulatory landscape that governs drug development, particularly the nuances of filing Investigational New Drug applications. 3. **Clinical Study & Start-up Activities - Joseph Ma, Pharm.D.** - Presented by Associate Professor Dr. Joseph Ma, this module focuses on the initial activities required to launch clinical studies, guiding learners through foundational practices that set the stage for successful clinical trials. 4. **Clinical Trials: Phase 1 - Yazdi Pithavala, Ph.D.** - Dr. Pithavala, Senior Director at Pfizer, provides a thorough overview of Phase 1 clinical trials, which are essential for assessing drug safety and pharmacokinetics. His industry perspective enriches the learning experience with real-world applications. 5. **Clinical Trials: Phase 2 - Kourosh Parivar, M.Pharm.** - Continuing the exploration of clinical trials, Kourosh Parivar discusses Phase 2 trials, focusing on the efficacy of drugs and further safety assessments. His insights as Vice President & Head of Clinical Pharmacology at Pfizer are invaluable for understanding the intricacies of this phase. 6. **Industry Considerations with Phase III Clinical Trials - Katie Lyons, Pharm.D. and Kelly Hogan, Pharm.D.** - This collaborative module addresses the critical Phase 3 clinical trials, which are pivotal in determining a drug's effectiveness in larger populations. The dual perspectives from both Dr. Lyons and Dr. Hogan provide a holistic view of the industry's approach to this stage. 7. **New Drug Application, Filing, Product Labeling - Kelly Hogan, Pharm.D.** - In the final module, Dr. Hogan discusses the comprehensive process involved in preparing for a New Drug Application (NDA), focusing on the intricacies of product labeling, which is essential for conveying important safety and efficacy information to healthcare providers and patients. #### Recommendations The "Drug Development" course is highly recommended for various audiences: - **Pharmacy Students:** It provides a solid foundation and practical insights that complement academic learning. - **Healthcare Professionals:** Those working in clinical settings can enhance their understanding of the drug development process, which may inform their practice. - **Industry Professionals:** Individuals currently employed in the pharmaceutical sector will find this course to be a valuable refresher on regulatory and clinical processes. - **Curious Learners:** Anyone with a general interest in the pharmaceutical industry will benefit from the comprehensive and engaging material covered in this course. #### Conclusion Overall, the "Drug Development" course at UCSD offers a rich, educational experience that combines theoretical knowledge with practical insights from industry experts. The course structure, featuring prominent figures from academia and notable companies like Pfizer, ensures that participants receive a well-rounded perspective on drug development—from initial regulatory considerations through to product labeling. If you're looking to deepen your understanding of the pharmaceutical landscape or aspiring to contribute to this dynamic field, this course deserves a spot on your learning agenda.

Syllabus

Welcome!

This week we hear from Dr. Susan Trieu, who in her 12+ years in the industry has worked in regulatory affairs. Since then, Dr. Trieu has gone on to work in Industry at MedImpact as their Drug Information Pharmacist.

This module is presented by Dr. Joseph Ma, Associate Professor in the UCSD Skaggs School of Pharmacy and Pharmaceutical Sciences.

This module we will hear from Dr. Yazdi Pithavala, Senior Director, Clinical Pharmacology at Pfizer.

Next we hear from Kourosh Parivar, M. Pharm, Vice President & Head, Clinical Pharmacology at Pfizer