Course Detail

This course is designed to provide you with an understanding of how pharmaceutical and biotechnology companies discover new drugs.  This course will focus on the discovery of small molecule drugs.  (In other courses, you will learn about the discovery of biological drugs and vaccines).  The course will follow the process of pharmaceutical drug discovery from selection of targets to discovery of a product candidate, and the characterization of that drug necessary for initiation of clinical trials. In the companion course (ALS-333), you will learn about the clinical development and commercialization of small molecule drugs, which importantly involves interactions with governmental agencies that regulate the commercialization of pharmaceutical products.  

In this course, you will learn the key steps that define how potential drugs are identified, optimized, and characterized in the preclinical setting and gain understanding of the key management challenges in the drug discovery process. 

The course will provide the terminology, timelines and practical examples for successfully understanding the challenges in progressing an idea for a drug from the earliest discovery stages through to clinical trials.  Case studies from industry will be presented detailing companies and products that utilize state-of-the-art drug discovery technologies.  This is a science course that freely intersperses business and regulatory issues into the lectures and assignments.

Required Reading
Readings for ALS330 are found on the ALS330 Sakai site.  For this course, there are reading notes to guide you through the required readings.  Read the reading notes first – they help you get oriented to the readings.

Supplemental Text
Ng, Rick Drugs: From Discovery to Approval, 2004, Wiley-Liss, A John Wiley & Sons Inc., Publication

This book is not required, but is very good for providing overview & background.  It costs $72 on Amazon.com, and is a book that might easily be shared among a few students to provide a useful supplemental text.

Target identification & validation
Finding the chemical starting point - high throughput, virtual, fragment-based screening methods
Hit prioritization, lead selection, lead optimization
Preclinical studies - Models of efficacy, pharmacokinetics/ADME, evaluation of safety
Preparation for first-time in human studies - formulations, chemistry, manufacturing & controls
Discovery technologies: costs, timing & other management issues

After completing this course, you should have (1) a fundamental knowledge of the overall process in the discovery of small molecules for human health; (2) an appreciation of the scientific challenges facing drug discovery scientists at different stages in the drug discovery process; (3) an appreciation of the management challenges facing companies that aim to discover new pharmaceutical products; (4) the ability to assess technical documents and contribute to the assessment of a drug discovery project or company portfolio.

Classroom attendance and participation in discussions 15%
Written assignments 5%
Examinations 80%