Course Detail

This course is designed to provide an understanding of how pharmaceutical and biotechnology companies discover, develop and bring drugs to market.  This course will focus on the discovery and development of small molecule drugs.  (ALS 331 and ALS 332, cover biological drugs and vaccines).  The course will follow the process of pharmaceutical drug discovery from selection of targets to discovery of a product candidate. The course will then transition to drug development, following the drug substance through the process of becoming a drug product, and then into clinical development and commercialization.

During the pharmaceutical discovery phase, students will learn the key steps that define how potential products are identified, optimized, and characterized in the preclinical setting and gain understanding of the key management challenges in the drug discovery process.

During pharmaceutical development phase, the key steps by which the drugs are formulated, characterized, manufactured and advanced through the regulatory pathway toward marketing authorization will be examined and analyzed. 

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 product approval and launch.  Case studies from industry will be presented detailing companies and products that utilize state-of-the-art discovery technologies and advanced drug delivery systems.  This is a science course that freely intersperses business and regulatory issues into the lectures and assignments.

Required Course Book

Course book for drug discovery – Bound copies of the papers you will need to read for the first half of the course can be found at Huntley Bookstore.  The bound copies also include associated reading notes.

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
High throughput screening
Hit prioritization, lead selection, lead optimization
Preclinical studies – Models of efficacy, pharmacokinetics, evaluation of safety
Discovery technologies: costs, timing & other management issues
Package Inserts – Begin With the End in Mind
Regulatory Applications: IND
Active Pharmaceutical Ingredients (API), GRAS excipients, Pharmacopeia
Small Molecule Formulation and Product Characterization
GMP, Contract Manufacturing
GCP, Clinical Trials
Regulatory Applications: NDA
Drug delivery systems (oral, pulmonary, injectable, needle-less injectors, device based)

After completing this course, students should have

1. a fundamental knowledge of the drug discovery and development process, including scientific challenges and management issues that arise during the key phases of pharmaceutical discovery; product development and regulatory approval processes;
2. comprehension of the methodologies used in the discovery, preclinical development, formulation, clinical characterization, and manufacturing of drugs;
3. an understanding of the regulatory pathways used to register drugs in the United States;
4. a broad overview of improved outcome products for therapies utilizing drug delivery systems.

Classroom attendance and participation in discussions                  25%
Oral presentations                                                                          15%
Written assignments                                                                       10%
Midterm and final exams                                                                 50%