ALS 430: Advanced Pharmaceutical Discovery
Course Number: ALS 430
Course Name: Advanced Pharmaceutical Discovery
Year: Second-year
Semester: Fall
No. Units: .5
Description
This course should provide you with a deeper understanding of how pharmaceutical and biotechnology companies discover new drugs, and how larger companies manage their drug discovery portfolios. You will expand your knowledge of the processes by which potential drugs are identified, optimized, and characterized in the preclinical setting, and begin to understand the process by which companies evaluate what they have and make decisions to move forward or to terminate a project.
Hopefully, this course will provide you with valuable information if you are intending to work for a pharmaceutical company, company that provides products or services to pharmaceutical companies, or a management consulting firm. The types of positions that you might consider based on information in this course include: consulting, business development, and project management.
You are expected to already know the fundamental terminology and timelines of drug discovery, from initial idea to IND. ALS330 is a requirement for this course - sorry, no exceptions. We will explore additional case studies from industry that exemplify state-of-the-art drug discovery technologies and managerial practices. This is a science/technical course that will freely intersperse business and regulatory issues into the lectures and assignments.
Topics Covered
|
Topic |
READINGS |
Company |
|
|
1 |
Review drug discovery and development process |
|
|
|
2 |
Merck case - integrating the portfolio |
Wharton case; Karan Girotra, Christian Terwiesch, Karl Ulrich (2007), Valuing R&D Projects in a Portfolio: Evidence from the Pharmaceutical Indust, Management Science, 1452-1466 |
|
|
3 |
New target validation |
Comb Chem High Throughput Screen. 2008 Mar;11(3):175-84. Discovery of novel targets with high throughput RNA interference screening. Kassner PD. Lead Discovery Department, Amgen Inc., South San Francisco, CA 94080, USA. pkassner@amgen.com |
Amgen |
|
4 |
Finding the hit molecules - new approaches in screening |
Curr Opin Drug Discov Devel. 2008 Jul;11(4):553-8. The impact of diversity-based, high-throughput screening on drug discovery: "chance favours the prepared mind". Snowden M, Green DV. GlaxoSmithKline Research & Development Ltd, New Frontiers Science Park, Third Avenue, Harlow, Essex, CM19 5AW, UK. mike.a.snowden@gsk.com |
GSK ???HARLOW |
|
5 |
Lead identification - flow diagrams and decisions |
Drug Discov Today. 2006 Aug;11(15-16):718-24. HTS technologies in biopharmaceutical discovery. Wu G, Doberstein SK. Five Prime Therapeutics, 1650 Owens St., Suite 200, San Francisco, CA 94158, USA. ge.wu@FivePrime.com |
Five Prime |
|
6 |
Lead optimization - predictive toxicology |
Preformulation designed to enable discovery and assess developability. Hageman MJ. Bristol Myers-Squibb Research and Development, Discovery Pharmaceutics in Pharmaceutical Candidate Optimization, Route 206 & Province Line Road, Princeton, New Jersey 08540, USA. michael.hageman@bms.com |
BMS |
|
7 |
Preclinical studies - preparing for the IND filing |
In silico toxicology for the pharmaceutical sciences. Valerio LG Jr. Science and Research Staff, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, White Oak 51 Room 4128, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, USA. Luis.Valerio@fda.hhs.gov |
FDA |
Learning Objectives
After completing this course, you should have:
(1) Additional examples that expand your knowledge of the overall process of the discovery of small molecules for human health;
(2) Additional appreciation of the scientific challenges and difficulties facing drug discovery scientists and managers at different stages in the drug discovery process;
(3) Ability to contribute to the assessment of technical documents describing a drug discovery project, which might be part of a company portfolio or a potential in-licensing or out-licensing opportunity.
(4) Ability to contribute to the management of a drug discovery project.
Grading
Classroom attendance, participation in discussions 35%
Written assignments (individual) - due week 2 15%
Team project - due throughout the course 50%