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The goal of this course is to provide an introduction to biotechnology and pharmaceutical industry and to help students enter this field and plan their careers. Topics covered in this course include:
-overview of biopharmaceutical industry
-innovation in research and development
-intellectual property
-drug approval
-regulatory issues and agencies
-business development
-marketing
-manufacturing
-capital structure and financing
-careers in biopharmaceutical industry.
The first class meets on 1/11/2005.
Prerequisite: None. Students of all years and all majors are welcome.
Preliminary Course Outline:
(the course starts on Jan 11 rather than Jan 4.)
Jan 11. Introduction to the Pharma and Biotechnology Industry - overview, comparisons, historical trends and experiences:
Mark Edwards, Recombinant Capital
Jan 18. Innovation in research and development; development of an intellectual property portfolio.
Jan 25. Drug development: phases and processes.
Hal Barron, MD., VP and Chief Medical Officer, Genentech
Feb 1. Drug approval: regulatory issues and agencies; NDA/MAA.
Nancy Isaac, VP, Aerogen
Feb 8. Business development.
Feb 15. Marketing - getting your drug to the patient.
Jean-Jacques Bienaime, CEO, Genencor, and David Lilienfeld
Feb 22 Manufacturing.
Janne Wissel of Jazz Pharmaceuticals
Mar 1. Capital structure and financing.
Kurt Von Emster, MPM Capital
Mar 8. Final project presentation/debate