The CEO of Biogen Idec face a set of challenging decisions regarding a promising drug for Multiple Sclerosis that is headed for early approval by the FDA. The first in a series, focuses on operational choices triggered by the drive for early approval. Discharges discussion about a leader's economic, legal, and ethical responsibilities to multiple constituencies, and how a leader can direct an organization to perform efficiently, executing those responsibilities, in a scenario that is complicated.
Decisions facing the company include how to ensure insurance company compensation, and how to confirm credible research on the efficacy and safety of the drug, how to increase manufacturing capacity to meet anticipated demand. All of these challenges arise against the backdrop of the accelerated approval process, uncertainty about what the FDA will ultimately determine, and whether the business should really pursue early acceptance.
PUBLICATION DATE: November 14, 2007 PRODUCT #: 408025-PDF-ENG
This is just an excerpt. This case is about LEADERSHIP & MANAGING PEOPLE
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