The CEO of Biogen Idec is facing a number of difficult decisions regarding a promising drug for multiple sclerosis, which is headed for early approval by the FDA. The first in a series, focuses on operational decisions triggered by the drive for early approval. Sparks talk about a leader in the economic, legal and ethical responsibilities to multiple constituencies, and how a leader can run a business effectively, to manage the performance of these tasks in a complex situation. Decisions with a view to t … Read more »

The CEO of Biogen Idec is facing a number of difficult decisions regarding a promising drug for multiple sclerosis, which is headed for early approval by the FDA. The first in a series, focuses on operational decisions triggered by the drive for early approval. Sparks talk about a leader in the economic, legal and ethical responsibilities to multiple constituencies, and how a leader can run a business effectively, to manage the performance of these tasks in a complex situation. Decisions to which the company belongs, how credible research about the drug’s efficacy and safety, how to increase manufacturing capacity is to be anticipated demand, and how to secure the insurer to obtain reimbursement upright. All of these challenges arise in the context of the accelerated approval process, uncertainty about what the FDA will ultimately decide, and whether the company should in fact pursue early admission.
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from
Joshua D. Margolis,
Thomas J. DeLong
Source: Harvard Business School
17 pages.
Publication Date: Nov 14, 2007. Prod #: 408025-PDF-ENG
Antegren: A Beacon of Hope HBR case solution

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