Discuss the history of how biotechnology partnering strategies evolved. Use Genentech as an
example.
Explain the objectives of the preclinical phase of development. How does a company decide to
go forward with initiating a clinical trial? What types of communication is necessary with the
FDA to initiate a Phase I trial?
What are the clinical phases of drug development? Provide a summary of the objectives of
each. Give an example of success at each stage.
Provide a detailed discussion of the approval process. Make sure to define and differentiate
between accelerated approval, fast track status and priority review. What role does the
advisory committee play?
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