Explain how and why modern biotechnology has evolved. Make sure to provide in your answer
how biotechnology and pharmaceutical companies differ. Include in your discussion the big
pharma approach as well as the novel approach employed by biotechnology. Incorporate the 3
characteristics that describe biotechnology.
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
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