Explain the objectives of the preclinical phase of development.

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


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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