- rovide 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 clinical 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?
- What is the Hatch-Waxman Act and why was it enacted? What does it allow for? How is it
applicable to generics?
- What are Orphan Drugs? Why have orphan drugs historically not been the focus of drug
development in early-stage biotechnology companies?
- How does a start-up biotechnology company begin? Explain how management teams are
usually structured
