What are the clinical phases of drug development?

  1. 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.

  2. Discuss the history of how biotechnology partnering strategies evolved. Use Genentech as an


  3. 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?

  4. What are the clinical phases of drug development? Provide a summary of the objectives of

    each. Give an example of success at each stage.

  5. 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?

  6. What is the Hatch-Waxman Act and why was it enacted? What does it allow for? How is it

    applicable to generics?

  7. What are Orphan Drugs? Why have orphan drugs historically not been the focus of drug

    development in early-stage biotechnology companies?

  8. How does a start-up biotechnology company begin? Explain how management teams are

    usually structured

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