Bench to commercialization | Biology homework help

 I have Bench to commercialization’s class and the Dr gave us some questions to do the research ( each question should be at least one page) could you please assist me

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  • Explain how and why modern biotechnology has evolvedMake 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 evolvedUse Genentech as an 
    e
    xample.

  • Explain the objectives of the preclinical phase of developmentHow 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 approvaprocess. 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

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