Bench to commercialization

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 meExplain how and why modern biotechnology has evolved. Make sure to provide in your answerhow biotechnology and pharmaceutical companies differ. Include in your discussion the bigpharma approach as well as the novel approach employed by biotechnology. Incorporate the 3characteristics that describe biotechnology.Discuss the history of how biotechnology partnering strategies evolved. Use Genentech as anexample.Explain the objectives of the preclinical phase of development. How does a company decide togo forward with initiating a clinical trial? What types of communication is necessary with theFDA to initiate a Phase I trial?What are the clinical phases of drug development? Provide a summary of the objectives ofeach. Give an example of success at each stage.Provide a detailed discussion of the approval process. Make sure to define and differentiatebetween accelerated approval, fast track status and priority review. What role does theadvisory committee play?What is the Hatch-Waxman Act and why was it enacted? What does it allow for? How is itapplicable to generics?What are Orphan Drugs? Why have orphan drugs historically not been the focus of drugdevelopment in early-stage biotechnology companies?How does a start-up biotechnology company begin? Explain how management teams areusually structured

 

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