Write 5 pages paper about regulatory process for biological

Write 5 pages paper about regulatory process for biological

I need 5 pages paper about regulatory process for biological, I have attached the general question and how to write the paper, but the specific question ( Scenario) is this:

You are a primary reviewer in CBER at the U.S FDA. A biotech company is submitting an application to license a viral-vector hemophilia therapy. They are using an adeno-associated virus vector expressing the factor VIII gene. The vector transduces cells and persists as episomes within the cell. Clinical trials have been performed to demonstrate and efficacy of the approach in Europe and in the United States.

Also, I have attached some important questions that the answers should be written in the paper and an example, so you can take a look. Also, the reference should be the same as in the example.

Solution Preview

Hemophilia therapy in the United States has advanced from substitution treatments for the on-request treatment of seeping to prophylaxis to decrease the recurrence of dying. Current substitution treatments use plasma-determined coagulation factor or recombinant factor concentrates. Prophylaxis has been appeared to forestall joint harm in kids and permits lower factor use contrasted with on-request therapy, and is as of now the ideal treatment for hemophilia. Dosing interims with prophylaxis are related with pinnacles and troughs and go for keeping up through levels >1% between dosages. Consistency with dosing is a vital part of prevention, and patients may encounter achievement draining scenes that require treatment with swap treatments for control of dying. The primary antagonistic occasion related to factor substitution therapy is the advancement of inhibitors (killing antibodies) to factor VIII or factor IX, which requires utilization of elective treatments to defeat the impact of the Inhibitor (Ginn et al 2018).

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