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 Scenario is this:
You are a scientist working for health Canada. you review dossiers in the Biology & Gene Therapies Directorate. A dossier is being submitted for a DNA plasmid expressing the melanoma antigen recognized by T-Cells (MART-1) gene from rats. This plasmid is proposed to be used to treat malignant melanoma in humans, by inducing cross-reactive immune responses to the human MART gene product, thus breaking immunological tolerance for self antigens. This concept has been proven in dogs by a licensed veterinary product in Australia. That DNA plasmid product express the human MART gene, and cure dogs of melanomas.
I have attached some important questions have to be answered in the paper. there is an example attached( please follow it) Lastly, the reference should be the same as in the example.