I am a scientist working at Health Canada, working under the directorate of Biology and Gene Therapy.
I have been tasked with the responsibility of reviewing a dossier on the applicability of a DNA plasmid
in treating malignant melanoma in humans through cross-reactive immune responses to the human
MART gene product, and as a resulting dismantling the cycle of immunological tolerance among selfantigens. The research has been considered viable due to its recent success when conducted on dogs
through a certified veterinary commodity in Australia. This paper is therefore a review of some of the
significant considerations that have to be made before and after the submission of the research dossier.
Possibility of a meeting between the applicant and regulators.
A meeting between the national regulators and the applicant remains unknown due to the fact that the
regulator’s official website offers no such details.  However, a meeting between the two parties
could be easily arranged to allow for the formalization of the key concepts that are discussed in the
proposal. In addition, the meeting would provide a good opportunity for various elementary
assessments on the research to be conducted by both parties independently. The meeting would
primarily involve members from Health Canada’s department of Biology and Gene therapy directorate,
state officials from the department of health and delegates from the applicant’s side. Also in attendance
would be representatives from the Australian veterinary department whose purpose would be to verify
that indeed the proposed drug worked on dogs in the country.
Type of dossier to be submitted
This dossier will be characterized by the submission of a request to test the applicability of melanoma
antigen recognized by T-Cells (MART-1) gene from rats. This plasmid is proposed to be used to treat