Tailor-Made Pharmaceuticals: A change in the regulatory paradigm

Abstract

This thesis examines the future of medical treatment and its implications with the regulatory framework for the commercialization of pharmaceutical products. By reviewing the possibilities of gene therapy and personalized medicine to achieve the production of Tailor-made pharmaceuticals, together with the regulatory pathway that every drug must undertake to enter into the market, I highlight some of the difficulties that the system in force presents for the existence and development of medicines meant to be used by specific patients taking into account all the relevant factors that should be considered for an adequate treatment. The purpose of this dissertation is to understand how the current scheme can create such an obstacle and to offer a potential solution that may help to surpass it safeguarding the interests of all the parties involved in the approval and use of a new pharmaceutical product.

Keywords: Tailor-Made Pharmaceuticals, Gene Therapy, Personalized Medicine, Manufacturing Processes, Registry Paradigms, Pharmaceutical Regulation