THE PATH OF PERSONALIZED MEDICINE: REGULATORY PERSPECTIVE
Abstract
Personalized medicine (PM) has become a topic of great interest because of its potential to improve patient care and optimize therapeutic strategy. The way we understand and treat disease is changing rapidly. The traditional form of personalized medicine has been based on the observable manifestations of a disease or treatment, such as a tumour on a mammogram, the appearance of cells under the microscope, etc. But now personalized medicine promises to introduce a new standard of healthcare by using molecular analysis to achieve optimum medical outcomes in the management of a patient’s disease or disease predisposition. PM is providing the right treatment, to the right patient at the right time by using modern biology’s new methods and tools. The objective of this paper is to focus on a realistic scenario for its evolution, and to explore the issues affecting the development and implementation of personalized medicines and various regulatory pathways involved in its regulation. This paper also highlights the roles and applications of personalized medicine. The success of personalized medicine depends on having accurate diagnostic tests that identify patients who can benefit from targeted therapies. The common goal: an integrated policy framework that balances patient, industry and scientific interests without hindering advancement of this tremendously important sector. Through these efforts, we can help ensure that personalized medicine is able to fulfil its promise as rapidly as possible.
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