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Master Thesis

Enjeux et opportunités pour le co-développement de médicaments et de tests diagnostiques dans le cadre réglementaire actuel

Abstract : Over the past 20 years, incredible progress has been made in identifying and understanding the human genome. Clinical practice eventually will evolve to a personalized approach for treating patients. Therapeutic decisions will be made based on the information provided by results of tests called "companion diagnostics", specifically designed to predict response to a targeted treatment. This new paradigm of medicine is full of hope, as many diseases remain untreated or perhaps partially treated due to the lack of effective therapy in specific subset of non-responders. This work aims to present stakes and opportunities for co-developing companion diagnostics and their associated medicines. It gives an overview of the recent changes in the regulation of in vitro diagnostics in Europe and compares the European (current and new) regulation to the United States'. Two case studies are discussed to illustrate a co-development and its double-edged aspects. Finally, the limit of nowadays environment is introduced from the perspective of four main players in personalized medicine: pharmaceutical and diagnostics companies, regulators, payers and physicians.
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Master Thesis
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https://dumas.ccsd.cnrs.fr/dumas-00979614
Contributor : Jean-Hugues Morneau <>
Submitted on : Wednesday, April 16, 2014 - 2:16:00 PM
Last modification on : Tuesday, May 11, 2021 - 11:36:17 AM
Long-term archiving on: : Monday, April 10, 2017 - 2:21:25 PM

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  • HAL Id : dumas-00979614, version 1

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Seya Colloud. Enjeux et opportunités pour le co-développement de médicaments et de tests diagnostiques dans le cadre réglementaire actuel. Sciences pharmaceutiques. 2014. ⟨dumas-00979614⟩

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