title: Personalized Medicine: how to Switch from the Concept to the           Integration into the Clinical Development Plan to Obtain Marketing           Authorization.
abstract: One of the challenges of the coming years is to personalize medicine in order to provide           each patient with an individualized treatment plan. The three objectives of personalized           medicine are to refine diagnosis, rationalize treatment and engage patients in a           preventive approach.          Personalization can be characterized by various descriptors whether           related to the field, biology, imaging, type of lesion of the entity to be treated,           comorbidity factors, coprescriptions or the environment As part of personalized medicine           focused on biological markers including genetics or genomics, the integration of the           clinical development plan to obtain marketing authorization may be segmented in 3 stages           with a known descriptor identified before clinical development, a known descriptor           discovered during clinical development or a known descriptor known after clinical           development. For each stage, it is important to clearly define the technical optimization           elements, to specify the expectations and objectives, to examine the methodological           aspects of each clinical development phase and finally to consider the fast changing           regulatory requirements in view of the few registered therapeutics complying with the           definition of personalized medicine as well as the significant technological breakthroughs           according to the screened and selected biomarkers.          These considerations should be           integrated in view of the time required for clinical development from early phase to MA,           i.e. more than 10 years.          Moreover, business models related to the economic environment           should be taken into account when deciding whether or not to retain a biomarker allowing           the selection of target populations in a general population.
authors.affiliation: Clinical Research Unit, Bicêtre Hospital, Paris, France.
authors.forename: Laurent
authors.initials: L
authors.lastname: Becquemont
authors.forename: Régis
authors.initials: R
authors.lastname: Bordet
authors.forename: Dominic
authors.initials: D
authors.lastname: Cellier
mesh_terms: D015415:Biomarkers; D006801:Humans; D040541:Marketing; D009369:Neoplasms; D057285:Precision Medicine; D012922:Social Change
chemical_list: D015415:Biomarkers