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Perspectives for new treatments at Novartis
Author(s) -
BURIAN G
Publication year - 2012
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/j.1755-3768.2012.3223.x
Subject(s) - medicine , specialty , presentation (obstetrics) , drug development , clinical trial , personalized medicine , authorization , health care , clinical practice , alternative medicine , engineering ethics , family medicine , drug , pathology , engineering , pharmacology , political science , bioinformatics , computer science , surgery , computer security , law , biology
Clinical research in the current clinical practice and regulatory environment related to development of Medicinal Products has evolved in recent years to encompass areas beyond the primary aim of achieving a Marketing Authorization. A model of “development continuum” appears to recently emerge to address key aspects in this new setting: the area of personalized medicine and specialty care, and associated outcomes research, which together aim to achieve therapeutic optimization at individual patient level, in both endemic as well as in rare diseases. This type of clinical research is conducted in late development phase of drugs, most often post‐marketing, under continuous regulatory guidance for drug label optimization. Novartis recognizes and is interested in this changing environment, and is hence committed to address these emerging unmet medical needs that impact clinical practice. Collaboration with the wider group of healthcare professionals in the global community to facilitate the design and implementation of clinically relevant research projects is an important aspect to drive scientific and medical progress in this area. In this presentation, concepts of clinical development and trials design for optimization of drug outcomes and therapeutic patient management will be discussed from an industry perspective. The regulatory and Novartis guidelines for supporting them will be explained, using focussed examples from the field of Ophthalmology, particularly areas of research interest in chorioretinal vascular diseases.