Abstract

PERSONALIZED MEDICINE AND POLICY TO BE IMPLEMENTED: THE EUROPEAN CHEMIST POINT OF VIEWPersonalized medicine may represent a dramatic change of paradigm in the medium-term future. For a chemist, personalized medicine means the definition and under-standing of any disease on molecular level for each individ-ual or group of individuals (personalized diagnosis) ideally leading to the design of a drug that efficiently counteracts or prevents any molecular dysfunction, ie, a personalized drug without side effects.The interdisciplinary research required for personalized medicine should overcome a myriad of obstacles not the least being to find specific biomarkers and targets for each individual or group of individuals suffering from a given disease. Chemists enter then into action and will model/design drugs and drug delivery pathways for a personal-ized therapy. They will either tap into the numerous drugs candidates, which were abandoned at some stage of clini-cal trials, or synthesize new drugs, mainly those “small mol-ecules” mimicking the activity of natural products.This view has obvious economic, ethical, and social impli-cations, beyond scientific challenges. All stakeholders will have to take them into account. Policy makers will have to examine all disciplines of regulatory science among which the thorny economics (cost-benefit analysis of specific re-search and development projects) are of paramount im-portance and critical to the development of personalized medicine.Thus competing/conflicting interests of “drugs producers” and “drugs payers” need to be reconciled. It requires resolv-ing intricate issues, which include how to advance trans-lational medical science, how to “reward” new findings on old drugs, and how to deal with intellectual property rights when new products and approaches are incorporat-ed into clinical practice as the results of an interdisciplinary endeavor, very often not stemming from a single country. As a corollary, there is as well European Patent question, which looks a bit of a holy grail, and ultimately the most important one: is it cost-effective for the very different health care systems to uptake personalized medicine?From the chemist’s point of view, these are several of the key policy issues needing to be addressed and answered to help personalized medicine have a bright future, that is for physician/clinician to prescribe the right drug at the right dose at the right time for every person.MEDICINAL CHEMISTRY AND PERSONALIZED MEDICINE AS THEY ARE AND AS THEY MIGHT BEMedicinal chemistry comprises several scientific disci-plines: organic chemistry, bioorganic chemistry, physical organic chemistry, biochemistry, pharmacology, toxicol-ogy, molecular biology, analytical chemistry, engineering, genetics, etc. Nowadays, this complex approach is signifi-cantly developing and allows gaining a novel level – per-sonalized medicine. It means: choice of a drug and its use regime should fit every individual specifically, so efficacy of medicinal treatment would improve sig-

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