Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : The role of biomarkers

Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : The role of biomarkersSpeaker: Stefan BLANKENBERG, Hamburg, GERAbstract : The role of biomarkersL’auteur n’a pas transmis de conflit d’intérêt concernant les données diffusées dans cette vidéo ou publiées dans la référence citée.9th Global Cardiovascular Clinical Trialists Forum • Paris 2012 ESC Working group on cardiovascular pharmacology and drug therapyInternational Society of Cardiovascular Pharmacotherapy (ISCP)CardioVascular Clinical Trialists (CVCT)Joint sessionPERSONALIZED CARDIOVASCULAR MEDICINE AND DRUG DEVELOPMENT: TIME FOR A NEW TRIAL PARADIGMChairpersons: Juan Carlos KASKI, London, GBR - Bertram PITT, Ann Arbor, USA - Luis RUILOPE, Madrid, ESP- “Drugs, in general, act not on single targets operating in a vacuum, but perturb a complex network of interacting proteins or metabolites to modify the dynamic output of a system that can extend well beyond the pathway in which the original target is operative. Therefore, to develop drugs in this century, one needs to move beyond the  reductionist biomedical science of Occam, Descartes, Osler, and Ehrlich, and consider the complex biological system within which a drug acts holistically, in its tractable entirety. One needs to apply the principles of systems biology to pharmacology, and thereby establish the new discipline of systems pharmacology.”Dr Joseph Loscalzo, Lewis A. Conner Lecture, Circulation 2012.- “We need to develop a robust, viable business model through which the pharmaceutical industry can move from drug development strategies that are population-based to strategies that focus on increasingly individualized therapies. There needs to be an alignment of incentives that move the industry from conventional blockbuster drugs developed in large populations with single drug targets within which one size fits all toward smaller, better defined systems pharmacologybased molecular pathophenotypes that benefit from these well conceived therapies with minimal risk.”Dr Joseph Loscalzo, Lewis A. Conner Lecture, Circulation 2012.- “Heart Failure is not a disease and we should no longer approve drugs for a heterogeneous broad population, but for a well defined sub-population where we can demonstrate a marked benefit”Dr. Stephen Grant, Deputy Director, Division of Cardiovascular Renal Products, CDER- “Regulatory bodies like the FDA and the EMA will most likely require new trials to scrutinize events (i.e. AMI) very strictly. Well conducted registries will be important in this context so clinicians can report their findings in real life patients. Academic institutions and independent pharmacological and pharmacotherapy associations such as ISCP should provide mechanistic data as to the possible reasons for the detected increased prevalence of MI in some patient groups receiving treatment with direct thrombin inhibitors. Lessons learned with other new pharmacological agents in the past will necessarily require that the medical and pharmacological communities together with industry and regulatory agencies take up the challenge and work synergistically and in synchrony to clarify the side effects and excess MI risk – albeit minimal according to current studies - associated with the newer anticoagulants.- We are all now at the start of a long and winding road that should hopefully take us to better understand the mechanism of action, the therapeutic efficacy and the adverse effects associated with the use of the new anticoagulants. Together we should prevent unnecessary complications that might derive from the use of these important agents in the wrong patient groups.”Juan Carlos Kaski, Cardiovasc Drugs Ther, 2012Réalisation, production : Canal U/3S et CERIMESKeyword : Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, cardiovascular pharmacology, ISCP