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<title><string language="fre"><![CDATA[Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Journal editor’s viewpoints]]></string></title>
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<string language="fre"><![CDATA[Title : Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 : Journal editor’s viewpoints
Speaker: Joseph LOSCALZO, Boston, USA, Circulation
Discussant: Rita REDBERG, San Francisco, USA, Arch Intern Med
Abstract : 
L’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 therapy
International Society of Cardiovascular Pharmacotherapy (ISCP)
CardioVascular Clinical Trialists (CVCT)
Joint session
PERSONALIZED CARDIOVASCULAR MEDICINE AND DRUG DEVELOPMENT: TIME FOR A NEW TRIAL PARADIGM
Chairpersons: 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, 2012
Réalisation, production : Canal U/3S et CERIMES
Keyword : Cardiovascular Clinical Trialists, Paris, 2012, Cardiovascular prevention, cardiovascular pharmacology, ISCP]]></string></description>
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NOTE:REDBERG Rita, San Francisco, USA&lt;br&gt;Rita F. Redberg, MD, MSc, has been a cardiologist and Professor of Medicine at the University of California, San Francisco since 1990. Dr. Redberg is currently the Chief Editor of Archives of Internal Medicine and has spearheaded the journal’s new focus on health care reform and “less is more”, which highlights areas of health care with no known benefit and definite risks. Her research interests are in the area of health policy and technology assessment focusing on how evidence relates to FDA approval, insurance coverage and medical guidelines and practice, particularly in the area of medical devices. Dr. Redberg is a member of the Medicare Payment Advisory Commission, which advises Congress on Medicare payment issues. She also served on the Medicare Evidence, Development and Coverage Advisory Committee from 2003- 2006 and was reappointed in 2012 as Chair of MEDCAC. Dr Redberg is a member of the California Technology Assessment Forum, the Medical Policy Technology and Advisory Committee, and the Food and Drug Administration Cardiovascular Devices Expert Panel, and is a consultant for the Center for Medical Technology Policy. She gave Congressional testimony four times in 2011 in hearings related to the issue of balancing safety and innovation in medical device approvals Dr. Redberg worked in the office of Senator Hatch and with the Senate Judiciary Committee on FDA-related matters during her tenure as a Robert Wood Johnson Health Policy Fellow, 2003-2006. Dr. Redberg was a member of the Institute of Medicine’s Learning Health Care Committee, which produced the report Best Care at Lower Cost in September 2012. She chaired the AHA/ACC Writing Group on Primary Prevention Performance Measures and is a member of the American College of Cardiology’s (ACC) Clinical Quality Committee and serves on the Quality in Technology Work Group. She does comparative effectiveness research, and serves on the American College of Cardiology’s Comparative Effectiveness Work Group, represents the ACC on the Institute of Clinical and Economic Review Advisory Board and serves on other ACC Committees, including several on appropriate use of cardiac imaging. She was honored by receiving the Women’s Day Red Dress Award in 2011 for her leadership in the area of heart disease in women. Dr. Redberg graduated from Cornell University and the University of Pennsylvania Medical School and has a Master of Science in Health Policy and Administration from the London School of Economics. 
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