2 CVCT Zannad PITCH Webinar_sg
Transcription
2 CVCT Zannad PITCH Webinar_sg
Faiez Zannad Université de Lorraine, Institut Lorrain du Coeur et des Vaisseaux Hypertension and Heart Failure Unit Inserm, Clinical Investigation Center and 1116. Organised by Bertram Pitt (Ann Arbor, USA) Co-Founder and Co-chairman of CardioVascular Clinical Trialists (CVCT) Forum and Workshop, since 1998. CVCT Forum 2015 : ü Professor of medicine emeritus at the University of Michigan School of Medicine. ü Chairman or co-chairman of a number of clinical trials in cardiology ü Member of a numerous medical journal editorial boards ü Member of a number of medical organizations and has served as an advisor to the clinical trials branch of the NHLBI and a member of the FDA cardio-renal advisory board. ü Awarded the James B. Herrick Award by the Council of Clinical Cardiology of the American Heart Association and has been elected to the Society of Scholars of the Johns Hopkins University. ü Over 500 articles in peer reviewed journals Ø CARDIORENAL TRIALS: PREVENTION AND MANAGEMENT OF HYPERKALEMIA Ø Ø CARDIOVASCULAR OUTCOMES IN CKD TRIALS AND RENAL OUTCOMES IN CV TRIALS Ø PHENOTYPING HEART FAILURE – IS PRECISION MEDICINE THE WAY FORWARD? ARTS-HF trial and perspectives with FINESSE”. Jeffrey Borer (New York, USA) ü Jeffrey S. Borer is Professor of Medicine, Cell Biology, Radiology and Surgery at SUNY Downstate Medical Center. ü He performs clinical service, teaching and research, the latter primarily in valve diseases and in therapeutic efficacy of heart rate modification. He has been a USFDA Advisor for 37 years, chaired the CardioRenal Drugs Advisory Committee for 3 terms and the Circulatory Devices Advisory Panel for 1 term, was a life sciences Advisor to NASA for 24 years, served as officer/board member of national professional societies (currently President, Heart Valve Society of America), published almost 500 scientific papers and 6 books, participated in numerous clinical trials, editor-in- chief of the journal, Cardiology, received several recognitions for his work (most recently, the Lifetime Achievement Award of the joint heart valve societies (2014), and a Legend of Cardiology Award at the 10th Annual Complex Catheter-based ü ü ü ü ü ü CVCT Forum 2015 : PHENOTYPING HEART FAILURE – IS PRECISION MEDICINE THE WAY FORWARD? “Ivabradine crosses the Atlantic. Is this good enough?”. Carolyn Lam (Singapore, SGP) ü Carolyn Lam, is an Associate Professor of the Yong Loo Lin School of Medicine, Singapore; a Consultant Cardiologist at the National University Heart Centre, Singapore; and the Director of the first Women’s Heart Health Clinic in Singapore. ü Principal investigator of an ongoing nationwide heart failure study in Singapore (the Singapore Heart Failure Outcomes and Phenotypes [SHOP] study) and a multinational Asian study of patients with heart failure across 11 Asian countries (Asian Sudden Cardiac Death in Heart Failure [ASIANHF] study). ü Executive Committees member of several global heart failure trials. ü She was awarded the L’Oreal Women In Science Award (2012) for her work in women’s cardiovascular disease, was named an Inter Academy Medical Panel Young Physician Leader at the World Health Summit in Berlin (2012), and is currently recipient of the Senior Investigator Clinical Scientist Award (2013). ü She is the editor-in-chief of the ASEAN Heart Journal. CVCT Forum 2015 : PHENOTYPING HEART FAILURE – IS PRECISION MEDICINE THE WAY FORWARD? USE IN TRIALS AND IN CLINICAL PRACTICE OF BIOMARKER AND BIOSENSORS A family of one main global and 2 regional meetings NEW. Since 2014 CVCT aiming to reach out the CV trial community in Asia. Next CVCT Asia is scheduled on July 2016 Main Global CVCT, now in its 11th year, is set to alternate between Paris and Washington, DC LATEST developments . CVCT aiming to reach out the CV trial community in Africa and Middle East. First CVCT ME scheduled in April 2016 13-‐1 4th April2016 CVCT 2015, Planned partnership with Ø American College of Cardiology Ø International Society of Cardiovascular Pharmacology Ø American Society of Hypertension Ø American Society of Nephrology Ø Heart Failure Society of Americas Ø Heart Rhythm Society CVCT Meetings ethos and format • Rather than lecturing, time is dedicated to discussion among experts, with the aim of addressing issues, and suggesting innovative solutions. • At CVCT Forum and CVCT Workshop speakers and discussants have a limited time for their presentations, meant only to raise issues to be discussed thoroughly. • At CVCT Forum 15-‐20 expert panelists are seated in a U shape table facing the audience and engaging all in intense discussion. • The unique meeting rooms seating is essential for fostering fruitful discussion CVCT Forum 2 days with 300-‐400 experts Aims • Building relationships with a variety of stakeholders in the cardiovascular clinical trial community. • Fostering discussion among international leaders from all sectors of the CV trial community including physicians; industry representatives; regulatory bodies; venture groups; and numerous partnership societies (such as ACC, HFSA, HRS, ASH, ASN, ISCP) public institutions (Inserm, NHLBI), regulatory bodies (FDA, EMA, PMDA) and major journal editors (NEJM, The Lancet, JAMA, Circulation, JACC, EHJ..). • Addressing the myriad of complex challenges faced by today’s investigators, companies, regulators, and academicians as they plan, design, conduct, and report outcomes for cardiovascular trials that address unmet therapeutic needs and will, ultimately, shape the future of medical practice. • Helping investigators and Industry R&D experts improve trial design, reporting and interpretation and gain greater clarity for regulatory pathways; and for more cost-‐effective approaches to improve outcomes for patients. Chairmen: Bertram Pitt (Ann Arbor, USA), Faiez Zannad (Nancy, FRA) COURSE DIRECTORS – PARTNERS BOARD Ø Atherosclerosis trials Wolfgang Koenig (Munich, GER) Ø Biomarker and Personalized medicine trials Jim Januzzi (Boston,USA) Ø CardioRenal trials Murray Epstein (Miami, USA) ; Patrick Rossignol (Nancy, FRA) Ø Device and telemonitoring trials William Abraham (Columbus, USA); Ileana Piña (New York, USA) Ø Diabetes, Weight loss Trials Faiez Zannad (Nancy, FRA) Ø Heart Failure trials Christopher O’Connor (Washington DC, USA) Ø Interventional Cardiology trials Roxana Mehran (New York, USA) ; Patrick Serruys (Rotterdam, NED) Ø Methodology and Statistics Stuart Pocock (London, UK) Ø Thrombosis trials Freek Verheugt (Amsterdam, NED) LEARNED SOCIETIES – INSTITUTIONAL PARTNERS Main organizer: INSERM, France Ø Ø Ø Ø Ø Ø Ø Ø Ø American College of Cardiology (ACC) : Henry Solomon (Washington, USA) CVCT Asia : Carolyn Lam (Singapore, SGP) Editors : John Jarcho (NEJM, Boston, USA), Stuart Spencer (Lancet, London, UK) European Association of Clinical Pharmacology and Therapeutics (EACPT) : Tabassome Simon (Paris, FRA) Heart Failure Society of Americas (HFSA): JoAnn Lindenfeld (Denver, USA) International Society of Cardiovascular Pharmacology (ISCP) : Felipe Martinez (Cordoba, ARG) American Society of Nephrology: Murray Epstein (Miami, USA) American Society of Hypertension : William White (Farmington, USA) Heart Rhythm Society: David Van Wagoner (Cleveland, USA) Participating at CVCT is a unique opportunity for them to learn and network with senior KOLs to help shape their future practice and career. 37 Young trialists from Australia Canada France Japan Netherlands Portugal Romania Slovakia Tunisia United K ingdom USA Publications The CVCT writing group produces manuscripts resulting from high-‐level scientific discussions at the CVCT Forum, working with key faculty and leadership from the sessions. Among topics to be featured in papers arising from CVCT Forum in 2014: • • • • Thrombosis trials New drugs and future trials in HF Working with r egulatory partners Diabetes CV safety trials • • • Neural modulation trials Assessing the PARADIGM trial Pulmonary hypertension trials CVCT Workshop – Aims • Aims to foster an international exchange of ideas – and perhaps innovative thought leadership. • Areas of focus are generic trial issues, not necessarily related to specific therapeutic areas. • Topics include trial design and methodologies (incl. adaptive trials; imbedded registries); trial interpretation; methodologies to share data; regulatory pathways (global and country specific); streamlining the clinical trial process to develop more cost-‐effective ways of implementing research; pros and cons of CROs and AROs; and trial publication. CVCT Workshop – Format 2 days closed, on-‐invitation only 45 experts workshop • All faculty members attend the 2 full day meeting and are seated in a U shaped table and debate collectively all topics. • The unique meeting rooms seating is essential for fostering fruitful discussion CVCT Workshop More on www.globalcvctforum.com