24 mai 18h00 -  Webinar 'Simplification des Essais cliniques' (en anglais)

Avec :

• Prof. Ken Getz, Executive Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine, USA - Founder and Board Chair, CISCRP
• Frédéric Fleury, Directeur, Oncology, Roche France: "Simplifying clinical trials from a Pharma Industry standpoint"
• Marc Buyse, Chief Scientific Officer, IDDI and CluePoints, Belgique: “How to simplify trials : focus on what really matters - a statistical perspective”.
• Denis Comet, Co-founder and CEO of Axonal-Biostatem et past -président, AFCROs : "There are ways to reduce delays, energy and costs to simplify the conduct of clinical trials, the CRO perspective"

Modérateur : David Pérol, Directeur DRCI, Centre Léon Bérard

About the speakers:

Ken Getz is the Executive Director and a professor at the Tufts Center for the Study of Drug Development, Tufts University School of Medicine, where he conducts grant-funded research on pharmaceutical R&D management and execution; protocol design optimization; contract service provider and investigative site management; e-clinical technology and data usage; and patient engagement.  He is the chairman of CISCRP – a nonprofit organization that he founded to educate and raise public and patient awareness of the clinical research enterprise.

Frederic Fleury: Heading early and late-stage clinical trials programs in onco-hematology in France since 2010, Frederic Fleury started in a CRO in 1993 as a CRA, Project Manager and Monitoring Unit Manager, then moving to Roche France in 2001 to head medical affairs clinical trials teams before current position.

Marc Buyse holds degrees from Brussels University (Belgium), Cranfield University (UK) and a ScD in biostatistics from the Harvard School of Public Health (USA). Prior to founding the International Drug Development Institute (IDDI) in 1991, he had worked at the European Organization for Research and Treatment of Cancer (EORTC) in Brussels and at the Dana Farber Cancer Institute in Boston. He is also the founder of CluePoints, a company dedicated to statistical monitoring of clinical trials, and an Associate Professor of biostatistics at the Limburgs Universitair Centrum, Diepenbeek, Belgium. He currently works on statistical methods for personalized medicine. (http://publicationslist.org/marc.buyse).

Denis Comet, Medical Doctor, university degree in methodology applied to clinical research, university degree in health evaluation, management course in HEC school.

After several years of freelance work in medical writing for the pharmaceutical industry and medical press, I founded the company Axonal-Biostatem in 1989 with other physicians, a French full services CRO (Clinical Research Organization) in the top 3 of French independent CRO and leader in observational research. Our business is mainly (70%) on Real World Data (Early Access programs, post-approval studies) in the field of drug, medical device; 30% in Phase II and III CT. In the last 10 years, we setup alliance with other CRO, and Axonal-Biostatem become an European company thru those partnerships.

Associative memberships: former President and current Vice-President of AFCROs (Association Française des CROs, CROs French association), member and former coordinator of pharmacoepidemiology working group of AFCROs. Actual co-chair of Real World Data & Digital Health Working Group of EUCROF (EU CRO Federation) and French representative at the full member board of EUCROF.

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