9th Annual Biomarkers Congress
4th European Cardiac Safety Conference
Hotel Le Meridien
1 Promenade Des Anglais
Nice, Provence-Alpes-Côte d'Azur
http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=23320&eventType=Meeting
 Cardiovascular safety of new drugs has been at the center of public
   attention and concern for more than a decade. Since the release of the
   ICH -E14 guidance in May 2005 the industry, regulatory and academic
   debate evolved from a focus on a single dedicated and thorough QT (
   TQT ) study to the broader aspects of developing robust and continuous
   non-clinical and clinical models to establish scientific and practical
   methods for cardiovascular risk assessment. While the TQT study is
   still the centre-piece of clinical QT assessment, there are several
   initiatives on-going, which look into the predictive value of
   alternative approaches, such as combining non-clinical data with
   intense QT assessment in early clinical studies. In addition, with the
   benefits of more data and better knowledge, drug-induced effects on
   other ECG parameters, such as the PR and QRS intervals, and on
   hemodynamic parameters, such as blood pressure, have gained attention
   as potential risk markers for adverse cardiovascular effects. These
   and other topics will be discussed at the forthcoming DIA
   Cardiovascular Safety meeting, alongside presentations of new
   technologies, methodologies and novel biomarkers for early detection
   and risk management of drug related cardiovascular toxicity. Event
   Code: 10113


   1 Promenade Des Anglais , Nice, Provence-Alpes-Côte d'Azur, F- 06046
   , France

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Schedule of Presentations:

Monday, October 25, 2010
08:00:00 Registration
08:30:00 THE FUTURE OF THOROUGH QT ASSESSMENT: WHERE DO WE GO FROM HERE? Robert M. Wallis, Börje C. Darpö
08:35:00 Chairman Introduction Börje C. Darpö
09:00:00 How can we Redesign Non-Clinical Studies to meet the New Objective? Robert M. Wallis
09:30:00 Concentration Effect Modelling of Non-Clinical Data as a Translational Tool Börje C. Darpö, Piet Van Der Graaf
10:00:00 How can Assay Sensitivity be Demonstrated in Early Clinical Studies? Charles Benson
10:30:00 Estimation of QT Prolongation using Concentration-effect Modelling Steve Riley
11:00:00 Integration of Non-Clinical and Early Clinical Data to Predict QT Prolongation in Patients John E. Koerner, Philip T. Sager
12:15:00 Lunch
13:45:00 CV SAFETY BEYOND THE QT INTERVAL - DRUG EFFECTS ON OTHER ECG INDICES Robert M. Wallis, Pierre J Jordaan
13:50:00 Chairman Introduction Robert M. Wallis
14:15:00 What are the Mechanisms that can affect QRS and P-R Interval and how do these Translate to Man? Jean-Pierre Valentin
14:30:00 Bridging Pre-Clinical and Early Clinical Studies: Evaluating drugs affecting cardiac excitation and conduction Gary A. Gintant
14:45:00 What is the Regulatory Concern with respect to QRS and P-R Interval Changes? Colette Strnadova
15:30:00 CV SAFETY OF DRUGS FOR THE TREATMENT OF TYPE 2 DIABETES MELLITUS (T2DM) Krishna Prasad, Boaz Mendzelevski
15:35:00 Chairman Introduction Krishna Prasad
16:00:00 Diabetes and CV Risk: Do the glucose-lowering medications used in type 2 diabetes contribute? Philip Home
16:30:00 CV Safety of T2DM Drugs - The CHMP draft guideline on clinical investigation of medicinal products in the treatment of DM Eberhard Blind
17:00:00 Impact of the New Guidance on Size and Design of Confirmatory Clinical Studies in Patients with Diabetes Mary Jane Geiger
Tuesday, October 26, 2010
08:30:00 CV SAFETY ASSESSMENT FOR ONCOLOGY DRUGS Boaz Mendzelevski, Börje C. Darpö
08:35:00 Chairman Introduction Boaz Mendzelevski
09:00:00 Thorough QT Assessment for Non-Adjuvant Oncology Drugs - A sponsor's perspective Milton L. Pressler
09:30:00 Careful Assessment of QT prolongationand other ECG Effects for Oncology Drugs - A regulator's view Colette Strnadova
10:00:00 How does 'QT liability' Translate into Labelling for Oncology Drugs? Boaz Mendzelevski, Krishna Prasad
11:00:00 UPDATE ON ICH E14 Boaz Mendzelevski, Börje C. Darpö
11:05:00 Chairman Introduction Börje C. Darpö
11:15:00 The Implementation of ICH E14 in Japan Kaori Shinagawa
11:30:00 The Implementation of ICH E14 in Japan – From the perspective of the sponsor Maki Ito
11:45:00 Extrapolation of Foreign TQT Data into Japanese NDA Boaz Mendzelevski
11:50:00 Optimal Design of TQT Studies: An update from the IRT Joanne Zhang
12:05:00 Lunch
13:30:00 CV SAFETY BEYOND THE QT INTERVAL: DRUG EFFECTS ON HEMODYNAMIC INDICES Krishna Prasad, Pierre J Jordaan
13:35:00 Chairman Introduction Pierre J Jordaan
14:00:00 The Preclinical Perspective on Evaluating Haemodynamic Indices Peter Hoffmann
14:30:00 A Clinical Perspective on Haemodynamic Indices: What is new? Milton L. Pressler
15:00:00 The Regulatory Perspective in terms of changes in HR and BP during Clinical Studies: Current status and new developments Börje C. Darpö, Robert Fiorentino
16:00:00 End of Conference
4th Annual Pharma R&D Asia Congress
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