9th Annual Biomarkers Congress
2nd Annual: Pre-clinical and clinical safety testing for new drugs
Swissôtel Le Plaza
BaselMesseplatz 25,
Basel,, Switzerland
http://www.informa-ls.com/drugsafety
2nd Annual: Pre-clinical and clinical safety testing for new drugs
Informa Life Sciences
http://www.informa-ls.com/drugsafety
Swissôtel Le Plaza 
BaselMesseplatz 25,
Basel
Switzerland

Schedule of Presentations:

Tuesday, December 2, 2008
08:30:00 Registration & Coffee
09:00:00 Opening Remarks from the Chair
09:10:00 IMPROVING TRANSLATION OF STUDIES FROM PRE-CLINICAL TESTS TO FIRST IN MAN TRIALS
09:10:00 Translational Medicine: The use of PK/PD modelling and simulation to bridge the gap between pre-clinical and clinical safety assessment Piet H. van der Graaf,
09:45:00 Improving the study design for your ‘first in man’ trials Paul Jones,
10:20:00 SPOTLIGHT SESSION:
10:55:00 Morning Coffee
11:25:00 Making the right choice of animal model for your pre-clinical safety tests Michael Markert,
12:00:00 Reducing primate use in monoclonal antibody development: avoiding a tick box approach Kathryn Chapman,
12:35:00 ICH M3(M) "Non clinical safety studies for the conduct of human clinical trials for pharmaceuticals" Elke Stahl,
12:35:00 REGULATORY AFFAIRS
13:10:00 Networking Lunch
14:30:00 Session 2:A regulatory perspective on acute toxicity testing Susanne Brendler-Schwaab
14:30:00 Moving away from acute toxicities: do the regulators approve?
14:30:00 Mini-Panel Session: REGULATOR
14:30:00 Session 1:Why the industry is challenging the need for acute toxicity tests in the development of new medicines Sally , Robinson
15:30:00 Handling clinical safety when a drug goes to submission and post marketing Diana Koprivec,
16:00:00 High Speed Networking
16:40:00 Prediction of drug:drug interactions in early development Stefano Persiani,
16:40:00 DRUG:DRUG INTERACTIONS
17:15:00 What’s new in drug-drug interactions: possible effects of food, herbs and natural integrators Paola Tocchetti,
17:50:00 End of Day One
Wednesday, December 3, 2008
08:30:00 Registration & Coffee
08:55:00 Opening Remarks from the Chair
09:00:00 HEPATOTOXICOLOGY
09:00:00 Translation of liver toxicity: an overview Assem S el Baghdady
09:30:00 Improving translation to clinical trials through the use of human hepatocytes in culture CASE STUDY: Armin Wolf,
10:00:00 Mechanisms in drug induced liver injury Jürgen Borlak,
10:30:00 Reactive metabolite assessment in drug discovery and early development as an integral part of drug safety: Minimising the risk for idiosyncratic liver toxicity Axel Pahler,
11:00:00 Morning coffee
11:30:00 What could be introduced into the pre-clinical toolkit to more accurately predict TdP risk. Is this necessary? Bérengère Dumotier
11:30:00 CARDIAC SAFETY TESTING
12:00:00 What happens after positive ‘thorough’ QT studies? Corina-Dana Dota,
12:30:00 Networking Lunch
14:00:00 Implementing investigations to follow pre-clinical QT-related signals in early studies of the clinical program Marek , Malik
14:30:00 CNS SAFETY TESTING
14:30:00 Suicidality and Phase III John Warren,
15:00:00 Preclinical evaluation and prediction of CNS side effects Thomas Stöhr,
15:30:00 SPOTLIGHT SESSION:
16:00:00 Afternoon Refreshments
16:30:00 Strategies for the non-clinical assessment of the abuse liability of new chemical entities Andy Mead,
17:05:00 How will an increased requirement for juvenile toxicity testing affect your safety studies Clemens Guenther,
17:05:00 PAEDIATRIC STUDIES
17:40:00 End of Day Two
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