22nd AGAH Annual Meeting 2013
Annual Meeting 2013, Nice Sophia Antipolis
Joint Conference of European Human Pharmacological Societies
EARLY CLINICAL UTILITY ASSESSMENT OF NEW MEDICINES IN DEVELOPMENT
Dear Colleague
2013 is a special year for CLUB PHASE 1, as this year itcelebrates its 20th anniversary, welcoming fellowEuropean colleagues of AGAH, BAPU and AHPPI to thestunning region of NICE, where we will join forces tooffer our second joint meeting.
It will be a great opportunity to share our views on thechallenges currently being faced by the Early ClinicalDevelopment and Clinical Pharmacology.
The meeting will focus on Early Clinical UtilityAssessment of new medicines and how earlydevelopment should be conducted to optimize thechallenging process of reaching efficient and earlygo/no go decisions.
After review of some “historical” cases, this meeting willupdate attendees on new translational tools andinnovative approaches, and will highlight the need for astrong presence of European Human Pharmacology inEarly Development.
We hope that the plenary lectures and workshops willprovide ample opportunity to discuss ideas, strategies,methods, technology and experience in early clinicaldevelopment.
Looking forward to welcoming you in Sophia Antipolis,France.
Doctor Yves Donazzolo
Club Phase 1 President
8:00
Registration
8:30
Welcome and introduction to the Joint Conference of Club Phase I, AGAH, BAPU and AHPPI
Session 1:
Lessons learned from late phase failures
and successes
Chairs
Y. Donazzolo, Grenoble (France)
M. Raghoebar, Antwerp (Belgium)
8:45
Lessons learned from Rimonabant and other CB1 blockers: did we try to crack a nut with a sledgehammer?
R. F. Witkamp, Wageningen (The Netherlands)
9:15
Clinical Pharmacology and Clinical Utility of Abiraterone Acetate
E. Mannaert, Beerse (Belgium)
9:45
The role of Phase I in the quest for “good” cholesterol – failure of the CETP modulator Dalcetrapib
M. Derks, Basel (Switzerland)
10:15
Break
Session 2:
New translational tools and methodologies
Chairs:
A. Patat, Rennes (France)
M. Hammond, Slough, Berkshire (UK)
10:45
Usefulness of modeling and simulations in drug development
E. Pigeolet, Basel (Switzerland)
11:15
Pharmacometrics: a new tool for optimizing early drug development in oncology
R. Gomeni, La Fouillade (France)
11:45
New biomarkers for drug-induced liver injury: first² insights from clinical quantification
M. Merz, Basel (Switzerland)
12:15
Quantification of EEG: pre-competitive consortium on the use of EEG as a CNS biomarker
Ph. Danjou, Paris (France)
12:45
Lunch Break
14:15
Parallel Workshops
WS1
Cardiac safety, QT assessment
B. Mendzelevski, London (UK)
J. Taubel, London (UK)
WS2
PK/PD modeling
R. Gomeni, La Fouillade (France)
WS3
Application of Bayesian Statistics in early development studies
P. Sanwald Ducray, Basel (Switzerland)
F. Vandenhende, Genappe (Belgium)
WS4
Adaptive study design in early phase clinical research
M. O’Kane, London (UK)
U. Lorch, London (UK)
WS5.a
Suicidality assessment
E. Legangneux, Basel (Switzerland)
15:45
Break
Session 3:
Training and education in early clinical drug development
Chairs:
K. Breithaupt-Grögler, Frankfurt (Germany)
J. de Hoon, Leuven (Belgium)
16:15
European post-graduate training in pharmaceutical medicine and drug development
I. Klingmann, Brussels (Belgium)
16:35
Human Pharmacology courses: the UK experience
J. Posner, London (UK)
16:55
Open Forum Discussion: “Diploma-level training for Phase 1 Investigators – need or nice-to-have?
17:15
End of Sessions on Day 1
19:30
Scientific Conference Dinner
Session 4:
Innovative approaches to Proof-of-Concept
Chairs:
J. Taubel, London (UK)
O. van Schoor, Antwerp (Belgium)
9:00
Rapid transition from bench to bedside:
An overview; what is new, what has proven its value, what are the latest trends in translational medicine
J. Theis, Bergisch-Gladbach (Germany)
9:30
Network-based drug discovery – rationale
and successful application to epilepsy
M. Johnson, London (UK)
10:00
Cutting edge developments: biomarker qualification as an indicator for clinical endpoints and their role in setting an optimal biologic dose
S. Jurcevic, London (UK)
10:30
Break
11:00
Parallel Workshops
WS1-WS4
Repetition of Day 1
WS1
Cardiac safety, QT assessment
B. Mendzelevski, London (UK)
J. Taubel, London (UK)
WS2
PK/PD modeling
R. Gomeni, La Fouillade (France)
WS3
Application of Bayesian Statistics in early development studies
P. Sanwald Ducray, Basel (Switzerland)
F. Vandenhende, Genappe (Belgium)
WS4
Adaptive study design in early phase clinical
research
M. O’Kane, London (UK)
U. Lorch, London (UK)
WS5.b
Pain Models
Ph. Danjou, Paris (France)
12:30
Lunch Break
Session 5:
Strengthening European Human Pharmacology for the Early Development of New Medicines
Chairs:
P. Dewland, Cardiff (UK)
H. Sourgens, Munich (Germany)
13:30
A critical review of the proposed EU
Clinical Trial regulation
W. Janssens, Brussel (Belgium)
Federal Agency for Medicine and Health Products
14:15
Need for a uniform European registration
system for volunteer participation?
A. Peremans, Aalst (Belgium)
15:00
Risk adapted approaches and clinical trial notification scheme
M. O’Kane, London (UK)
16:00
End of Conference
Hotel Sophia Country
3550 Route des Dolines BP 15
06410 Biot-Sophia Antipolis (FRANCE)
Phone: +33 4 92 966878
Intercom Kongresse GmbH
Antje Blömeke | Matthias Runow
Eppendorfer Baum 39a
20249 Hamburg (GERMANY)
Phone/-Telefax: +49 40 480610 -62/ -66
abloemeke@intercom.de | mrunow@intercom.de
| Member of* | 380 € |
| Non-Members | 430 € |
| Junior Scientist | 270 € |
*CP1: http://www.clubphase1.com
*AGAH: http://www.agah.info
*BAPU: http://www.bapu.be
*AHPPI: http://www.ahppi.org.uk
Start Online-Registration and Hotel reservation by
http://l.hh.de/JointConference_2013
Programme of the Annual Meetings 2013
JointConference2013_3rdAnnouncement
11. April 2013 - 12. April 2013
22nd AGAH Annual Meeting 2013
Annual Meeting 2013
Nice Sophia Antipolis
Frankreich