2nd Joint Annual Meeting and 17th AGAH Annual Meeting 2007
Annual Meeting 2007, Bad Homburg
Positioning Human Pharmacology for the Future
April 26-27, 2007, Bad Homburg von der Höhe, Germany
The second Joint Annual Meeting of Club Phase 1 and AGAH took place in April 2007 in Bad Homburg von der Höhe and addressed the vital question how to position human pharmacology for the future. More than 300 participants from 10 countries discussed different aspects during the four scientific sessions in various workshops and symposia.
AGAH and Club Phase 1 were delighted to welcome also their colleagues from the Belgian association of phase I units (BAPU) to the meeting.
Human Pharmacology for the Future
Second Joint Annual Meeting Club Phase I and AGAH 2007
This second joint meeting of Club Phase 1 - the French Associati- on of Early Human Drug Development — and AGAH — the German
Association for Applied Human Pharmacology - addresses a vital question:
„How to position human pharmacology for the future?“
Which role can and should human pharmacology play in the development of new classes of drugs and biologicals?
This meeting will attempt to find answers to these questions and also to highlight technical-, safety- and regulatory issues impacting on clinical development.
AGAH and Club Phase 1 are delighted to welcome our Belgian Colleagues from BAPU to this meeting and are looking forward to their scientific contributions and collaboration. This will certainly foster the widespread mutual interest for a pan European collaboration of human pharmacologists Positioning
Date:
April 26 and 27, 2007
Conference venue:
MARITIM HOTEL BAD HOMBURG
Kurhaushotel/Kongresszentrum
Ludwigstraße 3
61348 Bad Homburg vor der Höhe
Germany
Telephone: +49 (0)6172 660-0
Fax: +49 (0)6172 660-100
Registration:
INTERCOM Dresden
Antje Blömeke
Zellescher Weg 3
01069 Dresden
Germany
Telephone +49 (0)351 4633 3014
Fax +49 (0)351 4633 7049
E-mail: abloemeke@intercom.de
Homepage: www.agah-web.de
Fees
250,00 € Member (early registration)
275,00 € Member
275,00 € Nonmember (early registration)
300,00 € Nonmember
200,00 € Junior Scientist
125,00 € Junior Poster (Member)
150,00 € Junior Poster (Nonmember)
200,00 € Day Ticket
275,00 € Industry Exposition Staff
Early bird reductions applied for registration up to January 31, 2007.
Fees include admission to all sessions, lunches and coffee breaks.
Accommodation:
A number of rooms at special discounted
rates are available at the Venue.
08.30
Registration and coffee
09.00
Opening remarks
Presidents AGAH and Club Phase I
Session I Current approaches in human pharmacology
Chair
Y. Donazzolo, Gières, T. Thomsen, Andernach
09.05
Pharmacokinetics and bioavailability: Examples from variousbody fluids
W. Cawello, Monheim
09.40
Tolerability and safety: Predictability of QT prolongation in healthy subjects from preclinical experiments
H. Caplain, Paris
10.15
Dose/concentration-effect relationship: Biomarkers in CNS drug development - effects of opioid analgesics
F. Fliegert, Aix-la-Chapelle
10.50
Coffee break
11.15
Parallel workshops
• An introduction to state of the art pharmacokinetics
W. Cawello, Monheim
• PK and PD as predictors of a clinical effect
J. Grevel, Verona
• Need for and approaches to a European trial subjects database
B. Schug, Oberursel, R. Schäfer, Francfort, A. Peremanns, Brussels, Y. Donazzolo, Gières, T. Thomsen, Andernach
• Designs of human pharmacology trials for paediatric populations
E. Jacqz-Aigrain, Paris, H. Seyberth, Landau
• Current regulatory developments relevant o human pharmacology in the EU
I. Klingmann, Brussels, C. Schneider, Langen
12.30
Lunch break and Poster Session
Session II
What is human pharmacology expected to deliver in the future?
Chair
K. Breithaupt-Grögler, Francfort, A. Patat, Rennes
14.00
From understanding the disease to implementing the diagnostic biomarker and the effective treatment—practical examples
S. Stürzebecher, Aix-la-Chapelle
14.35
Development of meaningful interaction studies for combination therapies
J. van Gerven, Leiden
15.10
Imaging techniques in the early development of new compounds
P. Danjou, Paris
15.45
Coffee break
16.00
Round table discussion
Chair: I. Klingmann, Brussels, I. Paty, Paris
Will human pharmacology be needed to develop individualized treatments?
Participants: D. Austin, London, H. Caplain, Paris, T. Sudhop, Bonn, S. Stürzebecher, Aix-La-Chapelle, M. Zühlsdorf, Basle
17.15
End of Day I
18.30
Conference Dinner Event
Session III
Challenges and limitations of human pharmacology
Chair
L. Tritsman, Brussels, J. van Gerven, Leiden
08.30
Human pharmacology for biologicals—first into man
D. Austin, London
09.00
Genotyping: A reliable predictor for safety and tolerability?
M. Schwab, Stuttgart
09.30
Interpretation of early safety signals
M. Sibille, Lyon
10.00
Coffee break
10.30
Parallel workshops:
- Microdosing: myths and reality; scientific, regulatory and financial perspectives
J. de Hoon, Leuven, D. Pegg, Ann Arbor, C. Schneider, Langen, C. Garner, Haslington - Predictability of pharmacological methods
J-L. Pinquier, Paris - Biomarkers in specific areas
M. Zühlsdorf, Basle - Sustainability of the pharmaceutical development pipeline: methods, facts and perspectives
W. Seifert, Berlin - Do population kinetics work without densedata sampling?
N.O. Hoem, Hamburg
12.00
Lunch break and Poster Session
Session IV
Getting fit for the future of human pharmacology
Chair
H. Caplain, Paris, C. Hinze, Rheinau
13.30
Scientific requirements: Perspective of an editor for an international clinical pharmacology journal
U. Fuhr, Cologne
14.00
Oxford debate on how to establish tolerability and safety —MTD versus pharmacological activity
M. Sibille, Lyon, J. van Gerven, Leiden
14.45
New regulatory requirements for first into man studies in Germany and France
T. Sudhop, BfArM, Bonn, D. Tremblay AFSSAPS, Paris
15.45
Closing remarks
H. Fuder, Hamburg
D. Austin
D._Austin_25.05.07
Human pharmacology for biologicals – First into man studies
H. Caplain
CPI_AGAH_HC_042207
Tolerability and safety: Predictability of QT prolongation in healthy subjects from preclinical experiments
W. Cawello
W._Cawello__2__25.05.07_01
Pharmacokinetics and bioavailability derived from various body fluids
Ph. Danjou
Ph._Danjou_21.06.07_01
Imaging in Early Drug Development
F. Fliegert
F._Fliegert__30.05.07_01
Biomarkers in CNS drug development
J. van Gerven
Development_Of_Meaningful_Interaction_Studies_For_Combination_Therapies
Development of Meaningful Interaction Studies for Combination Therapies
J. Grevel
J.Grevel_25.05.07_01
PK and PD as predictors of clinical effect
Ch. Schneider
Ch._Schneider_BAPU_WS_31.05.07
Handling of First-in-man trials: regulatory rethink?
Ch. Schneider
Ch._Schneider__2__WS_31.05.07
Current regulatory developments relevant to human
B. Schug
B._Schug_25.05.07
Need for a European Trial Data Base Introductory Remarks
W. Seifert
H._Seyberth_26.05.07_WS_I_01
Workshop: Designs of human pharmacology trials for paediatric populations
M. Sibille
M._Sibille_25.05.07_EarlySafety_01
Interpretation of early safety signals
M. Sibille
M._Sibille_25.05.07_MTD_Oxford_debate_01
Is priority to MTD – maximal tolerated dose – the best way?
Ch. Steffen
C._Steffen_FIM
Clinical Trial Authorisation in Germany for First-in-Man Trials with NCEs
D. Tremblay
D._Tremblay_26.05.07
New regulatory requirements for first into man studies in France
26. April 2007 - 27. April 2007
2nd Joint Annual Meeting and 17th AGAH Annual Meeting 2007
Annual Meeting 2007
Bad Homburg
Deutschland