
14th AGAH Annual Meeting 2005
Annual Meeting 2005, Strasbourg
Early drug development – scientific and regulatory challenges
March 17 – 18, 2005, Strasbourg
This first joint meeting of AGAH – The German Association for Applied Human Pharmacology – and Club Phase I – the French Association of Early Human Drug Development – focused on the scientific and regulatory challenges of early drug development.
It addressed technical, safety and regulatory issues impacting on global clinical development plans. In combining the congress concepts of the two sister organizations this meeting offered a wide array of both plenary lectures and workshops suitable both for newcomers and more experienced members of the scientific community.
A rbe it s gem e in s ch aft für an ge w an dte
Hu m an ph arm ak ol o gi e ( AG A H) e .
This first joint meeting of AGAH—the German
Association for Applied Human Pharmacology - and the
Club Phase I - the French Association of Early Human
Drug Development - focuses on the scientific and regulatory challenges of early drug development. It will
address technical, safety and regulatory issues impacting
on global clinical development plans. In combining the
congress concepts of the two sister organizations this
meeting offers a wide array of both plenary lectures and
workshops suitable both for newcomers and more experienced members of the scientific community. Strasbourg, the venue for this international congress was
chosen as a European Capital and for its role as a bridge
between France and Germany and, obv iously, for the
many attractions the region has to offer.
08.30
Registration and c offee
09.15
Opening remarks
G. Mikus (AGAH) and Y. Donazzolo (Club Phase 1)
Session I
Current approaches in human pharmacology
Chair
H Fuder and H Caplain
Plenary lectures
09.30
Is Phase I useful?
W. Seifert, Berlin
09.55
Healthy volunteers or patients as target population in Phase I trials
H. Fuder, Berlin
10.20
When to stop dose escalation: MTD or MLD or ...?
H. Caplain, Paris
10.45
Coffee break
Parallel workshops
- Design aspects of Phase I studies and recruitment bias during early development
M. Buise, Brussels ; B. Boutouyrie, Basel, G. Nemitz, Biberach - Women in Phase I studies
C. Klipping, Nijmegen ; D. HegerMahn, Berlin ; K. Breithaupt-Grögler, Frankfurt - Pediatric clinical trials
E. Autret-Leca, Paris - Special populations
B. Schug, Oberursel - New drugs in oncology
JL. Pinquier, Paris ; P. Squiban, Strasbourg
12.30— 14.00
Lunch break
Session II
Implications of the new EU-directive on clinical trials
Chair
Y Donazzolo and R Schulz
Plenary lectures
Experience reports from the first year of working wit hin t he new regulatory environment:
14.00
France
A. Patat, Paris
14.15
Germany
R. Frey, Wuppertal
14.30
United Kingdom
S. Warrington, London
14.45
The Netherlands
J. van Gerven, Leiden
15.00
Central Europe
C. Reh, Berlin
15.15
Comparison between European countries
A. Patat, Paris
15.45
Coffee break
16.00 - 17.15
Round table discussion
Chair: I Klingmann, Brussels
What is going well within the EU directive?
Necessary improvements?
ICH guideline for all?
What do clinical researchers require from the EU directive in 2010?
C. Belorgey, Paris ; G. Schwarz, Bonn ; F. Chapuis, Lyon ; T. Sudhop, Bonn ; B. Lehmann, Brussels ; A. Patat, Paris ; R. Frey, Wuppertal ; S. Warrington, London ; J. van Gerven, Leiden ; C. Reh, Berlin
Session III
Safety issues in Phase I trials
Chair
M Sibille, J van Gerven
08.30
Is Phase I safe?
M. Sibille, Lyon
09.00
First dose and dose escalation
B. Reigner, Basel
09.30
Allometric scaling
G. Sanderink, Paris
10.00—10.30
Coffee break
10.30 -12.00
Parallel workshops:
- QTc: Predictability, science, regulations
M. Drici, Nice ; P. Maisonblanche, Paris - Predictability of toxicity, population, CNS markers
J. van Gerven, Leiden - Biotech products: Predictability from preclinical data
M. Zühlsdorf, Wuppertal ; G. Lemm, Leverkusen ; P. Guillet, Paris - Bridging the tolerability gap between healthy volunteers and patients
H. Allain, Rennes ; U. Feifel, Biberach - Safety guidelines
D. Sallieres, Paris
12.00—13.30
Lunch break
Session IV
New tools in early drug development
Chair
G Mikus and P Rosenzweig
13.30
When and how do PK/PD modelling and simulations make sense in early development?
E. Fuseau, Aix-en-Provence
14.00
Informed consent process in pharmacogenomic studies (Germany, France, international views)
KL. Rost, Berlin
14.30
Imaging in early drug development
D. Brooks, London
15.15
Using proteomics to follow response to novel therapies
B. Acres, Strasbourg
15.45
Closing remarks
JL. Imbs, Strasbourg
Date:
17 and 18 March 2005
Conference venue:
Hotel Sofitel
4 Place Saint-Pierre-le-Jeune
67000 Strasbourg
France
Telephone +33 (0)388 15 49 00
Fax +33 (0)388 15 49 99
Registration:
Congress Office
c/o Optimed
1, rue des Essarts
38610 Gières
France
Telephone +33 (0)4 38 37 27 58
Fax +33 (0)4 38 37 27 41
E-mail meeting2005@clubphase1.org
Homepage www.clubphase1.org
www.agah-web.de
Fees:
225 € Members of AGAH and CP1, and full-time academics
250 € Non members
-25 € Additional discount for registrations received before 16 December 2004
Fees include admission to all sessions, lunch and coffee breaks
Accommodation:
A number of rooms at special discounted rates are available at the Venue and other Accor Group Hotels within easy walking distance. See the homepage for details. Please make your own reservations early.
Session I: Why do we need Phase I studies?
W. Seifert, Berlin
Is-Phase-I-useful-Seifert_01
Is Phase I useful?
H. Fuder, Mulhouse
Healthy-volunteers-or-patients-Fuder_01
Healthy volunteers or patients as target population in Phase I trials?
H. Caplain, Paris
Stop-dose-escalation-Caplain_01
When to stop dose escalation – MTD or MLD or ?
Session II: Implications of the new EU-Directive on clinical trials
A. Patat, Paris
EU-Directive-France-Patat
France
R. Frey, Wuppertal
EU-Directive-Germany-Frey
Germany
S. Warrington, London
EU-Directive-UK-Warrington_01
United Kingdom
J. van Gerven, Leiden
EU-Directive-Netherlands-van-Gerven
The Netherlands
C. Reh, Berlin
EU-Directive-Central-Europe-Reh
Central Europe
A. Patat, Paris
Comparisons-between-European-countries-Patat
Comparison between European countries
Session III: Safety issues in Phase I studies
M. Sibille, Lyon
Is-Phase-I-safe-Sibille_01
Is Phase I safe?
B. Reigner, Basel
First-dose-and-escalation-Reigner_01
First dose and dose escalation
G. Sanderink, Paris
Allometric scaling
No presentation available
Session IV: New tools in early drug development
E. Fuseau, Aix-en-Provence
PKPD-in-early-development-Fuseau_01
When and how does PK/PD modelling and simulation make sense in early development
K.L. Rost, Berlin
Informed consent process in pharmacogenomic studies (Germany, France, international view)
No presentation available
R. Myers, London
PET-scan-Myers_01
Imaging in early drug development
B. Acres, Strasbourg
New compounds derived from research on proteomics
No presentation available
Workshops
H. Allain, Rennes
Pharmacogenomics-and-drug-safety-Allain_01
Pharmacogenomics and drug safety
P. Maisonblanche, Paris
QTc-Maisonblanche_01
QTc: Predictability, Science, Regulation
M. Buyse, Bruxelles
Phase-I-in-oncology-Buyse_01
Phase I in Oncology
17. März 2005 - 18. März 2005
14th AGAH Annual Meeting 2005
Annual Meeting 2005
Strasbourg
Frankreich