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.

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08.30

Registration and c offee

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09.15

Opening remarks

G. Mikus (AGAH) and Y. Donazzolo (Club Phase 1)

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Session I

Current approaches in human pharmacology

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Chair

H Fuder and H Caplain

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Plenary lectures

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09.30

Is Phase I useful?

W. Seifert, Berlin

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09.55

Healthy volunteers or patients as target population in Phase I trials

H. Fuder, Berlin

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10.20

When to stop dose escalation: MTD or MLD or ...?

H. Caplain, Paris

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10.45

Coffee break

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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

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12.30— 14.00

Lunch break

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Session II

Implications of the new EU-directive on clinical trials

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Chair

Y Donazzolo and R Schulz

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Plenary lectures
Experience reports from the first year of working wit hin t he new regulatory environment:

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14.00

France

A. Patat, Paris

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14.15

Germany

R. Frey, Wuppertal

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14.30

United Kingdom

S. Warrington, London

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14.45

The Netherlands

J. van Gerven, Leiden

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15.00

Central Europe

C. Reh, Berlin

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15.15

Comparison between European countries

A. Patat, Paris

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15.45

Coffee break

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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

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Chair

M Sibille, J van Gerven

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08.30

Is Phase I safe?

M. Sibille, Lyon

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09.00

First dose and dose escalation

B. Reigner, Basel

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09.30

Allometric scaling

G. Sanderink, Paris

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10.00—10.30

Coffee break

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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

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12.00—13.30

Lunch break

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Session IV

New tools in early drug development

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Chair

G Mikus and P Rosenzweig

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13.30

When and how do PK/PD modelling and simulations make sense in early development?

E. Fuseau, Aix-en-Provence

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14.00

Informed consent process in pharmacogenomic studies (Germany, France, international views)

KL. Rost, Berlin

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14.30

Imaging in early drug development

D. Brooks, London

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15.15

Using proteomics to follow response to novel therapies

B. Acres, Strasbourg

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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.