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14th AGAH Annual Meeting 2005

17. March 2005 - 18. March 2005
Annual Meeting 2005, Strasbourg

Early drug development – scientific and regulatory challenges

Announcement

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.

Introduction

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.

Day 1, Thursday, 17 March 2005


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

Day 2, Friday, 18 March 2005

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

Congress Information

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.

 

Presentations of the Annual Meeting 2007


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. March 2005 - 18. March 2005

14th AGAH Annual Meeting 2005

Annual Meeting 2005


Strasbourg
Frankreich