Name: 3rd Joint Annual Meeting and 18th AGAH Annual Meeting 2009
Start: 2009-04-28T00:00:00+02:00
End: 2009-04-30T23:59:59+02:00
Location: Annual Meeting 2009

28. April 2009 - 30. April 2009
Annual Meeting 2009, Lyon

Announcement

April 28 – 29, 2009, Lyon (Hotel Espace Tete d’or), France

Biologics and small molecules are a challenging experience and expectations as to their potential are high. However, the first administration of a new compound to man is a particularly critical moment in drug development, pre-clinical information is limited and not necessarily transferable to humans. New molecules with not yet fully understood pharmacological action can yield unpredictable outcomes of otherwise well designed trials.

This meeting addressed how sponsors, investigators, regulatory authorities and ethics committees might adapt to these new challenges. It was also the third Joint Meeting of AGAH and Club Phase 1 and we were delighted to welcome also many of our colleagues from Belgium and the UK.

Introduction

MANAGING CHALLENGES IN EARLY
DRUG DEVELOPMENT
Biologics and small molecules are a challenging experience and expectations as to their potential are high.
However, the first administration of a new compound to
man is a particularly critical moment in drug development, pre-clinical information is limited and not necessarily transferable to humans. New molecules with not
yet fully understood pharmacological action can yield
unpredictable outcomes of otherwise well designed
trials.
This meeting will address how sponsors, investigators,
regulatory authorities and ethics committees are adapting to these new challenges. It is already the third Joint
Meeting of AGAH and Club Phase 1 and we are delighted to also welcome our colleagues from Belgium
and the UK.

Day 1, Tuesday, April 28, 2009

08:30

Registration

09:00

Opening Remarks
A. Patat, Rennes; M. Sibille, Lyon;
T. Thomsen, Andernach

Session 1:

New biological entities and vaccines

Chair

H. Caplain, Paris; J.-F. Nicolas, Lyon

09:15

New targets – new vaccines
J.-F. Nicolas, Lyon
Early development plan for a vaccine
R. Forrat, Lyon
Development of new biological entities
J.-Y. Bonnefoy, Strasbourg

10:45

Coffee Break

11:15

Parallel w orkshops
1) Update on the design of studies of drug-drug interaction with special focus on transporters
D. Chassard, Paris; J.-M. Scherrmann, Paris
2) Human pharmacology’s contribution to the preparation of paediatric development plans
I. Klingmann, Brussels; W. Seifert, Berlin
3) Critical appraisal of studies with elderly in early development
C. Reh, Berlin
4) Determination of antibodies following administration of small proteins
I. Paty, Paris; F. Bérard, Lyon; P. Cortez, Montpellier
5) What to expect from Holter ECGs in early development?
P. Voiriot, Nancy
6) AHPPI workshop:
Translational medicine – dream or nightmare?
P. Dewland, Llanyre; T.Mant, London

12:45

Lunch Break

Session 2:

Current European experience with trial approval in early development

Chair

I. Klingmann, Brussels; A. Patat, Rennes

14:00

AFSAPPS: Data on timelines, missing aspects in dossiers, reasons for delays, questions to applicants, how to improve the process
C. Belorgey, Paris
BfArM / PEI: Data on timelines, missing aspects in dossiers, reasons for delays, questions to applicants, how to improve the process
T. Sudhop, Bonn
Belgium: Data on timelines, missing aspects in dossiers, reasons for delays, questions to applicants, how to improve the process
W. Janssens, Brussels
UK: Data on timelines, missing aspects in dossiers, reasons for delays, questions to applicants, how to improve the process
J. Ward, London

15:30

Coffee Break

Differences in responses from Ethics Committees to clinical trial applications in France
F. Chapuis, Lyon
Differences in responses from Ethics Committees to clinical trial applications in the UK
M. Bone, Newcastle
Differences in responses from Ethics Committees to clinical trial applications in the Netherlands
R. A. de Zeeuw, Assen
Applicants perspective on data from the approval process between 2004 and 2008
T. Ruppert, Berlin

17:00

Round table discussion on trial approval in early drug development
All speakers of the afternoon session Introduction: ICREL results on trial approval
I. Klingmann, Brussels

17:45

End of Session

19:30

Conference Dinner

Day 2, Wednesday, April 29, 2009

Session 3

Managing the risk of Phase I trials

Chair

Y. Donazzolo,Grenoble; K. BreithauptGrögler, Frankfurt/M

08:45

Identification and mitigation of risks in first-inhuman clinical trials - pitfalls and challenges of a unified process within a worldwide CRO
M. Grossmann, Berlin
Usefulness of MABEL concepts
B. Laurijssens, London
Accreditation of phase I units in the UK
J. Täubel, London
Accreditation of phase I units in France
A. Patat, Rennes
Accreditation of phase I units in Germany
T. Thomsen, Andernach

10:30

Coffee Break

11:00

Parallel w orkshops
7) Monoclonal antibodies in or out of oncology.
G. Salles, Lyon; N. Franchimont, Zug
8) Society for Pharmaceutical Medicine workshop: MABEL Concept
D. Jones, London; B. Laurijssens, London
9) Personalized medicine / theragnostics.
M. Zühlsdorf, Cologne
10) Informed consent in pharmacogenomics / individualized medicine – responses from various ethics committees within the EU.
M. Könen-Bergmann, Ingelheim
12) Exploratory trials workshop
Y. Donazzolo, Grenoble; D. Tremblay, Paris
11) BAPU workshop: What is a healthy volunteer?
D. van der Mijnsbrugge, Antwerp;
S. Ramael, Brussels

12:30

Lunch Break

Session 4

Safety concerns in early development

Chair

I. Paty, Paris; H. Fuder, Hamburg

13:30

Stopping criteria in first-in-man studies
A. Patat, Rennes, M. Sibille, Lyon
Serious adverse event registry
M. Sibille, Lyon, C. Hinze, Rheinau
Lessons learned from thorough QTc studies performed by a pharmaceutical company
H. Caplain, Paris
New approaches for the assessment of drug abuse liability
J.-L. Pinquier, Paris

15:45

Closing Remarks
A. Patat, Rennes

16:00

End of Meeting