Lade Veranstaltungen

3rd Joint Annual Meeting and 18th AGAH Annual Meeting 2009

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

Managing Challenges in Early Drug Development:

Biologicals and Small Molecules

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

Fees

 

Fees

Members* 325 EUR
Non-members 375 EUR
Day ticket 200 EUR

*) Members of AGAH, CPI, AHPPI, BAPU, and SPM

Online registration and hotel reservation:
Please use the link to the Kuoni registration form at www.clubphase1.fr or www.agah-web.de


Online registration and hotel reservation:
http://www.intercom-dresden.de/agah2010/

 

Downloads

Bélorgey, Ch.

French experience Ch Belorgey 01.pdf(151 kB)

Current European Experience with trial approval in early development: Afssaps (France)


Bone, M.

Bone Ethics review UK AAHP Lyon 01.pdf(2.1 MB)

Research Ethics Review in The UK: Improving the process with a focus on the Integrated Research Application System (IRAS)


Chassard, D.

Praes. Chassard DDI DC 30MAR09 2 01.pdf(371 kB)

Drug-Drug interactions. Update on the Study Design


Cortez, P.

Workshop AGAH Club Phase I P Cortez version pour edition May2009 01.pdf(1.0 MB)

Immunogenicity of Biological products


Dewland, P.

Translational Nightmare PDewland 01.pdf(226 kB)

Translational Medicine


de Zeeuw, R.

Presentation Lyon Rokus de Zeeuw 01.pdf(78 kB)

Trial Approval in Early Drug Development: Current Experiences in The Netherlands


Donazzolo, Y. & Tremblay, D.

Exploratory trials DTremblay YDonazzolo 01.pdf(173 kB)

Exploratory clinical trials workshop


Janssens, W.

Belgium experience W Janssens.pdf(406 kB)

Timelines, missing aspects in dossiers, reasons for delays, questions to applicants, how to improve the process


Laurijssens, B.

MABEL BLaurijssens 01.pdf(0.9 MB)

Usefulness of MABEL concepts


Mant, T.

Translational Dream or Nightmare TMant 01.pdf(1.7 MB)

Translational Medicine: Dream or Nightmare?


Patat, A.

France CPU Accreditation APatat 01.pdf(77 kB)

Accrediation of Phase I Units and protection of the subjects participating in clinical trials in France


Patat, A., Sibille, M., Caplain, H., Donazzolo, Y., Chalon, S.

Stopping rules APatat MSibille 01.pdf(696 kB)

Stopping rules in First entry into human studies


Salles, G.

Anticorps Kc G Salles.pdf(154 kB)

Phase I studies of MoAbs in Oncology


Sibille, M. & Hinze, C.

French and German SAE Registers MSibille CHinze 01.pdf(1.3 MB)

Serious adverse events in Phase I: French and German SAE Registers


Taubel, J.

UK CPU Accreditation JTaubel 01.pdf(223 kB)

Managing the risk of Phase I trials: Accreditation of Phase I Units in the UK


Thomsen, T.

Germany CPU Accreditation TThomsen 01.pdf(250 kB)

Managing challenges in early drug development: Biologicals and small molecules


Scherrmann, J.M.

Transporters in ADE 01.pdf(1.9 MB)

Transporters in ADE


Ward, M.

UK experience M Ward 01.pdf(789 kB)

Current UK experience with trial approval in early development

28. April 2009 - 30. April 2009

3rd Joint Annual Meeting and 18th AGAH Annual Meeting 2009

Annual Meeting 2009


Lyon
Frankreich