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20th AGAH Annual Meeting 2011

31. March 2011 - 1. April 2011
Annual Meeting 2011, Berlin

Joint Conference of European Human Pharmacological Societies and 20th Anniversary of AGAH

Exploratory Development of Modern Therapies – Biologicals, Advanced Therapies and Drug-Device Combinations

Announcement

Human Pharmacology is still a relatively young discipline. Only in the 1980ies clinical pharmacologists performing Phase I studies founded dedicated scientific associations to exchange experience, to foster systematic research and to harmonise quality standards. Since then great progress has been made in early drug development of small molecules for many different indications. Human pharmacology today is crucial for early go/no-go decisions. The growing number of biologicals, new advanced therapies and innovative modes of drug application like drug/device combinations or nano particles call for new scientific tools. Human pharmacologists have to adapt to completely new mechanisms of action, pharmacological characteristics, models, methodologies and techniques in Phase I/II clinical trials.

The best way to compile the current level of knowledge and to exchange the sparse experience on new methodologies is international collaboration. The German AGAH e.V, the French Club Phase I, the Belgian BAPU and the British AHPPI decided to join forces and have the great pleasure to invite you to their 1st joint conference. This meeting will update you on new approaches in exploratory development of modern therapies and provides ample opportunity to discuss ideas, strategies, methods, technologies and experience with the early development of biologicals, advanced therapies and drug-device combinations in 2 days of plenary sessions and workshops.

Celebrating its 20th anniversary, AGAH is proud to welcome three sister associations to in Berlin, where it was founded in 1991. We are most happy to celebrate the development and continuous growth of AGAH, providing “home” for the majority of human pharmacologists working in pharma companies, CROs and academic units in Germany.

Introduction

 

Human Pharmacology is still a relatively young discipline. Only in the 1980s clinical pharmacologists performing Phase I studies founded dedicated scientific
associations to exchange experience, to foster systematic research and to harmonise quality standards. Since
then great progress has been made in early drug development of small molecules for many different indica- tions. Human pharmacology today is crucial for early
go/no-go decisions. The growing number of biologicals,
new advanced therapies and innovative modes of drug
application like drug/device combinations or nanoparticles call for new scientific tools. Human pharmacologists have to adapt to completely new mechanisms of
action, pharmacological characteristics, models, methodologies and techniques in Phase I/II clinical trials.
The best way to compile the current level of knowledge
and to exchange the sparse experience on new methodologies is international collaboration. The German
AGAH e.V, the French Club Phase I, the Belgian BAPU
and the British AHPPI decided to join forces and have
the great pleasure to invite you to their 1st joint conference. This meeting will update you on new approaches
in exploratory development of modern therapies and
provides ample opportunity to discuss ideas, strategies,
methods, technologies and experience with the early
development of biologicals, advanced therapies and
drug-device combinations in 2 days of plenary sessions
and workshops.
Celebrating its 20th anniversary, AGAH is proud to
welcome three sister associations to Berlin, where it
was founded in 1991. We are happy to celebrate the
development and continuous growth of AGAH, providing a “home” for the majority of human pharmacologists
working in pharmaceutical companies, CROs and academic units in Germany.

Day 1, 31 March 2011


09:00

Welcome and introduction to the first joint meeting of AGAH, Club Phase I, BAPU, AHPPI


Session 1:

PRINCIPLES OF EARLY DEVELOPMENT
OF BIOLOGICALS


Chairs:

A Patat, Rennes, I Klingmann, Brussels


9:15

Impact of the ICH-M3 guideline on the early development of biologicals
S Plassmann, Munich


9:45

Predictivity of toxicological tests for the early development of biologicals
J-J Legrand, Evreux


10:15

Fixed dosing versus weight-based dosing in clinical development of biotherapeutic proteins
D Wang, La Lolla-California


10:45

Coffee Break


Session 2:

REGULATORY ASPECTS


Chairs:

M Hammond, Slough, O Van Schoor, Antwerp


11:15

EMA’s role and responsibilities for the devel- opment of modern therapies
E Flory, Langen


11:45

The role and responsibilities of a national competent authority in the development of modern therapies
E Godfrey, London


12:15

Signal detection and risk management in early clinical development
H Caplain, Chilly-Mazarin, P Van der Auwera, Basle


12:45

Lunch Break


14:00

PARALLEL WORKSHOPS


WS 1

Early clinical development of vaccines
M Peeters, Rixensart, G Hale, Abingdon


WS 2

QT-Studies for biologicals
P L’Hostis, Rennes, J Täubel, London


WS 3

Stopping rules in exploratory drug development
A Patat, Rennes, Y Donazzolo, Lyon


WS 4

Biologicals vs. small molecules – What’s the difference?
P Lloyd, Horsham, G Narayan, London


15:30

Coffee Break


Session 3:

EARLY DEVELOPMENT OF DRUGDEVICE COMBINATIONS


Chairs:

T Thomsen, Andernach, U Lorch, London


16:00

Toxicological programme and predictivity of toxicological results for drug-device combinations
A McLean, London


16:30

Regulatory background for medicinal product / medical device development
T Sudhop, Bonn


17:00

Example for an early drug-device development plan
B Schug, Oberursel


17:30

End of Day 1


19:30

Conference Dinner

Day 2, 01 April 2011

Session 4:

EARLY DEVELOPMENT OF ADVANCED THERAPIES


Chair

K Breithaupt-Grögler, Frankfurt, L Van Bortel, Gent


9:00

Gene therapy studies
R Yanez, Egham


9:30

Stem cell therapy studies
S Janssens, Leuven


10:00

Tissue-engineered products
F Luyten, Leuven


10:30

Coffee Break


11:00

PARALLEL WORKSHOPS


WS 5

Preparation and management of Phase I
studies with stem cell therapy
G Tiedemann, Rostock, D Sawitzky, Leipzig


WS 6

Modelling and simulation to help MABEL definition
B Laurijssens, Chambonas, S Martin, Sandwich


WS 7

Ethical dilemmas in modern therapies
I Klingmann, Brussels, C Heberlein, Ebmatingen


WS 8

Practical application of risk assessment and
management in early clinical development
H Caplain, Chilly-Mazarin, P Van der Auwera, Basle


12:30

Lunch Break


Session 5:

STRENGTHENING EUROPEAN HUMAN PHARMACOLOGY FOR THE EARLY DEVELOPMENT OF MODERN THERAPIES


Chair

J de Hoon, Leuven, Y Donazzolo, Lyon


13:30

Open forum discussion:
Need for a uniform European accreditation system for Phase I units?
Introduction: U Lorch, London


14:15

Open forum discussion:
Need for a uniform European registration system for volunteer participation?
Introduction: A Peremans, Antwerp


15:00

Open forum discussion:
Need for SAE-reporting in Phase I studies across countries?
Introduction: A Patat, Rennes


15:45

Closing remarks
I Klingmann, Brussels


16:00

End of conference

Information

 

Venue
Langenbeck-Virchow Haus
Luisenstr. 58/59, 10117 Berlin
Phone: +49 (30) 2887 9834

Date
Thursday, 31 March & Friday, 01 April 2011

Fees

Members of AGAH, CPI, AHPPI, BAPU 340 EUR
Non-members 400 EUR
Junior scientists 250 EUR
Day ticket 200 EUR

50,00 € reduction for early bird registration prior to 15 January 2011


Inquiries
Intercom Kongresse GmbH
A. Blömeke
Eppendorfer Baum 39a
20249 Hamburg, Germany

T.: +49 (0)40 4806 1061
F.: +49 (0)40 4806 1066
abloemeke@intercom.de

AGAH: www.agah.info
CP1: www.clubphase1.fr
BAPU: www.bapu.be
AHPPI: www.ahppi.org.uk

 

 

31. March 2011 - 1. April 2011

20th AGAH Annual Meeting 2011

Annual Meeting 2011


Berlin
Deutschland