
20th AGAH Annual Meeting 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
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.
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.
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
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
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