17th AGAH Annual Meeting 2008
Annual Meeting 2008, Weimar
Safety and Risk Management in Translational Medicine
April 17 – 19, 2008, Weimar (Germany)
The Annual Meeting 2008 focused on discussing techniques, systems and strategic approaches to improve the safety of study participants, to minimize their risk of serious adverse reactions and to improve the predictivity of the safety profile of a new compound. Concepts and guidelines for the new regulatory environment for Phase I studies in the EU were presented. Experts from all involved research areas shared their experiences, discussed their limitations in interpreting the clinical relevance of their studies‘ results and presented their concepts for improving the drug development process.
SAFETY AND RISK MANAGEMENT
IN TRANSLATIONAL MEDICINE
Drug development must find a balance between the excitement
of discovering new treatment options and the protection of
subjects participating in clinical trials. Healthy volunteers and staff
responsible for their well-being are relying on the adequacy of
the procedures applied to minimize risk during the exploratory
phases. Hence, the results of pre-clinical pharmacological
models, toxicological studies and foregoing clinical trials in
healthy volunteers and patients are expected to be of predictive
value for the next step. With the increasing number of biologicals
and compounds with completely new mechanisms of action this
concept may no longer be satisfactory, as has been painfully
experienced with the first administration of TGN1412 to healthy
volunteers.
Today’s drug development is subjected to a highly regulated and
segmented setting. A closer cooperation between pre-clinical and
clinical experts is essential to identify and select the appropriate
investigational tools, to early identify potential safety issues, and
to translate the findings of exploratory trials into efficacious and
safe new drugs.
This conference focuses on finding appropriate techniques and
strategic approaches to improve the safety of study participants,
to minimize risk, and to improve the predictive value of the
safety profile for a new compound. Concepts and guidelines
for the new regulatory environment for Phase I studies in the EU
will be presented. Experts from all research areas involved will
share their experience, discuss the limitations of interpreting the
clinical relevance of their studies‘ results and present concepts for
improving the drug development process.
The meeting will be held in English.
18:00
Get-together
19:00
AGAH General Assembly
08:30
Registration
09:00
Opening remarks (Torben Thomsen)
Session I
The Predictive Relevance of Preclinical Safety Information
Chair
Hermann Fuder, Michael Zühlsdorf
09:10
Fundamental international regulatory requirements for human trials
Eckhard von Keutz, Wuppertal
09:40
Implications of pharmacological models for risk assessment
Ulrich Kalinke, Langen
10:10
Can toxicogenomics predict safety?
Frank Staedtler, Basel
10:40
Relevance of toxicological findings for drug safety in humans
Klaus Olejniczak, Bonn
11:10
Coffee Break
11:40
Parallel workshops:
• Studies with radiolabelled drugs in Germany
(Gerhard Scheuch, Gauting)
• Literature search and how to improve knowledge
management (Oliver Renn, Biberach)
• Comparison of International First-in-Man
Guidelines (Ingrid Klingmann, Brussels)
13:10
Lunch
Session II
The Predictive Relevance of Human Pharmacology Trials
for Drug Safety
Chair
Gerd Mikus, Wolfgang Timmer
14:30
Rationale for determining the MTD – which findings are really important?
Joachim Gerloff, Würzburg
15:00
Relevance of Phase I SAEs, SUSARs and important medical
events for patient safety
Michel Sibille, Lyon
15:30
How predictive is QTc prolongation really?
Wilhelm Haverkamp, Berlin
16:00
Coffee Break
Session III
The expedited CTA – a suitable approach for Europe?
Chair
Ulrich Feifel, Thomas Sudhop
16:30
A Panel and Open Forum Discussion
(T. Reum, Bonn; E. Stahl, Bonn; S. Hockertz, Seelze;
W. Beier, Munich; E. von Keutz, Wuppertal)
19:30
Conference Dinner (Alte Remise, Tiefurt)
Session IV
Integrated Preclinical and Clinical Safety
Assessment and Applications
Chair
Kerstin Breithaupt, Torben Thomsen
08:30
Assessment of drug-relationship of AEs in Phase I
Matthias Großmann, Berlin
09:00
Relevance of pre-clinical findings for the interpretation of Adverse Events
Timothy Mant, London
09:30
Safety signals in Phase I as triggers for go/no-go decision in further development
Georg Wensing, Wuppertal
10:00
Coffee Break
10:30
Parallel workshops:
- Minimising risk by optimising clinical trial design and performance
Wolfgang Timmer, Mannheim - Experience with and options for microdosing studies
Berend Oosterhuis, Zuidlaren; Andreas Kovar, Darmstadt - Practical aspects of clinical trials with challenge agents
Hermann Fuder, Hamburg - Burn-out and work-life balance (in German)
Wolfgang Seifert, Berlin; Katharina Erb-Zohar, Hanau
12:00
Coffee Break
Session V
Human Pharmacology for Biologicals
Chair
Christian Hinze, Ingrid Klingmann
12:10
Relationship between CMC and toxicology in the development of biologicals
Stefan W. Hockertz, Seelze
12:40
Clinical development programmes for biosimilars
Hildegard Sourgens, Munich
13:10
Specific challenges in human pharmacology trials with biologicals
Wolfgang Greb, Neuss
13:40
Closing Remarks
Gerd Mikus
13:45
Farewell lunch
Date:
April 18 – 19, 2008
Conference venue:
Leonardo Hotel Weimar
Belvederer Allee 25
D-99425 Weimar, Germany
Tel.: +49 (0) 3643 - 722 - 0
Fax: +49 (0) 3643 - 722 - 2320
Web: www.leonardo-hotels.com
Registration:
INTERCOM Dresden GmbH
Antje Blömeke
Zellescher Weg 3
D-01069 Dresden, Germany
Tel.: +49 (0) 351- 4633 - 3060
Fax: +49 (0) 351- 4633 - 7049
E-mail: abloemeke@intercom.de
Web: www.agah-web.de
Fees
| Members | 325 EUR |
| Non-members | 375 EUR |
| Junior Scientist* | 200 EUR |
| Industry Exposition Staff | 275 EUR |
| Day ticket | 200 EUR |
* under the age of 30 years
Fees include admission to all sessions, lunches and
coffee breaks.
Accommodation:
A number of rooms at special discounted rates are
blocked and available via INTERCOM Dresden GmbH.
AGAH e.V.
PO Box 540116
D-01311 Dresden, Germany
Tel.: +49 (0) 351 - 410 99 71
Fax: +49 (0) 351 - 410 99 72
E-mail: sekretariat@agah-web.de
Web: www.agah-web.de
Ingrid Klingmann, Kerstin Breithaupt-Grögler, Ulrich Feifel,
Hermann Fuder, Christian Hinze, Wolfgang Timmer
H. Fuder
AGAH-WS ChallengeAgentsHFuder190408pdf.pdf(537 kB)
AGAH-Workshop “Practical aspects of clinical trials with challenge agents”
W. Greb
AGAH-WS_ChallengeAgentsHFuder190408pdf
Specific Challenges in Human Pharmacology Trials with Biologicals
T. Mant
AGAH__Weimar_-_Germany__presentation__version_for_website_
Relevance of pre-clinical findings for the interpretation of Adverse Events
B. Oosterhuis
1st_presentation_Oosterhuis_AGAH
AGAH Workshop „Experience with and options for microdosing studies“
2nd_presentation_Oosterhuis_AGAH
AGAH Workshop „Experience with and options for microdosing studies“
W. Seifert and K. Erb-Zohar
AGAH-Workshop „Burn-out and work-life balance“
H. Sourgens
Clinical Development Programmes for Biosimilars und Literatur
Retacrit__INN_-_epoetin_zeta_01
W. Timmer
AGAH-Workshop „Minimising risk by optimising clinical trial design and performance“
17. April 2008 - 19. April 2008
17th AGAH Annual Meeting 2008
Annual Meeting 2008
Weimar
Deutschland