AGAH-Workshop at German Pharm Tox Summit 2019

Wednesday, 27 February 2019 in Stuttgart

Introduction to biomarkers and pharmacodynamic models and their use in drug development

The workshop addresses young scientists working in basic pharmacological research and other colleagues involved in biomedical research who would like to know more about early phase clinical development.

Biomarkers and pharmacodynamic models will be the focus of this workshop. Translation from knowledge derived from non-clinical studies to planning and conduct of early clinical trials aims at mitigating risk as well as at increasing the predictability for a safe and successful development. Biomarkers fit for purpose and meaningful pharmacodynamic models are most important tools in this context.

Learn from experts in early medicines development how to assess safety and tolerability, how to investigate mechanisms of action and how to demonstrate proof of concept for promising new compounds in healthy subjects and patients.

Breaks present a good opportunity for networking with faculty and colleagues. The number of participants is limited to 50 persons. Participation fee is 40 Euro for delegates fully registered for the GPTS and 100 Euro for a day ticket for the AGAH Workshop only.

Day 1: Wednesday, 27 February 2018

Morning Session

Chairs: Barbara Schug, Oberursel; Georg Wensing, Wuppertal
09:00 

Welcome
Georg Wensing, Wuppertal

09:05 - 10:45  
(100 min)

Pharmacodynamic endpoints and inclusion of biomarkers in early clinical trials
Jens Rengelshausen, Aachen and Michael Zühlsdorf, Darmstadt

10:45 – 11:45

Break for plenary lecture GPTS

11:45 – 12:15  Networking lunch break 

Afternoon session

Chairs: Kerstin Breithaupt-Grögler, Frankfurt; Jens Rengelshausen, Aachen
12:15 - 13:00
(45 min) 

Biomarkers for cardiovascular pharmacodynamic effects – may ‚digital‘ biomarkers provide more realistic data than bedside assessments?
Frank Kramer, Wuppertal

13:00 – 13.45  
(45 min)

Challenges in using biomarkers for developing anticoagulants
Dagmar Kubitza, Wuppertal

13:45 – 14:00

Break

14:00 – 15:15
(75 min) 

Safety markers in early phase trials (drug induced renal and liver injury, assessment of neurological adverse reactions)
 Introduction to topic: Frank Donath, Erfurt; Specific safety markers: NN

15:15 – 16:00
(45 min)

How to evaluate drug effects on the QT(c) interval in healthy subjects and patients
Jens Rengelshausen, Aachen

16:00 – 16:15 Break
16:15 – 16:45 Stratified medicine – development of companion diagnostics
Michael Zühlsdorf, Darmstadt
16:45 – 17:00 
(15 min)  

Wrap-up and conclusion
Kerstin Breithaupt-Grögler, Frankfurt; Jens Rengelshausen, Aachen

17:00 End of Workshop

Language

English

Workshop Venue

Stuttgart (Germany)

Contact

Association for Applied Human Pharmacology (AGAH) e.V. 
Goernestraße 30
20249 Hamburg
Germany

phone: +49 40 30770300
fax:    +49 40 30770301
e-Mail: info ( a t ) agah.eu