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
|Chairs: Barbara Schug, Oberursel; Georg Wensing, Wuppertal|
|09:05 - 10:45 |
Pharmacodynamic endpoints and inclusion of biomarkers in early clinical trials
|10:45 – 11:45|| |
Break for plenary lecture GPTS
|11:45 – 12:15||Networking lunch break|
|Chairs: Kerstin Breithaupt-Grögler, Frankfurt; Jens Rengelshausen, Aachen|
|12:15 - 13:00 |
Biomarkers for cardiovascular pharmacodynamic effects – may ‚digital‘ biomarkers provide more realistic data than bedside assessments?
|13:00 – 13.45 |
Challenges in using biomarkers for developing anticoagulants
|13:45 – 14:00|| |
|14:00 – 15:15 |
Safety markers in early phase trials (drug induced renal and liver injury, assessment of neurological adverse reactions)
|15:15 – 16:00 |
How to evaluate drug effects on the QT(c) interval in healthy subjects and patients
|16:00 – 16:15||Break|
|16:15 – 16:45||Stratified medicine – development of companion diagnostics|
Michael Zühlsdorf, Darmstadt
|16:45 – 17:00 |
Wrap-up and conclusion
|17:00||End of Workshop|
Association for Applied Human Pharmacology (AGAH) e.V.
phone: +49 40 30770300
fax: +49 40 30770301
e-Mail: info ( a t ) agah.eu