Drug development presents the experts in all disciplines involved with unexpected challenges during the complex process it takes to bring new medicines in a variety of indications to the market. These challenges require integration into what proves to be a demanding journey through often unknown territories which need to be explored as the route unfolds itself on the way.
What do we understand at a specific moment in time when we are facing an issue? Will this issue be a “show stopper” or only make us take a more complicated but still potentially successful route? How can we mitigate potential risks in humans? How reliably can we translate data from animals or clinical studies to the patient target population? How can we responsibly balance potential risks against essential benefits? How certain can we be as to whether we have asked the right questions along the way? Are we sure that we do really understand the answers we get?
Expect the unexpected – this AGAH workshop provides practical insight into critical situations arising during successful drug development with a focus on non-clinical and clinical development of biologics and anti-cancer drugs. Moreover, specific aspects regarding reproductive and juvenile toxicity and drug development for the paediatric patient population will be addressed.
Speakers and Chairs
- Graham Bailey, Johnson & Johnson, Beerse (Belgium)
- Paul Chamberlain, Biopharma Excellence, Munich (Germany)
- Axel-Rainer Hanauske, Lilly Deutschland GmbH, Bad Homburg (Germany)
- Viviane Klingmann, Universitätsklinikum Düsseldorf, Düsseldorf (Germany)
- Elisabeth Koch, PreClinical Safety Consultants Ltd., Denver (USA)
- Andreas Kovar, Consultant, Darmstadt (Germany)
- Shaun Maguire, Medimmune (AZ Biologics), Cambridge (UK)
- Carina Mallard, University of Gothenburg, Gothenburg (Sweden)
- Stephanie Plassmann, PreClinical Safety Consultants Ltd., Basel (Switzerland)
- Barbara Schug, Socratec R&D GmbH, Oberursel (Germany)
- Diane Seimetz, Biopharma Excellence, Munich (Germany)
- Jennifer Sims, Integrated Biologix GmbH, Basel (Switzerland)
- Hildegard Sourgens, Consultant, Munich (Germany)
- Lutz Wiesner, Bundesamt für Arzneimittel und Medizinprodukte, Bonn (Germany)
- Bettina Ziegele, Paul-Ehrlich-Institut, Langen (Germany)
Contact and further information
Association for Applied Human Pharmacology (AGAH) e.V.
Postfach 10 14 58