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From Pre-Clinic to Man
Harrison Clinical Research Germany is holding a joint complimentary meeting in Munich, on 6. May 2011, together with BioM BioTech Cluster Development GmbH. The title of this meeting is "From Pre-Clinic to Man" and it will be held, in German, from 08-45hr to approx 13-30 hr at the HCR offices, Albrechtstrasse 14, 80636 Munich.
The agenda of this meeting can be found below, as well as a link to a how-to-find-us map. After the meeting, participants will be invited to tour the HCR Clinical Pharmacology Unit as well as joining us for lunch. Invitations have been circulated to the German biotechnology community and replies are requested by April 29. 2011.
If one accompanies a new drug from the discovery of the active ingredient until drug registration, one has to deal with many hurdles. There are definite paths and path finders that one has to discover and negotiate both in pre-clinical development and before entry into phase I - II clinical development.
A high percentage of drug candidates do not make it through phase I - II, even though they have shown promise in the pre-clinical phase, on the basis of deficiencies in kinetics, reduced efficacy or, and this happens often, due to side-effects. It is absolutely essential to develop models that can be used in pre-clinical research and development and in clinical research in man, that will give reliable predictions about the further development of the drug.
Together with HCR, BioM is holding this information meeting for drug developers in the biotechnology industry, that will discuss these hurdles. The main themes will be safety and efficacy, financial aspects and the possibilities for cooperation between pharma- and biotech- companies in this area. A further highlight will be consideration of the choice of the "right patient", individualised study design and concomitant diagnostics.
BioM BioTech Cluster Development GmbH is a coordinating group for the biotechnology companies in the area of Munich, Germany. Since 2006, BioM also coordinates further biotechnology company cluster sites in Regensburg, Würzberg/Bayreuth and Nuremberg/Erlangen. See http://events.bio-m.org/harrison
Agenda
08-45hr | Registration and refreshments |
09-00hr | The "right patient": Study parameters, considerations |
09-45hr | The financing of project focussed companies as a |
10-25hr | Coffee break. |
10-40hr | Medium sized pharmaceutical companies as a partner |
11-25hr | The German pharmaceutical market in times of AMNOG the Pharmaceutical Industry e.V. (BPI). |
Feel free to phone us
Tel: (49) - 89 - 126680-0
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