A one-day seminar focusing on challenges in the scientific and business management of early clinical development - "Early Clinical Development Planning"
28 April 2005 / 9.00 - 16.00 / Ørestad / Copenhagen / Denmark
Entering clinical development is a major step forward in the life of emerging biotech companies and success, defined as proof-of-concept of the drug, is vital. This seminar addresses questions arising during early clinical development from a clinical perspective and related business decisions. It will help you to avoid pitfalls and to reduce risk.
View presentations from the conference.
PROGRAMME
8.45-9.15
Registration and coffee
9.15-9.30
Welcome and introduction of speakers
> Niels Gerner Larsen, Project Manager, Medicon Valley Alliance
9.30-10.15
Making early drug development possible, for small R&D companies - by reducing the finacial risks
> Daniel Spasic, CEO, Trial Form Support
10.15-11.00
Preparation for early clinical development - from research to First-in Man
> Dr.med. Poul-Martin Haahr, Vice President Clinical Pharmacology
Medicon A/S
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11.00-12.00
Early Clinical Development Planning – First-in-Man to Proof-of-Concept under the EU Clinical Trial Directive
Proof-of-Concept development plans
Effective ways to develop candidate drugs from First-in-Man to Proof-of-Concept
Examples from various therapeutic areas, e.g. CNS, Immunology, Metabolism
Use of biomarkers
> PD Dr. Dr.med. Karl-Ludwig Rost, Senior Director Medical Services Clinical Pharmacology and Pharmacogenetics, PAREXEL
12.00-13.00
Lunch
13.00-14.00
Does cancer research differ from other therapeutic areas?
Recent examples
> PD Dr. Dr.med. Udo Kiessling, VP Head of Worldwide Medical Services, PAREXEL
14.00-14.45
Speeding up Regulatory Process
How to save time and money through appropriate regulatory strategy
(Orphan Drugs, Accelerated Review, Fast Track)
> Peter Lassoff, Senior Director Drug Development Consulting, PAREXEL
14.45-15.15
Coffee break
15.15-16.00
The utility of imaging in early clinical trials
> Jacqui Gatehouse, Ph D, Director Scientific Client Services, SYNARC
16.00
Final remarks
More information
Anette Andersson, Medicon Valley Alliance, aa@mva.org, +46 46 286 3321