Best Practice Tips for Overcoming Obstacles in Biomarker Development

How can we overcome the latest challenges in Biomarker Development? Birgitte Søgaard, Divisional Director for Clinical Pharmacology and Translational Medicine at H Lundbeck A/S, discusses with Helen Winsor from Pharma IQ, the key challenges in this area, in particular the need for cost-efficiency. She outlines some of the solutions used by her organisation to address the obstacles commonly faced during Phase I, such as successful biomarker development, improving trial design and microdosing. She also offers her perspective on identification and validation of biomarkers and whether it can provide benefit within Phase I trials. Finally, Birgitte offers some best practice tips in assessing and working with CROs.

Practical Approaches to Phase I Trial Development in Order to Enable Faster Go / No-Go Decisions If you found this interesting, Birgitte Søgaard, Divisional Director, Clinical Pharmacology & Translational Medicine at H. Lundbeck A/S, will be speaking at Innovation in Phase I Clinical Development, taking place the 20th - 22th September 2010 at the Marriott Hotel, Munich, Germany. To find out more, download the brochure now!

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