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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.