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Monrovia, CA, United States, 2013/08/20 - Heiko Niessen, Principal Translational Expert & Team Leader of Clinical Imaging at Boehringer-Ingelheim Will Give a Presentation at GTC’s Biomarker Europe Summit on October 9 10, 2013 in Berlin, Germany - GTCbio.com.
Heiko Niessen, Principal Translational Expert & Team Leader of Clinical Imaging at Boehringer-Ingelheim, will give a presentation on “How to Select Imaging Biomarkers for Clinical Development” at GTC’s Biomarker Europe Summit on October 9 10, 2013 in Berlin, Germany
Translational medicine has an important function in the transition of projects from preclinical research into clinical development. In this phase preclinical animal models and first studies in healthy subjects or patients are used to generate first evidence of pharmacological response, to improve confidence in targets and drug candidates. Biomarkers obtained from translation imaging methods are an important part in this process between late stage research and early clinical development program to foster and build hypothesis about the mechanism, to test the clinical concept, to differentiate programs with similar clinical outcome, to support go/no-go decisions, and to de-risk large investments. However, in most cases it is not clear which imaging biomarker is best suited for the development program, e.g. which biomarker is most sensitive to disease progression and therapeutic response or most easy to implement in multi-center trials. In this contribution, Dr. Niessen will present examples of translational imaging biomarkers and the assessment and qualification of imaging biomarkers. Specifically, he will address the following points:
• What is the value of imaging biomarkers?
• How to translate and back-translate?
• What do we learn from competitor trials?
• How to qualify new/emerging imaging biomarkers?
Heiko G. Niessen, Ph.D., Principal Translational Medicine Expert for Clinical Imaging leads the Clinical Imaging Team within Global Translational Medicine of Boehringer-Ingelheim Pharma. His team develops and enables translational and clinical imaging strategies for early and late development programs.
GTC’s Biomarker Europe Summit 2013 will address the latest developments in the biomarker arena from discovery to translation to commercialization. Presentations span across multiple disciplines and cover topics such as discovery and validation strategies, the challenges of clinical translation, companion diagnostics, next-generation sequencing technologies, regulatory and reimbursement issues and companion diagnostics.