Critical Success Factors in the Development and Implementation of Biomarkers in Drug Development


Traditional biomarkers complemented with genomic biomarkers as key drug development decision tools in order to identify people who may benefit or be at risk through treatment using a particular drug. The promise of these biomarkers lies in the potential to identify sources of inter-individual variability in drug response to maximize effectiveness and minimize risk. This improved understanding of underlying drug function and patient characterization should yield more effective drug development and financial gain.

Successful implementation of biomarkers in drug development and clinical phases relies on the reproducible performance of pre-analytical and analytical workflows. The collection of biological samples and procedures employed for isolation and assaying of biomolecules can contribute to significant variability of results – diminishing the cost and time savings expected by the use of biomarkers. Standardization of workflows with interlinked sample and assay technologies is therefore of key importance to deliver unambiguous data from biomarker programs. QIAGEN offers a broad portfolio of sample and assay technologies that are considered standards in biomarker development and are routinely used in the pharmaceutical industry. The presentation will discuss novel technologies useful in biomarker discovery and development. A case study outlining QIAGEN’s technology implementation capabilities for pharma partnerships is also discussed.


Dirk Loeffert

Dirk Loeffert
Dirk Loeffert, Ph.D., is the Vice President, Head of Sample & Assay R&D at QIAGEN and has over 11 years of experience in the biotechnology industry. His team develops all products and research applications at QIAGEN for enzymes and reaction chemistries related to PCR, real-time PCR, cDNA synthesis, labeling, whole genome amplification, and real-time PCR assays. Dirk received his Ph.D. in molecular biology and immunology from the Institute for Genetics at the University of Cologne, Germany.