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Overcoming challenges of clinical validation and translation of Biomarkers

GTCbio | March 6th, 2017

Various types of biomarkers are being developed to help with decision-making in drug-development and clinical practice. However, several challenges remain in understanding the clinical and economic drivers of biomarkers.  According to National Biomarker Development Alliance, the key requirement for biomarker validation is that it has to serve as a surrogate endpoint in a clinical trial. While there are no specific guidelines for economic drivers, it remains to be critical for adaptation of new biomarkers.

GTCbio’s Biomarker Summit will showcase the following speakers from industry and academia. The summit will be held at the Hilton San Diego Resort & Spa on March 20-22, 2017 in San Diego, CA. 

  • Xuemei Zhao, Senior Principal Scientist at Merck

    Xuemei will give a presentation on overcoming challenges of clinical biomarker development. She will be discussing assay development, validation, and qualification for clinical biomarkers.
  • Dobrin Nedelkov, Research Scientist, Molecular Biomarkers Laboratory at Biodesign Institute, Arizona State University

    Dobrin’s presentation will discuss translating protein MS assays into the clinical laboratory. His talk will focus on some key aspects of protein MS assays translation that may help us answer the ultimate question: Are clinical protein MS tests prophetic or just rhetoric?
  • Steven Skates, Associate Professor, Medicine at Harvard Medical School

    Steven will discuss the challenges and experiences in ovarian cancer early detection trials using longitudinal algorithms.
  • Marica Grskovic, Associate Director, R&D at CareDx

    CareDx is a molecular diagnostics company focused on the discovery, development and commercialization of clinically differentiated, diagnostic surveillance solutions for transplant recipients. Marica will discuss donor-derived cell-free DNA as an accurate, precise, and dynamic biomarker for improved management of solid organ transplant patients.
  • Anuraag Shrivastav, Associate Professor, Department of Biology at the University of Winnipeg

    Anuraag will discuss the advances and challenges of colorectal cancer screening. His group have discovered biomarkers in the peripheral blood of CRC patients, which may aid in developing an efficacious blood test for screening CRC.

The Biomarker Summit is a place for leaders in the field to discuss the issues and challenges scientists and researchers face in all aspects of the biomarker and diagnostic development process from discovery to translation to commercialization. This Summit provides a unique opportunity to gain the latest biomarker developments in three major therapeutic areas, formally organized in the following tracks:

10th Oncology Biomarkers Conference: highlights include circulating discussion on tumor cells and microvesicles, liquid biopsy, circulating DNA and MicroRNA, immuno-oncology biomarkers, and novel technologies in oncology biomarkers.

6th Neurological Biomarkers Conference: highlights include CSF and blood based biomarker approaches, monitoring progression in neurodegenerative disorders, and novel technologies in neurological biomarkers.

6th Inflammatory & Immunological Biomarkers Conference: highlights include biomarkers of early progressive inflammatory and immunological diseases, biomarkers and surrogate endpoints for clinical trials in inflammatory diseases, microbiomes in immune modulation and inflammatory diseases, and inflammatory biomarkers in respiratory diseases.

 Plenary Session: highlights include discussions on overcoming challenges of clinical validation and translation, emerging technologies in biomarker development, big data analytics and bioinformatics for biomarkers development, overcoming commercialization challenges in biomarker development, and companion diagnostics development and partnering strategies