Menu Back toLeveraging-Biomarkers-and-Companion-Diagnostic-Approaches-to-Refine-Patient-Responses

DIA 2018 Global Annual Meeting

Personalized Medicine Approaches During Early-Phase Clinical Research

    Session Chair(s)
      David  Pepperl, PhD

      David Pepperl, PhD

      • Senior Consultant and Nonclinical Group Leader
      • Biologics Consulting Group, Inc., United States
    Recent advances in molecular screening, gene sequencing and microarray technology have not only accelerated the identification of novel biomarkers, but are also rapidly revolutionizing the field of personalized medicine, particularly in the oncology arena. As an example, next-generation sequencing is routinely used in early-phase clinical research for the detection of genetic mutations that are associated with disease. Using these novel methodologies, potentially significant mutations and biomarkers can be distinguished from those that are less likely to be significant at an early stage of development. Specifically, this session will discuss some of the novel approaches currently being used to identify and qualify novel biomarkers for tumor targeting and efficacy. Case examples highlighting the clinical use of novel biomarkers will also be presented. Finally, a number of the regulatory concerns and challenges in leveraging novel biomarker technology for early clinical development will also be discussed.
    Learning Objective : Identify some of the cutting-edge methods for shifting through genomic data to identify mutations that have the most potential for clinical significance; Describe some real-word applications of biomarker technology in early clinical development; Discuss the regulatory implications of utilizing biomarkers in drug development.
      Kate A. Simon, PhD

      Regulatory Implications of Utilizing Biomarkers in Drug Development

      Kate A. Simon, PhD

      • Senior Consultant
      • Biologics Consulting, United States
      Pavan  Kumar, PhD

      Biomarker Strategy and Clinical Implementation for H3B-6527; A FGFR4 Specific Inhibitor in Hepatocellular Carcinoma

      Pavan Kumar, PhD

      • Director of Biomarkers and Companion Diagnostics
      • H3 Biomedicine, Inc., United States
      Jannik  Andersen, PhD, MSc

      Biomarkers as an Integral Part of Modern Drug Discovery and Development

      Jannik Andersen, PhD, MSc

      • Vice President, Head of Research
      • Xios Therapeutics, United States