Predictive and Pharmacodynamic Biomarker Profiling Optimized to Conserve Precious Clinical Trial Samples

Life Sciences, Clinical Trials, Drug Discovery & Development, Biomarkers,
  • Wednesday, March 30, 2022

Comprehensive biomarker profiling is crucial for executing successful precision oncology and other drug and diagnostic development programs. Common obstacles to completing biomarker profiling studies, especially in retrospective exploratory biomarker research, are the lack of sufficient sample volume and reduced quality of formalin-fixed, paraffin-embedded (FFPE) samples and other clinical trial samples.

In this webinar, the featured speaker will describe optimized approaches to performing genomic, proteomic and cell-based biomarker analyses from low quantity, and in some cases low quality, clinical trial samples with a single chain-of-custody to make the most efficient use of these precious samples. These optimized protocols and processes facilitate more comprehensive biomarker profiling from each patient than was possible in the past, with the goal of enabling faster and more accurate targeting of therapies to the right populations.


Donald A. Skifter, Discovery Life Sciences

Donald A. Skifter, PhD, MBA, SVP, Genomics, Discovery Life Sciences

Don received his PhD in pharmacology and neuroscience focusing on the molecular and genetic mechanisms of learning and memory at the University of Nebraska Medical Center in 2002. He received his MBA from the University of Nebraska Omaha in 2001. On the heels of the completion of the human genome project in 2003, following a post-doctoral fellowship in Cambridge, MA, he pursued a career in the commercialization of genomic technologies and next generation sequencing services with particular expertise in facilitating oncology and other genomic biomarker profiling programs. Don’s work history includes Commercial and Technical Application Support leadership roles at several genomic technology and services companies including Invitrogen (now Thermo Fisher Scientific), Sequenom (now Agena Bioscience), Complete Genomics (IPO in 2010), the Broad Institute, and OneOme (a start-up pharmacogenomics spinout of the Mayo Clinic). He currently serves as the Senior Vice President, Genomics within the HudsonAlpha Discovery Genomics division of Discovery Life Sciences.

Message Presenter

Who Should Attend?

  • Pharma clinical development and biomarker groups struggling to collect or conserve sufficient quantity or quality of FFPE and other clinical samples for biomarker analyses
  • Immuno-oncology researchers and developers seeking to implement innovative biomarker strategies in any phase of development, especially translational and clinical trial phases of precision oncology programs.
  • Anyone involved in conducting biomarker or diagnostic studies in solid tumor and liquid biopsy indications that require:
    • Complete Genomic Profiling
    • High accuracy, sensitivity and precision
    • Orthogonal validation of diagnostic or other assays in development
    • Optimized methods to compare matched-patient solid tumor and liquid biopsy / cell-free DNA (cfDNA) mutational profiles with high sensitivity and low limits of detection

What You Will Learn

The following benefits of comprehensive biomarker evaluations optimized to conserve precious clinical samples are available to pharma and biotech by Discovery:

  • Providing a single location for sample receipt, accessioning, histology and downstream processing, avoiding the need to send samples to multiple contract research organizations (CROs) and specialty labs
  • Facilitating internal communication to conserve precious samples via a dedicated primary and multiple secondary project managers
  • Optimization of assays and processes based on yield and quality of clinical samples to preserve as much tissue as possible
  • Routine consultation with clients to identify the most optimal biomarker approaches based on QC results to conserve precious samples while producing the highest quality data possible
  • Extensive bioinformatic support infrastructure to analyze and draw insights from the data and share those insights in commonly accepted formats with partners
  • Coordinated data formatting and data delivery options across biomarker labs to meet the clinical database needs of pharma and biotech partners

Xtalks Partner

Discovery Life Sciences

Discovery Life Sciences is the company of Biospecimen and Biomarker Specialists™, combining the world’s largest commercial biospecimen inventory and procurement network with preeminent multi-omic biomarker service laboratories to accelerate new therapies supported by biomarker and companion diagnostic programs for cancer, infectious disease, and other rare and complex conditions. We are a leading provider of highly characterized human cellular starting materials and expert multi-omic analytical services to advance cell and gene therapy research, development, and manufacturing programs.

HudsonAlpha Discovery® is Discovery’s sequencing and bioinformatics division, a globally recognized service laboratory that leverages the most current genomic research technologies to comprehensively support discovery, translational, and clinical research.

Driven by leading scientific expertise and innovative use of current technologies, the Discovery team engages and consults with customers to more rapidly overcome obstacles and obtain results to make critical research and development decisions at market-leading speed. We are Science at your Service™!

You Must Login To Register for this Free Webinar

Already have an account? LOGIN HERE. If you don’t have an account you need to create a free account.

Create Account