MENU
FEB 24, 2021 9:00 AM PST

Keynote Panel Presentation: Biomarker assays - bioanalytical meets CLIA

C.E. Credits: P.A.C.E. CE Florida CE
Speakers
  • Vice President, Bioanalytical Services, ICON Laboratory Services
    Biography

      Roger Hayes, PhD, is the Vice President of Bioanalytical Services with the ICON Laboratory Services group. Roger joined ICON (Dublin, Ireland) in December of 2018. In this role, Roger holds overall management responsibility for our bioanalytical laboratory in Whitesboro, New York supporting pharmacokinetic, pharmacodynamic, immunogenicity and biomarker assays for large- and small-molecule drug development. Dr Hayes has held numerous leadership positions in the global life sciences industry and academia, leading teams in the development of state-of-the-art bioanalytical and analytical techniques, including mass spectrometry, chromatography, immunology and automation in bringing medical and chemical products to market. For nearly two decades, he led strategic and research initiatives for large pharmaceutical companies that included both GLP and non-GLP preclinical studies as well as clinical trials.

    • Senior Director, Scientific Affairs, ICON Laboratory Services
      Biography

        Dr Roche has a Degree and PhD from Trinity College Dublin and has since accumulated 20 years experience within the clinical trials industry with particular focus on the intricacies of biomarkers, associated laboratory methods and their ability to facilitate an efficient and accurate assessment of the clinical safety and efficacy of therapeutics moving through clinical trials.


      Abstract

      Reliable diagnostic, prognostic, predictive, pharmacodynamic, and pharmacokinetic biomarkers are critical to assure correct patient selection, drug dosing, and monitoring. Being able to identify the most effective biomarkers and then utilize them to stratify patients and evaluate therapeutic benefit can reduce both drug development time, clinical trial sizes and facilitate more rapid regulatory approvals and time to market. As such, in the early stages of drug development, a drug developer should begin to evaluate biomarkers for potential diagnostic application in parallel with the development of the therapeutic drug itself.  Early research will focus on identifying potential biomarkers based on knowledge of the drug’s mechanism of action. The goal is to identify measurable analytes that accurately correlate to an early biological effect; i.e., a measurable change in normal biology. The quality of the biomarker assay need only fulfil the requirements necessary for internal decision-making. How a biomarker assay is further applied to a drug's development, e.g., as a clinical endpoint (primary, secondary or exploratory) in a clinical protocol, will determine when an assay should evolve from research quality to a clinical diagnostic test or even a Companion Diagnostic (CDx). This presentation will provide guidance on how to navigate through this process.

      Learning Objectives:

      1. How do you determine what level of validation is required to measure a biomarker?

      2. Recommendation for assay validation of a biomarker method supporting:

      i. An exploratory endpoint

      ii. A pharmacodynamic endpoint

      iii. Patient selection, decisions, or safety endpoint


      Show Resources
      You May Also Like
      MAY 11, 2021 10:00 AM PDT
      C.E. CREDITS
      MAY 11, 2021 10:00 AM PDT
      Date: May 11, 2021 Time: 10:00zm PDT Your samples are some of the most valuable assets in the laboratory. After spending countless hours on extraction and preparation, your conclusions could...
      NOV 18, 2020 8:00 AM PST
      C.E. CREDITS
      NOV 18, 2020 8:00 AM PST
      DATE: November 18, 2020 TIME: 08:00am PDT We develop and implement technologies to solve some of the major bottlenecks in biomedical research. In particular, we establish new imaging approac...
      NOV 16, 2020 8:00 AM PST
      C.E. CREDITS
      NOV 16, 2020 8:00 AM PST
      Date: November 16, 2020 Time: 8:00am (PST), 11:00am (EST) CRISPR screening has become the prime discovery tool in modern biomedical research and drug discovery. At the same time, most screen...
      APR 01, 2021 8:00 AM PDT
      C.E. CREDITS
      APR 01, 2021 8:00 AM PDT
      Date: April 01, 2021 Time: 8:00am (PST), 11:00am (EST) Generating therapeutic antibodies is far more challenging than obtaining antibodies that merely recognize their targets. Engineering po...
      MAR 16, 2021 10:00 AM PDT
      C.E. CREDITS
      MAR 16, 2021 10:00 AM PDT
      Date: March 16, 2021 Time: 10:00am (PST) Scientific progress and breakthroughs today are often too expensive for most institutions to acquire. Each year, the National Institutes of Health (N...
      APR 19, 2021 8:00 AM PDT
      C.E. CREDITS
      APR 19, 2021 8:00 AM PDT
      Date: Apri 19, 2021 Time: 8:00am PDT, 5:00pm CEST Since the inception of modern biological research, BioSafety has evolved into a critical consideration in Good Laboratory Practices (GLP). Wi...
      Loading Comments...
      Show Resources
      Attendees
      • See more