Biomarker Development from Discovery Through Companion Diagnostic Commercialization

Life Sciences, Clinical Trials, Drug Discovery & Development, Medical Device, Biomarkers, Medical Device Diagnostics,
  • Tuesday, September 01, 2020

The FGFR Story: Experience and Real-World Example

Increasingly, biomarkers play a key role in therapeutic development programs and have been shown to improve drug approval success rates by nearly 3-fold. Some biomarkers transition to become a companion diagnostic and as such, are a required test for prescribing a specific therapy. In this webinar, we’ll focus on the development journey of a biomarker from early discovery, through clinical development and ultimately to an approved, commercially available companion diagnostic test. We’ll present the example of and best practices discerned from a recently approved companion diagnostic assay which is used to assess the eligibility of patients with urothelial cancer for treatment with the newly approved FGFR kinase inhibitor, BALVERSA™ (erdafitinib).

Speakers

http://Suso%20Platero,%20Covance

Suso Platero, PhD, Global Lead, Precision Medicine, Head, Biomarker Solution Center and Companion Diagnostics, Covance

Suso Platero is the global leader of precision medicine and head of the Biomarker Solution Center at Covance. He has worked with small molecules, antibodies, vaccines and bi-specific antibodies. Prior to his experience in the pharmaceutical industry, he worked at Becton Dickinson developing diagnostic and prognostic tests in oncology. He received his PhD from St Louis UnivBoard of Directors.

Message Presenter

Jennifer Quigley, Director, Oncology Precision Medicine, LabCorp

Jennifer leads LabCorp’s Diagnostic Oncology division activities in the commercialization of tests and capabilities that improve our patients access to cancer therapies. At LabCorp and Covance, Jen has brought her nearly 20 years of broad experience in diagnostic laboratory research, data, sales and marketing to drive connections between people and ideas and serve as a catalyst for novel programs, products, and insight leading to practical diagnostic solutions for cancer patients. She earned her bachelor’s degree in biology and geology (m) at the University of Pittsburgh.

Message Presenter

Who Should Attend?

This webinar is intended for biopharmaceutical sponsors and IVD Manufacturers involved or interested in therapeutic, biomarker and companion diagnostic development programs & commercial testing upon approval.

What You Will Learn

In this webinar, attendees will learn about and understand:

  • In vitro and in vivo systems approaches to biomarker discovery
  • Early clinical studies and application of data to establish biological plausibility
  • Biomarker transition through development, validation of clinical utility and approval as a companion diagnostic
  • Approaches, considerations and timing to establish readiness for commercial testing in the U.S.
  • Key learnings since commercial launch

Xtalks Partner

Covance

Covance is a business segment of LabCorp, a leading global life sciences company, which provides contract research services to the drug, medical device and diagnostics, crop protection and chemical industries. Employing over 21,000 people worldwide, we are the world’s most comprehensive CRO, dedicated to improving health and improving lives.

Covance is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical, and regulatory expertise. We generate more safety and efficacy data to support drug approvals than any other company, supporting our clients’ complete lifecycle management.

Together with our clients, Covance transforms today’s healthcare challenges into tomorrow’s solutions. Visit us at www.covance.com.

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