Companion diagnostics and clinical development in oncology: a statistical perspective

September 17, 2020

IDDI Complimentary Webinar on Diagnostics

Drug development in many diseases is now shifting towards molecularly targeted treatments that often rely on prognostic and predictive biomarkers for their application. Confronted with such major breakthroughs in the evolution toward personalized or precision medicine, the analytical and clinical validation of biomarkers and their eventual registration as in-vitro diagnostic devices (IVD) and companion diagnostic has received more attention recently.

  • This webinar provided a discussion around the need for integration of biomarker and IVD validation in clinical development, with a focus in oncology and companion diagnostics.
  • It highlighted how flawed analytical and/or clinical validation can jeopardize a biomarker’s and drug’s clinical utility and showcase why biomarkers deserved statistical rigor throughout the development and validation process.



In this webinar, participants

  • Became familiar with the processes of biomarker and IVD validation
  • Learned about the relationship between analytical performance and clinical utility of an IVD
  • Understood the implications of a flawed analytical validation


Elisabeth Coart IDDI Elisabeth (Els) Coart, PhD: Director, Consulting Services at IDDI

She is IDDI’s expert in analytical and clinical validation of IVDs. Els has a strong background in assay development combined with 15 years’ experience as statistician for biotech and diagnostic industries. She has a longstanding interest in Alzheimer’s disease (AD) biomarkers.
Areas of Expertise:

  • Expert consultancy in biomarker and IVD development and validation
  • Expert consultancy in clinical trial design
Everardo-Saad-IDDI Everardo Saad, MD: Medical Director at IDDI

He has over 15 years of experience in Medical Oncology and clinical trial designs. Everardo graduated in Medicine and trained in Internal Medicine in Sao Paulo, and did his fellowship in Medical Oncology at the University of Texas M.D. Anderson Cancer Center, in Houston.

After practicing for several years, he shifted his professional career towards education and research in Medical Oncology, and has a special interest in clinical trial methodology, the assessment of endpoints, and the development of novel therapies for cancer pat

Presentation Webinar: Companion diagnostics and clinical development in oncology: a statistical perspective

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