Drug development in many diseases is now shifting towards molecular-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 will provide a discussion around the need for integration of biomarker and IVD validation in clinical development, with a focus in oncology and companion diagnostics. It will highlight how flawed analytical and/or clinical validation can jeopardize a biomarker’s and drug’s clinical utility and showcase why biomarkers deserve statistical rigor throughout the development and validation process.
Elisabeth (Els) Coart, PhD, Director, Consulting Services, International Drug Development Institute (IDDI)
Elizabeth Coart is IDDI’s expert in analytical and clinical validation of IVDs. She has a strong background in assay development combined with 10 years’ experience as statistician for biotech and diagnostic industries. She has a longstanding interest in Alzheimer’s disease (AD) biomarkers. Her areas of expertise include expert consultancy in biomarker and IVD development and validation and expert consultancy in clinical trial design.
Everardo Saad, MD, Medical Director, International Drug Development Institute (IDDI)
Everardo Saad has over 15 years of experience in medical oncology and clinical trial designs. He graduated in medicine and trained in internal medicine in Sao Paulo. He 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 patients.
Who Should Attend?
Scientists, healthcare professionals, clinical researchers, statisticians and managers involved in biomarker development and in validation and registration of IVDs in the pharmaceutical, biotechnology diagnostic companies and medical device industries.
What You Will Learn
In this webinar, participants will:
- Become familiar with the processes of biomarker and IVD validation
- Learn about the relationship between analytical performance and clinical utility of an IVD
- Understand the implications of a flawed analytical validation
International Drug Development Institute (IDDI) is an expert center in biostatistical and integrated eClinical services for pharmaceutical and biotechnology companies in several disease areas, including oncology and ophthalmology.
IDDI optimizes the clinical development of drugs, biologics and devices thanks to proven statistical expertise and operational excellence. Founded in 1991, IDDI has offices in Belgium, Boston (MA), Raleigh (NC) and San Francisco (CA).
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