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Clinical and Analytical Validation of Companion Diagnostic Devices and Their Applications in Personalized Medicine

  • Fri, October 14, 2022
  • 10:00 - 12:00


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Fri, Oct 14, 2021, 10:00 – 12:00AM (PDT), 1:00 – 3:00PM (EST)


Applications of personalized medicine are becoming increasingly prominent. Examples of successful therapeutics linked to companion diagnostic devices include Vysis ALK Break Apart FFPE FISH Test (Crizotinib), HER2 FISH pharmDx and IHC HercepTest (Herceptin), and cobas 4800 BRAF V600 Mutation Test (Vemurafenib). A key component of personalized medicine is the development of companion diagnostics that measure biomarkers, e.g., protein expression, gene amplification, or specific mutations. An in vitro companion diagnostic device (or test) is an in vitro diagnostic device which is essential for the safe and effective use of a corresponding therapeutic product. This short course will provide an overview of CDx validation including study designs for both analytical and clinical studies, and challenges. One of such challenges is how to assess the CDx clinical validly if trial assay (CTA) instead of CDx is used to classify patient biomarker status at the clinical trial enrollment in the clinical trial. A bridging study from CTA to CDx is required in order to evaluate the drug efficacy in CDx intended use population. In this seminar, statistical methods for addressing key issues such as biomarker threshold determination, bridging study, prescreening issues, are discussed. The course will also cover the study design and data analysis for follow-on CDx.


A person wearing glasses Description automatically generated with low confidenceZhiheng Xu      A person wearing glasses Description automatically generated with medium confidence      A person smiling for the camera Description automatically generated with medium confidence

Speaker and panelist (left to right): Dr. Meijuan Li (Eisai US), Dr. Zhiheng Xu (FDA/CDRH), Dr. Yaji Xu (Janssen)

Co-host panelist: Joanne Lin (Illumina)

Dr. Meijuan Li has extensive and diverse experience in statistics, molecular biology, cancer biomarker development, and FDA regulation of precision medicine products, diagnostic devices, and radiology therapeutic devices etc. Dr. Meijuan Li currently is VP, Head Global Biostatistics and Head Translational Science, Eisai Inc., Oncology. Dr. Li assumes strategic leadership of the OBG Biostatistics line function. In this capacity, she is accountable for all developmental programs, clinical studies, regulatory submissions, and business development programs etc.

Before joining Eisai, Dr. Li spent about two and half years at Foundation Medicine (FMI) where she served as VP, Head of Biomarkers and Biometrics and led development in the following areas Statistics, Data Management, and Biomarker development and analysis. She played a critical role in the first FMI regulatory filing and approval for blood based NGS assay as well as in the expansion of FMI’s liquid and solid companion diagnostic portfolio. In addition, she was instrumental in developing several important bioinformatics algorithms including reversion mutation caller algorithm and FDA approved CDx, MSI detection algorithm.

Prior to joining industry, Dr. Li worked at the FDA for approximately 11 years holding various leadership positions of increasing responsibility. She oversaw all biostatistical aspects of pre- and post-approval studies pertaining to the regulation of biomarkers for oncology products, neurology products, radiology devices (diagnostic and therapeutic), and combination medical products etc. She worked numerous projects such as artificial pancreas and glucose monitoring devices, digital pathology whole slide imaging system, digital mammography imager, hematology, and microbiology diagnostic devices.

Dr. Li has co-authored numerous publications and book chapters on various technical topics including Bayesian statistics, survival analysis, missing data, biomarker and CDx, ctDNA, real world data, and personalized medicine. Dr. Li is the leading statistician in the field of companion diagnostic device in precision medicine and was named as “the Statisticians of the Month, 2020” by Medical Devices and Diagnostics Section, American Statistical Association due to her significant contributions to statistics of medical devices and diagnostics.

Zhiheng Xu is a mathematical statistician at FDA/CDRH. He has over 10 years’ experience in reviewing diagnostic devices ranging from cardiovascular devices, in vitro prognostic devices, molecular genetics devices to companion diagnostics. He has reviewed many complicated genetic/genomic diagnostic devices including tumor agnostic biomarkers, next generation sequencing assays, companion diagnostics, liquid biopsy, etc. He is the current president-elect for FDA Statistical Association (FDASA). He received his Ph.D. in Biostatistics from Emory University in 2011.

Dr. Yaji Xu is an Associate Director of Oncology Diagnostics at Janssen Research & Development. His areas of expertise are applications of statistics to the design and analysis of studies evaluating in-vitro diagnostic devices (IVDs), with particular emphasis on devices/assays related to molecular genetics and pathology for precision medicine. Previously, he was a mathematical statistician in the Division of Biostatistics at the FDA Center for Devices and Radiological Health. During his tenure at FDA, he participated in the regulatory review and authorizations on numerous companion diagnostic devices and tumor profiling assays. Dr. Xu was trained at MD Anderson Cancer Center and Yale University. He is also an adjunct professor in the Department of Statistics at the George Washington University in Washington, DC.

Joanne Lin is currently with Illumina focusing on product development and clinical validation studies of CDx in oncology, working closely with cross-functional teams internally and externally. Previously, Joanne served as an FDA CDRH statistician with experience in both therapeutics and diagnostics pre-market devices, including SaMD, CDx and IVD. The disease areas she covered included but not limited to neurology, orthopedics, and dermatology, using clinical study designs including clinical trial with RWD, clinical diagnostics study and bridging study. Additionally, Joanne also served as a pharma statistician for phase III clinical trials in neurology and nephrology which involved contemporary trial design such as interim analysis. Her academic training involved statistical method development for high-dimensional medical imaging and genomic data. Outside of her work responsibilities, she continuously participates in statistical and clinical research projects with diverse applications.


We are grateful that this event is co-sponsored by ASA New Jersey chapter, and tremendous help from President Shiling Ruan.

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