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DahShu's virtual journal club is held monthly to promote the most cutting edge research in the fields of data sciences. Click to download presentation slides and seminar recording materials for each event.

Chair and Associate Chairs

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Rui (Sammi) Tang

Chair

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Jiarui Zhang

Associate Chair

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Jing Lu

Associate Chair

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Upcoming events

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

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

    Abstract

    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.


    Speaker:

    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.

    Acknowledgement:

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



    Strategic Alliance:





Past events

Fri, July 15, 2022 Medical AI
Fri, June 24, 2022 Machine Learning for Evidence Generation from Real World Longitudinal Patient Electronic Health Records
Fri, April 29, 2022 Increasing the reproducibility and rigor of single-cell RNA-seq through the use of statistics and data science
Fri, February 25, 2022 Drug Discovery in the Era of Precision Medicine
Fri, January 21, 2022 Statistical analysis of single-cell RNA-seq data with multiple samples
Fri, November 19, 2021 Fusing multi-modal patient data for machine learning in cardiovascular disease
Fri, September 17, 2021 Single arm trials with a synthetic control arm built from RWD
Fri, August 20, 2021 In Search of Effective and Reproducible Clinical Imaging Biomarkers for Population Health and Oncology Applications of Screening, Diagnosis and Prognosis
Fri, June 25, 2021 The New FIRRMA Regulations and Their Impact on Biotechnology and Life Science Industries
Mon, May 24, 2021 Automated Image Labeling for Medical Imaging AI
Fri, April 23, 2021 Dynamic Data Monitoring of Ongoing Clinical Trials
Fri, March 19, 2021 IP Legal Considerations for Precision Medicine and Digital Health Companies
Fri, February 19, 2021 Machine Learning Based Integrative Multi-Omics Analysis— Presented by Global Champion of All Three PrecisionFDA AI Challenges
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Fri, November 13, 2020 Telehealth and Other Advancements in Healthcare Technology Spurred by COVID-19
Fri, October 02, 2020 A New Measurements-Based Approach to Machine Learning for Bioinformatics
Fri, September 25, 2020 Under the hood of 1Point3Acres COVID-19 map & tracker
Fri, August 28, 2020 Demystifying the drop-outs in single cell RNA-seq data
Fri, July 17, 2020 Using multiple natural experimental designs to triangulate the impact of a policy change
Fri, May 29, 2020 How AI is changing the financial service industry
Fri, March 13, 2020 AI Drug Discovery and Repurposing
Fri, February 28, 2020 The i3+3 Design: A Rule-Based Dose-Finding Approach for Phase I Trials
Fri, December 13, 2019 Statistical Considerations in the Clinical Development of Novel Cancer Therapies
Fri, November 15, 2019 15 Tips on Making Better Use of R Markdown
Wed, October 02, 2019 Principles of Data Science
Fri, September 20, 2019 AI Derived Personalized Solution: The Key Driver in the Era of Digital Health
Fri, August 09, 2019 Scalable Automatic Machine Learning with H2O
Fri, June 07, 2019 Network Meta-Analysis for Decision-Making
Fri, May 03, 2019 Global Prediction of Gene Regulatory Landscape Using Bulk and Single-Cell RNA-seq
Fri, March 08, 2019 Innovative adaptive design for immune-oncology trials
Fri, February 22, 2019 Survival analysis methods for non-proportional hazards
Tue, January 08, 2019 Design of Dose-Response Clinical Trials
Fri, November 16, 2018 Neyman-Pearson Classification Algorithms and NP Receiver Operating Characteristics
Fri, October 19, 2018 Machine Learning in Medical Imaging: the Challenge and Opportunity in Drug Development and Precision Medicine
Fri, September 14, 2018 Disease Heritability Inferred from Familial Relationships Reported in Medical Records
Fri, July 20, 2018 Big Data and Artificial Intelligence in Healthcare
Fri, May 25, 2018 The Genomic Landscape and Pharmacogenomic Interactions of Clock Genes in Cancer Chronotherapy.
Mon, May 21, 2018 Estimation of Treatment Effect under Non-Proportional Hazards
Mon, May 21, 2018 Subgroup Identification in Drug Development: Are Post-Selection Adjustments of Efficacy Useful?
Mon, April 30, 2018 An accurate and robust imputation method scImpute for single-cell RNA-seq data
Fri, March 30, 2018 Genome-scale signatures of gene interaction from compound screens predict clinical efficacy of targeted cancer therapies.
Thu, February 22, 2018 Expression Recovery in Single Cell RNA Sequencing
Wed, January 31, 2018 Single-cell transcriptomics reconstructs fate conversion from fibroblast to cardiomyocyte
Thu, October 19, 2017 Statistical Challenges in Immuno-Oncology, a Cellular Therapies Perspective
Tue, September 26, 2017 Big-Data Analysis Points Toward a New Cancer Therapeutic Discovery Approach
Thu, September 14, 2017 Software Patenting: The Current State of the Law
Mon, August 21, 2017 The Asthma Mobile Health Study, a Large Scale Clinical Study Using ResearchKit

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@Dahshu 2020

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