Statistical Methods in Biomarker and Early Clinical Development

​Liang Fang is an Executive Director and Head of Biostatistics in MyoKardia Inc. His research interests include statistical applications in drug development, precision medicine, and digital health.Cheng Su is an Executive Director of Data Science & Analytics at BioMarin, Inc. His research interests include statistical applications and tool development in drug discovery, biomarkers, clinical trials design, risk based monitoring, mobile health and big data.

• Predictive Subgroup/Biomarker Identification and Machine Learning Methods.- Characterize and Dichotomize a Continuous Biomarker.- Surrogate Biomarkers.- Innovative Designs for Biomarker Guided Trials.- Statistical Considerations in the Development of Companion Diagnostic Device.- Biomarker Assay Development, Qualification and Validation.- Validation of Genomic Based Assay.- Clinical Application of Molecular Features in Therapeutic Selection and Drug Development.- Big data, real-world data, and machine learning.- Design and Analysis of Clinical Pharmacology Studies.- Statistical Considerations in Proof of Concept Studies.- Safety in Early Phase Studies.- Statistical Evaluation of QT/QTc Interval Prolongation.- Phase II Dose Finding.- Pharmacometrics.