TITLE: Cell and Gene Therapy: Introduction and Overview of Important Regulatory, Statistical and Operational Considerations
SPEAKERS: Shihua Wen, Novartis, Patricia Anderson, ICON
MODERATOR: Ivan S. F. Chan


As the science of advanced therapy medicinal products continues to evolve, the impact of cell and gene therapies (CGT) on patients around the globe is increasing. In this half-day short course, presenter(s) from the American Statistical Association’s Cell and Gene Therapy Scientific Working Group will provide an overview on cell and gene therapy concepts, as well as highlight important regulatory, statistical (e.g., using historical information in clinical trials, estimand, data monitoring, etc.), and operational considerations during the clinical development of the CGT. The course will also include case studies from approved therapies or investigational products.

Speaker Bio:

Dr. Shihua Wen is currently a Sr. director of biostatistics in Novartis Pharmaceuticals Corp. (US).  He joined Novartis in 2016 and started to work in gene therapy area in the recent years. Dr. Wen has rich experience in late phase clinical development across multiple therapeutic areas. At Novartis, he served as the statistical lead for multiple global clinical development programs in neurology area and successfully supported regulatory submissions with major health authorities. Prior to Novartis, he worked in Abbott Laboratory / AbbVie Inc. as a biostatistician as well with increasing responsibility. Dr. Wen received his doctoral degree in statistics at University of Maryland, Collage Park, in 2007. His research interests are drug development, benefit-risk assessment, innovative trial design, data fusion, etc.



Patricia Anderson is currently Assoc. Director of Biostatistics and the Biometrics Lead for the ICON Centre for Cell and Gene Therapy. Her therapeutic experience spans diagnostic imaging (including national trials and registries), solid tumors, melanoma, blood disorders and cancers, stem cell transplant, cell and gene therapy, and others. Patricia began work in cell therapy and stem cell transplant in 2012 at MD Anderson Cancer Center. At ICON, Patricia developed a team of biometrics CGT subject matter experts and leads creation of new biometrics CGT training and standards. She received her undergraduate and graduate degrees from Brown University. Research interests have included adaptive randomization and early phase study design.
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