Weiguo

Director Biostatistics @Jazz Pharmaceuticals

Biostatistics product lead for Zepzelca (Lurbinectedin) in solid tumors • Manage a team of three, including a contract statistician and a permanent statistician • Led biostatistics support and execution for Zepzelca Canada New Drug Submission and addressed many rounds of questions from Health Canada. Zepzelca was approved for small cell lung cancer (SCLC) patients in Canada on September 29, 2021 • Represent Jazz as a statistical expert on external Zepzelca development teams by providing statistical oversight and expertise on 2 joint Zepzelca clinical programs (IMforte: Ph3 maintenance therapy for 1L SCLC patients; LAGOON: Ph3 for 2L SCLC patients), such as statistical modeling and strategic thinking for experimental designs and testing strategies. • Lead biostatistics support for the Zepzelca Ph2 basket trial for three tumor cohorts, including an innovative design and interim monitoring using Bayesian posterior probability; the development of SCD, synopsis, protocol, IND document, CRF, clinical database, and other study start-up activities • Lead biostatistics support for Zepzelca pediatric clinical development, including strategy discussion and experimental designs for pediatric studies; the development of SCD, and Proposed Pediatric Study Request (PPSR) document to FDA • Lead working groups to understand and research dose-response methodology for designing and modeling Ph2 dose-ranging studies in Neuroscience; oncology clinical trial simulation; applications of Bayesian methods to clinical trials