Binghao Wu
Clinical Biomarker Associate Director @ BeiGene
About
Well-developed interpersonal and team skills in an international cross-cultural environment with an enthusiastic pro-active attitude, good written and oral communication skill in both English and Chinese, rich experience in clinical biomarker from early first-in-human study to late phase3 pivotal studies
China
Jing'an District
Biotechnology
drug and biomarker discovery, data mining, High-throughput sequencing analysis, flow cytometry, In vitro, Molecular Biology, Western Blotting, Cell Culture, Cell Biology, Biotechnology, Life Sciences, Polymerase Chain Reaction (PCR)
Experience

Clinical Biomarker Associate Director
Shanghai, China
• Clinical biomarker study team lead for BCL2 program to oversight biomarker strategy planning and execution over 9 clinical studies from first-in-human study to phase 3 registrational study. • As clinical biomarker representative in clinical development core team and decision maker on clinical development plan • As clinical biomarker representative engaged in consultation with FDA. • Cultivate Junior people to accumulate talent pool for the company.

Clinical Biomarker Principal Scientist
Shanghai City, China
Main Achievement: • Lead biomarker strategies proposal and implementation for four phase 1 studies (three global, on China-only) and one phase2 pivotal study (China-only) • Lead two pharmacodynamic assays (FACS-based caspase 3 activation, FACS-based cytochrome c release) transfer from preclinical to central lab to support clinical sample testing, and lead pharmacodynamic data analysis and interpretation to confirm on-target effect and help dose finding • Lead vendor assessment (including CDx partners) from China and ex-China to select appropriate biomarker testing including but not limited to NGS, GEP, IHC, FISH, MRD to support BeiGene's multiple clinical studies • Have rich experience to input and review clinical trial related documents such as clinical trial protocol, ICF, IB, regulatory documents for IND, HGRAC and NDA submission • Engaged in testing lab audit and support CFDA inspection as biomarker representative • Lead clinical biomarker data analysis and interpretation, contributed to four Zanubrutinib publications (PMID:34253577; Clin Cancer Res. 2021 Jul) • Work with cross-functions to achieve company's milestone such as NDA filing • Lead t(11;14) FISH CDx/IVD development plan proposal Recognition and Reward: • Selected as best team award in 2019, and key contributor for Zanubrutinib China Approval in R/R Waldenstrom Macroglobulinemia in 2021

Postdoctoral Researcher
Charlestown
• Validated TEAD/YAP1 inhibitor MOA in cell line and mouse model (such as TEAD palmitoylation, TEAD/YAP1 interaction, TEAD/YAP1 oncogenic function) • Utilizing cell line profiling data and public omic data to explore potential predictive biomarker and combo strategy. Identified that ERBB2 positively regulates TEAD/YAP1 activity and ERBB2 amplification can predict TEAD/YAP1 inhibitor sensitivity • Lead rational exploration of co-targeting TEAD/YAP1 and DHODH, identified DHODH inhibition activates pyrimidine salvage pathway which is transcriptionally regulated by TEAD/YAP1. • Validated several membrane and secreted proteins (such as ST14, FOLR1) as early diagnose biomarker for ovarian cancer by IHC
Binghao Wu's Contact Information
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