Xuyang Song, PhD, MBA

• Provide strategic early development leadership for oncology assets including small molecules, biologics, and new modalities and drive progression from lead optimization through early clinical proof-of-concept. • Develop integrated translational plans bridging preclinical findings with early clinical execution, enabling seamless asset progression. • Partner with regulatory affairs on multiple IND submissions and NDA filing. • Lead cross-functional global teams for IND enablement and initiation of clinical development. • Design and implement an AI-powered ADMET prediction platform and develop digital SOPs, standardizing workflows.

• Oversees clinical studies in clin-pharm (CP, PMx, and BioA) across all development phases • Leads the clin-pharm team in the preparation of global filings and regulatory interactions for Buparlisib • Participates in pre-clinical development strategies • Involves in commercialization strategy and new drug launch strategy

Key achievements: • Contributed to the development and approval of Durvalumab (PD-L1), brand name IMFINZI®, and Tremelimumab (CTLA-4), brand name Imjudo®, to market in different countries - Contributions to the novel dose and schedule of the combination, which includes a single priming dose of Imjudo added to Imfinzi [publication: Clin Cancer Res CCR-22-1983. https://doi.org/10.1158/1078-0432.CCR-22-1983] • Led and participated in the preparation of multiple successful global filings and regulatory agency interactions (FDA, EMA, PMDA, NMPA, Health Canada, TGA, etc. ) • Led a group of 16 experienced clinical pharmacology scientists and pharmacometricians (including contractors) supporting Oncology programs with over 70 clinical trials from non-clinical through to late-stage/life cycle management -Led IMFINZI® and Imjudo® from ph1 to ph3 and life cycle management for various indications in Clin-pharm, including the global submission teams -Led MEDI5752 (PD-1/CTLA4 bispecific) from the initial discovery of the putative drug through ph3 ID -Led Monalizumab (NKG2a) from ph1 to ph3 studies and collaborated with Innate Pharma -Led and participated in MEDI0680 (PD-1), PD1/TIM3 bi-specifics, PD1/TIGITbi-specifics, gene delivery, T-cell engager, oncologic virus, and other programs in pre-clinical and early-clinical stage •Mentored multiple life science start-ups to support scientific and business planning in the platform of AZ- University of Cambridge and AZ- Johns Hopkins Tech Ventures

Developed Model-based Meta-analysis in support of the current clinical practice and FDA’s drug labels of not requiring sex-dependent treatment regimens for rheumatoid arthritis patients

Trained in applications of PKPD modeling to problems in drug development

Population PK/PD analysis in support of the clinical development of anti-Inflammation drug

Animal brain surgery and protein detection to support the development of gene therapy for Alzheimer’s disease

Advisor: Hartmut Derendorf, Ph.D.