Xinwei Wang, M.D.

Main Responsibilities:

• Lead preparation of clinical protocols and support other clinical/regulatory documents.
• Support site selection, site initiation, investigator meetings, and other site activities during study conduct.
• Conduct data review and medical monitoring of ongoing trials. Answer queries from investigators to ensure all procedures are compliant to the study protocol and the safety of patients in trials are protected.
• Support data analysis and interpretation, DMC meetings, as well as interactions with regulatory authorities.
• As country Asset Team Lead, lead the country product development strategies and provide solutions to development issues with cross-functional team including biostatistics, study operation, portfolio and project management, clinical pharmacology, pharmaceutical sciences, supply chain, and regulatory affairs, in alignment with global strategies.

Projects & Accomplishment:

• Had been appointed as Country Asset Team Lead for 5 different assets
• A CDK4/6 inhibitor (breast, phase 3-launch): leading study clinician in a phase 3 multi-regional trial (post-interim analysis to final CSR and publish), and in a phase 1 PK study supporting China NDA (final analysis to approval); led protocol development of a pivotal trial for new indication (protocol finalization, cancelled due to strategy shift)
• A PD-L1 antibody (head & neck, phase 3): country study clinician for a pivotal phase 3 multi-regional trial (from country initiation to interim analysis)
• · A BRAF inhibitor (colorectal, phase 3): led country strategy development and study planning (global protocol development to country initiation)
• Novel CDK inhibitors (breast, phase 1-3): led country strategy development and country-specific cohort design for 2 compounds (phase 1 planning to IND approval)
• A proteolysis targeting chimera estrogen-receptor degrader (breast cancer, phase 3): led country strategy development and study planning for 2 pivotal trials (planning to IND approval)
• A GUCY2C inhibitor (colorectal, phase 1): support country strategy development and IND submission (phase 1 planning to IND submission)
• Pfizer Development China Award (2018)
• Pfizer Development China TEA (Talent, Excellence, Achievement) Award (2019-2020)

• Medical support of EHR National Oncology Data Platform development and data validation
• Support the collaboration with external partners for cancer epidemiological studies and completed two pilot epidemiologic analyses in breast cancer and lung cancer.

• Develop and execute country medical strategy for responsible products. Draft training materials for local commercial and marketing team.
• Organize national medical education program to enhance the awareness of disease areas and products.
• Support investigator initiated studies in alignment with company strategy.

• Regular communication with KOLs for insight collection
• Draft and organize medical training for local commercial and marketing team
• Organize medical educational programs for local practitioners

• Daily medical management of inpatients.
• Respond to patients’ medical issues and assess patients’ medical conditions, order tests when necessary. Discuss the treatment options with patients under the supervision of attending doctors.