许玉 XU

医学监查，医学撰写，医学策略

负责IMM2510（抗PD-L1和VEGF双特异性分子）联合IMM27M（抗CTLA-4抗体）治疗晚期实体瘤患者I 期临床试验（适应症包括肝细胞癌和其他实体瘤），完成IND资料准备，参与方案设计，确定入选标准和排除标准，对IND各文件全程审核和修改，回复伦理意见，支持组长单位和分中心启动，支持EDC建库，拜访研究者/KOL，分析安全性事件并提供建议，修订方案，负责医学监查、数据审核、问题解答、培训、ClinicalTrials登记等 曾负责IMM2510治疗晚期实体瘤I 期临床试验（适应症包括非小细胞肺癌、三阴性乳腺癌、肝细胞癌、软组织肉瘤等），检索文献，收集竞争产品数据，协助部门调整研发策略，修订方案，更新研究者手册（IB），撰写剂量递增阶段临床研究报告（CSR），发表2次ASCO摘要和/或Poster，执行医学监查和数据审核，分析安全性信号事件（如SAE、免疫相关不良事件），与研究者沟通，支持安全审核委员会（SRC）会议，撰写CDE回复函，推进研究进入队列扩展阶段，在宜明昂科与Instil Bio的BD里程碑事件中参与数据准备工作；本项目已完成浦东科技发展基金验收，于2025年2月10日申请IMM2510专利（本人共同挂名） 参与IMM2510联合IMM01及联合或不联合化疗在晚期实体瘤中的Ib/II期临床试验的IND文件撰写，检索文献、撰写方案中部分研究背景内容，撰写2.7临床总结 曾协助IMM01联合阿扎胞苷治疗血液肿瘤的Ib/IIa期临床试验，包括医学监查和其他资料审核 曾协助IMM01治疗血液系统恶性肿瘤的I 期临床试验的医学监查

Engaged in the clinical work of Department of Obstetrics and Gynecology actively, under the leadership of the medical group chief, managed more than 60 inpatients, and participated in on-duty and clinical emergency treatment; Attended the department seminars, fellow up the development of gynecological tumour research and the latest clinical guidelines

Learnt and mastered the etiology, pathology, diagnosis, treatment and prevention of cervical cancer, ovarian cancer, endometrial carcinoma and other malignant tumour, as well as clinical theoretical knowledge of other common diseases in obstetrics and gynecology, and mastered various clinical operation skills Under the guidance of superior physicians, managed more than 200 cases of inpatients, conducted effective doctor-patient communication, wrote complete and compliant medical documents, conducted risk assessment of patients before and after surgeries, acted as surgical assistant, was on duty regularly, and was familiar with the rescue process of critical patients According to chemotherapy plans formulated for the tumor patients, complied with and implemented the programmes, monitored the adverse reactions (promptly reported and dealt with), filled in the chemotherapy evaluation forms, completed the cases registration, and ensured the patients' timely follow-up and reexaminations Complied with medical laws and regulations, closely cooperated with doctors and nurses in the department, acted as liaison and communicated with staff of cooperative departments, and successfully completed various clinical tasks Rotated around the departments of general surgery, neonatology, intensive care unit, and imaging, learnt the relevant knowledge and clinical skills

Practiced in clinical departments of cardiothoracic surgery, obstetrics and gynecology, pediatric surgery, pediatrics, respiratory, ophthalmology, etc., learnt related diseases' knowledge and cultivated clinical thinking and team spirit.