Ke Li

通过“专利信息检索”，收集整理细分行业的“重要专利”形成“技术发展路线图”，理解并提炼相关专利的技术方案形成“特征/功效矩阵”，建立技术和产品专利专题数据库；理解和分解研发人员的“技术方案”，找到“风险点/风险层级”，进行“防侵权检索分析Infringement Search”即FTO分析，理解和运用“侵权判定原则”并撰写报告；专利挖掘：新颖性、创造性的“可专利性检索分析”

肝素酶I、II、III，硫酸软骨素酶I、K5多糖裂解酶的重组表达、纯化、和活性测定。（分子克隆及native菌株蛋白表达、分离纯化）。生物活性多糖产品酶法制备研究。

抗PD-1单克隆抗体HX008联合贝伐珠单抗或仑伐替尼一线治疗晚期肝细胞癌的II期临床研究》（CTR20202078）和《LP002治疗复发或难治性原发纵隔大B细胞淋巴瘤患者的多中心、开放性、单臂Ⅱ期研究》（CTR20201901，NCT04600947）的医学审核，包括试验方案修订、临床试验CDE和Clinicaltrials.gov登记、ICF/CRF审核定稿，伦理意见回复，AE评估，EDC系统测试。对比K（Prembrolizumab）药和T（Atezolizumab）药等，参与可行性调研（feasibility study），包括研判可选适应症/建立相应临床中心和专家库、记录专家访谈建立可行性测算模型，研判适应症筛选策略，确立适应症优选建议。胃癌和肝癌详细调研，了解分期，治疗方法，AE特征，疗效评估等。 孵化器运营管理、制度和流程建设，基于产业链和价值链的孵化模式的创业企业孵化服务内容设计、协议拟定，专业孵化器（肿瘤免疫治疗领域）公共技术服务平台管理。

多中心临床试验-中心实验室-业务拓展（药企/CRO客户开发）。药物临床试验-检测指标报价、合同谈判，协助申办方的临床项目管理。苑东生物的糖尿病药物“优格列汀”临床试验II期的中心实验室“技术开发合同”的报价，洽谈，签署以及中心实验室手册的修改；银诺医药的糖尿病药物“苏帕鲁肽注射液”临床试验II期的的中心实验室“技术开发合同”的报价，洽谈，签署以及中心实验室手册的修改；君实生物的《特瑞普利单抗联合含铂双药化疗作为新辅助治疗用于可手术IIIA期非小细胞肺癌受试者疗效和安全性的随机、双盲、安慰剂对照、多中心III期临床研究》的“病理QC”（主要病理学缓解率（MPR）的测定）的初步接洽。

稳定性和放行检测。分析方法验证和确认。 偏差，OOS调查。质量标准建立。SOP撰写，文件变更。

International Projects Introduction and valuation, Start-ups settlement, Financial and investment severice networking.

Sustainably contacting customers from United States, Britain, the Netherlands, Australia, Hungary, Germany, South Korean and other countries, reporting project progresses, negotiating cooperation modes and projects, helping customers to apply for talent programs of the local government, establishing start-up company and facilitating financing and investment negotiations and so on. Having completed the negotiation and revising of Technology Development Contracts and License Agreements，having assisted the completion of Investment & Financing Materials. Having understood the grant projects of the Science and Technology Action Plan for Prevention and Treatment of Major Diseases initiated by the NHFPC-DCMST, participating into several grant project collaboration groups, coordinating international translational medicine projects.

Participated into the R&D and the Laboratory & Platform establishment of several projects such as complex enzyme preparation, peptide drug carrier and so on. Learned and understood the relevant laws and regulations of the pharmaceutical industry and the regulatory process of new drugs and other medical products. Completed a number of related patent researches and organizing tasks.

After completing the German undergraduate course, applied to this internship/work. After two weeks of induction and laboratory training, completed the tasks of producing several peptide antigens in the company's production laboratory and then was introduced by the company's leadership to Helmholtz Centre for Infection Research in the city where the company was located for completion of the Bachelor Thesis.

This graduate study can be applied with a graduation score of 2.8 or above in related German undergraduate studies. During the study period, courses and related experiments of two semesters have been completed, the examinations have been passed and transcripts of two semesters are presented as attachment here. The main courses are Immunology, Cell Biology, Microbial Genetics, Gene / Protein Design, Glycobiology and so on.