Hong Yan（严红）

Non-clinical Safety, as a toxicology in-house expert provides support for projects from discovery to clinical stage, and leads the toxicology evaluation-related activities. Responsibilities including non-clinical safety evaluation strategy design, risk identification/assessment/mitigation, CRO selection and management, study protocol review/data analysis/report finalization, IND/NDA dossier preparation (including CTD files, IB, DSUR, etc.). Supported projects including ADC and small molecules (oncology/non-oncology); toxicology studies completed/ongoing covering many comprehensive studies such as carcinogenicity studies (protocols approved by both FDA and CDE), juvenile animal toxicity studies, long-term repeat dose toxicity studies, reproduction toxicity studies (segment I/II/III), drug metabolites safety testing and in vivo phototosafety testing. · 1 NDA dossiers completed (drafted M2/IB/label/preNDA meeting packages, toxicity studies including carcinogenicity studies, reproduction toxicity studies, photosafey studies, etc.) · 1 IND approved (small molecule antitumor drug) · Supported 8+ clinical-stage projects and 3+ discovery-stage projects · Evaluated 20+ license-in projects and Go-No Go decisions · Drafted 15+ meeting packages (NMPA, FDA, EMA), 10+ DSURs/IBs 作为内部专家，负责非临床安全性风险评估及控制，评价策略制定（从立项-NDA），CRO机构选择和管理、研究方案设计、数据分析和整理、报告审阅和定稿，申报及沟通交流资料撰写（M2, M4, IB, DSUR等），BD支持等 负责的项目涉及ADC、小分子肿瘤和非肿瘤药物等，毒理研究涉及各类复杂研究：致癌性研究（含中美沟通）、幼龄动物研究、长期毒性研究、生殖毒性（I,II,III段）研究、代谢产物研究及体内光毒性等，申报沟通包含IND及NDA（包括中美监管机构的沟通交流）

Non-clinical Safety, responsible for designing non-clinical safety evaluation strategy, selecting and managing CRO, study design, data analysis, study report review, IND dossier prepare (including M2, M4, IB, and DSUR, etc.), toxicology-wise support to early discovery as well as BD activities. ·1 IND dossier submitted (bsAb, China/Australia filing, 5.5 months to complete all tox studies and IND dossier prep.) ·2 IND projects in progress (1 is expected in Q1 2022.; 1 finished CRO contracting, study design and methods transfer) ·Supporting 5 clinical-stage projects (including 2 biosimilar, 2 innovative, and 1 small molecular; NDA supporting preclinical TOX, IB update, and BD activities) Project Management, responsible for developing pre-IND timeline, coordinating multi-function works (including CMC, clinical, RA, etc.), organizing periodical/ad hoc project meetings, identifing issues and facilitating to solve them in timely manner. ·Management 3 projects at the same time, each project team involves 10+ functions with 20+ people ·1 IND submitted, 1 IND is expected in Q1 2022, 1 accelerating project reached the benchmark speed. ·Coordinator of company leadership weekly meeting (English meeting), responsible for collecting topics, hosting, taking meeting minutes, and following up the action items ·Participated in annual portfolio review as a core team member, facilitating pre-IND assets data collection, evaluation criteria making, workshop preparation, and follow-up actions. 毒理方向，中国认证毒理师，1项IND递交（双抗，中澳双报，5个月完成全套PK&毒理申报资料），1项IND研究进行中，1项完成外包、研究设计及方法转移； 项目管理方向，负责项目从PCC到IND阶段timeline设定、跨部门合作（研发，CMC, 临床等）、项目问题发现与协调解决，推动项目按照时间节点开发；1项IND已递交，1项即将递交，1项采用快速开发模式速度达行业标杆水平

Gene therapy Research for Hemophilia, project leader · Lead and conduct basic and applied research on developing new gene therapy strategies for hemophilia. The project is supported by NSFC (No. 81500108), and the manuscripts are in submission or under writing ·Study results showed a great potential of in vivo fusion expression of FIX and albumin in improving the efficacy and safety of gene therapy. ·Propose research plan, design experiments for hemophilia gene editing-based research, including CRISIPR/Cas system and stem cell related strategies BioDrug Research and Development for Hemophilia, preclincal lead ·Design and set up stable platforms for hemophilia drug evaluation ·Collect related FDA/EMA files and collaborate closely with Drug Safety Evaluation and Research Companies to evaluate the pre-clinical safety for hemophilia drugs ·Prepare the basic materials for IND files and familiar with the entire process for biodrug development, including CMC, pre-clinical evaluation and etc. ·Lead the reseach of producing long-acting FIXs in the mammary gland of transgenic animals. Results showed the trasgenic animal mammary gland is capable fo correctly and efficiently expression long-acting FIX. Submitted one patent and published one SCI paper. 主要从事血友病治疗研究，包括血友病基因治疗研究及重组蛋白药物研发。作为项目负责人主持国家级科研项目1项，院级科研项目1项；申请专利1项，已发表文章1篇，投稿中文章1篇

·Well-trained in pharmacology as well as molecular and cell biology techniques ·Skilled in animal care and establishing both in vitro and in vivo models for drug evaluation