金秋十月，美迪西与您相约韩国第46届非临床试验研讨会

美迪西展位#43

第46届韩国非临床试验研讨会 (The Korean Society of Nonclinical Study, KSNS) 将于2024年10月17-18日在韩国庆尚南道举行。本次大会由韩国非临床试验研究协会（KSNS）组织，是韩国最负盛名和最具影响力的非临床研究会议之一。届时来自生物医药技术领域研发公司的领导者和决策者，及众多非临床研究专家们都将参加此次活动。TFM of Medicilon Chuansha Site邹汉军博士DABT将带领美迪西美国团队出席此次大会，我们在展位#43，期待与您的交流！

时间 | October 17-18, 2024
地点 | Gyeongju, South Gyeongsang Province
美迪西展位  | 43，不见不散！

作为国内较早为客户提供临床前动物实验的CRO公司之一，美迪西具备全面的临床前研究服务能力，能够提供系统的体内药效学和GLP条件下的药代动力学、安全性评价研究服务。目前美迪西已拥有多种稳定的药效评价模型，可对细胞毒及靶向类小分子、单抗及双特异抗体等大分子药物、ADC、CAR-T/CAR-NK细胞治疗抗肿瘤新药提供全面系统的评价。美迪西对大量化学药物和生物药物建立了系统分析方法和体内外评价方法，包括小分子和大分子生物分析平台、免疫分析工作站及放射性同位素药代动力学研究平台等，支持早期筛选、成药性评价和IND申报等。美迪西拥有经中国NMPA认证的GLP资质，且通过了美国FDA的GLP现场检查，具备符合国际标准的GLP体系，并且获得AAALAC认证，实验动物管理质量标准获得国际认可。至2024年6月底，美迪西已为全球超2000家客户提供药物研发服务，参与研发完成的新药及仿制药项目已有490件IND获批临床，与国内外优质客户共同成长。

KSNS现场美迪西专家

邹汉军博士 TFM of Medicilon Chuansha Site

Dr. Hanjun Zou is currently the Testing Facility Management for Medicilon Chuansha site in Shanghai. Dr. Zou joined Medicilon in March 2023 as Senior Director in which he led the team or as the study director to be responsible for the overall planning and implementation of the nonclinical study programs, including but not limited to the IND/NDA package design, selection of species, dose determination, protocol design, results interpretation, report drafting and communication with regulatory agencies. The type of drugs he supported included small molecule chemicals, peptide, fusion protein, oligonucleotide, single/bispecific antibodies, ADC, CGT product etc. Before joining Medicilon, Dr. Zou has more than 16 years of experience in toxicity and preclinical safety assessment with most career working in multinational companies. Dr. Zou is also a certified toxicologist (DCST, ERT & DABT) in China, Europe and the United States.

美迪西非临床研究服务

Medicilon's state-of-the-art preclinical facilities hold full AAALAC accreditation. With advanced platforms and experienced scientists, Medicilon guarantees the utmost professionalism in drug efficacy and safety assessments services, adhering to global regulatory standards. Offering services from stand-alone preclinical studies to comprehensive IND-enabling packages, Medicilon provides flexible solutions to efficiently support biotech and pharmaceutical clients in reaching their developmental milestones. Medicilon's Preclinical Research Division services include the following for small molecules, biologics and medicinal herbs: Pharmacology, Pharmacodynamics, ADME, DMPK, Bioanalysis, Drug Safety Evaluation. Medicilon maintains a large in-house library of animal disease models to meet the research demands in different therapeutic areas.  Medicilon can also assist clients in the preparation of a preclinical safety evaluation package.

Pharmacology 

❖Tumor Animal Models (400+) 
❖Non-tumor Animal Models (270+)

DMPK & Bioanalysis

❖In Vitro ADMET 
❖In Vivo PK & Tox

Preclinical Safety Assessment (GLP & non-GLP) 

❖Single and repeated-dose toxicity studies
 ❖Reproductive/developmental and juvenile toxicity studies
 ❖Genotoxicity studies
 ❖Toxicokinetic studies
 ❖Safety pharmacology research
 ❖Immunogenicity studies
 ❖Local tolerance studies
 ❖Carcinogenicity studies

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