美迪西展位#43

第46屆韓國非臨床試驗研討會 (The Korean Society of Nonclinical Study, KSNS) 將于2024年10月17-18日在韓國慶尚南道舉行。本次大會由韓國非臨床試驗研究協會（KSNS）組織，是韓國最負盛名和最具影響力的非臨床研究會議之一。屆時來自生物醫藥技術領域研發公司的領導者和決策者，及眾多非臨床研究專家們都將參加此次活動。TFM of Medicilon Chuansha Site鄒漢軍博士DABT將帶領美迪西美國團隊出席此次大會，我們在展位#43，期待與您的交流！

時間 | October 17-18, 2024
地點 | Gyeongju, South Gyeongsang Province
美迪西展位  | 43，不見不散！

作為國內較早為客戶提供臨床前動物實驗的CRO公司之一，美迪西具備全面的臨床前研究服務能力，能夠提供系統的體內藥效學和GLP條件下的藥代動力學、安全性評價研究服務。目前美迪西已擁有多種穩定的藥效評價模型，可對細胞毒及靶向類小分子、單抗及雙特異抗體等大分子藥物、ADC、CAR-T/CAR-NK細胞治療抗腫瘤新藥提供全面系統的評價。美迪西對大量化學藥物和生物藥物建立了系統分析方法和體內外評價方法，包括小分子和大分子生物分析平臺、免疫分析工作站及放射性同位素藥代動力學研究平臺等，支持早期篩選、成藥性評價和IND申報等。美迪西擁有經中國NMPA認證的GLP資質，且通過了美國FDA的GLP現場檢查，具備符合國際標準的GLP體系，并且獲得AAALAC認證，實驗動物管理質量標準獲得國際認可。至2024年6月底，美迪西已為全球超2000家客戶提供藥物研發服務，參與研發完成的新藥及仿制藥項目已有490件IND獲批臨床，與國內外優質客戶共同成長。

KSNS現場美迪西專家

鄒漢軍博士 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.

美迪西非臨床研究服務

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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