(招生中)【專題課程】如何善用生物標記、臨床藥理和生物統計加速新藥發明及早期臨床開發(新藥系列)

2024/10/19 及10/26 (09:30~12:30 & 13:30~16:30)

Accelerating Drug Discovery and Early Clinical Development
-How can biomarkers, biostatistics, and clinical pharmacology help
如何善用生物標記、臨床藥理和生物統計加速新藥發明及早期臨床開發
 
【課程簡介】This specially tailored short course is designed to educate and empower new drug developers with the stat-of-art concept, best practice and application of biomarkers, clinical pharmacology and biostatistics in translation research and early clinical development of novel pharmaceutical products. Immerse yourself in cutting-edge technologies, including AI-driven drug design and data monitoring, multifaceted biomarkers, and statistical approaches to learn how they could optimize IND-enabling preclinical development, clinical pharmacology evaluation, and design of effective early clinical studies. You will acquire invaluable practical skills, industry insights from experts to propel your drug discovery and development endeavors to new heights.
 
【課程目標】授與學員:生物標記的最新概念、臨床藥理和生物統計學在新藥轉譯研究和早期臨床開發的有效應用，進而增強新藥開發效率。
【教學內容】講師們將分享尖端技術的實務運用，包括:多方位的生物標記和統計方法，臨床藥理學評估和人工智慧驅動的臨床數據監測、有效的早期臨床研究的設計，等等。
【預期效益】您將獲得寶貴的執行技能和專業深入見解，助您藥物開發推向新的里程碑。
 
【課程規劃專家】黃文英博士(安基生技新藥股份有限公司董事長兼總經理)
【上課日期與時間】2024/10/19 及10/26 (09:30~12:30 & 13:30~16:30)
【總時數】12小時  (每週六)
【上課地點】台北市大安區復興南路一段390號11樓(財團法人職訓研發中心) 暫訂
【課程費用】
    1. 非會員課程定價:NT：11,000
    2早鳥優惠價:NT：9/20前完成線上報名只要 : 10,500
    3 同公司或單位,3人以上報名可享優惠價:每人只要9,500
    4 本會團體會員特別優惠價: NT 9,000     (如報名額滿 ,以本會團體會員優先錄訓)
【報名方式】 線上報名<<<----額滿為止
 【諮詢專線】(02)2783-6028 分機11或 分機12 歡迎來電
【課程及師資預排表】

Date Lecture Subject 講題(中文) Lecturers
10/19
9:30 am-12:30 pm
 		 The Multifaceted Roles of Biomarkers in Medicine Development 生物標誌物在醫學上多樣化的運用 Jane Tsai
蔡秀娟
 
 
1:30-4:30 pm		 1.Overview of pre-clinical study, early clinical trials, and diagnostic tests
2.Understanding variability and reducing bias enable better decisions
3.Dynamic Data Monitoring (DDM) for Clinical Trials		 1. 臨床前研究、早期臨床試驗和診斷測試之生統概述
2. 了解變異性及減少試驗偏差
3. 臨床試驗動態資料監測		 1. Weichung Shih 施維中       
2. CF Chen 陳建豐
3. Tai Xie謝泰亮 
10/26
9:30 am-12:30 pm
 		 Optimize Early-Stage Clinical Pharmacology Evaluation to Accelerate Clinical Development in Oncology 如何運用臨床藥理評估加速臨床開發 Ya-Chi Chen
陳雅琪
 
1:30-4:30 pm 		 1.Early Phase Clinical Trial Design & Data Analysis
2.Statistical Approach to Translational Research		 1.早期臨床試驗設計及數據分析
2.轉譯研究的統計方法		 1.Mark Hsiao
蕭金福
2.Chao A. Hsiung
熊昭