(額滿/結業)【新藥開發-進階】主題專班(2) 新藥委外開發成功關鍵金三角-評估、管理與策略規劃
2020/10/24 及10/31 (週六 09:30~16:30)
【課程說明】
在藥品開發市場上，越來越多的公司以專案管理模式投入。此舉可望降低公司的營運壓力，並確保投資人的資金得以聚焦投入在新藥開發上。本課程針對此類管理模式，提供從:募資、開發策略、到委外單位的管控，引導學員有效率評估、規劃及管理生物藥的開發，並以各開發階段實務的成功與失敗案例、實務經驗融入課程中。引導學員檢視生物藥物開發中所面臨的財務、策略、技術等關鍵性成功因素，使學員所執行的各項專案得以達到預期目標並準時完成IND與BLA送件。
【適合對象】有醫藥開發與製造實務需求者、代工廠管理與評估實務需求者、相關專案管理人員、生技醫療相關產業人員、新創公司負責人等領域從業人員
【課程規劃專家】林淑菁 博士
【上課日期】10月24 及 31 每週六 (09:30~12:30 & 13:30~16:30)
【課程總時數】12小時
【上課教室】: 台北市大安區復興南路一段390號11樓
-本大樓一樓為:中小企業銀行/ 正對面為 星巴克咖啡
-公車站:信義/復興路口
【業界師資群】
- 俸清珠/副總經理 聯合生物製藥
- 李昭鋐/臨床藥理研究處副處長 聯合生物製藥
- 李元鳳博士/臨床醫學中心副總經理 聯合生物製藥
- 黃昭媛/總經理 得勝醫學
- 温國蘭 博士/策略長 先驅生物
【課程/教學大綱】
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| 講師 | 主題 | 時間 |
| 1 | 俸清珠/副總經理 聯合生物製藥 | -委託CDMO後之計劃管理與注意事項 | 10/24 |
| 2 | 李昭鋐/臨床藥理研究處副處長 聯合生物製藥 | -如何評估與選擇動物實驗委託公司(Preclinical CRO)與注意事項 | 10/24 |
| 3 | 李元鳳博士/臨床醫學中心副總經理 聯合生物製藥 | -如何評估與選擇Clinical 階段的 CRO與注意事項 | 10/24 |
| 4 | 黃昭媛/總經理 得勝醫學 | -以新藥開發公司角度評估與選擇CDMO與募資策略 | 10/31 |
| 5 | 温國蘭 博士/ 先驅生物 | -Start-up company 的策略聚焦 | 10/31 |
| 6 | --黃昭媛/總經理 得勝醫學 | **Panel discussion、 | 10/31 |
講師介紹:
課程規劃專家: 林淑菁 博士/總經理 聯合生物製藥
Dr. Shugene Lynn is the Chief Executive Officer and a member of the Board of Directors of United BioPharma (UBP). She has been with the UBI group since 1999, beginning as a bench scientist with increasing responsibility from project to program management, to corporate development, and has been associated with every step along the path of UBI growth in Asia. She was the first scientist in the UBI group to be engaged in the antibody humanization platform, and has since led a team to build the therapeutic monoclonal antibody process development platform, and brought the HIV drug candidate UB-421 from cell line development to clinical phase I and II stages. During her tenure at UBI Asia, the company was awarded 11 government research grants, and sponsored three monoclonal antibody drug candidates into clinical trials.
俸清珠/副總經理 聯合生物製藥
Pearl has worked over 15 years in the biotechnology industries to serve both operating and consulting roles for more than 30 biomedical projects. As Director of Project development, she operates in CMC, project management, project oversight, regulatory consulting and business development fields. Pearl’s educational credentials include a Bachelor of Nutrition and Health Science and a Master in Molecular Biology and Biotechnology. She has brought the very first biological medicinal product from preclinical to NDA approval in Taiwan.
李昭鋐/臨床藥理研究處副處長 聯合生物製藥
Samuel has more than 10 years of experience in biological drug development. His background includes extensive experience with preclinical in vitro pharmacology studies and animal studies, as well as bioanalytical method development and validation.
He has cooperated with many global and local contract research organizations (CROs) including Charlies River Laboratories, Covance, Joinn laboratories, etc. His experiences include CRO evaluation, preclinical animal study design, cost estimation, material shipment, project timeline management, analytical method transfer, site audit, invoice management, study report review, and IND submission.
李元鳳博士/臨床醫學中心副總經理 聯合生物製藥
Dr. Ywan-Feng Li is Vice President Clinical and Regulatory Affairs at United BioPharma (UBP). She leads the departments of Clinical/Medical and Regulatory Affairs responsible for the development of all UBP pipeline products. Since attaining her leadership role, Dr. Li has led the team to achieve several IND readiness and subsequent approvals with regulatory agencies in the United States, Taiwan, and China.
黃昭媛/總經理 得勝醫學
曾任台安創投副總經理，於分析及策略投資擁有多年經驗。
温國蘭 博士/ 先驅生物
Karen Wen is a pioneer in the field of process development and PIC/S GMP production of biological products including peptide, proteins, monoclonal antibodies, DNA vaccines and antibody-cell conjugate products. As the co-founder and CEO of Mycenax Biotech Inc. (the first CDMO in Taiwan), she has profound experience in CMC: chemistry, manufacturing and control. In her term, she completed one product launch, one biosimilar in a global trial of bioequivalence in pharmacokinetics, and several pipelines in the pre-IND stage.
【上課日期】10月24 及 31 每週六 (09:30~12:30 & 13:30~16:30)
【課程總時數】12小時
【課程費用】 原價:9,000
*非本會團體會員NT$8,400，
*本協會團體會員價NT$7,800
*9/28 前完成報名及繳費者可享優惠價 NT$ 6,500元(早鳥限額)
*2人以上同時報名,可享優惠價 每人NT$ 6,000 元
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*同時報名2班: 新藥進階主題專班(1)+(2) 可享同時報名價 : NT$ 12,000元
同時報名2班者須個別填寫報名/將由專人通知優惠繳費!
以上費用包含餐點及講義費
【諮詢專線】02-77003883 分機11或 分機12 歡迎來電
【線上報名】我要預約/報名
【諮詢專線】02-77003883 分機11或 分機12 歡迎來電
(注意事項:以上課綱及開課日期/授課師資/場地..等; 本協會保有異動權，如有變動將會提前通知)