2018 國際定量系統藥理研討會-2018 International Symposium on Quantitative Systems Pharmacology (QSP): Integration of Drug Discovery and Development

03-04-2018

近年來,以電腦模擬方式預測臨床藥物動力學,已被廣泛運用在新藥開發與法規審查。定量系統藥理(Quantitative Systems Pharmacology; QSP) 為一新興之跨領域學門,涵蓋醫學,藥理學,分子生物學,病理學,生理學,應用數學與電腦資訊等專業領域整合。藉由數學以及電腦模式運算將分子到細胞,組織到器官等不同層面所得到之數據參數整合,推導出最佳模式(Multi-Scales Model),可以有效協助新藥開發之關鍵決策,並可加速新藥審查,是新藥開發的重要關鍵工具。

QSP已受到歐美各大藥廠的重視,利用QSP 電腦模擬克服新藥開發所面臨的挑戰。美國FDA2017年初專家會議也建議將QSP整合數據納入未來新藥或學名藥審查資料。

為使台灣生技新藥以及學名藥公司了解此一趨勢及方法,TRPMA特別與台北醫學大學藥學院及臺北醫學大學國際生醫產學聯盟共同舉辦「2018 International Symposium on Quantitative Systems Pharmacology (QSP): Integration of Drug Discovery and Development」,邀請美國食品藥物管理署、俄亥俄州立大學、台灣國家衛生研究院,醫藥品查驗中心等知名機構專家,介紹QSP的概念、INDNDA的應用、QSP在美國FDA藥品審查中扮演的角色,以及QSP modeling在奈米藥物開發的應用等,歡迎國內、外生技醫藥產業及相關團體踴躍報名參加!

指導單位:科技部

主辦單位:台灣研發型生技新藥發展協會 (TRPMA)、台北醫學大學藥學院、台北醫學大學國際生醫產學聯盟 (TMU GloRIA BioMED)

協辦單位:台灣臨床試驗聯盟 (TCTC)

時間:107420 (星期五) 09:00-17:40

地點:臺北醫學大學醫學綜合大樓後棟16樓國際會議廳 (台北市信義區吳興街250)

報名:免費參加,僅限線上報名 ( https://goo.gl/forms/cJvB2Fxu6N2l6Kab2)

聯絡人:陶靚儀 TEL: (02)2783-1262#15 EMAIL: Email住址會使用灌水程式保護機制。你需要啟動Javascript才能觀看它

(報名者成功報名,本會將發出「確認電郵」通知,請報名者於截止報名後留意並查閱電郵)

議程:

Time Topic Speaker
08:30~09:00 Registration
09:00~09:20 Opening remarks

Jackson Wu, Ph.D.

Vice President, Taipei Medical University

Muh-Hwan Su, Ph.D. (TBC)

Director, TRPMA

Co-chaired by Prof. Jessie Au and Dr. Chien-Ming Hsieh
09:20~10:10 QSP: Background and Current Status

Jessie Au, Pharm.D., Ph.D.

Director, Institute of Quantitative Systems Pharmacology

10:10~10:30 Coffee Break & Networking
10:30~11:10 From IND to NDA (skype meeting)

Elora Gupta, Ph.D.

President, Drug and Device Advisory Group

11:10~12:00 Quantitative Pharmacology: A Mindset and A Key Decision- Making Tool to Improve Success Rate in Drug Development

Bin Chen, Ph.D.

Head of Clinical Sciences (CS) China, Pharmaceuticals, Bayer AG Research & Development

12:00~13:30 Lunch
13:30~14:20 US FDA Perspectives on Model-Informed Drug Development in Regulatory Submissions Liang Zhao, Ph.D.
14:20~15:00 Role of Modeling and Simulation in Regulatory Review

Li-Feng Hsu, Ph.D.

Senior Reviewer, Division of Pharmaceutical Science, Center for Drug Evaluation, Taiwan

15:00~15:20 Coffee Break & Networking
15:20~16:00 New Drug Discovery and Development in NHRI

Chiung-Tong Chen, Ph.D.

Director, Institute of Biotechnology and Pharmaceutical Research, National Health Research Institutes, Taiwan

16:00~16:20 Nanotechnology in Taiwan

Chien-Ming Hsieh, Ph.D.

Assistant Professor, College of Pharmacy, Taipei Medical University

16:20~16:50 Application of QSP modeling to Assist Nanotechnology Development

Roberto Abbiati, Ph.D.

Research Scientist, Institute of Quantitative Systems Pharmacology and Research Assistant Professor, University of Oklahoma Health Sciences Center

16:50~17:10

Panel Discussion:

Emerging role of Quantitative Systems Pharmacology in Drug Discovery and Development

Modulator:

Jessie Au, Pharm.D., Ph.D.

Panelists:

l   Elora Gupta, Ph.D.

l   Bin Chen, Ph.D.

l   Liang Zhao, Ph.D.

l   Li-Feng Hsu, Ph.D.

l   Chiung-Tong Chen, Ph.D.

l   Chien-Ming Hsieh, Ph.D.

l   Roberto Abbiati, Ph.D.

17:10~17:30 QSP's Value in Securing New IP and Product Management Goodwin Procter LLP
17:30~17:40 Closing remarks

Jing-Ping Liou, Ph.D.

Dean, College of Pharmacy, Taipei Medical University, Taipei, Taiwan