Introduction 引言
 

Drug Development is a complex long-term endeavor involved with a high cost and high risk investment. It takes multi-disciplined talents, who come from different drug development functions, to collaborate together in a carefully managed cross-matrix environment. United under one goal, we devote to lead new drug molecule candidates through the Preclinical and Clinical development maze to prove therapeutic concept, to demonstrate treatment efficacy, to push new drugs onto the market, and to bring hope to patients. This is not only a business but also involves a “patient-centric” vision and mission.

From 2015 Target Product Profile (TPP) Symposium discussion, we learned how to set up a drug development roadmap with a principle of “beginning with the end in mind”. In this process, we realized that with all of talents gathered in one team, we are facing an even bigger challenge how to build infrastructure and management to support an effective cross-functional team to synergize team’s talents to overcome drug developmental hurdles.

In this 2016 Drug Development Symposium, we will continue leading everybody down the path of “Drug Development” and promoting an innovative thinking paradigm to transform our researchers to become “true” developmental scientists. We will equip everybody’s tool bag with several critical “Technical Know-hows” including project team management, drug developmental strategies and planning, milestone management, product development process and strategies, as well as regulatory compliance and regulatory submission dossier preparation. After all, the new drug research and development should focus on scientific logical thinking, medical ethics, developmental strategy, policy and regulation.


藥物開發是一項涉及高成本與高風險投資的過程,必須經過長時間努力才能成功。它需要許多來自不同藥物開發專業的優秀跨領域人才,在嚴謹管理的跨組織環境下共同合作。在一個共有的目標下,致力引領有潛力的新分子藥物通過臨床前和臨床發展,以驗證其治療概念、展現其療效及推展新藥上市,最終藉此為病患帶來希望。這不只是一個商業行為,也是"以病人為中心"的願景和使命。

從 2015年目標產品概述 (TPP) 專題研討會中,我們學習到以 “beginning with the end in mind”的原則來設計藥物發展的路徑,也在學習過程中瞭解到所面臨的更大挑戰,即如何建立基礎結構和管理架構,來支援一個有效的跨職能團隊? 又如何協同團隊的人才來克服所有藥物發展的障礙?

在2016年藥物發展專題研討會中,我們將繼續帶領大家朝向“藥物開發”前進,並推動創新思維將研究人員轉變成為"真正的"藥物發展科學家。我們將提供幾個關鍵的 “技術錦囊”,包括專案團隊管理、藥物發展策略和計畫、里程碑管理、藥品開發過程和策略,及法規監管和藥品送審檔案準備。最終,所有新藥研發都須強調恪守科學邏輯思維、醫療倫理、發展策略、政策和法規規範。