新藥研發專案的預應式風險管理架構之研究

新藥研發由實驗室經過前臨床試驗、人體試驗到最後的藥物審核，往往需要十幾年的時間和數百億資金的需求；一旦失敗，有可能會造成企業倒閉的危機。有鑑於目前的新藥研發專案缺乏主動監控的風險管理模型，本研究藉由風險管理的相關研究，結合平衡計分卡與品質機能展開，提出預應式(proactive)風險管理的架構，由四個部份組成，(1)風險確認:應用平衡計分卡和品質機能展開的概念對指標進行質化分類，進而探討指標間關係的強弱程度。(2)風險評估與分析：分析各個透過模型計算而得的指標風險值，並按照其高低程度予以排序。(3)風險回應計劃：將分析結果應用於風險回應計劃之後，採取相關的因應行動。(4)風險監測與控制：對整個新藥研發流程的相關風險採取監控的方式，探究每個階段風險形成的原因，達到風險預應的效果。本研究貢獻如下，(1)結合平衡計分卡與品質機能展開的機制進行績效指標的質化分類，使新藥研發專案在衡量時能夠反應出組織的策略與目標進而達到預應的效果；(2)利用績效風險模型將風險量化以提供決策者做為主動監控的依據；(3)結合績效衡量系統提出預應式風險管理架構應用於生技製藥產業。

關鍵字

風險管理；新藥研發專案；平衡計分卡；品質機能展開

並列摘要

New drug development involves a large degree of uncertainty which will lead to high R&D risk and result in many project failures. However, there is lacking of a risk management methodology to manage R&D risks proactively for drug development projects. The objective of this research is to develop a new proactive risk management framework that integrates the balanced scorecard (BSC) and quality function deployment (QFD) for managing R&D risks during drug development. The framework is composed of four parts including (1) risk identification, (2) risk assessment, (3) risk response planning, and (4) risk monitoring and control. The proposed framework that links the R&D risk management with the firm's performance measurement system allows managers to allocate scarce resources effectively to achieve strategic goals of an R&D organization. In addition, the proposed performance risk model quantifies risks and it allows project managers to monitor risks proactively and increase the success rate of the drug development project.