Exploration of Evaluation Models for R&D Projects in the Biomedical Industry of Taiwan - The Case of Company A

研發計畫的評估是一個複雜且重要的問題，特別是在新興的生技醫藥產業，生技醫藥產業雖然爆發力強，卻具有研發時程長、風險大的特性，再加上投資金額龐大，回收期長，如何在有限的資源及高度的不確定性下，進行正確的投資評估變成了關乎未來公司存亡的關鍵。 一般而言，質化的評估方式，容易受決策者主觀意見所影響，造成決策品質的不確定性。而量化的評估方式，並不易讓企業管理者瞭解與使用，加上模式的限制可能只適用於某些特定情形，造成決策的真實情境無法完全由數學模式中表達出來，而降低了決策的參考性。 以藥物開發為例，針對生醫產業的特性，從評估參與人員、質化評估、量化評估、評估要求、評估標準、評估程序等不同的構面去探討與分析可能合適的研發評估模式。本論文進一步以個案訪談的方式，收集實際運作的經驗與意見，瞭解目前業界目前實務上使用的評估方式，並與先前的生醫產業評估模式對照比較，瞭解理論與實務上的落差，探討其關鍵要素，以整體的效益評估觀點，對公司決策者或研發主管提出建議。The evaluation for R&D project is usually regarded as an important and complicated issue for enterprises, especially in the biomedical industry. Such a concern may be highly applied to the biomedical industry, which is involved with lengthy R&D process, high level of risk, and large cost. This project, therefore, will attempt to study the appropriate approaches to determine whether a proposed R&D project is worthwhile to be launched for a biomedical enterprise with limited resources. In general, qualitative research may be involved with the evaluator’s personal experience, negatively influencing the evaluation results. On the other hand, not each of the selected models employed by quantitative research is fully compatible to evaluation process. This study suggests that either qualitative or quantitative research may not be the most appropriate tool to conduct R&D project evaluation. This study aims to use drug development as a study target and further to discuss the most appropriate evaluation approach from the five aspects, including reviewer’s professional, evaluation items of qualitative research, evaluation items of quantitative research, requirement for evaluation process, and criteria for project approval. This study also assumes that a final review process is required to be proceeded in addition to taking the above five aspects into account. This study begins with related references and collecting the opinions provided by the professionals working in the biomedical industry about real cases. Through the case study method, the study may better understand the difference between the theoretical models and real practices and further to identify the key successful factors for the evaluation model. Finally the study suggests a comprehensive evaluation model to decision makers or research managers