Introduction

近十幾年來，全球轉譯醫學的發展在各國政府的積極推動下，有越來越多學研基礎研究成果成功轉化為藥品或醫療器材進入臨床應用，進而協助改善許多病患的生活品質。然藥品及醫療器材的開發是一段漫長的過程，為使資源有效投入，「以終為始」，是重要的開發心法。產品開發之初，價值主張是最重要的一步，待目標確認、各環節可行策略制定後，再依規劃按部就班推進執行。由於開發過程中充滿了抉擇與挑戰，除了需要臨床、科研、法律、商管等領域的人才共同的投入外，聆聽並吸取專家經驗更是加速開發的重要利器。

2019 SPARK Translational Medicine Symposium有幸邀請到5位生醫產品開發領域經驗豐富的專家，針對選題、商化價值創造、藥物安全、臨床試驗設計以及生醫領域的新興技術應用及趨勢等議題，分享他們的策略與寶貴經驗，誠摯邀請對藥品及醫療器材開發議題有興趣的學研產業先進踴躍報名參加。

In the past decade of Translational Medicine Symposium development, with the dynamic participation of numerous governments, the results of an increasing number of fundamental academic researchers have been successfully turned into pharmaceutical products or practical medical appliances for clinical use for the sake of improving the patient's quality of life. However, in any case, the development of drugs and medical devices is a long and daunting process. In order to invest resources efficiently, the right strategy for initial development is to "starting with the end in mind". In the early stage of product development, value proposition is the most important step. After confirming the target and formulating feasible strategies for each condition should be considered, it will be implemented step by step according to the plan. As the process of development is full of choices and challenges, in addition to the common investment of talents in the fields of clinical, scientific research, law, business management and so on, listening and absorbing expert experience are also important tools for accelerating that development.

2019 SPARK Translational Medicine Symposium has the great privilege of welcoming five specialists with tremendous experience in the field of biomedical products development to discuss the selected topics and issues related to such as commercial value creation, drug safety, clinical trials design and the application of emerging technologies and trends in the biomedical field and so on. To share their strategies and valuable experience, we sincerely invite interested seniors from the academic and industrial research fields, who are involved in the development of pharmaceuticals and medical devices, to register and participate.