Introduction

生物基礎研究與醫藥產業之間一直存在著鴻溝，世界各地積極透過轉譯醫學及產學合作等模式，找尋能有效率加速研發成果商品化的方法。台灣政府推動生醫產業創新推動方案，以提升生醫產業創新效能為目標，鼓勵研發創新同時慎選醫藥產品研發主題，透過資源整合協助學研團隊成果商品化。然而如何從學術研究跨越死亡之谷(Valley of Death)走向市場，中間層層關卡及驗證攸關著產品能否成功。美國史丹福大學(Stanford University)長期致力於鼓勵校內教授與學生新創，其中SPARK Program及Biodesign都是知名生醫成果商化培訓機制，亦為各國多年持續交流學習之指標。SPARK Program引進多位灣區生技界的業師，從計畫一開始就教導以創投藥廠的角度來帶領團隊，配以專利規劃與臨床試驗的規劃來協助計畫發展，大幅幫助學校團隊接軌業界，以利技轉與新創公司；Biodesign自史丹福發跡，也逐漸在日本及新加坡等國家落地發芽，共同促進醫材開發的創新能量。

今年度我們很榮幸邀請到4位來自史丹福大學SPARK Program及Biodesign的專家來台，探討生醫團隊商品化所遇到的挑戰以及因應之道: 藥物開發部分，我們將針對臨床前的毒理試驗設計策略及早期專利佈局策略兩大主題進行討論；醫材開發部分，則針對選題與市場策略作探討。我們希望藉此研討會鼓勵台灣生醫團隊在概念驗證同時，謹記以提升病人之福祉為目標，釐清臨床的實際需求同時策略性的降低產品風險，才能勇於跨越死亡之谷，邁向成功。

There has always been a chasm between biological fundamental research and the pharmaceutical industry. It has been highly in need of searching for the methods of accelerating the efficiency of commercializing R&D achievements through translational medicine and industry-academia cooperation all over the world.

The Taiwanese government promote the Biomedical Industry Innovation Program with the aim to improve the performance of innovation in the industry, to encourage R&D innovation while conducting needs finding and screening of biomedical products, and to assist the research team to commercialize their achievements through integration of resources. However, the key success of a product lies in the numerous check points as well as verification process. And that could lead academic research to cross the Valley of Death to the market.

Stanford University has long been committed to encourage professors and students to be creative and innovative. Among the programs launched, the SPARK Program and Biodesign are well-known commercialization training mechanisms for biomedical achievements which serve as indicators for many countries to learn from. The SPARK Program has introduced a number of mentors in biotechnology field from the Bay Area to lead the teams with the perspective of a pharmaceutical venture capital from scratch, along with patent mapping and clinical trial planning to foster the development of the project. For the purpose of technology transfer as well as founding start-up companies, the project devotes to bridging university research teams with industry. As for Biodesign, it is originated from Stanford and has gradually rooted in countries such as Japan and Singapore where they jointly promote the innovative energy in the development of medical devices.

This year, we are very honored to invite four mentors from SPARK Program and Biodesign from Stanford University to Taiwan to discuss the challenges and the coping strategy faced by the biomedical team regarding commercialization of the products: In the drug development segment, there will be two main themes being discussed upon - the design strategy of the pre-clinical toxicity test and the early patent portfolio strategy. As for the medical device segment, we shall discuss how to conduct needs finding and screening as well as market strategy.

We hope to leverage this seminar to encourage the Taiwan biomedical researchers to keep in mind the aim of improving the well-being of the patients while conducting proof of concept; and to identify the actual clinical needs while strategically reducing the risk of products. Only then can we bravely leap over the Valley of Death and step on the road to success.