Date & Time: 

   2024 / 4 / 26 (Fri) 14:20 - 16:20

Location: 

   Delta Building R216, NTHU

Speaker: 

   蔡承恩 醫師/博士

   安成生物科技股份有限公司 總經理兼醫務長
   Tron Future Tech Inc.

Topic: 

   Drug Development: Past, Present, and Future

Abstract: 

   Drug development is a long, expensive, and high-risk process taking 10–15 years and is associated with a high attrition rate. Recently, the median capitalized research and development investment to bring a new drug to the market in the US was estimated at 985.3 million USD. Drug discovery and development in the last two centuries span three main periods. The first period can be traced to the nineteenth century, where drug discovery mainly relied on the chance discoveries of the medicinal chemists. The second period started around the early twentieth century, when new drug structures were discovered in a new era of antibiotic discovery. Over the subsequent decades, with the development of powerful new techniques such as molecular modelling, combinatorial chemistry, and automated high-throughput screening, increasingly rapid advances occurred in drug discovery towards the end of the century. Moreover, the emergence of recombinant DNA technology in this period was revolutionary in bringing about protein drugs against specific targets. With all the expansion of innovative technologies and the dawn of the “omics” era in the twenty-first century, the third period has started with an increase in cutting-edge drugs in personalized medicine.

Autobiography: 

    蔡承恩 醫師/博士

    蔡醫師的工作經歷涵蓋臨床診療、基礎醫學研究、醫院管理、法規科學、藥品業界及 醫藥科技評估。在加入安成生技之前,蔡醫師於浩鼎生技與太景生技擔任新藥臨床研 發的副總經理,督導所有第一期至第四期的臨床試驗及醫學事務,並負責太景生技首 次公開募股的臨床相關事務。他並率領團隊完成一個新成分新藥的三期樞紐試驗,之 後順利獲得台灣及中國大陸的上市許可,並協助完成其台灣健保申請。蔡醫師曾在台 灣醫藥品查驗中心,分別擔任臨床組審查員(負責新藥及新醫療器材的審查)及醫藥 科技評估組資深正研究員(負責與健保收載及給付相關的評估工作),期間共達五 年。蔡醫師並經由擔任臨床試驗的試驗主持人、必治妥施貴寶公司(台灣及香港)的 醫學顧問、及醫藥品查驗中心的資深正研究員,對藥物研發過程、臨床試驗的設計與 執行、及試驗結果的評估有廣泛且全面的經驗。他專長的疾病領域包括罕見/遺傳疾 病、糖尿病、痛風、骨關節炎、傳染疾病、血癌、乳癌及肺癌。 蔡醫師具有完整的臨床醫學訓練及十二年醫學中心臨床醫師的工作資歷。蔡醫師於國 立台灣大學取得醫學學位,於英國劍橋大學取得分子遺傳學及生物學的博士學位。他 是小兒科醫師,且具有醫學遺傳學/臨床遺傳學的次專科醫師資格。

    Chen-En Tsai, MD, PhD

    Dr. Tsai’s career path has spanned clinical services, basic medical research, hospital management, regulatory science, the pharmaceutical industry and HTA (health technology assessment). Prior to joining TWi Biotechnology, Dr. Tsai acted as Vice President of Clinical Development at OBI Pharma and TaiGen Biotechnology. In that role, he supervised the design, initiation and execution of phase 1 to phase 4 studies, led all medical affairs activities, and was the medical expert for TaiGen’s initial public offering in Taiwan. He led the team to finish the pivotal phase 3 study of a new quinolone in pneumonia, gain its marketing approval in Taiwan and China, and file its reimbursement application in Taiwan.

    Dr. Tsai also previously worked as a Senior Principal Researcher at the Divisions of Clinical Sciences (reviewing new drugs and medical devices) and HTA, Center for Drug Evaluation, Taiwan, for five years. His comprehensive experience with designing, managing and reviewing clinical trials was also accumulated through working as a trial principal investigator at a medical center, a Medical Advisor at Bristol-Myers Squibb (Taiwan and Hong Kong) and a Senior Principal Researcher at the CDE. The disease areas of his expertise include rare/genetic diseases, diabetes, gout, osteoarthritis, infectious diseases, leukemia, and breast and lung cancers.

    He has had well-rounded clinical training and 12 years of clinical practice in medical centers in Taiwan. Dr. Tsai obtained his medical degree from National Taiwan University and Ph.D.in molecular genetics and biology from Cambridge University, UK. He is a pediatrician with a subspecialty in medical/clinical genetics.