Linus Kao

Vice President
Europe-Taiwan Biotech Association

Dr. Kao has over 20 years of research and work experience in the field of life science, gaining extensive expertise across various domains including research and development, manufacturing operations, regulatory affairs, and commercialization of innovative life science products. Dr. Kao holds a PhD degree in Biomedical Engineering from the Case Western Reserve University in the United States.
In 2010, Dr. Kao established the Biophotonics group in A*STAR Singapore, where he served as a Principal Investigator. During his tenure at A*STAR, Dr. Kao led an interdisciplinary research group focused on developing point-of-care biophotonic sensors. In 2012, Dr. Kao took on the role as R&D Manager at QIAGEN and established the company’s first Asia Pacific Instrumentation R&D center in Singapore, contributing to the growth and expansion of QIAGEN's presence in the region. 
Dr. Kao relocated to Switzerland in 2015 and demonstrated his entrepreneurial spirit by founding the Europe-Taiwan Biotech Association (ETBA). Through ETBA, he sought to bridge the life science communities between Europe and Taiwan, fostering bilateral collaboration and knowledge exchange. Currently, Dr. Kao holds a position as a Senior Expert at Novartis in Basel. In this role, he plays a crucial part in advancing Decentralized Clinical Trials and Digital Health solutions, with a focus on improving patient outcomes.

Speech title & Synopsis

US/EU Regulation and Development on Decentralized Clinical Trials

Clinical trials are the most costly and time-consuming part of drug development, where an estimated $1bn and 7 years timeframe spent on each marketed drug alone. To address this issue, pharma companies are moving towards the concept of ‘trial from home’ or decentralized clinical trials (DCT), where some part of clinical trials are conducted within participants’ homes rather than from designated clinics. This new generation of clinical trial design has been gaining traction particularly during the COVID pandemic, where access to clinics has been restrained. The health authorities in EU and US recently published recommendation paper and draft guidance to foster the regulation of DCTs. In this talk the speaker will illustrate latest the regulatory views on DCT from EU and US as well as share the considerations when conducting clinical trials with DCT elements.