Event Information

Time: September 21, 2016 (Wednesday)

Place: TRPMA Conference Room

TRPMA and Act Genomic jointly organized the forum on “Precision Oncology for Drug Development”. Dr Chen Shu-Jen, the Technology Director of Act Genomic, and Dr Hsieh Chi-Yi, the Medical Director of ASLAN Pharmaceuticals, were invited to share with the audience their experiences of applying precision medicine to the development of better cancer drugs.

Firstly, Dr Chen introduced the technology and advantages of liquid biopsy and the methods and features of circulating tumor DNA (ctDNA). She gave suggestions on the things to be considered when researchers carry out sampling and analysis. The ctDNA is fractions of DNA from dead tumor cells. It provides opportunities for minimally-invasive cancer diagnosis, prognosis and tumour monitoring. It also helps to detect relapse and drug resistance. This new technology provides a new option for patients who are unable to undergo biopsy. It presents a new opportunity for new drug R&D and the design of clinical trials.

Dr Hsieh introduced how to apply next generation sequencing (NGS) to clinical trials on special patients. He also briefed the audience on the concepts and strategies of researches of biomarkers. Dr Hsieh introduced the background of the “Precision Medicine Initiative” and the “Cancer Moonshot Project” implemented by the US FDA in 2015 and 2016 respectively. The US government set 10 major targets for shortening the R&D procedures for cancer prevention, diagnosis, treatments and care. It involves changes in regulations, infrastructure and funding. The US FDA also established the Oncology Center of Excellence (OCE), which coordinates the clinical and regulatory experts in small molecular drugs, biologics and medical devices to reform the review of innovative cancer treatments. The trend is to start from precision medicine and to move towards personalized medicine.