Event Information

Time：October 20, 2015 (Tuesday)
Place：TRPMA Conference Room

In order to help the biopharmaceutical industry in Taiwan to understand the latest trends in precision medicine, TRPMA invited Mr Lu Chia-Fong, a lawyer working for Baker & McKenzie in the US, to give a special speech on “Navigate the Unchartered Waters of Precision Medicine Paradigms in the U.S”. Mr Lu analysed the problems faced by the industry at the roll-out of the Precision Medicine Initiative in the U.S. from the aspects of laboratory development test (LDT), companion diagnostics (CD) and NGS.

The US FDA is going to establish a risk-based supervision system for LDT or to introduce a marketing registration system. In the meantime, the Classification Panels are planned to manage and monitor drugs which have no similar products on the market or are not subject to any existing regulations.

Also, when developing products of companion diagnostics, the industry should consider finding a partner to collaborate in product development in order to smooth the product development process. Prospective developers should also evaluate whether the product can share the reimbursement with the drug and consider issues concerning patient compliance.

As for NGS, it provides a test platform. Therefore, developers who intend to apply NGS to precision medicine will have to answer questions about clinical appropriateness, costs, test quality and convenience, etc.