2020台灣生技月 Bio Taiwan 生物科技大展

2020 台灣生技月 南港展覽館

講師

Rachel Hoffman

Session 11 – From Precision Medicine to Precision Health
Date: 24 July (Friday) 10:40 – 12:10 (GMT+8)
Venue: 701EF, 7F, TaiNEX2 / Online event platform


Rachel Hoffman

Executive Director, Clinical Development, Medical Device & Diagnostics
Syneos Health


Ms. Hoffman has a degree in biomedical engineering from Duke University and an academic research background in biomaterials, genetics, and molecular biology.  After entering the biotechnology industry in 2008, Ms. Hoffman has worked for both Clinical Research Organizations and medical device manufacturers.  Her expertise spans research & development, clinical research, and United States regulatory strategy.


Speech title & Synopsis

Use of Companion Diagnostics in Precision Medicine Clinical Research

Companion diagnostics are used in precision medicine to identify patients most likely to benefit or those who are most at risk for adverse effects from a therapy; companion diagnostics may also be used to monitor response to treatment and determine treatment adjustment.  The principles of developing and validating companion diagnostics will be presented.
 
The co-development of companion diagnostics and therapeutic products is critical to the advancement of precision medicine.  Testing and use of companion diagnostics in drug clinical research will be discussed.  An overview of types of samples will be provided, along with considerations for clinical operations and logistics planning.