[ Title ]
- Current Trends in Personalized Medicine and Companion Diagnostics: A
Summary From the DIA Meeting on Personalized Medicine and Companion
Diagnostics
[ Journal ]
- THERAPEUTIC INNOVATION & REGULATORY SCIENCE
[ Author ]
- Tsourounis, M
Stuart, J
Pignato, W
Toscani, M
Barone, J
[ Abstract ]
- Personalized medicine has reached the mainstream, accounting for more
new drug approvals and a promising pipeline of candidate therapeutics.
Recent advances in genomics, computational biology, medical imaging,
diagnostic technologies, and translational medicine are creating the
possibility for scientists to develop diagnostic tools and new
treatments for cancer, genetic disorders, and infectious diseases that
may be particularly effective in biomarker-defined subpopulations. Drug
development under this model creates new challenges that will require
the need for increased regulatory flexibility, novel clinical trial
designs, and translational science development. In this review, the
authors highlight key developmental and regulatory challenges in the
advancement of personalized medicines and their associated companion
diagnostics with the need for innovative clinical trial designs to
support drug/diagnostic development and registration. Further, the
clinical complexities of implementing new technologies are considered,
such as high-throughput next-generation sequencing in personalized
medicine, and offer a glimpse of the regulatory and policy
considerations shaping this methodology in multimarker diagnostic
development.
[ URL ]
- http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=Alerting&SrcApp=Alerting&DestApp=WOS&DestLinkType=FullRecord;UT=WOS:000357300100010