Advances in scientific knowledge and technology are driving growth and innovation for companion diagnostics, thereby enabling personalized therapies that:

• Target those patients most likely to benefit from treatment;
• Exclude those patients most likely to suffer harm; and
• Can be monitored during treatment for clinically significant changes.

Drug and device pairings allow treatment decisions to be tailored for each patient. However, development of companion diagnostics with targeted drug therapy continues to face challenges as regulatory policy tries to keep up with rapid advances in technology and health care demands. One of the primary goals of the FDA Safety and Innovation Act (FDASIA) involves the advancement and modernization of regulatory science. Such enhancements have had direct impact on both biopharmaceutical and in vitro diagnostic manufacturers.

This conference will provide a comprehensive overview of current companion diagnostic landscapes, practical approaches to the drug-device co-development processes, and global regulatory perspectives in this field. The conference will focus on:

• US and Global Regulations
• Innovative Clinical Trial Designs
• Next Generation Sequencing as Diagnostic Devices
• Laboratory-Developed Tests and Its Impact on Precision Medicine