Overview
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
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Want to learn more about DIA Companion Diagnostics Conference 2015: Connecting Science and Regulation to Advance Innovation in Precision Medicine and Companion Diagnostics? You've come to the right site!
Program Committee
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Miu Chau, PhD Senior Regulatory Program Director
Genentech, A Member of the Roche Group, United States -
Jennifer Dudinak-Dickson, PharmD Senior Vice President, Global Regulatory Sciences
Bristol Myers Squibb , United States -
Jennifer Shen, PhD Director, Regulatory Affairs
ORIC Pharmaceuticals, United States -
Eric Slosberg, PhD Senior Director, Translational Medicine
Novartis Oncology, United States -
Jeffrey N. Stuart, PhD Associate Vice President, Global Regulatory Affairs
Merck Sharp & Dohme LLC , United States
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