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Session 3 / Venue 2: Current Status and Perspectives for the Development of Companion Diagnostics and Personalized Medicine - Part 1
Session Chair(s)
Yoshinobu Tanaka
Japan Clinical Director, Oncology Clinical Development, Oncology Science Unit
MSD K.K., Japan
Takeharu Yamanaka, PhD
Professor, Department of Biostatics, School of Medicine
Yokohama City University, Japan
In promoting personalized medicine, the environment for developing companion diagnostics (CoDx) is essential. A delayed CoDx development may lead to a delay in the market release of a drug and there is thus increasing demand on drugs and diagnostic drugs to be developed in an integrated manner. However, in order to achieve this goal, multifaceted issues such as time line alignment for the concurrent development of drugs and CoDx, sharing of risk/ benefit among corporations, and intellectual property (IP) concerning gene patents must be tackled. In this session, we would like various parties including regulatory authorities, corporations which have actually developed CoDx, and bio IP experts to present their most up-to-date knowledge on the current status and issues in CoDx development and discuss and share the actions that will be required for optimal development of CoDx in the future.
Speaker(s)
Points to Consider: Concurrent Development of Companion Diagnostics and Corresponding New Drugs. What are Issues? Where are We? Where are We Going?
Masaaki Urata, PhD
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Reviewer, Office of New Drug V
Current Issues and Future Direction of Quality Control for Molecular Diagnostics – Challenges between IVD and LDT
Mikio Kawahara, MBA
U Tokyo IPC, Japan
Chief Investment Officer
Current Strategy for Companion Diagnostics Development in Pharmaceutical Company
Shigeru Takeshita, MSc
Astellas Pharma Inc., Japan
Manager, Clinical Pharmacology, Astellas Pharma Global Development
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