Back to Agenda
Session 2 / Venue 1: Drug Development thorough Collaboration with ARO and Future Prospects - Part 2
Session Chair(s)
Fumitaka Nagamura, MD, PhD
Professor
The University of Tokyo, Japan
MHLW has started to provide budgetary support to 15 Core Clinical Research Centers nationwide since 2011. It also requests those centers to build a new infrastructure called ARO (Academic Research Organization) to conduct clinical trials by themselves. Each center has built an organization to suit their specialty and promoted some activities although their goals and strategies are various. Some organizations develop pharmaceutical products and medical devices for specific indications, some establish centers for phase 1 trials, some set up groups using networks. We expect you have a lot of questions on ARO. What kind of improvement did they implement who already introduced ARO? What kind of challenges do they face in particular? Is it possible for Academia to develop pharmaceutical products and medical devices? What is the role of researchers? How the collaboration among Industry and Regulatory has been facilitated? We will discuss these questions asked and issues and would like to find out common understanding to the basic question “What is ARO?”
Speaker(s)
Attempt by National Center for Child Health and Development
Hidefumi Nakamura, MD, PhD
National Center for Child Health and Development, Japan
Director for Clinical R&D,
Attempt by the University of Tokyo Hospital
Takashi Moritoyo, MD, PhD
The University of Tokyo Hospital, Japan
Professor, Head of Clinical Recerch Promotion Center
Ideal ARO Model from Sponsor’s Perspective
Kazuhisa Uchiyama
Daiichi Sankyo Co., Ltd., Japan
Senior Director, Group III, Clinical Development Department
Expectation for the ARO - Regulatory Perspective
Yoshiaki Uyama, PhD, RPh
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Associate Executive Director
Have an account?