Medical Center for Translational Research
(Medical Center for Translational Research)
The roles of Medical Center for Translational Research include, for a start, exploring research basic ideas for practical application of biomedical research conducted in the academia such as universities; supporting a series of early clinical development processes, such as first-in-human trials of drugs, medical devices and regenerative medical products and POC acquisition in humans, to incubate promising ideas; and translating the ideas into practical use as medical technology and turning them into a commercial reality by the pharmaceutical industry, i.e. promoting translational research (TR). As the implementer at one of the TR Core centers for Japan Agency for Medical Research and Development, Medical Center for Translational Research comprehensively manages translational research projects of a number of promising seeds for development, provides consultation from the basic research stage, conducts non-clinical research, secures intellectual property, and provides business matching, licensing agreement, support relating product development regulatory affairs, support for cell therapy product preparation, clinical trial management, support for research funding, and investigational drug manufacturing through cooperation with the hospital pharmaceutical department. We will promptly and reliably support difficult tasks by highly specialized staffs who have carrier working for pharmaceutical companies, CROs, or regulating authorities. Through these kinds of support, we are making efforts day and night so that excellent research could be practical use and delivered to patients as fast as possible.
Strategic Planning Office
Strategic Planning Office strives to promote implementation of advanced medical technology seeds from academia into our society through strategic planning and facilitation of industry-government-academia collaboration. Specifically, in collaboration with relevant organizations inside and outside of Osaka University, we promote search & evaluation for academia research seeds, provide advices for implementation, and follow progress to optimize support for each seed. Furthermore, we offer various kinds of support as appropriate; such as facilitation of communication among researchers with diversified background, IP strategy development, seeking potential partner companies, and agreement negotiation.
Project Management (PM) Group
In PM group, project managers who have lots of clinical and research experiences give all the kinds of supports to researchers who promote translational research of novel medical technologies. Those include consultation aimed at practical application of new technologies, progress management, and advices for development projects. We also support patent applications and strategies, and consultations to Pharmaceuticals and Medical Devices Agency, cooperating with other groups.
Development Planning and Regulatory Affairs
Today's regulatory requirements are too complex for most of academia researchers and start-ups to comply with. The Regulatory Affairs Group of MTR provides various regulatory affairs services for them to accelerate development of innovative drugs, medical devices and regenerative medical products. The services include development of regulatory strategy, facilitating good communication with PMDA in Regulatory Science General Consultation/Regulatory Science Strategy Consultation (R&D), and promoting successful application of Advanced Medical Care B program to the MHLW. The group also provides medical writing services of clinical trial protocols, investigator brochures, clinical study reports, and other non-clinical/clinical research documents requiring highest expertise and reliability.
Cell and Genetic Medicine Unit
The Cell and Genetic Medicine Unit provides high-quality cell products for use in physician-initiated and company clinical trials to researchers aiming to develop cell and gene therapies in the future.
Under GCTP control standards, we have the number one manufacturing experiences in the country and provide detailed services that are supported by advanced technologies, including the production of iPS-related products, to meet the great need of researchers.
As a reliability assurance test, we provide a non-clinical study (tumorigenicity test) for safety evaluation.
The unit also operates a cell bank of high-quality xeno-free mesenchymal stem cells as a development basis MSC-based regenerative medicine for Academia.
The Cellular and Genetic Medicine Unit creates a future medical treatment!
Medical Device Unit
The Medical Device Unit provides comprehensive development support specialized in medical devices by taking advantage of the characteristics of academia and hospital affiliation to provide support for unmet needs finding, concept building, and clinical development of medical devices, as well as advice on exit strategies such as regulation and insurance unique to medical devices. In addition, by focusing on the field of digital health, our unit will support to resolve issues unique to SaMD（Software as a Medical Device）during development and encourage early social implementation, by providing support for practical development based on the characteristics of cutting-edge SaMD.