As we see with the rapid spread of open innovation, academia is increasingly expected to contribute to the development of therapeutic technologies against intractable and rare diseases, the treatment of which is currently unsatisfactory.
Meanwhile, the development of translational research institutes is underway with the CTSA program of NIH in the United States and AMED in Japan. These organizations are supposed to "sow the seeds" from academia and support its exit strategies. Regulatory agencies such as PMDA have also agreed to support the development of seeds from academia.
The development of medicines and medical devices demands a great outlay of resources and time to put them to practical use. For this reason, it is important to have an exit strategy that looks ahead to global expansion right from the start. Moreover, seeds from academia require the early transfer of technology to business enterprises so that research and development can be spurred.
Pursuing global expansion requires, for each country and region where you operate, a correct understanding about differences in particulars such as the disease structure, the system for provision of healthcare, regulatory requirements, amortization of insurance and the funds for research. You also need know-how for facilitating development with an approach tailored to the relevant country and region. If the translational research institutes grow capable of facilitating cooperation among different countries and regions and supporting global development from an early stage, more opportunities for open innovation and early clinical development could be expected.
This symposium will include an explanation about the current activities of the Japanese and U.S. translational research institutes, and a discussion about problems in international cooperation in open innovation and clinical developments and about cooperation between institutes and regulatory agencies.
●Date&time: September 27 (Wed) 16:30-19:10
●Venue: Nihonbashi Life Science Building 201 Conference Room
●Registration site: Click here
●Registration fee: Free
●Hosted by: UC San Diego, Tukuba Clinical Research and Development Organization (T-CreDO), LINK-J
For inquiry, please contact LINK-J
【E-mail】contact@link-j.org
【Tel】03-3241-4911
