Seeds Finding, Incubation and Evaluation

Transcription

1 The REACTA FORUM November 26-27, 2015 Chiba, Japan, Chiba University School of Medicine Memorial Hall Seeds Finding, Incubation and Evaluation -Role of the Core Clinical Center in ARO Network- Kohei Ueda Designated Professor Center for Advanced Medicine and Clinical Research, Nagoya University Hospital

2 one-stop service to incubate various seeds 1 Research Support Advanced Medicine 2 Material Preparation Division 3 Quality Management 4 Information Technology 5 IP Strategy Translational Reseasrch Network Program Ministry of Education, Culture, Sports, Science and Technology (MEXT) Government Project (operated by Japan Agency for Medical Research and Development ;AMED) Innovation of Creative Center for Novel Medical Technology Integrated process from the discovery of new ideas to their advancement into clinical application Clinical Research Core Hospital Program Clinical Research Division 7 9 Quality Management 8 Monitoring Study Management Ministry of Health, Labour and Welfare (MHLW) 6 Planning

3 Process of Conventional Drug R&D Natural Products, Protein / Gene, High throughput Screening (HTS), Structure-activity relation, Chemical Synthesis, Extraction, Bio-technology, Modality, Animal Model, Manufacturing method, Formulation Development, Quality Control, Conventional drug R&D process has been established for last half century. It has been generated by the discussion between government agency and pharmaceutical industry, and made it more complex. Role of Academic Research Organization has been limited in the conventional drug R&D process. It sometimes prevents scientific innovation and advanced medicine from being promptly applied to the clinical practice. Business value creation takes precedence over clinical application in the process. Academic Research Organization (ARO) Clinical Practice Appropriate Use of Medicinal Product Toxicity Study, DMPK, Specification &Testing method, Clinical Application (Launching) Strategy Biostatics Industry Pharmacovigilance

4 Current Role of ARO in Conventional R&D Natural Products, Protein / Gene, High throughput Screening (HTS), Structure-activity relation, Chemical Synthesis, Extraction, Bio-technology, Modality, Animal Model, Manufacturing method, Formulation Development, Quality Control, Toxicity Study, DMPK, Specification &Testing method, Clinical Application (Launching) Strategy Nagoya University Hospital Funding for Clinical Research /Development Discovery Seeds A Intelectual Property Seeds B Pre-clinical POC Seeds C Clinical POC Academic Research Organization (ARO) License Out Industry Government Project Operated by AMED Innovation of creative Center for Novel Medical Technology Biostatics Clinical Practice Appropriate Use of Medicinal Product Pharmacovigilance

5 Difference in R&D between Industry and ARO Mission Industry To Secure the Source of Value Creation for the Next Business Academic Research Organization (ARO) To Develop the New Medical Service for the Next Generation Exit Product Launch Disease Cure Drug, Device, Technology, Procedures, Equipment, Systems, etc. Strategy Social and Economical Goal Process To Rely on Market Needs To Follow the conventional R&D process Profit from business: Return on invested capital To select the last candidate for clinical use from many test materials after making many STOP decision. To Respond to Medical Needs To Challenge the innovative R&D process Application of advanced medicine: Cost effectiveness To find the any way to clinical use for patient s disease treatment by making the best use of the innovation from advanced basic research Industry s Project Evaluation Criterion is not Enough for ARO Seeds Evaluation

6 Chubu Regional Consortium for Advanced Medicine C-CAM Kanazawa Univ. Gifu Univ. Aichi Med. Univ. Mie Univ. Kanazawa Medical Univ. Nagoya City Univ. Ten university hospitals and two national clinical centers clustered in network established the C-CAM, to rapidly deliver the new medical technology and devices that fulfill social needs through participation. Hokkaido Tohoku Nagoya Med. Center Nagoya University Tokyo National Center for Geriatrics and Gerontology Univ. of Toyama. Fujita Health Univ. Hamamatsu Univ. School of Med. Kyushu Okayama Kyoto Osaka Chubu Region (Central-Japan) From Nagoya and Chubu, to the World

7 Expecting Role of ARO in Sustainable R&D Natural Products, Protein / Gene, High throughput Screening (HTS), Structure-activity relation, Chemical Synthesis, Extraction, Bio-technology, Modality, Animal Model, Manufacturing method, Formulation Development, Quality Control, Toxicity Study, DMPK, Specification &Testing method, Clinical Application (Launching) Strategy Academic Research Organization (ARO) From Patients To pursue the etiology, pathology and onset mechanism To find the innovative medicine and technology for diseases To the Patients Information and bio-specimen from patients Biostatics Industry Unexpected change of bio makers, genetic mutations Unexpected clinical symptoms and findings, Adverse events Bio-bank big-data Clinical Practice Appropriate Use of Medicinal Product Pharmacovigilance

8 Nagoya University Hospital key to success of ARO network is sharing the mission, information, service, fund and fair evaluation criteria for seeds from collaborating organizations. Thank you very much