The Role and Contribution of Academia

Transcription

1 The Role and Contribution of Academia K-H Symposium Oct 13, 2010 Mamoru Narukawa Associate Professor Division of Pharmaceutical Medicine Kitasato University Graduate School of Pharmaceutical Sciences

2 Today s Talk The Role of Academia in New Drug Development Strength of Japan / Japanese Industry Importance of Early/Exploratory Studies Academia as a forum for human resource development 2

3 Industry, Government, and Academia Importance of collaboration among industry, government, and academia But how and what?? 3

4 The Role of Academia in New Drug Development Basic research for the discovery and synthesis of new compounds Conduct and support of clinical research Development of human resources Policy recommendations based on sound science 4

5 Closure of Laboratories in Japan Companies Laboratories in Japan Banyu-Merck &Co. Selling out of the Tsukuba Laboratory (2009) Novartis Closure of the Tsukuba Laboratory (2008) Pfizer Closure of the Central Laboratory (2008) GlaxoSmithKline Closure of the Tsukuba Laboratory (2007) Bayer Closure of the Kobe Research Center (2007) 5

6 Various Stages of Drug Development Basic Research Non-clinical Research Translational Research Clinical Studies for NDA Exploratory Confirmatory Launch Epidemiological Research 6

7 Open and Globalized Research System Clever Distinction between Open and Closed System is needed Based on the stage of the development Based on the characteristics of the research (closeness to the commercial activity, ) Synergistic Effect is expected through: Selection/concentration of research programs Risk hedging 7

8 Basis of Economic Activity Three Factors of Production Capital Labor Natural Resources Organizing Power 8

9 Strength of Japan / Japanese Industry Information exchange through human networks based on mutual trust Individual diligence, honesty, corporate loyalty Technological competence 9

10 Importance of Early/Exploratory Studies Suited to Japan/Japanese? Diligence Accumulated know-how Elaborate design, small sample size Scientific interest 10

11 Consideration from the Strategy (1) Japan US EU? Phase 3 studies Phase 1 / Phase 2 studies 11

12 Consideration from the Strategy (2) Japan US EU Third countries?? Phase 3 studies? Phase 1/ Phase 2 studies Phase 1/ Phase 2 studies 12

13 Drug Development Strategy in the age of Globalization Balance between Efficacy and Safety Balance between Profit and Expenditure Flexibility depending on the Situation Willingness to take some Risks Confidence based on knowledge and experience to take risks 13

14 Division of Pharmaceutical Medicine Kitasato University Graduate School Graduate School for Working People 10 doctoral students 3 master s students 3 students received PhD 2 students received master s degree Foster human resources capable of: Designing and implementing world-class clinical trials Developing innovative new drug development strategies with quality and efficiency Playing actively in pharmaceutical companies, regulatory agencies, and academia/medical institutions 14

15 Division of Pharmaceutical Medicine Kitasato University Graduate School Lectures and Workshops Pharmaceutical regulations Clinical trial design & analysis Development strategy, project management Health insurance, patent, licensing, organizational capacity Communication, presentation, critical thinking, debate, Investigation of review reports (JPN, US, EU) Discussion on critical issues related to drug development Drawing up clinical trial protocols and development strategies 15

16 A Forum for Discussing HRD Society for Regulatory Science of Medical Products レギュラトリーサイエンス学会 R&D, Evaluation/Review, Manufacture/Sale and Post-marketing Measures of Pharmaceuticals, Medical Devices, and others Participants from Industry, Government, and Academia Regulatory Science?? Science of evaluation and decision Regulate the advance of science and technology into the most desirable form for the individuals and society 16

17 Regulatory Science is NOT a Magic Wand Solution 17

18 Exchange of Human Resources Industry Government / Regulatory Agency Academia Government / Regulatory Agency Industry 18

19 Conclusion Establishment of strong areas and dissemination of the results Japan, Company, Individual Academia as a forum for human resource development A person capable of investigation, consideration, and communication 19

20 Thank you for your kind attention. 20