State of the Biotechnology Industry in Japan

Global Forum on Biotechnology, OECD, Nov.12,2012

The Next Challenges in Biotechnology of Japan

Mitsuru Miyata, The excutive leader writer, Nikkei Business Publications,Inc. 宮田満日経BP社

Outline

Current status of BT and Pharma in Japan History :National Policy to promote BT Top down Policy does not go well now. The Next Challenges of BT in Japan For Last minutes, critical problems in Biotechnology in Japan

Expected market in 2010 on “National BT Strategy ” Medical Foods 8.4 trillion yen 6.3 trillion yen

＊Pharmaceuticals ＊Functional Foods (3.2) ＊Medical devices ＊ Others (3.1) Total

25 Tools/Informatics Environment/Energy trillion yen

4.2 trillion yen 5.3 trillion yen ＊Bio-process (3.6) ＊Instruments/Reagents(3.1) ＊Biomass (0.2) ＊Bioinformatics (2.2) ＊Bioremediation (0.4)

25 trillion yen = 220 bil. dollars 21 Real Bio Market in Japan

Over 2.4Tyen in 2010

( in M\ ) Pharma in Japan are failing down Patent expiration of Major Product

Conservative culture Bad and Poor Science Policy Gap between industry and Academy Poor venture financing and activity Poor Public Acceptance especially to GMO

The New strategy for national growth by DPJ Dec.39,09 Av.3% GDP Growth until 2020 GDP 650 T Yen in 2020 (473T Yen,2009) Unemployment rate less than 4%

Emerging Technology Information 9 Center、All Right Reserved, Nikkeib Business Publications,Inc.2003 Goal :Job Creation for Brain workers No one believes the policy in Japan Energy/Environment Health/Medical/Care

Emerging Technology Information 11 Center、All Right Reserved, Nikkeib Business Publications,Inc.2003 But, Big Pharma may loose good opportunities of Bio Innovation in Japan New type of biotechnological research based on Japanese culture ----Full Length cDNA Project

not enough money and human resources for whole human genome analysis in Japan From 1997, focusing research on full length cDNA due to less than 1% of genome Now, We have about 30,000 cDNA Applying to Targeted Proteomics to find the function of genes and make them patentable. Full Length cDNA Project leads to Innovation of iPS Cell Full Length cDNA Project leads to Innovation of iPS Cell 20th Nov,2007 Human iPS Cell 2006, Murine iPS Cell Established 4Genes Introduced Oct3/4、Sox2、（c- Myc）、Klf4 ,selected from cDNA Database

New type of biotechnological research based on Japanese culture Personalized Medicine

Hap- map Program  Genomic Cohort study From 2003, the national program collecting DNA and MR from 300,000 patients

GWAS can find genes with high risk of diseases

Disease Risk gene

50万個のSNPが並んでる〔鎌谷、2008） Poteligent CH Engneering

Eradication fucose from IgG Poteligeo Launched 29 May in 2012 Kyow Kirin antiCCR4 Mab with modified Sugar chains/ Adult T Cell Leukemia

Emerging Technology Information 19 Center、All Right Reserved, Nikkeib Business Publications,Inc.2003 The only one commercial plant for recombinant hAlbumin Oct. 2007 operation Pichia based Fermentation plant

Bio Computer Super Computer “KEI” began operation in Sept. of 2012

Emerging Technology Information 22 Center、All Right Reserved, Nikkeib Business Publications,Inc.2003 Molecular Dynamics Protein/Ligand Simulation with KEI Virtual Drug Discovery 3.5PFLOPSの京コンピュータ上で、 1.315PFLOPSの性能を達成 効率 37% 細胞混雑下でのタンパク質動態シミュレーション 1.8億原子、カットオフ これまで行われたタンパク質の分子動力学シミュレーションで最高の性能 ※ 本成果は、グランドチャレンジプロジェクト「次世代生命体統合シミュレーション」の一環であり、早期の成果創出の要求に基づきマシン割り当てに特別な配慮をいただいて実現したものです。 23 New type of biotechnological research based on Japanese culture ----Functional Food  Food for enhancing health , based on research of traditional dishes in Japan  Our longevity is partly due to Japanese food  More than 2000M$ for functional food market  Modern Biotechnology is applied to study and to understand healthy element in food at molecular level

March 11th ,2011 East Japan Earthquake and Tsunami

Emerging Technology Information 25 Center、All Right Reserved, Nikkeib Business Publications,Inc.2003 Big Money to RecoverTohoku area Some in Advanced Medicine Tohoku Medical Megabank 15.8Byen（2011）＋5.6Bye（2012） 3Generation Genome Cohort、150,000people Multi Omics Research Center Fukushima Drug Discovery Platform 25.8Bye for 10years from 2012 Multi Omics Research Center Fukushima Pref. Med. Examination 2Mpeople Emerging Technology Information Center、All Right Reserved, Nikkeib 26Business Publications,Inc.2003 Multi Omics Research Center in Fukusima

Source: OECD 1999-2004, IVC Research Center 2004 Failure to Get Public Acceptance to GMO in last 2decades Almost everyone believe no GMO in Japan The largest importer of GMO on the globe is Japan Japanese travelers love to eat rPapaya in Hawaii nether in Japan

Hoping Bright Future By Continuous Scientific Innovation By Fusing BT,ICT, NT and ET By Combining Innovation , Precise Manufacturing and Design By Creating and Financing Smart Bioventure Companies BY Alliance with Global Talent and Brain The Last Critical Question: Can we pay for Next Biotechnological Inovation? 10.0% of GDP for Healthcare 1000TYen National Debt The fastest aging society on the globe. The Final Option →VAT or DEAD/Debt  Austria ２０．０１%  France ２０．６１%  Italy ２０．０１ %  Germany １６．０１%  England １７．５%

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