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1 No.16-1 March JAMTTC News Letter Japanese Association for Molecular Target Therapy of Cancer TEL: ext.5413 FAX:

2 ...1 JAMTTC AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (2011 San Francisco) JAMTTC-JSGDT

3 FDA2005Drug-Diagnostics Co-Development JAMTTC3 TR (JSGDT) JAMTTCJSGDT TR7TR TR JAMTTC March,

4 JAMTTC No No JAMTTC Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

5 PDFWORD TEL: ext FAX: jamttc@jfcr.or.jp March,

6 PDFWORD TEL: ext FAX: jamttc@jfcr.or.jp 4 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

7 () 3 () () () March,

8 Year in Review Year in Review 1 Year in Review TEL: , jamttc16@umin.ac.jp 6 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

9 March,

10 News DNA ATRA 3019Trastuzumab LapatinibHer2GefitinibErlotinibCetuximabPanitumumabLapatinib Epidermal growth factor receptoregfrimatinibbcr-ablc-kit 2011CrizotinibRuxolitinibALKJAK SorafenibSunitinibPazopanib VandetanibAxitinibImatinib Bcr-AblDasatinibNilotinib mtortemsirolimuseverolimus BRAF V600EVemurafenib2011 DNA (DNMT)AzacitidineDecitabine (HDAC)VorinostatRomidepsin4 CD20RituximabCD52Alemtuzumab (VEGF)BevacizumabRANKLDenosumabCTLA-4 IplimumabBortezomib 20121HedgehogHhVismodegib News LetterNo.15-2RuxolitinibAxitinibVismodegib3 : 8 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

11 March,

12 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (2011 San Francisco) EORTCNCI AACR 1 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 22nd EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics PKPDPhaseII , Treatment of Premalignant ConditionsClinical Trial Paradigms in the Era of Novel Therapies2Educational Session13Opening Plenary SessionNovel Clinical Paradigms in Personalized Medicine Lessons from the BRAF-Targeted Therapy of MelanomaPlenary Session14 Developing Novel Validated Preclinical ModelsMechanistic-Based ImmunotherapyPlenary Session PI3K Concurrent Session 15The Epigenome as a Therapeutic Target Targeting Tumor Stroma InteractionPlenary SessionDNA Concurrent Session16 Rational Cancer Drug Development for Targeted Drugs: The Interface Between Industry, Academia, and RegulatorsTargeting Tumor MetabolismPlenary Session Phase IPK&PD BRAFmTOR/PI3K plenary session Phase Phase disease-based drug screening 10 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

13 AACR-NCI-EORTCEORTC-NCI-ASCO J AMTTCJSGDT AACR-NCI-EORTC EORTC-NCI-ASCO2 AACR-NCI-EORTC EORTC-NCI-ASCO Molecular Markers in Cancer AACR-NCI-EORTC Vemurafenib (Zelboraf )Crizotinib (Xalkori ) FDA2005 Drug-Diagnostic Co-Development JAMTTCJSGDT 2008 Phase I microenvironmentimmunologymetastasis/invasion stem cellnew assay March,

14 tumor metabolism EORTC-NCI-ASCO5 AACR-NCI-EORTC Molecular Markers in Cancer PDF PDF 2 EORTC-NCI-ASCO AACR-NCI-EORTC EORTC-NCI-ASCO 12 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

15 (JAMTTC)(JSGDT) JAMTTCJSGDT2011 JAMTTC JSGDT FDA JAMTTCJSGDT March,

16 I I I-1 I-2 II II III 14 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

17 March,

18 16 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

19 17 March, 2012 PD PD 2 PD PD Go/NoGo PD PD PD 1 PD mtorps6 I-1 PD

20 RatainPD PD Go/NoGo PD Bolen Bolen ubiquitin-like proteins: UBLsNEDD8E1 NEDD8-activating enzymenae MLN4924MLN4924 NEDD8NAE I bulk MLN4924E3 NEDD8cullin-RING CRLs Cdt1Nrf2CRL MLN4924 Cdt1Nrf2 I NAEPD NAE DNAre-replication >4NDNA Chk1-3 PD BolenNEDD8UBLs CRLNAEPD NEDD8UBLs 18 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

21 E3 PD Go/NoGo PD March,

22 I Drug- Diagnostic Co-development 1 20 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

23 8 (MD) MD 2008 MD 2008 NEDO MD proof of concept(poc) (eind) PET MD MD 2 in vivo PET, MRI (Always ON) Activatable March,

24 PET, MRIcm mm Herceptin in vitroin vivo Herceptin ( gamma-glutamultranspeptidase, GGT) 3 ALKoma Hunting ALK ALKEML4-ALK multiplex RT-PCR ALK (iaep) (IHC)EML4-ALK IHC EML4-ALK ALK 5-RACEKLC- ALKALK ALK ALK 3 22 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

25 II 1 / DNARNAEU (ICH)E15 2FDA Valid Biomarkers Known Valid Biomarkers Probable Valid Biomarkers March,

26 Exploratory Biomarkers outocome AHRQ EGAPPEvidence-Based Review of Genomic Tests 3UGT1A1 genotypinginsufficient evidence Centers for Disease Control and Prevention, CDC ACCE wheel 4Analytic Validity Clinical Validity Clinical Utility [Ethical, legal, and social implications(elsi)]4 ACCEACCE OECDCDC JCCLS Tentative Guideline 4 24 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

27 4 () Pharmacogenomics Working Group SNP (UGT1A1CYP2C19CYP3A5 CYP2C9VKORC1) k-ras SNP March,

28 ( ) (JCCLS) ( ( ( ) JCCLS (201012) home-brew 26 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

29 )(PGx) UGT1A1 () ()PGx PGx PGx PGx UGT1A14 PGx PGx PGx PGx March,

30 4 Molecular Targets and Cancer Therapeutics PGx PGx K-Ras PGx PGx CoDx 28 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

31 codevelopment March,

32 30 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

33 31 March, 2012

34 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

35 March,

36 34 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

37 March,

38 36 Japanese Association for Molecular Target Therapy of Cancer News Letter No.16-1

39

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