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University of Bologna ( UNIBO ) Institute of Hematology and Medical Oncology

Personalized medicine in hematological malignancies : a new horizon. Giovanni Martinelli as EHA representative ECCO-ESMO-ESTRO Congress Amsterdam 29th September. University of Bologna ( UNIBO ) Institute of Hematology and Medical Oncology “L. e A. Seragnoli” Bologna Italy.

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University of Bologna ( UNIBO ) Institute of Hematology and Medical Oncology

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  1. Personalized medicine in hematologicalmalignancies: a newhorizon Giovanni Martinelli as EHA representative ECCO-ESMO-ESTRO Congress Amsterdam 29th September University of Bologna (UNIBO) Institute of Hematology and MedicalOncology “L. e A. Seragnoli” Bologna Italy

  2. Road map of my perspective The NGS-PTL project: “From patients genomes, in few days, to be able to set up a individualized target therapy” with information by snpsarray, transcriptome-GEP and NGS thus providing for each “hematological” patients an “avatar” with pharmaco-genomic information, and providing targets suitable to personalized THERAPY. • The 'state of the art' in haematological personalized medicine research • Why a need to support haematological research?

  3. The personalized “avatar” for each haematological patient to get right target therapy, in a correct dosage, (possible at home) 1 week work = “molecular make up” CURE “Avatar” Diagnosis: es. BCR-ABL1 like ALL Genome Analyzer II (Illumina/Solexa)/Roche 454 Simulation or Computer assisted decision, in vitro identification of new drugs, etc. Design and apply experimental “individual” and personalized clinical trial (need regulatory EMEA changes ) Extra Rapid (mins not months) Bioinformatics NGS analysis ( e.g. KNOME analysis) done by a medical doctor “Back to bed, soon” reads for each gene RNA/DNA 1 day work Old Classic therapy + ? (ex. Tki, Antibiotic, Vitamin,..) Individual new therapy Old therapy combined with new (eg.TKI) therapy Individual New Target(s) diagnosis relapse

  4. The NGS-PTL project: Project details • Title:"Next Generation Sequencing platform for targeted Personalized Therapy of Leukemia“ • Acronym:NGS-PTL • Grant agreement: n. 306242 • Call identifier: FP7-HEALTH-2012-INNOVATION-1 • Funding scheme: Collaborative project • EC contribution: 5,870,815 € • Duration:3 years (starting date: 1-11-2012)

  5. Partners KatholiekeUniversiteitLeuven (KU Leuven) Belgium MuenchnerLeukaemiaLabor GmbH (MLL) Germany Personal Genomics SRL Italy MasarykovaUniverzita (MU) Czech Republic FASTERIS SA Switzerland University of ULM (UULM) Germany University of Bologna (UNIBO) Italy Fundacion De Investigacion Del Cancer De La Universidad De Salamanca (FICUS) Spain SINAPTICA IT SRL Italy University of Turin(UNITO) Italy 5 academic partners + 5 SMEs

  6. Objectives • To develop a European Hematological/NGS network of physicians and scientists. • To discover novel insights into the mechanisms involved in leukemogenesisand to develop genetic models that accurately define novel leukemia subtypes based on the genomic profile of individual patients. • To develop biostatistic andbioinformatic tools for coupling genomicdata with clinical/molecular ones. • Todevelop “leukemia diagnostic panels” to drive personalized treatmentsand tailor therapies: • To different stratified groups of leukemia patients. • To treat elderly and unfit patients • To provide out come therapies (home sweet home)

  7. Work plan 8 Work Packages (WPs) spanning a temporal frame of 36 months √ √

  8. “Cloud” based “avatar” patient information suitable for home care therapy

  9. Work plan ( first 8 months reports) 8 Work Packages (WPs) spanning a temporal frame of 36 months √ √ √ 200 Acute Myeloid leukemia 150 Acute Lymphoblastic Leukemia 130 CLL >600 hema disease.. √

  10. The 'state of the art' in haematological personalized medicine research Hematopathology has advanced in parallel with technological developments that have expanded our understanding of the phenotypic, genetic, and molecular characteristics of the hematological neoplasms.

  11. Diagnostics The future: CIRCULAR DNA ON BLOOD Screening, follow-up, clonal evolution, drug-resistance, risk-assessment, etc….. Gene/s candidate Discovery

  12. Next Generation Sequencing and identification of genetic defect and possible target for personalized therapy Landscape of Somatic Mutations in Hema Neoplasms CLL Leukemia TP53 NOTCH1 (PEST) SF3B1 (HEAT) FBXW7 MYD88 XPO1 Multiple Myeloma TP53 B-RAF Hairy Cell Leukemia B-Raf Next Generation Sequencing Acute Myeloid Leukemia MDS EZH2 IDH1 IDH2 TET2 SF1 SF3A1 SF3B1 U2AF1 ASXL1 CBL NPM1 TP53 IDH1/IDH2 EZH2 DNMT3A CEBPA CBL KRAS TET2 RUNX1 BCOR PML-RAR alpha CML and Acute Lymphoblastic Leukemia Myeloprolipherative Disease and Ph- TP53 NOTCH1 FBXW7 IKZF1 BCR-ABL IL7R CRLF2 TP53 EZH2 IDH1 IDH2 TET2 CBL KRAS

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