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www.m4.deMunich Biotech Cluster m4–m4 – Personalized Medicine and Targeted TherapiesBioM Biotech Cluster Development GmbH
www.m4.deContent• Clustermanagement by BioM• Profile of the Munich Biotech Cluster m4• Leading-Edge Cluster “m4 – Personal...
www.m4.de1989 Munich’s first biotech company is founded1996 Munich is awarded in the BioRegio Competition of theBMBF(DM 50...
www.m4.deBioM – cluster management since 1996• Scouting & Incubation• Consulting for start-ups• Consulting about fundingAc...
www.m4.deMission of BioMBioM is the central point of contact forbiotechnology in Munich and Bavaria.The major goal of BioM...
www.m4.deSource: IZBLocation of BioMCampus Martinsried-Großhadern
www.m4.deContent• Clustermanagement by BioM• Profile of the Munich Biotech Cluster m4• Leading-Edge Cluster “m4 – Personal...
www.m4.deThe Munich Biotech Cluster m4 is a SME cluster129265329 25Biotech Smalland MediumCompanies(SMEs)BiotechCompanies ...
www.m4.deThe Munich Biotech Cluster m4 is a TxDx Cluster010203040506070Fields of Activity of Munich’s Biotech SME,in %, Bi...
www.m4.deContent• Clustermanagement by BioM• Profile of the Munich Biotech Cluster m4• Leading-Edge Cluster “m4 – Personal...
www.m4.deLeading-Edge Cluster Competition 2010€ 40 mio. funding from BMBF< € 40 mio. from industy< € 10 Mio. from state of...
www.m4.dem4 – Partners for innovation and develoment
www.m4.dePersonalized medicine takes into account therapy-relevant differences between patient groups
www.m4.dePersonalized medicine increases the efficacy of drugs• 90% of all drugs are efficeint in only 30-60 % of the pati...
www.m4.de• 800 mio. US-$ per new therpeutic• Time-to-market 10-15 years and attrition rates of 90%• Attition rates cause a...
www.m4.deA new Dimension in Drug DevelopmentSymptom Based Medical Treatments• „one fits all“ / blockbuster approach• limit...
www.m4.dePatient historyFamiliy diseasesAge, sex,…Psyche, CompliancePersonalized medicine is an integrative conceptBest th...
www.m4.deFive m4 structural projects support the valued-addedchain of personalized medicinem4 Trial Service Centerservices...
www.m4.deContent• Clustermanagement by BioM• Profile of the Munich Biotech Cluster m4• Leading-Edge Cluster “m4 – Personal...
www.m4.deBiomarker development:PM2: Biomarker-gestützte funktionelle WirkstofftestungPM6: Bestimmung von Immun- und Tumorp...
www.m4.deNew therapeuticsT2: Zyklopeptid COR-1 gegen Herzinsuffizienz – verkauft an JanssenT3: Präklinische u. klinische E...
www.m4.deExample: Spherotec GmbH, LMU und MRI: Diagnosticplatform for cancer therapy decisionCancerpatient2nd step: Sphero...
www.m4.deExample: CD38 mAb (MOR202) as a therapy againsthematological tumorsCD38MOR202(Anti-CD38)ADCCApproved drugsNK cell...
www.m4.deTranslation into the clinic Preclinical studies Validation of (newly) established animal modesl Development of...
www.m4.deContent• Clustermanagement by BioM• Profile of the Munich Biotech Cluster m4• Leading-Edge Cluster “m4 – Personal...
www.m4.dem4 Scouting & Incubation: support for innovation and start-ups in the area of personalized medicine• m4 AwardNew ...
www.m4.dem4 eAcademy – Establishment of a Master and EMBAproramme for Life Sciences• Custom-fitSpecialised vocational trai...
www.m4.dem4 Biobank Alliance provides a central accessto high-quality bioprobesQualityInformedconsentLMU Biobank i.A. HTCR...
www.m4.dem4 Data Integration System:Data management and processing• Clinical systemsIdentity, diagnosis, therapyPatient re...
www.m4.dem4 Trial Service Center (TSC)• Consulting for translational research and development• Network of experts for clin...
www.m4.de• ContactBioM Biotech Cluster Development GmbHAm Klopferspitz 19a82152 MartinsriedGermanyPhone: +49 (0) 89 89 96 ...
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  1. 1. www.m4.deMunich Biotech Cluster m4–m4 – Personalized Medicine and Targeted TherapiesBioM Biotech Cluster Development GmbH
  2. 2. www.m4.deContent• Clustermanagement by BioM• Profile of the Munich Biotech Cluster m4• Leading-Edge Cluster “m4 – Personalized Medicine”• m4 R&D projects• m4 structural projects
  3. 3. www.m4.de1989 Munich’s first biotech company is founded1996 Munich is awarded in the BioRegio Competition of theBMBF(DM 50 mio.)1997 BioM ist founded as a central point of contact for the GreaterMunich Area2007 Munich is awarded in the BioIndustry 2021 Competition(industrial biotechnology) of the BMBF (€ 5 mio.)2010 Munich is awarded in the Leading-Edge Cluster Competitionof the BMBF(€ 40 Mio.)2013 Today about 260 Life Science companies30.000 employees in industry and scienceHistory of the Munich Biotech Clusterwww.bio-m.org
  4. 4. www.m4.deBioM – cluster management since 1996• Scouting & Incubation• Consulting for start-ups• Consulting about fundingAcademiaBig Pharma• Partnering• Seminars & workshops• Networking• EventsSME• Consulting about funding• Partnering• Business development• Networking• Vocational training• Eventswww.bio-m.org
  5. 5. www.m4.deMission of BioMBioM is the central point of contact forbiotechnology in Munich and Bavaria.The major goal of BioM is to foster thedevelopment of the Munich & BavarianBiotech Cluster and promote it as one ofthe leading life science clusters in Europe.www.bio-m.org
  6. 6. www.m4.deSource: IZBLocation of BioMCampus Martinsried-Großhadern
  7. 7. www.m4.deContent• Clustermanagement by BioM• Profile of the Munich Biotech Cluster m4• Leading-Edge Cluster “m4 – Personalized Medicine”• m4 R&D projects• m4 structural projects
  8. 8. www.m4.deThe Munich Biotech Cluster m4 is a SME cluster129265329 25Biotech Smalland MediumCompanies(SMEs)BiotechCompanies (non-SMEs)ContractResearchOrganisations(CROs)PharmacompaniesUnternehmenOthersNumber of Biotech Companiesin the Greater Munich Area,BioM 20100 20 40 60 801-10 Mitarbeiter11-50 Mitarbeiter51-100 Mitarbeiter101-250 MitarbeiterPer centemployeesemployeesemployeesemployees
  9. 9. www.m4.deThe Munich Biotech Cluster m4 is a TxDx Cluster010203040506070Fields of Activity of Munich’s Biotech SME,in %, BioM 2010
  10. 10. www.m4.deContent• Clustermanagement by BioM• Profile of the Munich Biotech Cluster m4• Leading-Edge Cluster “m4 – Personalized Medicine”• m4 R&D projects• m4 structural projects
  11. 11. www.m4.deLeading-Edge Cluster Competition 2010€ 40 mio. funding from BMBF< € 40 mio. from industy< € 10 Mio. from state of Bavaria About € 100 mio. forPersonalized Medicine in thenext 5 years35 R&D projects5 Structural projectsFostering of collaborations betweensmall and medium-sized entreprises,large companies and academia.www.m4.de
  12. 12. www.m4.dem4 – Partners for innovation and develoment
  13. 13. www.m4.dePersonalized medicine takes into account therapy-relevant differences between patient groups
  14. 14. www.m4.dePersonalized medicine increases the efficacy of drugs• 90% of all drugs are efficeint in only 30-60 % of the patient populationThe Case for Personalized Medicine, 2011.
  15. 15. www.m4.de• 800 mio. US-$ per new therpeutic• Time-to-market 10-15 years and attrition rates of 90%• Attition rates cause a yearly loss of about 300 mio. US-$Phase III and submission failures, n=83Nature Rev Drug Discov 10: 87 ( 2011 )• Deficient efficacy (66%) and safety (21%) are main reasons forattritionsPersonalized medicine increases the efficiency ofdrug development
  16. 16. www.m4.deA new Dimension in Drug DevelopmentSymptom Based Medical Treatments• „one fits all“ / blockbuster approach• limited efficacy (only 40-60%)• high rate of unwanted side effects• high number of failures• long development times• high costs for drug developmentPersonalized Medicine• tailored for patient (sub)populations• more effective drugs• safer drugs• lower failure rates• up to10 x smaller clinical trials• lower costs for clinical trialsclassicaldiagnosisclassical diagnosis+ biomarker tests
  17. 17. www.m4.dePatient historyFamiliy diseasesAge, sex,…Psyche, CompliancePersonalized medicine is an integrative conceptBest therapy availableDiagnosisClinical parametersMulti morbiditityMedicationLife styleNutritionBMIPredictionResponseDosePrognosisBiomarkerGenom, Epigenom, Transcriptom, Proteom, Metablom,…
  18. 18. www.m4.deFive m4 structural projects support the valued-addedchain of personalized medicinem4 Trial Service Centerservices and consultingphase I unitonsulting, patient recruitingBio probesm4 Biobank Alliancecentral access, ethical and legal harmonization,shared quality standardsinformationinformationm4 Data Integration Systeminformation integration, web portalm4 eAcademyMaster of Translational Science and Drug Development;Executive MBA of Life Sciencepersonellinnovationm4 Scouting & Incubationm4 Award, m4 Scoutsidentification & incubationm4 R&Dprojectsresearch clinical Phase I - IIIpreclinic approvalclinical validation test kit certificationbiomarker identification and validation
  19. 19. www.m4.deContent• Clustermanagement by BioM• Profile of the Munich Biotech Cluster m4• Leading-Edge Cluster “m4 – Personalized Medicine”• m4 R&D projects• m4 structural projects
  20. 20. www.m4.deBiomarker development:PM2: Biomarker-gestützte funktionelle WirkstofftestungPM6: Bestimmung von Immun- und Tumorparametern im SerumPM7: Imaging BM für TumoresponsePM8: CT und MRT als BiomarkerPM13: Integrale Netwerkanaylse zur StratifizierungPM15: Biobank der Blutspender, Plattform für PräventivdiagnostikPM16: Wirksamkeitsvorhersagen über PhosphosignaturenPM20: Identifikation von Mutationen beim malignen Melanom als BMPM21: Bildgebende LRRK2 BM bei ParkinsonPM23: KIR1.4 Antikörper als BM zu Prognose, Prädiktion und Monitoring bei MSPM24: NGS Ansatz zur Identifizierung von BM für SchizophreniePM25: BM beim Adenokarzinom aus Barett ÖsophagusPM27: BM Identifizierung bei Helicobacter pylori Infektion – drug target bei MagenkrebsDrug development – preclinical development:PM1: Individualisierte Therapie neuroendokriner TumorePM4: Immunmonitoring innerhalb eines IIT mit Catumaxumab und FBTA05PM5: Innovative Stammzellbasierte Therapie für maligne und nicht-maligne ErkrankungenPM9: Bildgebende Verfahren zur Unterstützung der antiangiogentischen Therapie mittels eines RGD-PeptidsPM10: Herstellung von Fluor-18 markierten PET Radiotracern für die personalisierte MedizinPM14: Reversible Streptamer Reagenzien für die klinische ZelltherapiePM18: Präklinsche Entwicklung eines gegen c-met gerichteten AnticalinsPM19: Entwicklung eines IL-3 spezifischer Antikörpers für die Behandlung von rheumatoider ArthritisPM26: Präklinische Entwicklung eines TLR7/8 Antagonisten für die Tumortherapiem4 R&D cooperation projects
  21. 21. www.m4.deNew therapeuticsT2: Zyklopeptid COR-1 gegen Herzinsuffizienz – verkauft an JanssenT3: Präklinische u. klinische Entwicklung eines PI3 Kinase InhibitorsT4: CD38 mAb zur Behandlung hämatologischer TumoreT5: Fc Rezeptoren zur Therapie von AutoimmunerkrankungenT6: micro RNA basierte Therapien für kardiovaskuläre ErkrankungenT9: Inhibitoren gegen essentielle bakterielle targetsPlat form technologiesT14: Targeting von Biotherapeutika in die LungeT15: „Pasylation" für optimierte PharmakokinetikT16: Rekombinante Spinnenseide als BiomaterialträgerT17: Strukturbasierte AK-CharakterisierungT18: Verbesserung der Effektivität und Spezifität von RNAi AnsätzenP2: Transgene Produktionsplattform für rekombinante AntikörperP3: Herstellungsbereich für GLP Produktionen für präklinische TestungenPK1: Advances Preclinical Animal Models – Großtiermodellem4 R&D cooperation projectshttp://www.m4.de
  22. 22. www.m4.deExample: Spherotec GmbH, LMU und MRI: Diagnosticplatform for cancer therapy decisionCancerpatient2nd step: Spheroid TechnologyTMtissueSterile tumor sampleSelection of drugs with bestpossible efficacybiomarker profiling Therapy relevantmolecules Resistence markerGrindingMicro tumors In vitro therapy of micro tumorsefficacy/dose/sequenceOptimal therapyphysician1st step: biomarker profiling9 daysBest possible therapy for the individual patient
  23. 23. www.m4.deExample: CD38 mAb (MOR202) as a therapy againsthematological tumorsCD38MOR202(Anti-CD38)ADCCApproved drugsNK cellactivationDirecteffectsFc ReceptorantibodyInokuliertKontrolleµ-CTAnalyse derTibiaInokulation der MMZellen in die TibaMultiples MyelomTumormodell in der MausAK Vermittelte ZytoloyseSynergistic efficacyby combination
  24. 24. www.m4.deTranslation into the clinic Preclinical studies Validation of (newly) established animal modesl Development of new animal models for m4 partnersDrug discovery Preclinical tests PatientNew biomarkers Applicable ModelsProof of principle Similarities in physiology/anatomyExample: “Advanced Preclinical Animal Models”Used in m4 projects concerning Cell therapy Respiratory diseases Cancer therapy Diabetes
  25. 25. www.m4.deContent• Clustermanagement by BioM• Profile of the Munich Biotech Cluster m4• Leading-Edge Cluster “m4 – Personalized Medicine”• m4 R&D projects• m4 structural projects
  26. 26. www.m4.dem4 Scouting & Incubation: support for innovation and start-ups in the area of personalized medicine• m4 AwardNew regional competitionfunding for innovative pre-seed projects• m4 IncubationTargeted development of the projects byindividual and professional projectmanagement• m4 ScoutingTargeted identification and support forresearch projects with high innovationpotential• m4 Mentor CircleMentoring programme for scientistsand young entrepreneurs
  27. 27. www.m4.dem4 eAcademy – Establishment of a Master and EMBAproramme for Life Sciences• Custom-fitSpecialised vocational training formanagers and scientists aiming at thechallenges of personalized medicine• Modular and extra-occupationalFlexible training• Application-oriented and internationalCurricula developed in cooperation withindustry• Master of Translational Science and Drug Development• Master of Business Administration Life Science
  28. 28. www.m4.dem4 Biobank Alliance provides a central accessto high-quality bioprobesQualityInformedconsentLMU Biobank i.A. HTCRPathology, Surgery, Clinical ChemistryTUM BiobankPathology, Surgery, (Clinical Chemistry)ethics, governance, frameworkm4BiobankServicesCenterCentral accessCentral contact forindustry andscienceHigh, commonquality standardsIntegration of furtherclincal institutesIntegration of/cooperation withfurther biobanksTransparencyEthical standards28Helmholtz Zentrum München
  29. 29. www.m4.dem4 Data Integration System:Data management and processing• Clinical systemsIdentity, diagnosis, therapyPatient recordFollow up of clinical data• Research systemsencrypted identityanalysis dataFollow-up of molecular data• Inter-institutional infrastructure• Central portal, data warehouse• ID management, pseudonymisation, anonymisation
  30. 30. www.m4.dem4 Trial Service Center (TSC)• Consulting for translational research and development• Network of experts for clinical studies• Infrastructure & ressources for clinical studies: Service unit for early clinical phases Imaging Center Technology platforms• Network of experts / clinics / service providers• Synergy with other m4 structural projects(m4 Biobank Alliance and m4 Data Integration System)
  31. 31. www.m4.de• ContactBioM Biotech Cluster Development GmbHAm Klopferspitz 19a82152 MartinsriedGermanyPhone: +49 (0) 89 89 96 79 - 0Fax: +49 (0) 89 89 96 79 -79Email: info@bio-m.org• WebCluster management BioM http://www.bio-m.orgPersonalized Medicine in Munich http://www.m4.de
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