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1 Munich Biotech Cluster m 4 m 4 Personalized Medicine and Targeted Therapies Bio M Biotech Cluster Development GmbH

2 Content Clustermanagement by Bio M Profile of the Munich Biotech Cluster m 4 Leading-Edge Cluster m 4 Personalized Medicine m 4 R&D projects m 4 structural projects

3 History of the Munich Biotech Cluster 1989 Munich s first biotech company is founded 1996 Munich is awarded in the BioRegio Competition of the BMBF(DM 50 mio.) 1997 Bio M ist founded as a central point of contact for the Greater Munich Area 2007 Munich is awarded in the BioIndustry 2021 Competition (industrial biotechnology) of the BMBF ( 5 mio.) 2010 Munich is awarded in the Leading-Edge Cluster Competition of the BMBF( 40 Mio.) 2013 Today about 260 Life Science companies employees in industry and science

4 Bio M cluster management since 1996 SME Consulting about funding Partnering Business development Networking Vocational training Events Big Pharma Partnering Seminars & workshops Networking Events Academia Scouting & Incubation Consulting for start-ups Consulting about funding

5 Mission of Bio M Bio M is the central point of contact for biotechnology in Munich and Bavaria. The major goal of Bio M is to foster the development of the Munich & Bavarian Biotech Cluster and promote it as one of the leading life science clusters in Europe.

6 Campus Martinsried-Großhadern Location of Bio M Source: IZB

7 Content Clustermanagement by Bio M Profile of the Munich Biotech Cluster m 4 Leading-Edge Cluster m 4 Personalized Medicine m 4 R&D projects m 4 structural projects

8 The Munich Biotech Cluster m 4 is a SME cluster Biotech Small and Medium Companies (SMEs) 26 Biotech Companies (non- SMEs) Contract Research Organisations (CROs) Pharma companies Unternehmen Others Number of Biotech Companies in the Greater Munich Area, Bio M Mitarbeiter employees Mitarbeiter employees Mitarbeiter employees 1-10 Mitarbeiter employees Per cent

9 The Munich Biotech Cluster m 4 is a TxDx Cluster Fields of Activity of Munich s Biotech SME, in %, Bio M 2010

10 Content Clustermanagement by Bio M Profile of the Munich Biotech Cluster m 4 Leading-Edge Cluster m 4 Personalized Medicine m 4 R&D projects m 4 structural projects

11 Leading-Edge Cluster Competition mio. funding from BMBF < 40 mio. from industy < 10 Mio. from state of Bavaria About 100 mio. for Personalized Medicine in the next 5 years 35 R&D projects 5 Structural projects Fostering of collaborations between small and medium-sized entreprises, large companies and academia.

12 m 4 Partners for innovation and develoment

13 Personalized medicine takes into account therapyrelevant differences between patient groups

14 Personalized medicine increases the efficacy of drugs 90% of all drugs are efficeint in only % of the patient population The Case for Personalized Medicine, 2011.

15 Personalized medicine increases the efficiency of drug development 800 mio. US-$ per new therpeutic Time-to-market years and attrition rates of 90% Attition rates cause a yearly loss of about 300 mio. US-$ Phase III and submission failures, n=83 Nature Rev Drug Discov 10: 87 ( 2011 ) Deficient efficacy (66%) and safety (21%) are main reasons for attritions

16 A new Dimension in Drug Development Symptom 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 development Personalized Medicine tailored for patient (sub)populations more effective drugs safer drugs lower failure rates up to10 x smaller clinical trials lower costs for clinical trials classical diagnosis classical diagnosis + biomarker tests

17 Personalized medicine is an integrative concept Biomarker Genom, Epigenom, Transcriptom, Proteom, Metablom, Prediction Response Dose Prognosis Patient history Familiy diseases Age, sex, Psyche, Compliance Diagnosis Clinical parameters Multi morbiditity Medication Life style Nutrition BMI Best therapy available

18 Five m 4 structural projects support the valued-added chain of personalized medicine m 4 Scouting & Incubation m 4 Award, m 4 Scouts identification & incubation m 4 eacademy Master of Translational Science and Drug Development; Executive MBA of Life Science innovation personell m 4 R&D projects research preclinic biomarker identification and validation clinical Phase I - III approval clinical validation test kit certification Bio probes onsulting, patient recruiting m 4 Biobank Alliance central access, ethical and legal harmonization, shared quality standards information m 4 Trial Service Center services and consulting phase I unit information m 4 Data Integration System information integration, web portal

19 Content Clustermanagement by Bio M Profile of the Munich Biotech Cluster m 4 Leading-Edge Cluster m 4 Personalized Medicine m 4 R&D projects m 4 structural projects

20 m 4 R&D cooperation projects Biomarker development: PM2: Biomarker-gestützte funktionelle Wirkstofftestung PM6: Bestimmung von Immun- und Tumorparametern im Serum PM7: Imaging BM für Tumoresponse PM8: CT und MRT als Biomarker PM13: Integrale Netwerkanaylse zur Stratifizierung PM15: Biobank der Blutspender, Plattform für Präventivdiagnostik PM16: Wirksamkeitsvorhersagen über Phosphosignaturen PM20: Identifikation von Mutationen beim malignen Melanom als BM PM21: Bildgebende LRRK2 BM bei Parkinson PM23: KIR1.4 Antikörper als BM zu Prognose, Prädiktion und Monitoring bei MS PM24: NGS Ansatz zur Identifizierung von BM für Schizophrenie PM25: BM beim Adenokarzinom aus Barett Ösophagus PM27: BM Identifizierung bei Helicobacter pylori Infektion drug target bei Magenkrebs Drug development preclinical development: PM1: Individualisierte Therapie neuroendokriner Tumore PM4: Immunmonitoring innerhalb eines IIT mit Catumaxumab und FBTA05 PM5: Innovative Stammzellbasierte Therapie für maligne und nicht-maligne Erkrankungen PM9: Bildgebende Verfahren zur Unterstützung der antiangiogentischen Therapie mittels eines RGD-Peptids PM10: Herstellung von Fluor-18 markierten PET Radiotracern für die personalisierte Medizin PM14: Reversible Streptamer Reagenzien für die klinische Zelltherapie PM18: Präklinsche Entwicklung eines gegen c-met gerichteten Anticalins PM19: Entwicklung eines IL-3 spezifischer Antikörpers für die Behandlung von rheumatoider Arthritis PM26: Präklinische Entwicklung eines TLR7/8 Antagonisten für die Tumortherapie

21 m 4 R&D cooperation projects New therapeutics T2: Zyklopeptid COR-1 gegen Herzinsuffizienz verkauft an Janssen T3: Präklinische u. klinische Entwicklung eines PI3 Kinase Inhibitors T4: CD38 mab zur Behandlung hämatologischer Tumore T5: Fc Rezeptoren zur Therapie von Autoimmunerkrankungen T6: micro RNA basierte Therapien für kardiovaskuläre Erkrankungen T9: Inhibitoren gegen essentielle bakterielle targets Plat form technologies T14: Targeting von Biotherapeutika in die Lunge T15: Pasylation" für optimierte Pharmakokinetik T16: Rekombinante Spinnenseide als Biomaterialträger T17: Strukturbasierte AK-Charakterisierung T18: Verbesserung der Effektivität und Spezifität von RNAi Ansätzen P2: Transgene Produktionsplattform für rekombinante Antikörper P3: Herstellungsbereich für GLP Produktionen für präklinische Testungen PK1: Advances Preclinical Animal Models Großtiermodelle

22 Example: Spherotec GmbH, LMU und MRI: Diagnostic platform for cancer therapy decision 1st step: biomarker profiling tissue Sterile tumor sample Grinding biomarker profiling Therapy relevant molecules Resistence marker Selection of drugs with best possible efficacy Cancer patient 2nd step: Spheroid Technology TM Micro tumors In vitro therapy of micro tumors efficacy/dose/sequence Best possible therapy for the individual patient physician 9 days Optimal therapy

23 Example: CD38 mab (MOR202) as a therapy against hematological tumors Approved drugs Direct effects NK cell activation Multiples Myelom Tumormodell in der Maus Inokulation der MM Zellen in die Tiba Kontrolle µ-ct Analyse der Tibia Fc Receptor MOR202 (Anti-CD38) Inokuliert CD38 ADCC AK Vermittelte Zytoloyse Synergistic efficacy by combination antibody

24 Example: Advanced Preclinical Animal Models Preclinical studies Validation of (newly) established animal modesl Development of new animal models for m 4 partners Translation into the clinic Drug discovery Preclinical tests Patient New biomarkers Applicable Models Proof of principle Similarities in physiology/anatomy Used in m 4 projects concerning Cell therapy Respiratory diseases Cancer therapy Diabetes

25 Content Clustermanagement by Bio M Profile of the Munich Biotech Cluster m 4 Leading-Edge Cluster m 4 Personalized Medicine m 4 R&D projects m 4 structural projects

26 m 4 Scouting & Incubation: support for innovation and startups in the area of personalized medicine m 4 Award New regional competition funding for innovative pre-seed projects m 4 Incubation Targeted development of the projects by individual and professional project management m 4 Scouting Targeted identification and support for research projects with high innovation potential m 4 Mentor Circle Mentoring programme for scientists and young entrepreneurs

27 m 4 eacademy Establishment of a Master and EMBA proramme for Life Sciences Master of Translational Science and Drug Development Master of Business Administration Life Science Custom-fit Specialised vocational training for managers and scientists aiming at the challenges of personalized medicine Modular and extra-occupational Flexible training Application-oriented and international Curricula developed in cooperation with industry

28 m 4 Biobank Alliance provides a central access to high-quality bioprobes Ethical standards Transparency ethics, governance, framework Central access Central contact for industry and science m 4 Biobank Services Center Quality Informed consent LMU Biobank i.a. HTCR Pathology, Surgery, Clinical Chemistry TUM Biobank Pathology, Surgery, (Clinical Chemistry) Helmholtz Zentrum München Integration of further clincal institutes Integration of/ cooperation with further biobanks High, common quality standards 28

29 m 4 Data Integration System: Data management and processing Inter-institutional infrastructure Central portal, data warehouse ID management, pseudonymisation, anonymisation Clinical systems Identity, diagnosis, therapy Patient record Follow up of clinical data Research systems encrypted identity analysis data Follow-up of molecular data

30 m 4 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 m 4 structural projects (m 4 Biobank Alliance and m 4 Data Integration System)

31 Contact Bio M Biotech Cluster Development GmbH Am Klopferspitz 19a Martinsried Germany Phone: +49 (0) Fax: +49 (0) Web Cluster management Bio M Personalized Medicine in Munich

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