Munich biotech cluster
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www.m4.de Munich Biotech Cluster m 4 – m 4 – Personalized Medicine and Targeted Therapies Bio M Biotech Cluster Development GmbH
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Personalized Medicine M4
Transcript of Munich biotech cluster
www.m4.de
Munich Biotech Cluster m4 –
m4 – Personalized Medicine and Targeted Therapies
BioM Biotech Cluster Development GmbH
www.m4.de
Content
• Clustermanagement by BioM
• Profile of the Munich Biotech Cluster m4
• Leading-Edge Cluster “m4 – Personalized Medicine” • m4 R&D projects • m4 structural projects
www.m4.de
1989 Munich’s first biotech company is founded
1996 Munich is awarded in the BioRegio Competition of the
BMBF(DM 50 mio.)
1997 BioM 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
30.000 employees in industry and science
History of the Munich Biotech Cluster
www.bio-m.org
www.m4.de
BioM – cluster management since 1996
• Scouting & Incubation • Consulting for start-ups • Consulting about funding
Academia
Big Pharma
• Partnering
• Seminars & workshops
• Networking
• Events
SME • Consulting about funding
• Partnering
• Business development
• Networking
• Vocational training
• Events
www.bio-m.org
www.m4.de
Mission of BioM
BioM is the central point of contact for
biotechnology in Munich and Bavaria.
The major goal of BioM is to foster the
development of the Munich & Bavarian
Biotech Cluster and promote it as one of
the leading life science clusters in Europe.
www.bio-m.org
www.m4.de
Source: IZB
Location of BioM
Campus Martinsried-Großhadern
www.m4.de
Content
• Clustermanagement by BioM
• Profile of the Munich Biotech Cluster m4
• Leading-Edge Cluster “m4 – Personalized Medicine” • m4 R&D projects • m4 structural projects
www.m4.de
The Munich Biotech Cluster m4 is a SME cluster
129
26
53
29 25
Biotech Small and Medium Companies
(SMEs)
Biotech Companies (non-
SMEs)
Contract Research
Organisations (CROs)
Pharma companies
Unternehmen
Others
Number of Biotech Companies in the Greater Munich Area, BioM 2010
0 20 40 60 80
1-10 Mitarbeiter
11-50 Mitarbeiter
51-100 Mitarbeiter
101-250 Mitarbeiter
Per cent
employees
employees
employees
employees
www.m4.de
The Munich Biotech Cluster m4 is a TxDx Cluster
0
10
20
30
40
50
60
70
Fields of Activity of Munich’s Biotech SME, in %, BioM 2010
www.m4.de
Content
• Clustermanagement by BioM
• Profile of the Munich Biotech Cluster m4
• Leading-Edge Cluster “m4 – Personalized Medicine” • m4 R&D projects • m4 structural projects
www.m4.de
Leading-Edge Cluster Competition 2010
€ 40 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. www.m4.de
www.m4.de
m4 – Partners for innovation and develoment
www.m4.de
Personalized medicine takes into account therapy-relevant differences between patient groups
www.m4.de
Personalized medicine increases the efficacy of drugs
• 90% of all drugs are efficeint in only 30-60 % of the patient population
The Case for Personalized Medicine, 2011.
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=83 Nature Rev Drug Discov 10: 87 ( 2011 )
• Deficient efficacy (66%) and safety (21%) are main reasons for attritions
Personalized medicine increases the efficiency of drug development
www.m4.de
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
www.m4.de
Patient history
Familiy diseases
Age, sex,…
Psyche, Compliance
Personalized medicine is an integrative concept
Best therapy available
Diagnosis
Clinical parameters
Multi morbiditity
Medication
Life style
Nutrition
BMI
Prediction
Response
Dose
Prognosis
Biomarker
Genom, Epigenom, Transcriptom, Proteom, Metablom,…
www.m4.de
Five m4 structural projects support the valued-added chain of personalized medicine
m4 Trial Service Center services and consulting
phase I unit
onsulting, patient recruiting Bio probes
m4 Biobank Alliance central access, ethical and legal harmonization,
shared quality standards
information information
m4 Data Integration System information integration, web portal
m4 eAcademy Master of Translational Science and Drug Development;
Executive MBA of Life Science
personell innovation
m4 Scouting & Incubation m4 Award, m4 Scouts
identification & incubation
m4 R&D projects
research clinical Phase I - III preclinic approval
clinical validation test kit certification biomarker identification and validation
www.m4.de
Content
• Clustermanagement by BioM
• Profile of the Munich Biotech Cluster m4
• Leading-Edge Cluster “m4 – Personalized Medicine” • m4 R&D projects • m4 structural projects
www.m4.de
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
m4 R&D cooperation projects
www.m4.de
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
m4 R&D cooperation projects
http://www.m4.de
www.m4.de
Example: Spherotec GmbH, LMU und MRI: Diagnostic platform for cancer therapy decision
Cancer patient
2nd step: Spheroid TechnologyTM
tissue
Sterile tumor sample Selection of drugs with best
possible efficacy
biomarker profiling
Therapy relevant molecules Resistence marker
Grinding
Micro tumors In vitro therapy of micro tumors
efficacy/dose/sequence
Optimal therapy physician
1st step: biomarker profiling
9 days
Best possible therapy for the individual patient
www.m4.de
Example: CD38 mAb (MOR202) as a therapy against
hematological tumors
CD38
MOR202 (Anti-CD38)
ADCC
Approved drugs
NK cell activation
Direct effects
Fc Receptor
antibody
Inokuliert
Kontrolle
µ-CT Analyse der
Tibia Inokulation der MM
Zellen in die Tiba
Multiples Myelom Tumormodell in der Maus
AK Vermittelte Zytoloyse
Synergistic efficacy by combination
www.m4.de
Translation into the clinic
Preclinical studies
Validation of (newly) established animal modesl Development of new animal models for m4 partners
Drug discovery Preclinical tests Patient New biomarkers Applicable Models Proof of principle Similarities in physiology/anatomy
Example: “Advanced Preclinical Animal Models”
Used in m4 projects concerning Cell therapy Respiratory diseases Cancer therapy Diabetes
www.m4.de
Content
• Clustermanagement by BioM
• Profile of the Munich Biotech Cluster m4
• Leading-Edge Cluster “m4 – Personalized Medicine” • m4 R&D projects • m4 structural projects
www.m4.de
m4 Scouting & Incubation: support for innovation and start-ups in the area of personalized medicine
• m4 Award New regional competition
funding for innovative pre-seed projects • m4 Incubation Targeted development of the projects by
individual and professional project management
• m4 Scouting Targeted identification and support for
research projects with high innovation potential
• m4 Mentor Circle Mentoring programme for scientists and young entrepreneurs
www.m4.de
m4 eAcademy – Establishment of a Master and EMBA
proramme for Life Sciences
• 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
• Master of Translational Science and Drug Development • Master of Business Administration Life Science
www.m4.de
m4 Biobank Alliance provides a central access
to high-quality bioprobes
Quality
Informed
consent
LMU Biobank i.A. HTCR Pathology, Surgery, Clinical Chemistry
TUM Biobank Pathology, Surgery, (Clinical Chemistry)
ethics, governance, framework
m4
Biobank
Services
Center
Central access
Central contact for
industry and
science
High, common
quality standards
Integration of further
clincal institutes
Integration of/
cooperation with
further biobanks
Transparency Ethical standards
28
Helmholtz Zentrum München
www.m4.de
m4 Data Integration System:
Data management and processing
• Clinical systems Identity, diagnosis, therapy Patient record
Follow up of clinical data • Research systems encrypted identity analysis data
Follow-up of molecular data
• Inter-institutional infrastructure • Central portal, data warehouse • ID management, pseudonymisation, anonymisation
www.m4.de
m4 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)
www.m4.de
• Contact
BioM Biotech Cluster Development GmbH Am Klopferspitz 19a 82152 Martinsried Germany
Phone: +49 (0) 89 89 96 79 - 0 Fax: +49 (0) 89 89 96 79 -79 Email: [email protected]
• Web Cluster management BioM http://www.bio-m.org
Personalized Medicine in Munich http://www.m4.de
