EuroBioForum 2012 | 18 April 2012 Presentation by Horst Domdey, Managing Director of BioM Biotech Cluster Development GmbH

1. The Munich Biotech Cluster m4 Approach
towards Personalized Medicine"
Horst Domdey
BioM
www.m4.de

2. BioM – Partner for Sustainable Innovation
SME
Big Pharma
• Funding
• Partnering • Partnering
• Business Development • Seminars & Workshops
• Networking • Networking
• Professional Training • Events
• Events
Academia
• Scouting & Incubation
• Start-up Consulting
• Funding
www.m4.de www.bio-m.org

3. The Munich Life Science Cluster
- a Leading Pharma and Biotech Location
• > 250 life science companies (126 SMEs)
• > 50% of SMEs focus on Tx & Dx
• impressive drug development pipe line
• innovative platform technologies:
imaging, genomics, proteomics, kinomics, etc.
• 8 excellent research institutions
• high density in hospitals, study centers
• 27 pharma companies CLUSTER-
MANAGEMENT
• 50 CROs
• 30,000 employees in the life sciences and the life science industry (SMEs: 2,850)
• > € 3 bn invested since1996
www.m4.de

4. Munich‘s Drug Development Pipeline
Market 5
Phase III 8
Phase II 36
Phase I 33
Preclinic 59
0 10 20 30 40 50 60
Number of Clinical Candidates of Biotech SMEs in the Greater Munich Area,
BioM 2010
www.m4.de

5. 4 Strong Partners for Munich
€ 100 mn Biotech
Program
Science
in Munich
and Pharma
in Munich
on Cluster
Personalized
Hospitals Management
in Munich for Munich
Medicine
www.m4.de

6. Structure of the m4 Program
Board
Personalized SP1 – m4 Trial
Medicine Steering Committee Service Center
Representatives from
Academia & Industry SP2 – m4
Structural Projects
Targeted Biobank Alliance
R&D Projects
Therapies
m4-Clustermanagement SP3 – m4 Data
BioM Integration System
Production
Processes SP4 – m4 Scouting
& Incubation
Preclinical Associated Partners
Academia & Industry SP5 – m4
Models
eAcademy
www.m4.de

7. m4 Strategy: Establishing a Sustainable
Infrastructure through Structural Projects
Scouting &
Incubation eAcademy
special award, scouts, Master of Translational Science
targeted identification, Executive MBA of Life Science Management
active incubation
Innovation Human Capital
Pre Clinic Clinical Trials Phases I - III Approval
Human Biomaterial Consulting, Recruiting
Biobank Alliance Trial Service Center
central access, service and advice
legal and ethical harmonization phase I unit
highest quality standards platform service
Transfer of Information
Data Integration System
information integration
web portal
safety concept
Translational Seed Fund: seed financing opportunities in PM (in progress)
www.m4.de

8. m4 Scouting & Incubation
• m4 Scouting
Identification of (bio)pharmaceutical research
projects with a high innovationspotential
• m4 Mentor Circle
Professional mentoring by retired experts from
academia and industry
• m4 Award
Regional pre-seed program for innovative
research projects in the field of biomarkers
and drug development
• m4 Incubation
Assisted incubation of the m4 Award projects
www.m4.de

9. m4 Award
• Bavarian pre-seed program for Personalized
Medicine: € 8.5 Mio until 2015
• € 500,000 per project over 2 years; additional
€ 30,000 for coaching and special advice
• 80 short proposals received
until 31st January, 2011
• 28 full length proposals received
unti 30th April, 2011
• m4 Award Committee: experts from
Biotech, Pharma and Venture Capital
• 5 grants awarded on 18th July, 2011
www.m4.de

10. Winners of the First Round of the m4 Award
• K-P Hopfner, F Oduncu, G H Fey (LMU):
Triplebodies against AML
• D. Schendel, C Geiger, M Javorović (HMGU):
Individualised Dendritic Cells as Vaccines for
Patients with Hormone-resistant Prostate Cancer
• M Conrad, J A Schick (HMGU):
New Drugs for the Treatment of
Neurodegenerative Diseases
• F Hausch, M Paez-Pereda (MPI Psychiatry):
Development of FKBP51 Specific Molecules
to Treat Depression
• O Ritter (Univ. Würzburg):
Calportin as First Line Treatment of Heart Failure
www.m4.de

11. m4 Strategy (II): Boosting Innovation through
40 R&D Projects (mostly Cooperations)
PK1
P2
T17
T16 Biotech SME
T15
T14
T12
T10 Pharma/Medtech
T9
T6
Industry
T5
T3
T2 Academia / Clinics
PM 14
PM5
PM4
P3
PM9
Drug Development Preclinic Clinical Trials Phase I - III Approval Market
Value Chain of Personalized Medicine
Biomarker Companion Diagnostic Validated
Approval Market
Identification & Validation Feasibility and Benefit Test Kit
PM 2 Focus on:
PM6 -> new targeted therapeutics
PM 7
PM 8 -> innovative therapy concepts
PM10
PM12
-> identification and validation of biomarkers
PM13 by molecular diagnostics and imaging
PM15
PM 16
techniques
T4 -> set up of platform technologies
PM 17
PM1
main indications: oncology, cardiovascular
diseases, chronic lung diseases, autoimmune
www.m4.de diseases and inflammation

12. COR-1 – an m4 Lighthouse Project by Corimmun
• Ex vivo, COR-1 showed good
COR-1 is a cyclic peptide
efficacy to neutralize anti ß1
which neutralizes
receptor autoantibodies.
stimulatory autoimmune
antibodies directed against • In animal models, COR-1
the beta-adrenergic receptor prevented the generation of heart
mimicking the effect of failure and also reversed existing
natural ligands like heart failure.
adrenaline and thus leading • In a placebo-controlled phase
to a chronic over-stimulation I clinical trial COR-1 was shown
of the receptor. to be well tolerated.
Consequently this leads to • COR-1 is now being investigated
hypertrophy and reduced in a phase II clinical trial; it is
function of the heart. administered to a subgroup of
heart failure patients who have
been stratified by a specific
diagnostic test.
COR-1, a new Drug for the Treatment
of a Severe Form of Heart Failure
www.m4.de

13. m4 – Evolution through Innovation
Winner in the
Leading Edge Cluster
Competition
Winner in the
BioRegio Contest
Munich
Gene Center m4
International Cluster of Excellence
in Personalized Medicine
1984 1996 2010 2020
www.m4.de

14. P4 Medicine – Healthcare of the Future
Predictive Personalized
Biomarkers
Stratification of Patients
- DNA/RNA-omics
- Herceptin
- Proteomics
- Erbitux
- ...
Preventive
Life Style and Treatment
- Phenylketonuria Participatory
- Diabetes Informed Decisions
- Cancer by informed Patients
- 1000$ Genome
www.m4.de