Consortium management. Using methylation detection as early diagnostic tools against cancers

1. Methylome against cancers
From innovation to a key business case
December 8th, 2010
Dr. Sandra HUYGEN, PhD, MBA

2. Innovative Molecular Diagnostics
Value Chain
PCR Methylation Oncology
 Diagnosis
 Personnalized med.
OutcomeObjectivesResources TechnologyInstrumentation
 18 proves of concept
 IP rights on >300 biomarkers
and Companion Dx
 Outlicencing to Selfscreen
 Commercial deal with GSK-Bio
 Sample collection
 Publications (in prep.)
Partners
Budget - 3.739.054 €
Manpower - 20 FTEs
3.5 Y Dec 2010
2
July 2007

3. 3
How does it work?

4. 4
PEOPLE
SYNERGY
INNOVATION
Business
model
S. O.
Commerc.
Key factors

5. 5
People

6. Synergies
MDxHealth
GSK-BioULg - Patho
Leading vaccine
manufacturer
Antigen Specific Cancer
Immunotherapies
development
MSP technology
Patented gene portfolio
Academic advisors
Commercial channels
Leading European
gynecological cancer expertise
Stored and prospective clinical
samples
Leading European cancer
expertise in particular in
cervical oncology and HPV
field
ULg - Gyneco

7. Innovation
Methylation Specific PCR (MSP) Technology
 Methylation present in all cancers
Methylation regulates gene expression
 Specific genes methylated in each cancer
Abnormal methylation of specific genes is correlated
with cancer development
 Sensitive detection in all sample types
Detects 1 cancer cell among 10,000 normal cells
 One or few genes suffice for tests
No complicated algorithms, etc.
 Technology runs on any PCR
Equipment already installed worldwide
 Straight-forward testing
Automatable
 Patented Technology
Both detection technology and individual genes (biomarkers)

8. Strategy & Business model
Commercial partners
 Diagnostic & pharma companies
 Service lab US: CLIA lab
 Service lab Wallonia
Development
& test Clinical
Trials & FDA
Approval
Mass
Market Kit
Sales
Commercialization:
Service Lab Sales
Kit Dev. Kits sales
Service
Lab Dev.
Prototype
definition
Biomarker
discovery
Reg.
Review
Lab Service sales
Basic research Applied research Commercialization
OncoMethylomic project
Academic partnerships
MSP technology
Prototype
development
Clinical
verification

9. Structures - Organisation - Strategies (SOS)

10.  Organization,
 Project management,
 Partner rights & obligations
 IP,
 Access rights,
 Publications,
 Confidentiality,
 Royalties & Fees
Legal framework
Consortium
agreement Clinical Research
Agreements

11. Steering committee
Business development
Valorization committee
Executive committee
Task forces
BioWin RW – DGO6
Consortium organization

12. R&D – Technical review
Regulatory AffairsMarketing- BD
Clinical Affairs
Design control
QA
IP

13. 13
Conclusion
Creates a culture of openness and
partnership favorable to innovation

14. 14
For further information
Sandra HUYGEN
Sandra.huygen@AllianSes.be
www.AllianSes.be
Mobile: 0032/486.467.191