novio gendix - jack schalken 25032010
DESCRIPTION
TRANSCRIPT
From ‘science in practise’ to ’science in business’
Jack A Schalken
M2M concentrates all expertise and facilities needed for imaging (molecule-to-man) and translational innovation (bench-to-bed)
AMBITION
A) Imaging from molecule-to-man B)Translational research – from bench-to-bed
Molecular imaging
(Sub)cellular imaging
Organ & body imaging
Imag
ing
Prod
ucti
on
Clinical imaging(volunteers, patients)
Preclinical imaging (in vitro / in vivo)
Small scale GMP-production &
labeling
Chemical synthesis
1
2
3
4
Basic science & discovery
Pre-clinical testing
Proof of concept
Clinical Trials
Individualized medicine & evidence based practice
small molecule virus ribosome animal cell drosophila mouse
10nm 100nm 10 μ 100 μ 1cm 1dm 1m
Globular protein bacterium plant cell mosquito homo sapiens
New biomarkers for prostate cancer are ‘ready for prime time’
Biomarker Substrate Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6GSTP1+methylation
Urine/Bx yes yes ongoing ongoing yes no
PCA3DD3 Urine yes yes yes yes End 2006PROGENSATM
Gen-ProbeCE-marked
2007/2008 PROGENSATM
Gen-Probe
T2-erg Urine yes yes yes ongoing yes no
DRE
Cells in Prostatic urethra
‘..Molecular Uroscopy..’Progensa PCA3
2003
•Unique biomarker and urine as specimen (can be obtained non invasively)
‘Science in practise’ (1996-2003)‘Science to business’ (2003-2006)
•Diagnocure (2000; PCA3 license from RUNMC)•Genprobe (2003; sublicense PCA3 based
molecular diagnostics)•2007; Progensa PCA3 launched
What now?
•PCA3 is a ‘specialty’ test • Expertise• Dedicated personel• Facilities
•NL needs an Oncology Specialty Lab!!
•Solution: found one yourselves• Opportunity meets ambition
‘Times they are a changin’
Knowledge valorisation ‘95•Ad hoc, often attenuating
& ‘06•Pro-active, enabling
NoviogendixA spin off from the Radboud University Nijmegen Medical Center
Noviogendix
•Founded November 2006 by two RUNMC scientists and a business developer
•First round financing Dec 2007 (Biogeneration Ventures, PPM Oost)
•Clear terms between Radboud & Noviogendix• Full transparency• Clearly defined • Negotiations took 6 months (much better than average)
Molecular Diagnostics‘core business’
•Specialty Oncology Laboratory • Extensive panel for infectious diseases• First on the EC market with PrCa marker,
-Progensa PCA3-• Expanding prostate cancer test panel• Expanding in other GU(genito-urinary) diseases
•Research• Marker IP portfolio GU
•Molecular profiling PrCa, RCC, TCC•Target validation (well annotated biorespositories)
Technology & fields of expertise
•Core technology: molecular/gene based diagnostics•Real time PCR (Roche)•NASBA (Biomerieux)•APTIMA DTS 400 (Genprobe)
•Disease focus• Oncology
•GU(genito-urinary)
• Infectious diseases
Noviogendix y
•Good functioning management team (founders)•Efficient and effective marketing and sales team (2)•Key personel for research •10 people in total
•Milestones• > 2000 tests sold• New IPR• Health kennis clusterregeling gemeente Nijmegen• Co-applicant for CTMM & PIDON
Noviogendix Oncology Specialty Laboratory
•Netherlands•UK•Germany•Belgium•France•Sweden•Italy•Misc. Overseas (incl south America and Australia)
Noviogendix Oncology Specialty Laboratory
Noviogendix Research
•RU(NMC) together with Health valley and the city of Nijmegen provide good soil for biotechnological initiatives
•Growing entrepreneurial spirit at RUNMC•Noviogendix can be ‘launched’ in 2009
Noviogendix Challenges
•Strengthen the management team•Be prepared for a second round of financing•Oncology Specialty Laboratory
• Move to new facility and get certification• Develop strategy to increase sales• Extend test portfolio
•Research• Validation of markers• Explore the licensing opportunities
(in- and out-)