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From ‘science in practise’ to
          ’science in business’
                Jack A Schalken
AMBITION
 M2M concentrates all expertise and facilities needed
 for imaging (molecule-to-man) and translational
 innovation (bench-to-bed)
A) Imaging from molecule-to-man                                                            B)Translational research – from bench-to-bed


small molecule virus ribosome animal cell     drosophila    mouse
                                                                                            Basic           Pre-
                                                                                            science &                        Proof of   Clinical
    Globular protein   bacterium      plant cell     mosquito       homo                                    clinical
                                                                    sapiens                 discovery                        concept    Trials
                                                                                                            testing

       10nm    100nm          10 μ    100 μ          1cm    1dm     1m
                                                                                                                                                   Individualized




                                                                              Production
                                                                                            1                     3 Small scale GMP-               medicine &
                                                                                                Chemical                                           evidence
                                                                                                                       production &
                                                                                                synthesis                                          based practice
                                                                                                                         labeling



                                                                                                 2                             4
                                                                              Imaging
                                                                                                     Preclinical imaging              Clinical imaging
                                                                                                      (in vitro / in vivo)         (volunteers, patients)



  Molecular                 (Sub)cellular            Organ & body
   imaging                    imaging                  imaging
New biomarkers for prostate cancer are ‘ready
 for prime time’


Biomarker     Substrate   Phase 1   Phase 2   Phase 3   Phase 4   Phase 5      Phase 6
GSTP1+        Urine/Bx    yes       yes       ongoing   ongoing   yes          no
methylation
PCA3DD3       Urine       yes       yes       yes       yes       End 2006     2007/2008
                                                                  PROGENSATM   PROGENSATM
                                                                  Gen-Probe    Gen-Probe
                                                                  CE-marked
T2-erg        Urine       yes       yes       yes       ongoing   yes          no
Cells in
Prostatic urethra
                    DRE
Novio gendix - jack schalken 25032010
Novio gendix - jack schalken 25032010

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Novio gendix - jack schalken 25032010

  • 1. From ‘science in practise’ to ’science in business’ Jack A Schalken
  • 2. AMBITION M2M concentrates all expertise and facilities needed for imaging (molecule-to-man) and translational innovation (bench-to-bed) A) Imaging from molecule-to-man B)Translational research – from bench-to-bed small molecule virus ribosome animal cell drosophila mouse Basic Pre- science & Proof of Clinical Globular protein bacterium plant cell mosquito homo clinical sapiens discovery concept Trials testing 10nm 100nm 10 μ 100 μ 1cm 1dm 1m Individualized Production 1 3 Small scale GMP- medicine & Chemical evidence production & synthesis based practice labeling 2 4 Imaging Preclinical imaging Clinical imaging (in vitro / in vivo) (volunteers, patients) Molecular (Sub)cellular Organ & body imaging imaging imaging
  • 3. New biomarkers for prostate cancer are ‘ready for prime time’ Biomarker Substrate Phase 1 Phase 2 Phase 3 Phase 4 Phase 5 Phase 6 GSTP1+ Urine/Bx yes yes ongoing ongoing yes no methylation PCA3DD3 Urine yes yes yes yes End 2006 2007/2008 PROGENSATM PROGENSATM Gen-Probe Gen-Probe CE-marked T2-erg Urine yes yes yes ongoing yes no
  • 8. 2003 •Unique biomarker and urine as specimen (can be obtained non invasively)
  • 9. ‘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
  • 12. What now? • PCA3 is a ‘specialty’ test • Expertise • Dedicated personel • Facilities • NL needs an Oncology Specialty Lab!! • Solution: found one yourselves • Opportunity meets ambition
  • 13. ‘Times they are a changin’ Knowledge valorisation ‘95 & ‘06 • Ad hoc, often attenuating •Pro-active, enabling
  • 14. Noviogendix A spin off from the Radboud University Nijmegen Medical Center
  • 15. 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)
  • 16. 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)
  • 17. 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
  • 18. 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
  • 19. Noviogendix Oncology Specialty Laboratory • Netherlands • UK • Germany • Belgium • France • Sweden • Italy • Misc. Overseas (incl south America and Australia)
  • 22. •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
  • 23. 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-)