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Smb 30012014 jack schalken novio gendix

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Smb 30012014 jack schalken novio gendix

  1. 1. NovioGendix; ‘..learning by doing..’ Prof dr Jack A Schalken Co-founder and CSO NovioGendix Dr Willem Melchers Co-founder and interim CEO NovioGendix
  2. 2. S’thing about me Jack A Schalken Background Current job Research director (‘86)and Professor of experimental urology (2001) CSO Noviogendix (2006) CSO Oncodrone (2013) Ambition… Make a difference in diagnosis and treatment ‘..personalized medicine..’
  3. 3. Why NovioGendix ? • Co-founders were early developers and users of (molecular) Dx • Gap between research-(RUO), LDT- and IVD-clinical test • Co-founders combined respective expertise of discovery and clinical validation with - implementation • Growing support in the market • ‘…the PCA3 case…’ • Profit for investors, science, RUMC and founders
  4. 4. The PCA 3 trail… Discovery in well annotated Validation clinical specimens (POP) Clinical study cohort 1 2007 HQ PrCa samples Validation in sample pre-Bx (test cohort) (urine)/ proof of principle 1994-1999 Clinical study cohort 2008 2003 (verification/validation cohort) CE marked test 2007 FDA pivotal studies 2010 FDA PMA approval 2012 Radboudumc CUR Hologic Genprobe
  5. 5. An important ‘clinical unmet need’ in PrCa • • 11% ; life time risk to be diagnosed with prostate cancer! Early diagnostics • ‘Unmet need’ ; A test that identifies men with potentially lethal cancer early in the disease
  6. 6. The Biomarker Pipeline ‘..discovery to clinical validation..’ Clinical unmet need; intended use Discovery in well annotated HQ PrCa samples Validation clinical specimens (POP) Validation in relevant clinical sample -Urine -Blood -Tissue Clinical study cohort 1 (test cohort) Clinical study cohort 2 (verification/validation cohort) Test format; RUO/LDT ~ 12 Months ~ 6 Months ~18 Months
  7. 7. ‘my BV’ ‘..Pre-valorisation era @ RUNMC..’ Founding scientists seek business developer Pre-pre fase 2000-2005 Business plan 2006 Founding NG 11-2006 Series A financing 12-2007 TTT, Term sheet Tango a Trois BGV/PPM Oost-founders-RUNMC Most ‘entrepreneurial scientists regarded the new streamlined route towards a spin off as ‘quit an improvement’ ‘..Every large fluctuation is associated with (expectations of) PCA3..’ All critical work including clinical studies were done @RUMC CEO/NG facility 5-2009
  8. 8. NovioGendix Winnaar van Mercator Award 2009 for Knowledge-Based Entrepreneurship Een spin-off van Radboudumc
  9. 9. Critical steps • Negotiate and settle terms with Radboudumc (‘..we were front runners..’) • Dedicated lab space (pre-NovioTech ..) • Hand picked and committed employees/employees on NG contracts • From founding management team to an MT led by new full time CEO • From ’green rookies’ to entrepreneurial scientists with their first experiences gained and illusions lost, like.. • If you don’t deliver you dilute • No ‘freebies’ in this business • Learn the language of Business Administration • E.g. an ‘EXIT’ is not synonymous with ‘The End’ • A bridge financing is like a life support system (i.e. if you pull the plug, your ‘dead’) • …
  10. 10. The money thing…. • Take ‘€ burn rate’ seriously • Anticipate to (additional) financing needs • Prepare well for the discussion with the existing share holders • Understand relative position of the partners (VCs, founders, RUMC) • Understand the financing instruments (CLA, new shares..) • Financial planning should be realistic rather than optimistic • Take advantage of ‘grants’ • • • • WBSO CTMM/PCMM partner ARIBCA partner EFRO/UltrasenseMR partner • Only do so when they fit within business plan of the company (since, usually the grants require in kind and/or cash contribution from SME)!
  11. 11. Pipeline Year Quarter 1 2008 2 3 4 1 Biomarker discovery PCa early detection 2009 2 3 4 1 2010 2 3 4 1 4 1 2012 2 3 4 1 2013 2 3 4 1 Licensing Activities Clinical Study LDT Validation 2011 2 3 2014 2 3 4 2015 2 3 1 4 Product Launch CE-test (urine) Biomarker discovery Validation LDT Clinical Study PCa tissue panel Biomarker discovery BCa early detection LDT Validation CE-test Clinical Study (urine) Biomarker discovery BCa tissue panel Kidney cancer Biomarker discovery LDT Validation Validation LDT Clinical Study CE-test Clinical Study Service laboratory Year Quarter 1 2008 2 3 4 1 2009 2 3 4 1 PCA3 PC-Quattro Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformité Européenne-marked test 2010 2 3 4 1 2011 2 3 4 1 2012 2 3 4 1 2013 2 3 4 1 2014 2 3 4 1 2015 2 3 Service facility Quattro 4
  12. 12. Pipeline Year Quarter 1 2008 2 3 4 1 Biomarker discovery PCa early detection 2009 2 3 4 1 2010 2 3 4 1 4 1 2012 2 3 4 1 2013 2 3 4 1 Licensing Activities Clinical Study LDT Validation 2011 2 3 2014 2 3 4 2015 2 3 1 4 Product Launch CE-test (urine) Biomarker discovery Validation LDT Clinical Study PCa tissue panel Biomarker discovery BCa early detection LDT Validation CE-test Clinical Study (urine) Biomarker discovery BCa tissue panel Kidney cancer Biomarker discovery LDT Validation Validation LDT Clinical Study CE-test Clinical Study Service laboratory Year Quarter 1 2008 2 3 4 1 2009 2 3 4 1 PCA3 PC-Quattro Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformité Européenne-marked test 2010 2 3 4 1 2011 2 3 4 1 2012 2 3 4 1 2013 2 3 4 1 2014 2 3 4 1 2015 2 3 Service facility Quattro 4
  13. 13. Pipeline Year Quarter 1 2008 2 3 4 1 Biomarker discovery PCa early detection 2009 2 3 4 1 2010 2 3 4 1 4 1 2012 2 3 4 1 2013 2 3 4 Business Devpt Activities Clinical Study LDT Validation 2011 2 3 1 2014 2 3 4 2015 2 3 1 4 Product Launch CE-test (urine) Validation Times they Goal; discovery and clinical validationBiomarker discovery are a changin’ of PrCa test (Quattro) (400 patient prospective multicenter Biomarker LDT Clinical Study Validation study incl PCA3 as comparator) discovery New Strategy Biomarker discovery Validation PCa tissue panel BCa early detection (urine) BCa tissue panel Kidney cancer Biomarker discovery CE-test LDT Clinical Study CE-test Big Dx Service laboratory Year Quarter Clinical Study Platform Study Clinical Comp LDT Validation LDT 1 2008 2 3 4 1 2009 2 3 4 1 PCA3 PC-Quattro Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformité Européenne-marked test 2010 2 3 4 1 2011 2 3 4 1 2012 2 3 4 1 2013 2 3 4 1 2014 2 3 4 1 2015 2 3 Service facility Quattro 4
  14. 14. Conclusions • We were and are still enthusiastic • Academic spin offs can create ’win win’ situations • Being an entrepreneurial scientist does not threaten your scientific output (rather the opposite is true) • You have to acquire BA ‘skills’ • A constructive relation with the investors is beneficial for the company as a whole • The Nijmegen campus is now fully ‘equiped’ to house and launch biotech companies • It is mighty helpful if you are like a sheep with five legs

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