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Smb 13032014 hve jack schalken oncodrone

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Smb 13032014 hve jack schalken oncodrone

  1. 1. ..the entrepreneurial scientist…or ..the scientific entrepreneur.. Learning by doing!
  2. 2. S’thing about me Jack A Schalken Background Current job Ambition… Research director (‘86)- and Professor of experimental urology (2001) CSO Noviogendix (2006) CSO Oncodrone (2013) 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…’ • Logical extension of translational R&D activities at RUMC • Profit for investors, science, RUMC and founders
  4. 4. Pre‐pre fase Business plan      Founding NG         Series A financing             CEO/NG facility 2000‐2005 2006 11‐2006 12‐2007                             5‐2009 ‘..Every large fluctuation is associated with  (expectations of) PCA3..’ All critical work including clinical studies were done @RUMC ‘..Pre‐valorisation era @ RUNMC..’ Founding scientists seek  business developer TTT, Term sheet Tango a Trois BGV/PPM Oost‐founders‐RUNMC ‘my BV’ Most ‘entrepreneurial scientists regarded the new streamlined  route towards a spin off as ‘quit an improvement’
  5. 5. NovioGendix Winnaar van Mercator Award 2009 for  Knowledge‐Based Entrepreneurship
  6. 6. 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, you’re ‘dead’) • …
  7. 7. 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 • ETB/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)!
  8. 8. Clinical Study 1 2 3 4 2009 1 2 3 4 2010 1 2 3 4 2011 1 2 3 4 2012 1 2 3 4 2013 1 2 3 4 2014 1 2 3 4 2015 1 2 3 4 2008 Quarter Year Service laboratory NovioGendix Pipeline PCa early detection (urine) PCa tissue panel BCa early detection (urine) BCa tissue panel Kidney cancer 1 2 3 4 2009 1 2 3 4 2010 1 2 3 4 2011 1 2 3 4 2012 1 2 3 4 2013 1 2 3 4 2014 1 2 3 4 2015 1 2 3 4 2008 Quarter Year Biomarker discovery Validation Clinical StudyLDT ValidationBiomarker discovery LDT Clinical Study PCA3 Service facility Validation Biomarker discovery LDT Clinical Study CE-test Biomarker discovery Validation LDT Clinical Study CE-test Biomarker discovery Validation LDT CE-test Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformité Européenne-marked test Licensing Activities Product Launch PC-Quattro Quattro
  9. 9. Clinical Study 1 2 3 4 2009 1 2 3 4 2010 1 2 3 4 2011 1 2 3 4 2012 1 2 3 4 2013 1 2 3 4 2014 1 2 3 4 2015 1 2 3 4 2008 Quarter Year Service laboratory Pipeline PCa early detection (urine) PCa tissue panel BCa early detection (urine) BCa tissue panel Kidney cancer 1 2 3 4 2009 1 2 3 4 2010 1 2 3 4 2011 1 2 3 4 2012 1 2 3 4 2013 1 2 3 4 2014 1 2 3 4 2015 1 2 3 4 2008 Quarter Year Biomarker discovery Validation Clinical StudyLDT ValidationBiomarker discovery LDT Clinical Study PCA3 Service facility Validation Biomarker discovery LDT Clinical Study CE-test Biomarker discovery Validation LDT Clinical Study CE-test Biomarker discovery Validation LDT CE-test Abbreviations: LDT: Laboratory Developed Test; CE-test: Conformité Européenne-marked test Business Devpt Activities Product Launch PC-Quattro Quattro Goal; discovery and clinical validation of PrCa test (Quattro) (400 patient prospective multicenter study incl PCA3 as comparator) Big Dx Platform  Comp New  Strategy Times they are a changin’
  10. 10. Oncodrone Est 2013
  11. 11. Identification of  compounds  (hits) from  compound  libraries Screening and selection of compounds in in- vitro ‘EMT assays’ Determination of the  toxicity for each selected  compound to facilitate  follow‐up clinical research Efficacy of the selected  compounds with in  vivo animal models for  the targets of EMT Synthesizing analogous tested in the same in‐vitro  assays, resulting in  superior efficacy and  affinity  From concept to drug Q4 2013 Oncodrone
  12. 12. Result of long-standing PP partnership PRIMA FP6 project 2004‐2009 Three  targets PRO‐ NET II project 2010‐2013 Compound  development NGI‐ Preseed Company  Formation 2011‐2013 ONCODRONE
  13. 13. Vehicle (DMSO control) OCD155 5mg/kg/d, i.p. dorsal ventral Results Bone Metastasis Model
  14. 14. What did I learn from ‘..dossier NovioGendix..’ • Work with an experienced team • Take maximal advantage of funding for PP interactions • Appropriate timing of launching the company • I knew ‘’more or less’what I was talking about at the BA level
  15. 15. 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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