Health Valley 2014: Jack Schalken

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  • 1. ..the entrepreneurial scientist…or ..the scientific entrepreneur.. Learning by doing!
  • 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. 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. 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. NovioGendix Winnaar van Mercator Award 2009 for Knowledge-Based Entrepreneurship
  • 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. 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. 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. 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. Oncodrone Est 2013
  • 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. 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. Vehicle (DMSO control) OCD155 5mg/kg/d, i.p. dorsal ventral Results Bone Metastasis Model
  • 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. 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