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..the entrepreneurial scientist…or
..the scientific entrepreneur..
Learning by doing!
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..’
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
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’
NovioGendix
Winnaar van
Mercator Award 2009 for 
Knowledge‐Based Entrepreneurship
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’)
• …
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)!
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
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’
Oncodrone Est 2013
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
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
Vehicle
(DMSO control)
OCD155
5mg/kg/d, i.p.
dorsal ventral
Results Bone Metastasis Model
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
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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Smb 13032014 hve jack schalken oncodrone

  • 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’
  • 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’
  • 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
  • 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