..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 facility2000‐2005 2006 11‐2006 12‐2007                             5‐2009

‘..Every large fluctuation is associated with (expectations of) PCA3..’All critical work including clinical studies weredone @RUMC

‘..Pre‐valorisation era @ RUNMC..’Founding scientists seek business developer

TTT, Term sheet Tango a TroisBGV/PPM Oost‐founders‐RUNMC

‘my BV’

Most ‘entrepreneurial scientists regarded the new streamlined route towards a spin off as ‘quit an improvement’

NovioGendixWinnaar 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 42009

1 2 3 42010

1 2 3 42011

1 2 3 42012

1 2 3 42013

1 2 3 42014

1 2 3 42015

1 2 3 42008

QuarterYear

Service laboratory

NovioGendix Pipeline

PCa early detection

(urine)

PCa tissue panel

BCa early detection

(urine)

BCa tissue panel

Kidney cancer

1 2 3 42009

1 2 3 42010

1 2 3 42011

1 2 3 42012

1 2 3 42013

1 2 3 42014

1 2 3 42015

1 2 3 42008

QuarterYear

Biomarker discovery Validation Clinical StudyLDT

ValidationBiomarker discovery LDT Clinical Study

PCA3Service facility

ValidationBiomarker 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 42009

1 2 3 42010

1 2 3 42011

1 2 3 42012

1 2 3 42013

1 2 3 42014

1 2 3 42015

1 2 3 42008

QuarterYear

Service laboratory

Pipeline

PCa early detection

(urine)

PCa tissue panel

BCa early detection

(urine)

BCa tissue panel

Kidney cancer

1 2 3 42009

1 2 3 42010

1 2 3 42011

1 2 3 42012

1 2 3 42013

1 2 3 42014

1 2 3 42015

1 2 3 42008

QuarterYear

Biomarker discovery Validation Clinical StudyLDT

ValidationBiomarker discovery LDT Clinical Study

PCA3Service facility

ValidationBiomarker 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 2013Oncodrone

Result of long-standing PP partnership

PRIMA FP6 project2004‐2009

Three  targets

PRO‐NET

II project2010‐2013

Compound development

NGI‐Preseed

Company Formation2011‐2013

ONCODRONE

Vehicle(DMSO control)

OCD1555mg/kg/d, i.p.

dorsal ventralResults 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