20140828 rtm frans pieters

RTM wordt mede mogelijk gemaakt dankzij een bijdrage
uit het Europese Fonds voor Regionale Ontwikkeling (EFRO)
Radboud Translational Medicine B.V.
RadboudTranslational Medicine B.V.
a public private partnership for Personalized Medicine
Frans Pieters
Science Meets Business, August 28th2014

RTM: a brief historic overview
•
Discussions on realizing a cyclotron facility started in 2001
•
Due to (mainly) financial constraints the focus disappeared
•
Ambitions flared up around 2006
•
The focus was on translational research: it was acknowledged that a GMP‐ compliant cyclotron facility was an important missing link in the translational chain (“from molecule to man”)
•
A business plan for RTM was drafted in 2010
•
This formed the basis for a request for a €9 million grant from the European Regional Development Fund (EFRO), which was awarded in 2011
•
RTM was incorporated on August 18th2011
•
Radboudumc invests €11 million in the project (including PRIME)
2

Finance: requirementsEFRO
RTM shouldcomplywiththe goals definedbyEFRO:
Versterken innovatiekracht, kenniseconomie en ondernemerschap
Het versterken van de kenniseconomie, het regionale innovatieve vermogen en de concurrentiepositie van het bedrijfsleven zijn van groot belang om de toonaangevende positie van Oost‐Nederland verder uit te bouwen. De sterke punten van de regio vormen daarbij het uitgangspunt. Van daaruit wordt gestreefd naar verbetering van de samenwerking tussen bedrijven en kennisinstellingen, het wegnemen van belemmeringen en het geven van ruimte aan vernieuwende initiatieven.
Strengtheninnovativepower, knowledgeeconomyand enterpreneurship

Corporate structure
Consortium Translational
Medicine
Radboudumc
Radboud
University
Stichting Katholieke
Universiteit
RTM B.V.
Radboud UMC
Holding B.V.
RTM R&D B.V.
RTM ManufacturingB.V.
Partner X?
4
Partner Y?

Campus Radboudumcand university
RTM (M236)
Radboudumc
Radbouduniversity
Nuclear Medicine
5

Scope of the constructionproject
The project aims to realize the following functionality:
•
A vault for the housing of the cyclotron
•
Three GMP‐certified manufacturing lines
•
QC facilities for the release of radiopharmaceuticals
•
A radionuclide laboratory for pre‐clinical research activities
•
Logistic areas for the distribution of radiopharmaceuticals
•
Office space and meeting rooms
•
A basement floor (‐2) to house all technical facilities
Expansion with a vault for a second cyclotron has been anticipated, but will not be realized in this phase of the project.
6

Planning of the construction project
Important milestones:
•
Start constructionwork: 1 SEP 2014
•
Installationhotcells: 26 JAN ‐19 MAR 2015
•
Installationcyclotron: 2 MAR ‐17 APR 2015
•
Completionconstructionwork: 29 JUN ‐10 JUL 2015
•
Validation: 29 JUN ‐18 DEC 2015
•
Start pre‐clinicalresearch: AUG 2015
•
GMP inspection: NOV 2015
•
Start supplyGMP‐gradematerial: JAN 2016
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Working principle cyclotron

9

Radionuclidesthat can be produced
RadionuclideHalf‐life(t½)
F‐18110 min
C‐1120 min
N‐1310 min
O‐152 min
Zr‐8978 h
I‐124100 h
10

Cyclotrons in The Netherlands
Ten cyclotrons in use,
two cyclotron facilities under constructions (Rotterdam and Nijmegen)

RTM Strategy
1.
Joint venture between Radboudumc and RadboudTranslational Medicine BV
2.
A €14 million investment in housing, cyclotron facilities and GMP compliance
3.
A self‐sustaining technology platform for R&D and contract manufacturing
4.
To use excess capacity for contract manufacturing for the Dutch, German and Belgian market
5.
To find & bind a strategic partner for commercial exploitation of the facilities
6.
To provide facilities for top‐notch translational research
12

RTM in research (1)
•
Supplyof routine tracers(FDG, F‐DOPA, F‐choline, NaF, FLT)
•
Supplyof new(experimental) tracers(radiochemistrybythe customer)
•
Developmentof newtracers(radiochemistrybyRTM)
•
Validationof radiochemicalprocesses, processoptimization
•
Projectmanagement forpre‐clinicaland clinicalstudies
•
Support forresearch institutesto set up newimagingstudies
•
Acquisitionof newprojectsforexternalclients
13

RTM in research (2)
Internalpartners (positionin Radboudumc)
•
Close collaborationwithand strongsupport of the Departmentof Radiology& NuclearMedicine
•
Strong preclinicalpositionthroughcollaborationwithPRIME (pre‐clinicalimagingcenter Radboudumc)
•
Active participationin the Radboud TechnologyCenters, in the GMP‐cluster
•
Direct lineof communcationwithdirectors of the Radboudumc research inistitutes, themeleaders and researchers( togetherwithNucleaire Medicine)
•
Builda networkof externalpartners
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Whatmakesourpropositionunique?

Personalized Healthcare @ Radboudumc
People are different
Stratification by multilevel diagnosis
+
Patient’s preference of treatment
Exchange experiences in care communities
Select personalized therapy

Translational medicine @ Radboudumc

Orientation across the spectrum
from molecule to man to population
Orientation across the spectrum of diseases
Research theme
Technology Center
Research organisation
•
19 Research Themes to drive research
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3 Research Institutes to drive education
•
14+ Technology Centers to support

RadboudumcTechnology Centers
•
Proteins
•
Metabolites
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Preclinical
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Clinical
•
Behavioural
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Animal facility
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Systematic review
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Cell analysis
•
Sorting
•
Pediatric
•
Adult
•
Phase 1, 2, 3, 4
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Vaccines
•
Pharmaceutics
•
Radio‐isotopes
•
Malaria parasites
•
Management
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Analysis
•
Sharing
•
DNA
•
RNA
•
Internal
•
External
•
HTA
•
Evidence‐based surgery
•
Field lab
•
Statistics
•
Biological
•
Structural
•
Preclinical
•
Clinical
Expertises

Direct access to Technology Centers on Internet website
Technology centers
Technology centers

Challenges(1)
•
Finalizethe constructionworkwithinagreedtimelines
•
Complete qualificationwithmaximum efficiency (particularlyGMP license)
•
Start acquisitionof newprojectsas earlyas possiblefora flyingstart
•
Makea successof the commercial exploitationof the facility
•
Achievefinancialbreak even as quicklyas possible
22

Challenges(2)
•
Buildup expertise and credibilityquickly:
‐Radiochemistryexpertise
‐Translationalexpertise
‐Project management skills
‐Time management, costmanagement
•
Howto positionRTM in the scientificcommunity?
•
Buildup aninternaland externalnetworkof research partners
23

In 2018 RTM will:
•
Manufactureradiopharmaceuticalsfor8 hospitalsin the region(bothin the Netherlands and in Germany)
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Have fivepreclinicalstudies ongoingin collaborationwithRadboudumc research institutes
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Performtwolabellingexperimentsforregionalstart ups
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Run fiveclinicalstudies in collaborationwithRadboudumc research institutes, of whichtwoforbig pharma
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Be fullyresponsibleforat leastoneclinicalstudy
•
Have ownexpertise availablein the field of radiochemistry, project management, radiationsafety, GLP, GMP and GCP
24

Contact
Dr. Frans Pieters, Managing Director
E frans.pieters@radboudumc.nl
T +31 651294195

Questions?
26

20140828 rtm frans pieters

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