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.

Radboud Translational Medicine B.V.a public private partnership for Personalized Medicine

Frans PietersScience Meets Business, August 28th 2014


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 18th 2011• Radboudumc invests €11 million in the project (including PRIME)

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Finance : requirements EFRO

RTM should comply with the goals defined by EFRO:

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.

Strengthen innovative power, knowledge economy and enterpreneurship


Corporate structure

Consortium TranslationalMedicineRadboudumcRadboud

University

Stichting KatholiekeUniversiteit

RTM B.V.

Radboud UMCHolding B.V.

RTM R&D B.V.RTM Manufacturing B.V.Partner X?

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Partner Y?


Campus Radboudumc and university

RTM (M236)

Radboudumc

Radboud university

Nuclear Medicine

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Scope of the construction projectThe 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.

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Planning of the construction projectImportant milestones:• Start construction work: 1 SEP 2014• Installation hotcells: 26 JAN ‐ 19 MAR 2015• Installation cyclotron: 2 MAR ‐ 17 APR 2015• Completion construction work: 29 JUN ‐ 10 JUL 2015• Validation: 29 JUN ‐ 18 DEC 2015• Start pre‐clinical research: AUG 2015• GMP inspection: NOV 2015• Start supply GMP‐grade material: JAN 2016

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Working principle cyclotron


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Radionuclides that can be producedRadionuclide Half‐life (t½)

F‐18 110 minC‐11 20 minN‐13 10 minO‐15 2 minZr‐89 78 hI‐124 100 h

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Cyclotrons in The Netherlands

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


RTM Strategy

1. Joint venture between Radboudumc and Radboud Translational Medicine BV2. A €14 million investment in housing, cyclotron facilities and GMP compliance 3. A self‐sustaining technology platform for R&D and contract manufacturing4. 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 facilities6. To provide facilities for top‐notch translational research

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RTM in research (1)• Supply of routine tracers (FDG, F‐DOPA, F‐choline, NaF, FLT)• Supply of new (experimental) tracers (radiochemistry by the customer)• Development of new tracers (radiochemistry by RTM)• Validation of radiochemical processes, process optimization• Projectmanagement for pre‐clinical and clinical studies• Support for research institutes to set up new imaging studies• Acquisition of new projects for external clients

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RTM in research (2)Internal partners (position in Radboudumc)• Close collaboration with and strong support of the Department of

Radiology & Nuclear Medicine• Strong preclinical position through collaboration with PRIME (pre‐clinical

imaging center Radboudumc)• Active participation in the Radboud Technology Centers, in the GMP‐cluster• Direct line of communcation with directors of the Radboudumc research

inistitutes, theme leaders and researchers ( together with Nucleaire Medicine)

• Build a network of external partners

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What makes our proposition unique?


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 spectrumfrom molecule to man to population

Orie

ntation across

the spectrum

of d

iseases Research theme

Techno

logy Cen

ter

Research organisation

• 19 Research Themes to drive research

• 3 Research Institutes to drive education

• 14+ Technology Centers to support


Radboudumc Technology Centers

• Proteins• Metabolites

• Preclinical• Clinical

• Behavioural

• Animal facility• Systematic review

• Cell analysis• Sorting

• Pediatric• Adult• Phase 1, 2, 3, 4

• Vaccines• Pharmaceutics• Radio‐isotopes• Malaria parasites

• Management• 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)• Finalize the construction work within agreed timelines• Complete qualification with maximum efficiency (particularly GMP license)• Start acquisition of new projects as early as possible for a flying start • Make a success of the commercial exploitation of the facility• Achieve financial break even as quickly as possible

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Challenges (2)• Build up expertise and credibility quickly:

‐ Radiochemistry expertise‐ Translational expertise‐ Project management skills‐ Time management, cost management

• How to position RTM in the scientific community?• Build up an internal and external network of research partners

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In 2018 RTM will: • Manufacture radiopharmaceuticals for 8 hospitals in the region (both in

the Netherlands and in Germany)• Have five preclinical studies ongoing in collaboration with Radboudumc

research institutes• Perform two labelling experiments for regional start ups• Run five clinical studies in collaboration with Radboudumc research

institutes, of which two for big pharma• Be fully responsible for at least one clinical study• Have own expertise available in the field of radiochemistry, project

management, radiation safety, GLP, GMP and GCP

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Contact Dr. Frans Pieters, Managing DirectorE [email protected] T +31 651294195


Questions?

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Documents

20140828 rtm frans pieters