Publiek private samenwerking in de praktijk Ph. Scheltens Alzheimercentrum / NCA VUMC PSI
PPS: waarom?
• Funding vanuit overheid neemt (verder) af
• Maatschappelijk belang samenwerking academia-privaat • Concurrentiepositie NL (EU) • Pharma stoot (basic) research af: koopt in
• Valorisatie besef • ….
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Voorbeelden uit de praktijk
• Industry Alliance office VU/VUMC
• PSI • VUmc Alzheimercentrum • Deltaplan Dementie
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Facts and Figures
Founded in 2008, NCA is currently the largest neuroscience institute gathered on one campus in the Netherlands. 550 employees – 65% in the Medical Center / 35% in Faculties 26 departments, 70 principle investigators, 150 PhD students
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Facts and Figures
The Industry Alliance Office - representing the Neuroscience Campus Amsterdam - is a full service shop to the pharma and biotech industry for: •
Preclinical and clinical research on post mortem brain tissues
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PoC studies in (stem) cell models, mutant mouse models and humans
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Clinical Trials, Biobanking and Brain Imaging in large cohorts of patients
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Collaboration with stakeholders and alliance partners
Exploratory discovery
Drug Discovery
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Preclinical
Clinical Trials
Translational Neurosciences: We fit together
Example 1: Novel drug target identification – collaborative reseach & joint IP: High throughput proteomics and immunoprecipitation study of protein interactors of mutated gene products in FTD for external prospect: - Identification of 5000 proteins in postmortem, staged disease samples - Quantification of 2000 proteins per sample - Protein interaction analysis in vitro and in silico SynapSelect™ database
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Translational Neurosciences: We fit together
Example 2: Drug target validation - all new chemical IP owned by customer IRAK4 drug screening model in activated microglia from postmortem AD for midsize biotech: - Cellomics (automated) screen of small compound library - Effectiveness pharmacophenomics in APP(swe)/PS1(e9) mutant mice - Neuropathological validation
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Translational Neurosciences: We fit together
Example 3: Clinical expertise - therapy effectiveness analysis (fee-for-service project): High density EEG/MEG recording during phase II clinical trials in mild AD : - EEG - Frequency spectral analysis, functional connectivity and graph theory network analysis in 250-500 patients in multisite trials - MEG recordings at baseline and every 4-8 weeks as a parallel readout of cognitive enhancement due to intervention(s)
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PSI: the standard of research in UMCs Philip Scheltens Scientific director PSI
10/2/2013
Improving health by sharing science
PSI 2007-2011 • FES grant 32 M€ – – – –
Central management ICT Biobanking Pearl collections
• All 8 UMC’s • 8 diseases – ‘random’ selection – 9th added ‘CONCOR’ in 2010
• 1 coordinator per disease area • 1 coordinator per UMC/8 pearls
Diabetes Neurodegeneratief Nierfalen Erfelijke darmkanker CVA Lymfoom Rheuma IBD
From project to institute Part of national Hub UMC organisation 2013• collaboration with/ within BBMRI-NL • implementation central and • coördination Dutch clinical data and local infrastructure within biobanks UMC's • coördination UMC- data-and • PSI mode of working becomes national biobanken • PSI mode of working becomes standard
2012-2016 PROJECT 2007-2011 •central and local infrastructure • pearl collections
the standard!
Update PSI Groei 2012 25000
21555 20000
18504 01-jan-12
15282 15000 # inclusies
13701
10000
6609 5000
1538 0
informed consents
complete inclusies
Landelijke database (CI)
01-jan-13
From project to institute to standard practice.. • • • • • •
Central team (biobank, ICT etc) UMC per pearl: different approaches and support 4 (5) new pearls Market valorisation …. Information model incorporated within EPD! Create uniform workflow for research within care setting, in all UMC’s
Amyloid Imaging in AD
“[18F]flutemetamol is being investigated clinically as an amyloid imaging agent and has not yet been approved by any regulatory authorities”.
The Dutch Flutemetamol in Young Onset Dementia Study (2012-2016) Primary study objective • To investigate the clinical value of [18F]flutemetamol PET imaging in patients with young onset dementia in terms of – – – –
change in (level of confidence of) diagnosis; impact on patient healthcare management; diagnostic accuracy of final diagnosis at 2 years follow-up; cost-effectiveness.
Secondary study objectives • To assess the concordance of [18F]flutemetamol PET imaging with established biomarkers acquired from CSF (Aβ 1-42, total tau and ptau 181) and MRI (atrophy medial temporal lobe); • To assess the prognostic value of [18F]flutemetamol PET imaging. “[18F]flutemetamol is being investigated clinically as an amyloid imaging agent and has not yet been approved by any regulatory authorities”.
Interim results on first 80 patients •
48 out of 63 (76%) AD patients,
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1 out of 9 (11%) FTD patients
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3 out of 8 (38%) patients with other dementias.
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Confidence increased from 76±12% to 90±16% after disclosing PET results (p<0.001).
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change in diagnosis in 17 (21%) patients. −
In 11 out of 13 patients, a negative [18F]Flutemetamol PET caused a change of the initial AD diagnosis to another dementia.
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In 3 out of 4 other dementia patients the initial diagnosis changed to AD after revealing a positive [18F]Flutemetamol PET scan.
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In 28 (35%) AD patients, [18F]Flutemetamol PET results led to a change in patient healthcare management (of which 25 patients changed medication use and 9 patients received additional care).
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In addition, 13 patients needed additional ancillary investigations after [18F]Flutemetamol PET.
PPS van begin… Philip Scheltens Vice-voorzitter Bestuur DPD
4-4-13: VWS steunt het Deltaplan
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Pijler 1 Onderzoek • €32,5 miljoen van VWS voor eerste 4 jaar • €12,5 miljoen van Alzheimer Nederland (4 jaar) • uitvoering door ZonMw • programmacommissie geïnstalleerd op 17/9 • call for proposals op 1 oktober j.l. • Passend binnen LSH • 4 thema’s Oorsprong van ziekte (€6 miljoen) Diagnostiek (€5 miljoen) Behandeling en Preventie (€3 miljoen) Doelmatige zorg en ondersteuning (€2 miljoen)
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Pijler 2 Zorgportaal • fase van voorbereiding • inventarisatie uitgevoerd speelveld initiatieven randvoorwaarden
• invitational conference in november wie doen mee plan van aanpak
• implementatie zorgstandaard regiegroep ZSD praktijkverbeterprogramma Vilans
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Pijler 3 Register • fase van voorbereiding • werkgroep gestart Annette de Ruiter (Achmea) is trekker stakeholders betrokken plan van aanpak
• business case door KPMG/Plexus
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PPS in de praktijk
• Nodig en mogelijk
• Maatschappelijk belang: ja • Voor(oor)delen: ja • Politiek/publiek/wetenschappers: niet up to date en up to speed
• Science 3.0 ipv 1.0 • Valorisatie besef moet groeien en vereist attitude verandering; PPS§ helpt daar bij
• ….
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VUmc Alzheimer Center
