Publiek private samenwerking in de praktijk. Ph. Scheltens Alzheimercentrum / NCA VUMC PSI

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Damian Bosman
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1 Publiek private samenwerking in de praktijk Ph. Scheltens Alzheimercentrum / NCA VUMC PSI

2 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. 2

3 Voorbeelden uit de praktijk Industry Alliance office VU/VUMC PSI VUmc Alzheimercentrum Deltaplan Dementie 3

4 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 4

5 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 PoC studies in (stem) cell models, mutant mouse models and humans Clinical Trials, Biobanking and Brain Imaging in large cohorts of patients 5

clinical research on post mortem brain tissues PoC studies in (stem) cell models, mutant

6 Collaboration with stakeholders and alliance partners Exploratory discovery Drug Discovery Preclinical Clinical Trials 6

7 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 7

products in FTD for external prospect: - Identification of 5000 proteins in postmortem, staged disease samples -

8 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 8

postmortem AD for midsize biotech: - Cellomics (automated) screen of small compound

9 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 patients in multisite trials - MEG recordings at baseline and every 4-8 weeks as a parallel readout of cognitive enhancement due to intervention(s) 9

Frequency spectral analysis, functional connectivity and graph theory network analysis in 250-500 patients in

10 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

11 PSI FES grant 32 M Central management ICT Biobanking Pearl collections All 8 UMC s 8 diseases random selection 9th added CONCOR in coordinator per disease area 1 coordinator per UMC/8 pearls Diabetes Neurodegeneratief Nierfalen Erfelijke darmkanker CVA Lymfoom Rheuma IBD

2010 1 coordinator per disease area 1 coordinator per UMC/8 pearls

From project to institute PROJECT 2007-2011 central and local infrastructure pearl collections UMC organisation 2012-2016 implementation central and local infrastructure within UMC's coördination

12 From project to institute PROJECT central and local infrastructure pearl collections UMC organisation implementation central and local infrastructure within UMC's coördination UMC- data-and biobanken PSI mode of working becomes the standard! Part of national Hub collaboration with/ within BBMRI-NL coördination Dutch clinical data and biobanks PSI mode of working becomes national standard

data-and biobanken PSI mode of working becomes the standard!

13 # inclusies Update PSI Groei jan jan informed consents complete inclusies Landelijke database (CI)

01-jan-12 01-jan-13 10000 6609 5000 1538 0

14 Central team (biobank, ICT etc) UMC per pearl: different approaches and support 4 (5) new pearls Market valorisation. From project to institute to standard practice.. Information model incorporated within EPD! Create uniform workflow for research within care setting, in all UMC s

From project to institute to standard practice.

15 Amyloid Imaging in AD [ 18 F]flutemetamol is being investigated clinically as an amyloid imaging agent and has not yet been approved by any regulatory authorities.

16 The Dutch Flutemetamol in Young Onset Dementia Study ( ) Primary study objective To investigate the clinical value of [ 18 F]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 [ 18 F]flutemetamol PET imaging with established biomarkers acquired from CSF (Aβ 1-42, total tau and p- tau 181) and MRI (atrophy medial temporal lobe); To assess the prognostic value of [ 18 F]flutemetamol PET imaging. [ 18 F]flutemetamol is being investigated clinically as an amyloid imaging agent and has not yet been approved by any regulatory authorities.

Secondary study objectives To assess the concordance of [ 18 F]flutemetamol PET imaging with established biomarkers acquired from CSF (Aβ 1-42, total tau and p- tau 181) and MRI (atrophy medial

17 Interim results on first 80 patients 48 out of 63 (76%) AD patients, 1 out of 9 (11%) FTD patients 3 out of 8 (38%) patients with other dementias. Confidence increased from 76±12% to 90±16% after disclosing PET results (p<0.001). change in diagnosis in 17 (21%) patients. In 11 out of 13 patients, a negative [ 18 F]Flutemetamol PET caused a change of the initial AD diagnosis to another dementia. In 3 out of 4 other dementia patients the initial diagnosis changed to AD after revealing a positive [ 18 F]Flutemetamol PET scan. In 28 (35%) AD patients, [ 18 F]Flutemetamol PET results led to a change in patient healthcare management (of which 25 patients changed medication use and 9 patients received additional care). In addition, 13 patients needed additional ancillary investigations after [ 18 F]Flutemetamol PET.

In 11 out of 13 patients, a negative [ 18 F]Flutemetamol PET caused a change of the initial AD diagnosis to another dementia.

18 PPS van begin Philip Scheltens Vice-voorzitter Bestuur DPD

19 4-4-13: VWS steunt het Deltaplan 19

20 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) 20

21 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 21

22 Pijler 3 Register fase van voorbereiding werkgroep gestart Annette de Ruiter (Achmea) is trekker stakeholders betrokken plan van aanpak business case door KPMG/Plexus 22

23 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. 23

24 VUmc Alzheimer Center

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