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Working with Life Sciences Industry Insights from the Stroke Research Network and DeNDRoN Joint Health Research Conference Newcastle. Gary Ford Director SRN.
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Working with Life Sciences IndustryInsights from the Stroke Research Network and DeNDRoNJoint Health Research ConferenceNewcastle Gary Ford Director SRN
”To provide a world class infrastructure for stroke research that supports the delivery of high quality studies which improve the outcomes and quality of life of people with stroke and their carers” SRN Vision Hyperacute interventions • Reperfusion: drugs clot-retrieval • Neuroprotection Prevention • Sub-acute antithrombotic • Novel drugs Reparative therapies • Stem cells • Drugs • Mechanical: robots • Electro-mechanical: TMS, laser
Industry Opportunities Hyperacute interventions Reperfusion: novel drugs, clot-retrieval Neuroprotection: novel drugs backed by modern translational medicine Prevention Sub-acute antithrombotic: novel drugs Reparative therapies Stem cells Drugs: e.g. SRN009/ME1-2 Mechanical: robots Electro-mechanical: TMS, laser
Supporting Industry Studies • Feasibility - protocol review - patient carer input (protocol, information/consent material) • Study set up - MHRA, REC, IRAS submissions (foreign / small companies) Working with Clinical Trial Units / Chief Investigator - Site selection - Target setting • Delivery - setting and monitoring accrual - ‘Trouble shooting’ Teleconferences with LRNs/company/Chief Investigator • Dissemination - Trial results
SRN Study Portfolio Total Studies on Portfolio 95 56 open 13 setup 22 closed / follow up Commercial Studies 10 4 open 3 setup 3 closed/follow up Commerical studies That have been / are being discussed: 22 Adopted conditionally pending further information 2 Not adopted 2 Level 1 feasibility only (2 week initial opinion) 3 Considered and taken no further 2 Studies under discussion 3
Stroke LRNs and CLRNs Enabling all stroke patients across England to participate in research 2009/10 2010/11
Managed Infrastructure Developing our Hyperacute Capacity • Establish scheme to • fund 8-12 centres across England • to deliver one patient/centre/month into hyperacute studies • Build on service reconfiguration of hyperacute stroke services across England • London 8 hyperacute stroke units • Greater Manchester • Attract industry studies – compete with Germany, N America
Recruitment to PPD study • Study adopted in July 08 • UK target 30 • 4 experienced sites pre-selected • 4 inexperienced sites through DeNDRoN • exceeded target - May 09 3 new network sites initiated 4th network site initiated
Commercial SIROCCO study • UK target 30, competitive global recruitment • Concerns over delivery Dec 07 • DeNDRoN Action Plan Jan 08 - met UK target Recovery Planning
Contact Details North East DeNDRoN Manager: North East SRN Manager:Daniel.Herron@ntw.nhs.ukPenny.Williams@chs.northy.nhs.ukTel: 0191 223 2743 Tel: 0191 569 9089 North East DeNDRoN Clinical Lead: North East SRN Clinical Lead: j.t.o'brien@ncl.ac.uk Chris.Gray@chs.northy.nhs.uk DeNDRoN CC Industry contact: SRN CC Industry contact: Judith.headley@dendron.org.ukBogdan.Milojkovic@ncl.ac.uk Tel: 0117 942 0443 Tel: 0191 246 4665