Access to drugs, Reducing bottlenecks Matt Cooper Business Development & Marketing Director NIHR Clinical Research Network Supporting the life-sciences industry in UK clinical research delivery

Build Upon Our Past to Ensure Future Success The CRN is a flagship of achievement for the National Institute for Health Research and Department of Health Recruiting over 3 million patients into clinical research studies over the last 5 years Nearly 35,000 patients into commercial clinical trials in the previous year

UK landscape Political commitment to supporting life-sciences industry Health & Social Care Act 2012 / NHS Constitution 2013 –Embed clinical research in all aspects of care

One national network Research active engaged clinicians across all 30 therapy areas Detailed understanding of care pathways 15 Local Clinical Research Networks (LCRNs) Research ready workforce Links with rest of UK

Business Development Vision: The UK is the number one location in Europe, and in the top 5 worldwide, in which to conduct clinical research.

European Competition Data source: 1.Germany United Kingdom France Spain Belgium 365 (All Phase II, III, IV studies received from 01/04/2014 to 31/03/2015 funded by Industry) Retrieved online on 29 April 2015

Speed: UK vs the world Data source: Global CRO 1 Median time (weeks) for complex study set up. From final protocol AND global model ICF available, to 1 st site initiated in a given country

Quality National Network of Clinical Experts A research-ready workforce Embedded in the NHS to support investigators Thousands of healthcare professionals undertake our on-line GCP training each year Free to staff working on NIHR CRN clinical trials Supported by MHRA

FEASIBILITY Manage and deliver: Early Feedback Site Intelligence Site Identification COMMERCIAL COSTING TEMPLATES Support use Manage templates Trust, Primary Care & Device versions NIHR COORDINATED SYSTEM FOR GAINING NHS PERMISSION Support use MODEL AGREEMENTS Support use STUDY MANAGEMENT Collect & collate data Performance manage study FeasibilitySet-upDelivery Support My Study service

Performance N o studies up N o recruits up NHS engagement up Set up time down

Delivery 11 UK competes on expertise, set up & delivery Challenge is price and adoption of innovation Excellent delivery in DMD studies

12 Supporting innovation - study design & delivery

Strategic Industry Alliances Academic partnerships between CRN and individual companies to design investigator-led, academically-sponsored studies Aim: to optimise early phase testing of new therapies not part of the company’s main R&D programme Pilot in oncology

Building Capacity in Partnership with Charities Address capacity issue - impacting on the opportunity for life sciences companies to place more studies in some rare disorders in the UK and therefore reducing opportunity for patients to access potentially life- changing treatments. July - National Workshop on DMD Clinical Trial Capacity William van't Hoff & Katie Bushby – Newcastle Proposal

Proposal Charities to consider pump priming a post(s) to facilitate uptake of one or several studies Contract with site allows the charity to recover the costs of the new post over time from commercial revenue generated by delivery of the studies. The extent of ‘pump priming’ would depend on the study and anticipated revenue. It does not involve any specific contract between charity and a commercial sponsor

Summary 16 1)UK is open for business and conducts world leading science 2)Quality & delivery at pace is key 3)Innovation is part of a clinical research culture embedded in the NHS