National Industry Event 2014 Quality Changing perceptions Matt Cooper, Life-sciences Development Director, NIHR Clinical Research Network Delivering research to make patients, and the NHS, better Pipeline • Total value of the pharmaceutical industry’s R&D pipeline has grown by 46% in the last year to $419bn • A significant driver of growth is the programmed death-1 (PD-1) pathway - collective net present value of $63bn (4 of top 10 agents) • Humira projected to be world’s largest selling product worldwide sales forecast to be > $12bn • Biologics set to account for more than 50% of sales [ source: EvaluatePharma®] Trial Volume Europe Source: Thomson Reuters Trial Volume Worldwide Source: Thomson Reuters Increased volume of studies Number of new commercial studies added to the NIHR CRN Portfolio Increased patient recruitment Number of participants into commercial NIHR CRN Portfolio studies • • • 96,000 patients recruited to industry studies over the last 6 years 25,000+ patients recruited to commercial contract studies in 13/14 35 first global patients in 2013/2014 Delivery - time and target Percentage of NIHR CRN commercial studies recruiting to time and target • • • Year on year improvement 25% increase in performance of studies delivered to time and target compared to last year % even higher in some therapy areas Recruiting less that 100% of target or exceeding 100% of planned recruitment period Recruiting 100% of target within 100% of planned recruitment period Quality support • • • A research-ready workforce – 10,000+ GCP-trained nurses embedded in the National Health Service to support investigators with patient identification, screening, clinical delivery Proactive study management support – Study milestone schedule; monthly reviews of recruitment, RAG rating of studies to a site level Trouble-shooting from the inside – Our strong relationships with clinicians and detailed knowledge of other potential sites gives you options if a study hits a recruitment problem Quality training ICH GCP Training • Almost 23,000 healthcare professionals undertook our GCP training during 2013-14 • Free to staff working on NIHR CRN clinical trials • Supported by MHRA • Recently added to the list of GCP programs mutually recognised by TransCelerate member companies Study set up Median calendar days taken to obtain NHS permission (study) Partners Change perceptions • Change the global view of UK research environment – Government drivers – incentives to invest in UK – UK research infrastructure – Information Technology – NIHR CRN service offer • • • • • • • • NIHR systems Earlier Access to Medicines NIHR early and late phase SchemePractice Research Clinical Academic Health Science Patent Box Datalink Networks R&D Tax Relief Care.Data Health Research Authority Innovation Disease Registries Score Card Winning together • • • • The UK environment for clinical research has changed There is still work to do – and we are doing it The future looks bright We want to work with you to deliver for the UK