National Industry Event 2014 Quality Changing perceptions

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
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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
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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
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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
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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
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Change the global view of UK research environment
– Government drivers – incentives to invest in UK
– UK research infrastructure
– Information Technology
– NIHR CRN service offer
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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
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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