Post on 14-Apr-2017
RWE Patient level data at every stage of the drug life cycleeyeforpharma Amsterdam 2016
Vaneet Nayar Directorvaneetnayar@svmpharma.com, www.svmpharma.com
+44 (0) 1256 962 220Landmark House, Station Road, Hook, UK, RG27 9HA
WHAT IS SVMPHARMA?
• An innovative strategic consultancy, specialising in Real World Evidence (RWE) for the pharmaceutical industry
• Generates RWE within UK and Europe through bespoke online Real World Treatment Evaluators, leading to successful health technology appraisal (HTA) submissions
• Specialist teams focus on delivering the outcomes that matter to your brand
SVMPHARMA AND REAL WORLD EVIDENCE
SVMPharma Real World Evidence is built upon the foundations of– the intelligent use of
Technology
– sustained healthcare professional (HCP) Engagement
Real World Evidence Innovation
• What is innovation for Real World Evidence?
“Create new ideas, processes, engagement or technology which when implemented leads to positive effective change”
Clinical Feedback – Leading Professor
“...Randomised clinical trials we treat patients…”
“…Real world setting we manage patients…”
Can they tolerate the medication?
Will the patient finish the trial?
How long can I keep them on
the medication?
When do I add in a new drug or
give a treatment holiday?
Real World Evidence - A Rapidly Changing Landscape
RWE major eventsFebruary 2014David Haslam, the chairman of the National Institute for health and Care Excellence (NICE) gives a presentation titled ‘From promise to
reality: how is real world evidence shaping the future of healthcare?’
March 2014The European Medicines Agency (EMA) launches the Adaptive
Pathways pilot project
July 2015Alexia Tonnel (NICE Director of Evidence Resources) speaks about
RWE at the Financial Times (FT) Digital Health Conference
January 2016The FDA's device arm (CDRH) wants to increase the number of pre-
and post-market studies that leverage real-world evidence by 40% in 2016, and 100% 2017
Where Is Real World Evidence?
Registry data
Primary researc
h
Non RCT
studies
Insurance data
CPRDHES
Prescription data
Patient case
notes
Patients
Patient record studies
Delivering The Outcomes That Matter Alignment
Practicalities C
omplexity
Insights
Key Learnings
Summary
• Challenge– Health systems vary across regional and national boundaries– Leveraging electronic systems for the administration of healthcare records and provision of
real-world data is limited– Both of these points need to be considered when identifying resources for specific data
elements of interest
• Opportunity– Conducting primary research and retrospective case note reviews with practicing
physicians can help to gain an awareness and understanding of the types of real world data routinely recorded in clinical practice
SVMPharma has developed a systematic approach to identify and access real-world data within the UK and Europe
CONTACT SVMPHARMA
Vaneet NayarDirector SVMPharma
enquiry@svmpharma.comTel: +44 (0) 1256 962 220
SVMPharma LtdLandmark HouseStation RoadHook, HampshireRG27 9HA
Visit svmpharma.com
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