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

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