Access to drugs, Reducing bottlenecks

Matt Cooper

Business Development & Marketing Director NIHR Clinical Research Networkmatt.cooper@nihr.ac.uk

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 CompetitionData source: http://clinicaltrials.gov/

1. Germany 686

2. United Kingdom 675

3. France 501

4. Spain 465

5. 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 worldData source: Global CRO 1

Median time (weeks) for complex study set up. From final protocol AND global model ICF available, to 1st 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

Feasibility Set-up Delivery

Support My Study service

PerformanceNo studies up

No recruits up

NHS engagement up

Set up time down

Delivery

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UK competes on expertise, set up & delivery

Challenge is price and adoption of innovation

Excellent delivery in DMD studies

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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

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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