Embed Size (px)
Citation preview
Copyright © 2012 Quintiles
An Industry View of Working in NHS
Wales
Paula Jefferies – Site Relationship Manager Quintiles 11th December 2012
2
Quintiles Introduction
Quintiles conducts the largest number of commercial Clinical Trials in the UK
Quintiles conducts trials on behalf of the majority of BioPharma companies in the UK/globally
The UK is a key market and Quintiles is committed to protecting and growing the UK market
Quintiles is in a unique position to provide comparative data on performance which has been previously difficult to access
3
7 BILLION HUMANSOver 3.1 Million Individuals in Wales
3
4
The Path is Marked by Great Risk
Regulatory Pressures:
Complexity
Approval Times
Intense FDA/EMA Scrutiny
Ethical Concerns
Financial Pressures:
Costs
Capital Constraints
Demand for Value
Payer Pressure
ROI
Development Pressures:
Stakeholders Scrutiny
Patient Access Demands
Commercialization Stakeholders
R&D Timelines
Productivity
Patent Cliff
Product Pipelines
HIGH PRICE TAG
Current estimates for bringing a drug to market in the U.S. and E.U. exceed $1 billion. – Health Economics, February 2010
5
Quintiles Site Relationships
TACTICAL
• Relationship re-invented with every study;
• Little consistency or value for either party
Investigator Sites
1-2 studies per year
1 CRA per study
STRATEGIC
• Relationship actively managed
• Process alignment for efficiency
• Pipeline /capacity planning
• Therapeutic capability usually limited
Partner Sites
5+ studies per year
Relationship Manager
Multiple CRAs
Prime Sites
• Access to large volumes of patients in multiple therapeutic areas
• Joint corporate governance• Dedicated staffing• Infrastructure/capacity
development• Strategic planning• Close collaboration
TRANSFORMATIONAL
20+ studies per year
Alliance Manager
Dedicated CRAs
6
Welsh Sites have been key to our delivery of UK patient recruitment targets
Since 2002..........
• 487 patients into 49 protocols• 10 sites over 4 Health Boards
• 68% of these patients were recruited since 2009 from 2 Health Boards / NHS Trusts and 1 primary Care facility
7
Draft to Executed Contract(global median of 57 days over 52,907 studies)
Asia Pac
EMEA Japan Latin America
Canada UK Wales USA0
20
40
60
80
100
120
140
160
Number of Days
2003 2005 2007 2008 2009 2010 2011 20120
50
100
150
200
250
UK Performance Since 2003
All Wales Figures Since 2007
8
So What is the Problem in the UK?
Site Selection to Site Initiation
Asia P
ac
EMEA
Japan
Latin A
meric
aUSA UK
All Wale
s
ABMU
Canada0
50
100
150
200
250
300
350
Number of Days
9
Site Initiation Visit to FPFV
Asia P
ac
EMEA
Japa
n
Latin
Am
erica USA
Canad
aUK
All Wal
es
ABMU
0
5
10
15
20
25
30
35
40
45
Number of Days
10
Conclusion
• Research has an elevated profile in Wales
• Infrastructure to support ie: NISCHR AHSC
• Health Research Wales – single portal
• Unified approach – process simplification / alignment
• Established research centres offering wealth of experience and keen Investigator database
• Diverse patient population
• Ultimate aim is to differentiate performance against the UK to attract more successes
