Evaluation of the Prime Partnership between Accelence and Quintiles. James Brook Senior Director, Head Site Management Western Europe, Quintiles

Transcription

1 Evaluation of the Prime Partnership between Accelence and Quintiles James Brook Senior Director, Head Site Management Western Europe, Quintiles Copyright 2013 Quintiles Revised July 2013

2 7 BILLION HUMANS Our Quest: Make Them Healthier In the Face of Unprecedented Realities. 2

3 So how to get there together? Quintiles and Bordeaux/Accelence can help you increase your probability of success along the way. Quintiles has demonstrated an 11% higher likelihood of getting a pivotal Phase III trial approved compared to industry average. Quintiles internal data and Tufts CSDD industry average 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 Recent estimates for bringing a drug to market in the U.S. and E.U. exceed $1 billion. InnoThink Center For Research In Biomedical Innovation; Thomson Reuters Fundamentals via FactSet Research Systems,

5 BUT, IT IS ALSO PAVED WITH ENORMOUS OPPORTUNITIES Together, we ll help you seize them. Quintiles helped develop or commercialize all of 2012 s top 50 best selling products or compounds Evaluate Pharma 2012 Report Top Selling Products, accessed March 2013; Quintiles EBS Internal Analysis 5

6 Who We Are A fully integrated life cycle healthcare services provider We bring people and knowledge together for a healthier world. Biopharma Product Development Integrated Healthcare Services Clinical Services Differentiated Offerings New Markets Value-added partnership network Commercial Services Differentiated Offerings Payers Providers Continue to lead the transformation of biopharma development Excellence at Global People, Process & Technology Increase our connectivity with the payer/provider markets to bring new value to our customers CLINICAL COMMERCIAL Scientific, Therapeutic & Rx Expertise Quantitative & Analytical Expertise OUTCOME CONSULTING Leverage core competencies to provide integrated services that address the complex challenges faced by our customers 6

7 Improving Health Partnership, Ownership, Vision The patient is our inspiration, every day In everything we do, we think about the patients in our own lives who will benefit from our work and the power of clinical research: Success is proportionate to the mutual willingness to learn, develop, and deliver across all aspects of clinical trials from feasibility to database lock we can do things better, faster, and more efficiently TOGETHER Q Mission: To bring people and knowledge together for a healthier world Q Customer Promise: Improve your probability of success. 7

8 The top investigative sites in the world have the most patients but can be complicated to work with WHAT IF We could figure out how to work better together to accelerate clinical research 8 8

9 Site Management and Bordeaux/Accelence A synergistic approach to delivering clinical research Achieving results through integration, commitment, openness and collaboration Accelerate Start up Enrol Faster Enrol More Maximise Quality 9

10 The Strategy Right Path, Right Start, Right Patients Smarter, more efficient trials RIGHT PATH Optimal Approach RIGHT START Streamlined Start Up RIGHT PATIENTS Smarter Recruitment 10

11 The Global Impact Partner site productivity over other sites* Enrols Faster Enrols More 160% 140% 120% 100% 80% 60% 40% 20% 0% 143% 118% 118% 133% 160% 140% 120% 100% 80% 60% 40% 20% 0% 150% 120% 109% 150% Quintiles Partner consistently out perform non partner shown at 100% Normalized data regardless of protocol and individual country choices Demonstrates Partners performance versus their peers within a country/ study/indication Relationships build trust and enhance accuracy (ie: Key Performance Indicators) *Enrolment factor beyond base performance Data pull as of 21 August

12 The Bordeaux/Accelence History 2008 Partner Site 2011 Prime Site - Dedicated staffing Prime Associate Director and Strategic Relationship Manager - Joint corporate governance 2005 Tactical Site - Relationship re-invented with every study - Little consistency or value for either party - No long term vision - Relationship actively managed - Some process alignment - Pipeline/capacity planning - Clinical Research Coordinator 2010 to accelerate growth - Strategic planning - Internal focused support - Start up, Contracting, Finance, Clinical 1-2 studies a year Strategic 5+ studies year Transformational 50+ studies year 12

13 The Structure Joint oversight, shared goals Executive and Operations committees meet 3 and 4 times a year respectively senior Quintiles Oversight (European Board Level) Joint targets on key industry metrics: Patient and Protocol volume Financial review payments and overall contribution Start up overall and contracting Out performance performance better than normal sites Zero Enrollers reducing non performance Quality Paramount in all our activities Growth significantly above industry average Long term combined strategy supporting growth and investment Industry leading collaboration 13

14 The Innovation The only site in France with single contract template (80% of studies) Single Point of Contact for Feasiblity/Site ID 94% response rate!! OPA with specific action plan Quality/training Quality metric at 98.4% 250 attendees to GCP reminder training sessions Dedicated budget negotiation (Quintiles and Accelence) currently 65% quicker than median French time and fastest contracting in France Innovating to drive success! 14

15 The Results Growth Patients Phase 1 Studies National Coordinators Key Metrics Accelence Tactical French Site (400 sites on average in France per Year) Number of Protocols Number Investigators Pts Per Year Contract time (Days) Contribution 12% 78% 15

16 Bordeaux/Accelence Prime Site Global Position Globally No. 5 th highest recruiting site of 25 Prime!

17 The Future Further development of the Quintiles support model i. Dedicated CRAs ii. Additional Regional Start Up focus iii. Increased Finance and Contracting support. Strategic Plan to build infrastructure in support of A Right to Research 1000 Patient by 2016 Quintiles Bordeaux/Accelence 17

18 You ve got 7 billion reasons