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Partnerships with CROs
3 October - 4 October 2011
Partnerships with CROs
   

The SAE Media Group is proud to announce its 3rd annual conference on Managing Partnerships with CROs,  on the 3rd and 4th October 2011, in Central London, UK.

The pharmaceutical and biopharmaceutical industry is facing enormous challenges. With continuing R&D cuts, both in the workforce and financially, and compound attrition at all stages, productivity is low and efficiency is of paramount importance. Eliminating drugs from the development pipeline that don’t show promise early on has become essential to drug development activities.

The conference will heavily address the critical subject of improving relationships between Pharma & CROs both technical & academic. With the increasing reliance on positive and profitable relationships between these organisations, the conference offers case study presentations and instructional presentations on learning from and dveloping positive relationships to maximise your partnership.

The agenda is broken down in to 5 key sessions; Pharma vs CRO relationship, Success factors, Outsourcing, Selecting a partner & Project Risk Management Strategies. Each session will be covered in detail by speakers with relevant specific expertise. The speakers come from big Pharma, CROs and academic partnerhsips and provide for a balanced and dynamic agenda.

The conference is also partnered by two associated and valuable workshops. 'Lessons Learned' led by Amy Ylisaari provides a key forum for learning and debating ways to learn from the mistakes made in previous Pharma - CRO partnerships. Effective Collaborations with CROs: Touch-Points for Success, led by Graeme Ladds, takes a long term view toward improving relationships. Both sessions provide valuable and contructive feedback and transferable lessons for your business.

 

“The need to reduce costs has driven efficiency and pushed us to develop more innovative solutions. In recent years the CRO sector has made an increasing contribution to the global drug development enterprise, working more closely and collaboratively with biopharma customers in all markets around the world. Today, CROs constitute approximately half of the research workforce involved in drug and medical product development,”

Simon Higginbotham, Senior Vice President, Chief Marketing Officer, Kendle

 

 “Well organised with very appropriate content and speakers.  Very well organised and excellent conference.  Both preparation and running of the event was comprehensive and inclusive to ensure delegates and speakers were fully supported throughout.”

Global Operational Client Lead, Quintiles

"Presentations and slides were of a very good level.  Nice balance and representation from CRO/pharma/labs.  Good networking opportunities."

Senior Clinical Site Manager, Bristol-Myers Squibb

 

Our speaker line up includes;

Tony Carita, President, CTB Solutions  (formerly Director Clinical Outsourcing, Otsuka US)

Helen McGrath, Senior Clinical Site Manager and Co-lead of Global Hub Outsourcing Specialist Team, Bristol-Myers Squibb

Pasi Piitulainen, Senior Director, Business & Science Affairs, Actelion

Robert Snijder, Director Global Clinical Programming, Astellas

Georgi Georgiev, Manager, Clinical Research, AstraZeneca

Dominic Bowers, Associate Medical Director, Quintiles

Maria Palmer, Director, NHS R&D Forum

David Collier, Senior Research Fellow – Head of Team, William Harvey Research Institute Clinical research Centre

Patricia Leuchten, President, The Avoca Group, Inc.

Mike Bradshaw, Sales & marketing Director, Biocair International Ltd

Sally Osmond, VP, EMEA, Kendle

Roger Joby, Managing Director, 1to1to1 Consulting

John Bennet, Director, JABPharma

 

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Tony Carita

Tony Carita, President, CTB Solutions

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9:10

Making the best use of specialist carriers in your supply chain

Mike Bradshaw

Mike Bradshaw, Global sales and marketing director, Biocair International Ltd

• How to leverage cost savings
• Added benefits of using a specialist
• How to chose the appropriate service for your clients needs
• Managing the relationship

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9:50

Working with the National Health Service

Maria  Palmer

Maria Palmer, Director, NHS R&D Forum

• National Infrastructure supporting trials in the NHS
• Factors influencing NHS Trust performance in trials
• Working at the individual Trust level
• Stress-free working with the NHS

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10:30

Morning Coffee

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11:00

Pediatric Clinical Trials: a special challenge outsourced by most companies

Klaus Rose

Klaus Rose, MD, klausrose Consulting

• EU & US lediatric legislation, EU pediatric investigation plans (PIPs)
• Most frequent mistakes in PIP preparation & execution
• Specific challenges of pediatric clinical trials
• Identification of appropriate CROs and KOLs
• Monitoring pediatric trials
 

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11:40

In a new virtual world where are the walls of the house: outsourcing to crowdsourcing

Katya Tsaioun

Katya Tsaioun, Chief Scientific Officer , Cyprotex Plc

  • Changes in pharmaceutical industry and how they changed outsourcing landscape
  • Not if to outsource, but how to do this best
  • Different types of partnerships
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    12:10

    Panel Discussion: The future role of strategic partnerships

    Kirsty Barnes

    Kirsty Barnes, Editor, Biopharm Insight

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    13:10

    Networking Lunch

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    14:10

    What can a CRO partnership bring you?

  • Against the definitions of partnerships what are our expectations in bringing a CRO and Pharma company together
  • What can both parties expect to get out of the relationship
  • Where do the disappointments and positive rewards come through
  • How can we measure success
  • Sally Osmond

    Sally Osmond, Executive Vice President, Cardiovascular & Endocrinology, Clinical Development, INC Research

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    14:50

    Success factors for a Strong CRO partnership

    • Combining cultures
    • What should you look for in a major CRO
    - Governance
    - Communication
    - Therapeutic & Operational expertise
    - Quality Assurance and Planning
    - Leadership
    - Flexibility
    • Role of Strategic Partnerships

    Narinder Virk

    Narinder Virk, Senior Director Clinical Project Management, Quintiles Ltd

    Maulik Mehta

    Maulik Mehta, Senior Director Corporate Development, Quintiles Ltd

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    15:30

    Afternoon Tea

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    15:50

    Academic experiences in developing partnerships with industry

    David Collier

    David Collier, Senior Research Fellow - Head of Team, The William Harvey Research Institute, Barts and The London School of Medicine & Dentistry

    • Experience of setting up a prime site relationship between a CRO & a University
    • The learning curves on both sides
    • Challenges to overcome in maximising productivity of partnerships
    • Case study examples

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    16:30

    Local affiliate key responsibilities in a global outsourced study

    Helen McGrath

    Helen McGrath, Senior Clinical Site Manager, Bristol-Myers Squibb

    • How can local sponsor affiliates engage with the CRO team to ensure a speedy and efficient start-up process?
    • Examining quality oversight visits by local sponsor affiliates to CRO managed sites
    • Achieving optimal KOL management with CROs

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    17:10

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Tony Carita

    Tony Carita, President, CTB Solutions

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    9:10

    Understanding the hidden costs of strategic partnerships

  •  Examining the structure of a typical governance structure
  •  Exploring elements of strategic partnerships
  •  Understanding where hidden costs occur
  •  Overcoming the main pitfalls of hidden costs in strategic partnerships

     

  • Tony Carita

    Tony Carita, President, CTB Solutions

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    9:50

    Selection Process and Management of an FSP model CRO relationship

    Robert Snijder

    Robert Snijder, Manager Clinical Programming, Astellas Pharma Europe Ltd

    • Overview
    • The selection process
    • Integration  process
    • What has been learned & gained – initial experience
    • Developing the relationship in future

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    10:30

    Morning Coffee

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    11:00

    Case Study: Partnering with technical CROs

    Pasi  Piitulainen

    Pasi Piitulainen, Senior Director, Business and Science Affairs, Actelion Pharmaceuticals

    • Outlining functional outsourcing; what is it all about?
    • Comparison of partnering with technical CROs v. full-service providers
    • Assessing different partnering models and governance
    • Lessons learned at Actelion 

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    11:40

    The oversight of quality in outsourced clinical trials

    Patricia Leuchten

    Patricia Leuchten, President, The Avoca Group, Inc.

    • Assessing sponsors' and CROs' reported satisfaction with the delivery of quality in outsourced clinical trials
    • Are pressures to reduce cost and time overshadowing quality?
    • Examining needs, issues and best practices in the delivery of quality
    • What is the perceived quality of deliverables of clinical service providers by geographic region?
    • To what extent are companies being proactive about ensuring high quality?

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    12:20

    Networking Lunch

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    13:30

    What is project management delivering?

    Roger  Joby

    Roger Joby , Managing Director, 1to1to1, R & NR Consulting

    • Sharing responsibility in a partnership
    • Project management deliverables
    • Weaknesses of Pharma & CROs in project management
    • How to define minimum expectations
    • Itemising activities

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    14:10

    Improving risk management at the CRO – client interface

    John Bennett

    John Bennett, Director, JABPharma Limited

    • Why do so many clinical trials fail to meet timeline targets?
    • The pivotal role of understanding and managing risks and uncertainty.
    • Tools and techniques for improving risk management when working with a CRO

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    14:50

    Utilising technology to improve outsourcing performance

  • Exploring the advantages of using technology to improve performance
  • Developing a technology specification
  • Real life examples of technologies that have improved outsourcing performance
  • Tony Carita

    Tony Carita, President, CTB Solutions

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    15:30

    Afternoon Tea and close of conference

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    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

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