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The SMi 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




 Pain medication


  • Analyse what makes a Pharma-CRO relationship successful. Use case study reference and first hand experience to improve your knowledge of building a successful relationship.
  • Hear the Pharma, CRO and academic perspective on relationship management. Adapt your understanding of what your potential partners are looking for and develop more harmonious and profitable partnerships.
  • Examine the partnership selection process. Whether for a Pharma or CRO perspective, analyse how to improve your selection process and procedure. Build towards dynamic and mutually profitable relatiionships.
  • Learn how to adapt your strategy to different kinds of partners. Whether working with a technical CRO or a health institution such as the NHS, each partnership is different and strategy must be adapted accordingly.
  • Discuss the hidden costs of partnerships. Examine and explore the structure of partnership and where hidden costs may occur. Learn how to overcome these potential pitfalls for mutual benefit.
  • Develop superior project management strategy. Identify and eliminate weaknesses and share responsibility. Use these lessons in your communications with potential partners.
  • Study global outsourcing strategy. Analyse the challenges of outsourcing on a global scale and compare the lessons you learn in this session with presentations on localised experiences of Pharma/CRO relations.
  • Network with key industry professionals from the Pharma, CRO and academic fields. 


  • CEO
  • Chief Scientific Officer
  • Clinical Operations Sourcing Manager
  • Clinical Outsourcing Manager
  • Clinical Quality Lead for Contracts & Outsourcing
  • CRO manager
  • Director
  • European CRO Manager
  • European R&D Outsourcing Manager
  • Executive Director & Chief Operating Officer - Global External R&D
  • Executive Director, Head, Global Clinical Site Management
  • Global Alliance Leader
  • Global Director, Clinical Outsourcing and Novel External Delivery
  • Global Head Contracts & Outsourcing
  • Global Head, Alliance Management
  • Global Sourcing Strategy Lead, Contracts and Outsourcing
  • Head of Clinical Outsourcing and Resourcing Group
  • Head of Global Purchasing and Outsourcing
  • Head of In-and-Outsourcing
  • Head of Worldwide Strategic Outsourcing
  • Senior Contracts & Outsourcing Manager
  • Senior CRO Buyer
  • Senior Director
  • Senior Vice President Global Clinical Development
  • Senior Vice President, Global Development Operations
  • Vice President Global Clinical Strategic Resourcing
  • Vice President, Business Development & Alliance Management
  • Vice President, Global Development Operations
  • Vice President, Global Head of Strategic Alliances
  • Vice President, Legal

 SMi's Managing Partnerships with CROs event has been attended by delegates from; 3M Health Care, Abbott, Actelion, Allergan, Almirall, Amgen, Astellas, AstraZeneca, BARC HV, Baxter, Bayer, Biogen, BMS, Boehringer-Ingelheim, Celgene, Celtic Pharma, Clinstar, Daiichi Sankyo, Eli Lilly, F Hoffmann La Roche, Ferring, Genentech, Genzyme, GlaxoSmithKline, Grunenthal, Guy's Hospital, Hospira UK Ltd, i3 Research, ICON Clinical Research, INTERLAB GmbH, Johnson & Johnson, Lundbeck, MedImmune, Merck, Novartis, Novo Nordisk, Nycomed, Orion Pharma, PAREXEL, Phase Forward, Pfizer, Quintiles, RSSL, Sanofi-Aventis, Tech Observer, Teva, UCB & Verum De GmbH

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Tony Carita

Tony Carita, President, CTB Solutions

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

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

10:30 Morning Coffee

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

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
  • 12:10 Panel Discussion: The future role of strategic partnerships

    Kirsty Barnes

    Kirsty Barnes, Editor, Biopharm Insight

    13:10 Networking Lunch

    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

    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

    15:30 Afternoon Tea

    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

    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

    17:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Tony Carita

    Tony Carita, President, CTB Solutions

    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

    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

    10:30 Morning Coffee

    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 

    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?

    12:20 Networking Lunch

    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

    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

    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

    15:30 Afternoon Tea and close of conference


    Holiday Inn Bloomsbury

    Coram Street
    London WC1N 1HT
    United Kingdom

    Holiday Inn Bloomsbury

    Holiday Inn London-Bloomsbury is just 2 minutes' walk from the Tube at Russell Square station, for speedy connections across the capital. We're 10 minutes by bus from Eurostar connections at St Pancras station, and a 45-minute taxi ride from London Heathrow Airport. Check into your stylish Guest room, air-conditioned and connected to wireless Internet.



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    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:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.


    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.


    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SMI Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.


    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@smi-online.co.uk

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