Home
overview

Following on from the huge success of our inaugural event in 2009, SMi Group is proud to announce the second annual Managing Partnerships with CROs, due to take place in London on October 4th and 5th.
 


 About the conference

The CRO industry is growing fast, with an annual growth rate of over 8.5% and is expected to reach US$35bn by 2015.

Driven in part by the intense pressures of the global economic environment, shrinking product pipelines, generic competition and rapidly increasing costs, the pharmaceutical and biotech industries are increasingly outsourcing to CROs in order to reduce risk/costs, increase efficiencies and remain competitive.

Managing partnerships with external organisations presents many challenges and opportunities. Join us at SMi's 2nd annual Managing Partnerships with CROs conference and delve into these issues.

With a case study focused agenda with representatives from both sides of the table, you'll gain a unique insight into effective CRO partnership management from the key opinion leaders in this field.

Why not attend the associated workshop as well?

Associated with the conference there will be a half-day interactive workshop on "Mistakes in CRO selection: What goes wrong & how to solve these problems", taking place on 6th October.  It will cover basis for building and maintaining successful outsourcing partnerships, it will also address common sources of conflict and provide strategies to overcome these issues.  This will be led by Anne-Maria Ylisaari, Head of In-and-Outsourcing at Orion Pharma.  To see more information about the workshop, please see the workshop page.

For speaker opportunities, contact smiproduction@smi-online.co.uk

For sponsorship and exhibitioning opportunities, contact  sponsorshipdept@smi-online.co.uk

Clinical outsourcing trends

Estimated CRO market Growth ($bn), 2003- 2015

Copyright Business Insights Ltd, 2009

 


Keen to see the detailed programme?  Click here.

Want to download the brochure?  Click here.

Want to register your place? Click here.

Making a group booking? Discounts apply.

 


  • The future of Sponsor-CRO partnerships
  • Developing an ideal CRO relationship
  • Building quality and safety into CRO relationships
  • The role and outcome of multi-vendored studies
  • Offshore outsourcing opportunities
  • Minimising risk in CRO relationships
  • Choosing the right CRO partner
  • CRO trial negotiations
  • Metrics to build stronger partnerships

Mitchell Katz
Executive Director, Medical Research Operations
Purdue Pharma

Yariv Hefez
Director Global Business Development & Alliance Management
Merck Serono 

James Chennells
Head of Global Strategic Sourcing Pharma Development Services
Bayer Healthcare

Thomas Marchisello
Global Executive Director, Commercial Finance and Business Development Operations
Covance


Roderick Cameron
Deputy Director Global Clinical Outsourcing
Sanofi Pasteur 

Gary White
Global Operational Client Lead
Quintiles 

Jonathan Stewart
Disease Area Head, Neuroscience, Immunology and Pain
Bristol-Myers Squibb 

 

 See the full lineup...

 


 

 Members of Board, Vice President, Directors, Associate Directors, Heads and Senior Managers involved in:

  • Global Strategic Sourcing
  • Outsourcing
  • Clinical Operations
  • Contract Management/Administration
  • Finance
  • International Clinical Operations
  • Corporate Counsel
  • Business Development
  • Clinical Development
  • Planning
  • R&D
  • Accounting/Budgeting
  • Global Clinical Programs
  • Project Management/Planning
  • Risk ManagementClinical Trial Projects

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Mitchell Katz

Mitchell Katz, Executive Director, Medical Research Operations, Purdue Pharma L P

9:10 The future of Sponsor-CRO partnerships

  • Demand drivers, trends and expectations
  • Role of strategic partnerships
  • Planning for partnerships of the future
  • Illustrative examples
  • Mitchell Katz

    Mitchell Katz, Executive Director, Medical Research Operations, Purdue Pharma L P

    9:50 Outsourcing to a central laboratory

    Hermann Schulz

    Hermann Schulz, CEO, INTERLAB

  • Selection criteria: RFI versus lab visits
  • How to inspect global laboratories without being a lab expert
  • Logistical challenges: planning vs. Reality
  • Role of pre-analytical factors e.g. Blood collection, transportation, storage
  • Contractual aspects
  • 10:30 Morning Coffee

    11:00 Outsourcing medical governance

    Jonathan Stewart

    Jonathan Stewart, Disease Area Head, Neuroscience, Immunology and Pain, Bristol-Myers Squibb Pharmaceuticals Ltd

  • Selecting the CRO
  • Setting up the process
  • Ongoing oversight and review
  • Lessons learned
  • 11:40 What makes a good partner?

    Richard Beesley

    Richard Beesley, Director of European Strategic Business Relations , 3M Health Care

  • The importance of combining cultures
  • What key lessons have been learnt
  • Programme governance & operational protocols
  • Key challenges faced
  • 12:20 Networking Lunch

    13:20 How Biotech interacts with CROs

    Kristof Vercruysse

    Kristof Vercruysse, Director Clinical Operations, Ablynx

  • Ablynx History: Selection of CRO's
  • Maintaining flexibility during Clinical Development
  • How to deal with a diverse pipeline
  • Resulting into Strategic Partnership: win-win situation
  • 14:00 Choosing the right CRO partner

    Roger  Joby

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

  • How do you measure the value of a CRO
  • Traditional KPIs related to cost time and quality are 2 guesses and a phenomenon
  • Successful projects rely on high levels of collaboration and medium levels of structure
  • What should you look for in a CRO
  • Quality of information and communication
  • Quality of planning
  • Flexibility
  • 14:40 Developing metrics for successful R&D laboratory outsourcing relationships

    Roderick Cameron

    Roderick Cameron, Deputy Director of Global Clinical Immunology Outsourcing, Sanofi Pasteur

  • Developing metrics at the beginning of an outsourced partnership/relationship 
  • Optimising metrics based on past performances
  • Implementing Penalties and Bonuses "the carrot and stick approach"
  • Driving performance for continuous improvement
  • 15:20 Afternoon Tea

    15:50 Offshore outsourcing opportunities

    Jacquie Mardell

    Jacquie Mardell, Partner, Anhvita BioPharma Consulting

  • Staying abreast of a changing regulatory landscape
  • Standards in the emerging regions
  • Consent and vulnerability
  • Matching trials to the right country
  • Making the most of CRO partnerships
  • 16:30 Partnerships with Academic Research Organisations

    Rick Grobbee

    Rick Grobbee, Chief Scientific Officer, Julius Clinical Research

  • Advantages and shortcomings
  • COIs arising out of academic-industry relationships
  • Integrating academic expertise and industry clinical objectives
  • Unique considerations
  • Perceived differences
  • 17:10 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Albert Agro

    Albert Agro, President, HNZ Strategy

    9:10 The role and outcome of multi-vendored studies

    Albert Agro

    Albert Agro, President, HNZ Strategy

  • The pros of single vendor studies (from the CRO and sponsor side)
  • The pros of the multi-vendor study
  • Case studies looking at cost, timelines, data integrity, outcome, investigator enthusiasm
  • Two multi-vendor trials
  • Running two identical trials: one with multi-vendor the other with single vendor
  • 9:50 Managing long term Central Laboratory partnerships

    Gary White

    Gary White, Global Operational Client Lead, Quintiles

  • Aligning sponsor and provider interests
  • Developing clear expectations and avoiding miscommunication
  • Managing cultural dynamics
  • Focus on delivery and dealing with delays
  • Governance structure; dedicated sponsor-provider staffing
  • Case study: proactive Central Laboratory risk and performance monitoring
  • 10:30 Morning Coffee

    11:00 The business relationship as a driver of partnership success

  • Partner selection and reciprocal validation measures.
  • Fit-gap analysis - what actions are required to identify the business needs of the partnership.
  • Identification and implementation of fundamental requirements - how to build a core foundation for success.
  • Setting metrics/measures for partnership success - determining what those metrics are and the appropriate benchmarks.
  • Measures for continuous partnership and process improvements. 
  • Building and expanding a strong organizational culture (within and outside of the direct governance body).
  • Breakthrough ideas - driving operational and relationship value while minimizing waste.
  • James Chennells

    James Chennells, Head of Global Strategic Sourcing Pharma Development Services, Bayer Healthcare

    Thomas Marchisello

    Thomas Marchisello, Global Executive Director, Commercial Finance and Business Development Operations, Covance Inc

    11:40 Case study: Rolling out an innovative operational risk sharing CRO partnership model

    Yariv Hefez

    Yariv Hefez, Director Global Business Development & Alliance Management, Merck Serono

  • Why a new model was required
  • The benefits of switching to a delivery based model
  • True operational risk sharing with a few strategic partners
  • The organisational resistance to change and measures taken to mitigate
  • 12:20 Networking Lunch

    13:20 Interactive Panel Discussion

    Topics including:

  • Challenges being faced by sponsors and CROs
  • Differing business models and costing strategies
  • Opportunities for enhancement
  • Taking what we have learned over the past 2 days and making immediate improvements
  • Albert Agro

    Albert Agro, President, HNZ Strategy

    Sanjiv Kanwar

    Sanjiv Kanwar, Managing Director, Polaris BioPharma Consulting Ltd

    Thomas Marchisello

    Thomas Marchisello, Global Executive Director, Commercial Finance and Business Development Operations, Covance Inc

    James Chennells

    James Chennells, Head of Global Strategic Sourcing Pharma Development Services, Bayer Healthcare

    Yariv Hefez

    Yariv Hefez, Director Global Business Development & Alliance Management, Merck Serono

    14:00 Is outsourcing paediatric activities different to what we always do?

    Philippe Auby

    Philippe Auby, Director, International Clinical Research, Paediatric Neuro-Psychiatry, Lundbeck

  • What is the Regulatory paediatric background?
  • Is paediatric clinical development different?
  • What are the practical aspects of paediatric studies?
  • What could be an example of efficient governance?
  • 14:40 Afternoon Tea

    15:10 Smart collaboration: The importance of having IT at the table

  • Creating the mindset and behaviours for a successful partnership        
  • Are you ready for the key IT interventions, considerations and impacts on your organisation
  • Optimising processes, systems and tools with a common shared goal
  • Managing communication and assumptions
  • Potential pitfalls
  • Elvira Martin

    Elvira Martin, European Medical IT Program Manager, Lilly Research Centre Ltd

    Ian Hamilton

    Ian Hamilton, Medical IT Manager, Lilly Research Centre Ltd

    15:50 SMEs and CROs: How to get the best

    Mike Wood

    Mike Wood, Research Director, Vernalis Plc

  • Partnerships with CROs - how far to go
  • Understanding each other
  • Building a relationship
  • Measuring success
  • 16:30 Chairman’s Closing Remarks and Close of Day Two

    +

    Workshops

    Mistakes in CRO selection: What goes wrong & how to solve these problems
    Workshop

    Mistakes in CRO selection: What goes wrong & how to solve these problems

    Hilton London Kensington
    6th October 2010
    London, United Kingdom

    Hilton London Kensington

    179-199 Holland Park Avenue
    London W11 4UL
    United Kingdom

    Hilton London Kensington

    Expect a warm welcome the moment you arrive at Hilton London Kensington. We’re located in the leafy district of Holland Park, 30 minutes from Heathrow Airport, with excellent transport links into Central London and three different tube lines nearby. Step inside the hotel and you’ll find stylish rooms and suites, fantastic dining and first-class facilities for business and recreation — everything you need for a remarkable stay in the capital.

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download


    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:

    ‘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.

    CPD AND PROFESSIONAL INSTITUTES

    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.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    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.

    GLOBAL CPD

    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

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 1 Westminster Bridge Road, London, SE1 7XW, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.