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Managing Partnerships with CROs
5 October - 6 October 2009
Managing Partnerships with CROs

SAE Media Group's Managing Partnerships with CROs is now in its 2nd year - click below to view our 2010 event.

 

 


2009 Past Event Details:

 Outsourcing drug development can be an effective way of establishing a product’s true potential, but the information gap formed between a pharmaceutical company and a CRO after a project is outsourced can cause serious problems. Many factors need to be considered before and after a project has been passed over and partners must stay well connected if their relationship is to be a fruitful one.

CRO partnership conferences often focus on establishing a forum for networking and negotiation, but SAE Media Group’s Managing Partnerships with CROs event will also bring you a unique perspective on how to proceed after the contract has been signed. Attend and gain valuable insights into a range of topics from industry experts and explore the potential benefits of new strategies for your own organisation.

 


 

  • Rikke Winther, Head of Outsourcing Management, H. Lundbeck
  • Michael Herschel, Director, Clinical Research, GlaxoSmithKline

Conference agenda

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9:00

Chairman's Opening Remarks

Roger  Joby

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

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9:10

IT TAKES TWO TO TANGO – THE WAY TO EFFECTIVE VENDOR MANAGEMENT

Pasi  Piitulainen

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

  • Uniqueness of the pharmaceutical outsourcing market
  • What can and usually will go wrong
  • How to avoid the blaming game
  • Is there a way to do things differently?
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    9:50

    LONG TERM CRO RELATIONSHIPS

    Anne Maria Ylisaari

    Anne Maria Ylisaari, Senior Manager, Global Clinical Alliances & Sourcing, Orion Pharma

    Considerations for CRO selection
    Maximising the value of outsourcing
    Managing the relationship
    Considerations during working together – will it last forever?

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    10:30

    Morning Coffee

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    11:00

    TO PUNISH OR TO REWARD – DO WE NEED A STRATEGY CHANGE?

    Michael Herschel

    Michael Herschel, Director, Clinical Research, GlaxoSmithKline

  • Why the stick and the carrot rarely work
  • The benefits of implicit motivation
  • Have confidence, then build trust
  • Credible exit strategies and options
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    11:40

    FACILITATING EARLY PHASE PATIENT BASED COMMERCIAL CLINICAL TRIALS

  • Partnership Between a Major NHS Trust and a Major CRO
  • Motivation behind relationship
  • Contractual, financial and indemnity issues
  • Logistical and practical issues
  • Paul Astin

    Paul Astin, Clinical Research Business Manager, Joint Research and Development Office, Barts and the London NHS Trust & School of Medicine and Dentistry

    Brendan Ellis

    Brendan Ellis, Project and Business Development Manager, InCROM Europe

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    12:20

    Networking Lunch

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    13:50

    ALTIORA – PARTNERSHIP WITH CROs

    Davorka Sekulic

    Davorka Sekulic, Clinical Operations Director, Altiora

  • Difference between traditional preferred provider relationship and partnership
  • Is true partnership between Pharma and CROs possible?
  • Can a small CRO be a partner of large pharma company?
  • Challenges of true partnership
  • Opportunities for improvement
  • Development of project co-ordination function within CROs as a bridge to true partnership
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    14:30

    PRIME SITES – NEW POSSIBILITIES

    David Collier

    David Collier, Research Fellow in Clinical Pharmacology, William Harvey Research Institute, Barts and The London School of Medicine & Dentistry

  • Prime site concepts
  • Developing prime site relationships from the academic perspective
  • Future possibilities for engaging in new ways to improve study delivery
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    15:10

    Afternoon Tea

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    15:40

    SUPPLY OF INVESTIGATIONAL MEDICINAL PRODUCT – THE CMC PERSPECTIVE

    Dawn Padfield

    Dawn Padfield, Head of Technical Development and Clinical Supply, Norgine

  • Summary of CMC activities associated with supply
  • Advantages and disadvantages of in-house supply management
  • The CRO option
  • Working together for optimal supply of IMP
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    16:20

    CLINICAL RESEARCH NETWORKS – OPTIMISING STUDY DELIVERY

    Clare Morgan

    Clare Morgan, Director of Industry, NIHR Clinical Research Network Coordinating Centre

  • What is the NIHR Clinical Research Network?
  • Achieving a streamlined and rapid site set up
  • Supporting the delivery of clinical research in the NHS
  • CRO and sponsor partnerships
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    17:00

    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

    James Brook

    James Brook, Manager, Clinical Research Unit, William Harvey Research Institute, Barts and The London School of Medicine & Dentistry

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    9:10

    FROM TACTICAL TO STRATEGIC – CHANGES IN PHARMA PROCESS AND MINDSET

    Rikke Winther

    Rikke Winther, Divisional Director, Outsourcing Management, H. Lundbeck

  • Identifying and solving the resourcing problem through a team effort
  • Examining micro-management processes and resistance to letting go
  • Accurately comparing the internal hours spent on a study with outsourced spending
  • Making sure that internal resource spending decreases as outsourcing is increased
  • Re-thinking the way we are purchasing external resources
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    9:50

    IMPROVING PROJECT MANAGEMENT IN A CRO PARTNERSHIP

    Roger  Joby

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

  • CRO Selection
  • Project Risk Analysis Management (PRAM)
  • Earned Value Analysis
  • Stakeholder Analysis
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    10:30

    Morning Coffee

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    11:00

    OUTSOURCING TO A CENTRAL LABORATORY: HOW TO IDENTIFY IF PROMISES CAN BE HELD BEFORE SIGNING A CONTRACT

    Hermann Schulz

    Hermann Schulz, Chief Executive Officer, INTERLAB Central Lab Services - Worldwide

  • Selection criteria
  • How to inspect global laboratories
  • Logistical challenges: planning vs. reality
  • Role of pre-analytical factors
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    11:40

    EXECUTING CLINICAL PARTNERSHIPS WITH MILITARY PRECISION

    Chris Shilling

    Chris Shilling , Innovation Agent , Newhow Knowhow

  • Understanding the purpose of a clinical research partnership
  • Ensuring win-win outcomes through aligned intent
  • Using multi-criteria decision frameworks to build operational excellence
  • Developing a shared culture of success
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    12:20

    Networking Lunch

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    13:50

    REACTIVITY OF NICHE CROs – NIMBLE AND EFFECTIVE OR SLUGISH AND COSTLY?

    Albert  Agro

    Albert Agro, Senior Vice President, Clinical Development, TransTech Pharma

  • Benefits and drawbacks of functional outsourcing
  • Establishing criteria for patient recruitment
  • Case studies
  • The way ahead
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    14:30

    THE POSITION OF NHS TRUSTS IN PARTNERSHIPS WITH CROS

    Maria  Palmer

    Maria Palmer, Director, NHS R&D Forum

  • Influences on NHS Trusts following national NHS R&D developments
  • How to get the most effective partnerships with NHS Trusts
  • Navigating the new landscape – Trusts, networks and academia
  • Factors likely to influence future developments
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    15:10

    Afternoon Tea

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    15:40

    IS IT SAFE TO OUTSOURCE SAFETY?

    Graeme Ladds

    Graeme Ladds, Director, PharSafer Associates

  • What safety do you outsource?
  • What is the essential checklist for safety duties?
  • Post-marketing safety and the EU QP PV
  • Inspections and audits
  • When outsourcing needs to become insourcing
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    16:20

    WHEN YOU HAVE NO ALTERNATIVE BUT TO OUTSOURCE

    Sheila Weir

    Sheila Weir, Head of Project Management, Newron Pharmaceuticals

  • How small Biotechs face outsourcing relationships compared to big Pharmas
  • Finding the appropriate partner to suit your organisation
  • Big CROs vs. small CROs – Pros and cons
  • Understanding the cost structure
  • Building a relationship
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    17:00

    Chairman’s Closing Remarks and Close of Conference

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    HOTEL BOOKING FORM

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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:

    ‘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, SAE Media 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@saemediagroup.com

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