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Recent trends have shown outsourcing to be a strategic tool for both pharma and biotech companies wishing to improve clinical trial success whilst reducing costs. But how does the process work? When does a company decide to outsource and why? What are the hidden risks and challenges…?

SMi’s ‘Outsourcing Clinical Trials’ is the perfect platform to hear innovative and informative discussion on developing and implementing a global outsourcing strategy whilst managing the inherent legal and regulatory issues involved. Hear from leading industry experts as they discuss how to select the right service provider, ensure quality at the investigator site and manage relations between the sponsor and CRO to ensure the successful completion of outsourced clinical trials. Join us this November to unearth critical factors affecting success in major outsourcing agreements and keep up to date with the latest trends in outsourcing for clinical development.

An exceptional occasion to engage with dynamic industry experts, including:

  • Dr Brian O’Neill, Global Head, CQA External Alliances, F-Hoffmann-La Roche
  • René Sluijter, Global Head, Alliance Management, Solvay Pharmaceuticals
  • Dr Fidela Moreno, Senior Director, Global Development Operations, Asia & Latin America, Amgen
  • Julianne Hull, Senior Director, Operations Planning & Vendor Management, Wyeth Research
  • Anne Maria Ylisaari, Head, In- & Outsourcing, Orion Pharma
  • Maureen Hynes, Senior Clinical Contracts Manager, Genzyme Corporation
  • Sindy Denyer, Outsourcing Manager, Pfizer
  • Dr Michael Massaro, Director, Clinical Planning, MedImmune
  • Patricia Williams, Vice President, Global Contracts, Quintiles
  • Dr Peter Schüler, Vice President, Medical Affairs, PRA International

Attend this industry specific forum to guarantee you hear international and expert perspectives on:

  • MAKING THE DECISION TO OUTSOURCE: Learn how to define and evaluate your company’s core competencies whilst making the decision to outsource. What are the strategic, financial and operational considerations?
  • SELECTING THE RIGHT PROVIDER: What factors should a sponsor consider when deciding whether to do a project in- or-out-of-house?
  • LEGAL & REGULATORY CONSIDERATIONS: Listen to the experts as they discuss the key legal and regulatory issues to consider when strengthening an outsourcing relationship or aiding in the start-up of clinical development projects
  • PLANNING AND IMPLEMENTING AN OUTSOURCING STRATEGY: Understand every step of the outsourcing process to deliver successful and cost effective clinical trials. How can you avoid design hurdles in clinical trial outsourcing?
  • PROJECT GOVERNANCE: Hear best practice advice on the strategic management of outsourcing and learn how to perfect your project governance plan by defining the sponsor-provider relationship and reducing fatal misunderstandings
  • MITIGATING RISK: Learn how to develop and create strategic solutions to mitigate risk factors when using outsourcing services

Outsourcing Clinical Trials will provide an excellent opportunity to network, enhance your company’s profile and keep you up-to-date on the latest trends in outsourcing for clinical development.

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Julianne Hull

Julianne Hull, Senior Director, Operations Planning & Vendor Management, Wyeth Research

9:10 CURRENT TRENDS IN CLINICAL OUTSOURCING

Mark Lipscombe

Mark Lipscombe, Consultant, PA Consulting Group

  • What are the current trends affecting growth in the contract drug development industry?
  • How much is being spent on CRO services globally?
  • The size and growth of R&D spending, in- and out-of-house
  • Factors driving contract research strategy
  • Who is competing for what?
  • Smaller, regional CROs vs global players – who wins?
  • Is clinical outsourcing more strategic than in previous years?
  • Are we now focussing on development planning and protocols above all else?
  • What are the new service models?
  • Will the current trend to outsource clinical trials to Asia be successful?
  • 9:50 SOURCING AN INTERNAL OR OUTSOURCED TRIAL?

    Anne Maria Ylisaari

    Anne Maria Ylisaari, Head, In- & Outsourcing, Orion Pharma

  • When to rely on in-house capabilities
  • When to take advantage of an outsourced provider
  • Outsourcing some functions with a provider, while keeping other activities in-house – the possibilities
  • Deciding which aspects of the clinical trial process to outsource - depending on core competencies of both the vendor and sponsor
  • Full service providers vs niche providers
  • Challenges and limitations of having both in house and outsourced components of a trial
  • 10:30 Morning Coffee

    11:00 SUCCESSFUL PATIENT RECRUITMENT OUTSOURCING

    Michelle Jones

    Michelle Jones, Senior Director , Covance Clinical And Periapproval Services Ltd

  • What do you need to look for when outsourcing such a critical component of your company’s clinical studies?
  • Possibilities and pitfalls
  • Key considerations that exist in the patient and site recruitment arena
  • What should your providers expect from you?
  • Trends in patient recruitment
  • Future competition - will traditional pharma reduce the number of providers and carry out less transactional outsourcing, while forging closer relationships to increase efficiencies and quality delivery?
  • 11:40 OUTSOURCING YOUR CLINICAL TRIALS-SELECTING THE RIGHT PROVIDER

    Sindy Denyer

    Sindy Denyer, Outsourcing Manager, Pfizer

    ·  Key considerations for selecting an outsourcing partner
    ·  Central laboratory analysis, commodity or service?
    ·  Core competencies of the outsourcing partner (quality of service, flexibility, responsiveness, project management capabilities and price)
    ·  Identifying service providers for evaluation
    ·  Can e-Auction support successful price negotiations within the laboratory arena?
    ·  History, advantages, pitfalls and impact on business relationships/vendor psychology
    ·  Processes critical to e-Auction success:
    ·  Defining specifications, conducting RFIs
    ·  Cost model development to support "Apples to Apples" comparison
    ·  e-Auction design
    ·  Vendor training
    ·  Post e-Auction learning
    ·  Evaluating vendor capabilities and cost competitiveness
    ·  The role of the service user/stakeholder

    12:20 Networking Lunch

    13:50 PANEL DISCUSSION: THE PROS AND CONS OF OUTSOURCING CLINICAL TRIALS TO DEVELOPING ECONOMIES

    Maureen Hynes

    Maureen Hynes, Senior Clinical Contracts Manager, Genzyme Corporation

    Maria Makarovskaya

    Maria Makarovskaya, Associate Director, Clinical Outsourcing, Sepracor Inc

    Rene Sluijter

    Rene Sluijter, Global Head, Alliance Management, Solvay Pharmaceuticals

    14:30 BRINGING A RADICAL NEW MODEL FOR OUTSOURCING TO A BREAKTHROUGH LEVEL

    Rene Sluijter

    Rene Sluijter, Global Head, Alliance Management, Solvay Pharmaceuticals

    ·  Lessons learned from 5 years partnership
    ·  Levels of collaboration
    ·  Outlook of the next breakthrough level
    ·  The roadmap

    15:10 Afternoon Tea

    15:40 MANAGING LEGAL AND REGULATORY CONSIDERATIONS IN CLINICAL OUTSOURCING

    Paul Ranson

    Paul Ranson, Partner, Stringer Saul

    17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Michael Massaro

    Michael Massaro, Director, Clinical Planning, Medimmune Inc

    9:10 INTERCOMPANY AUDITING AGREEMENT AS PART OF STRATEGIC RISK MANAGEMENT OF SERVICE PROVIDERS

    Where and how can greater efficiencies be achieved in the quality risk management of our service providers?
    ·  Advantages available to both sponsor and service provider as a result of strategic co-operation among pharma companies in quality risk management of service providers routinely used
    ·  Results from an ongoing initiative set up as proof of concept for auditing co-operation between sponsor companies using the same service providers
    Alison Holland

    Alison Holland, Black Belt, Six Sigma, Business Development, Covance Clinical And Periapproval Services Ltd

    Brian O'Neill

    Brian O'Neill, Global Head, CQA External Alliances, F.Hoffmann-La Roche

    9:50 IMPLEMENTING A GLOBAL CLINICAL OUTSOURCING STRATEGY

    Maureen Hynes

    Maureen Hynes, Senior Clinical Contracts Manager, Genzyme Corporation

  • Practical considerations – assessing the level of difficulty to implement
  • International clinical trials – what are the regional advantages?
  • Standardising clinical outsourcing on a global scale
  • What are the regulatory, ethical, and cultural issues impacting studies conducted abroad?
  • How are sponsors, providers and study sites dealing with them?
  • Effective processes for multinational clinical trials
  • Best practice advice
  • 10:30 Morning Coffee

    11:40 ESTABLISHING AND MAINTAINING THE SPONSOR AND PROVIDER RELATIONSHIP

    Michael Massaro

    Michael Massaro, Director, Clinical Planning, Medimmune Inc

  • Developing a relationship that is clearly structured, productive and mutually beneficial
  • What are the sponsor’s and CROs expectations and how can they be delivered?
  • Negotiating and implementing a successful sponsor-provider relationship
  • What is the objective of the work to be outsourced? Who takes responsibility for what?
  • Increasing the value added from the CRO to the drug development process
  • Do risk sharing opportunities help or hinder the relationship?
  • 12:20 Networking Lunch

    13:50 PROJECT GOVERNANCE - MANAGING OUTSOURCED CLINICAL TRIALS

    Maria Makarovskaya

    Maria Makarovskaya, Associate Director, Clinical Outsourcing, Sepracor Inc

  • Perfecting your project governance plan - defining the sponsor- provider relationship to reduce fatal misunderstandings
  • Roles and responsibilities of project teams
  • Succession planning
  • Communication and decision-making
  • Expectations and performance metrics
  • Issue resolution
  • Budget planning and management
  • Improving trust and transparency to ensure more effective working relationships
  • 14:30 WHAT ARE THE STRATEGIC RISKS WITH CLINICAL OUTSOURCING?

    Peter Schuler

    Peter Schuler, VP, Medical Affairs, PRA International

  • Defining risk – making sure both parties are made aware of the threats to the successful completion of your outsourced clinical trials
  • How are sponsors minimising relationship risks with contractors?
  • Controlling the potential for risk
  • Key risks and mitigation actions
  • Confidentiality and intellectual property risks
  • Personnel risks
  • Company volatility risks
  • Production risks
  • Do the benefits far out weigh the risks?
  • 15:10 Afternoon Tea

    15:40 WHAT HAPPENS WHEN IT ALL GOES WRONG?

    Julianne Hull

    Julianne Hull, Senior Director, Operations Planning & Vendor Management, Wyeth Research

  • How challenging and unpredictable are clinical trials?
  • When vendors are involved how do the challenges increase?
  • Contingency plans – doesn’t every clinical vendor manager have one?
  • Case study – presenting real life scenarios to cover contingency lessons learned and how a potentially disastrous situation may be turned around
  • 16:20 MEASURING THE PERFORMANCE OF YOUR OUTSOURCING PARTNERS

    Ravin Warnakulasuriya

    Ravin Warnakulasuriya, Director, Operations, Averion Inc

  • Defining agreed targets for clinical studies
  • What strategies are companies adopting to improve time and success?
  • Setting a standardised approach for study reports
  • Using good metrics to improve trust and maximise clinical trial success
  • Using metric predictors to insure the site and study fit, if intervention is necessary and when it may be appropriate?
  • 17:00 Chairman’s Closing Remarks and Close of Day One

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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, 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

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