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As pressures within the industry mount, Pharmaceutical companies are increasingly moving towards outsourcing for all phases of drug development, from pre-clinical research, through to clinical R & D and drug manufacture, in order to improve efficiency and gain a competitive edge. With increasing R&D costs and the need to fill pipelines, Pharmaceutical companies are re-assessing their finances and looking at how to improve drug development strategies: Outsourcing certainly provides a promising option.

This Conference is looking to include contributions from key industry representatives who will discuss their recent experiences and current outsourcing strategies, from the perspectives of both the Contract Service Industry and the Sponsor. The event will look at how outsourcing strategies and trends compare in the US and in Europe and explore global opportunities for CROs. It will endeavour to evaluate how outsourcing practices vary for pre-clinical and clinical research and for manufacture and what can be learnt. Some of the other topics to be covered include the ethics of CROs, the division of responsibilities, communicative efficiency, the possibilities for outsourcing special services, as well as assessing the impact of the very latest industry regulations.

A unique opportunity to learn from leading industry experts including:
· Udo Breyer, European CRO Manager, Boehringer Ingelheim
· Dr Ian Braithwaite, Clinical Development Director, Experimental Medicine, AstraZeneca
· Peter Dellva, Senior Director, Manufacturing Management, Pharmacia
· Dr Patricia Seymour, Director, Supply Operations, Millennium
· Daniel Nasmyth-Miller, Global Project Manager, Chiltern International
· Dr R Graham Hughes, Scientific Director, Technomark Consulting Services
· Dr Jon Court, Chief Executive Officer, Fulcrum Pharma Developments
· Béatrice Deprez, Senior Director, Regulatory Affairs, Europe, Quintiles & Innovex
· Shin Kitaoka, Chief Executive Officer, BioGemini (formerly GlaxoSmithKline)

Benefits of attending:
· LEARN about deciding what and when to outsource
· REVIEW the globalisation of the market within Europe, the US and Japan
· HEAR about aligning outsourcing strategy to commercial requirements for product development
· EVALUATE the impact of the new EU Clinical Trial Directive
· CONSIDER virtual development providers – a new type of outsourcing?
· MEASURE the volatility and risk in making the decision

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Werner Feuerer

Dr Werner Feuerer, Vice President Medical Affairs & Clinical Operations, AAI International

9:10 KEYNOTE ADDRESS

Dr R Graham Hughes

Dr R Graham Hughes, Scientific Director, Technomark Consulting Services

  • Rising costs of research & development: factors driving outsourcing
  • What are the options and strategies available?
  • Advantages and disadvantages outsourcing vs in-house
  • What are the drawbacks?
  • The importance of maintaining flexibility
  • Growth of the pharmaceutical contract service industry
  • 9:40 REASONS FOR OUTSOURCING

    Shin Kitaoka

    Shin Kitaoka, Chief Executive Officer, BioGemini

  • Globalisation of the market within Europe, the US and Japan
  • What can you outsource?
  • Enhancing flexibility
  • Reducing time to market
  • Bridging strategy through outsourcing
  • How to select CRO for international registration
  • 10:20 DECIDING WHAT AND WHEN TO OUTSOURCE

    Udo Breyer

    Udo Breyer, European CRO Manager, Boehringer Ingelheim

  • Identifying needs across the company
  • Outsourcing needs to be included in the company’s strategic planning process
  • Examination of life-cycle of each product
  • Consideration of each production step
  • Measuring the volatility and risk in making the decision
  • 11:00 Morning Coffee

    11:20 THE IMPACT OF FORTHCOMING CLINICAL REGULATORY LEGISLATION

    Gill Le Du

    Gill Le Du, Director, Drug Development Consulting, ICON Consulting

  • Ethics committees
  • The application to competent authorities
  • GMP aspects and the need for QP and QS
  • Accession countries
  • What do you look for?
  • 12:00 CASE STUDY: DEVELOPMENT OF A NOVEL DRUG DELIVERY SYSTEM

    Jan Florence

    Jan Florence, Principal Consultant, PA Consulting Group

  • Getting supplier buy-in to adopting an incremental approach to drug development
  • Using supplier expertise to identify alternative drug development routes
  • Agreeing an acceptable risk profile and balancing this against timelines, overall cost and rate of spend
  • Building flexibility into relationships with suppliers
  • Managing multiple supplier relationships effectively
  • 12:40 Lunch

    14:00 OUTSOURCING – THE FEAR

    Daniel Nasmyth-Miller

    Daniel Nasmyth-Miller, Global Project Manager, Chiltern International

  • Loss of project control
  • Concerns over confidentiality
  • Sponsor understands the project best
  • Stability of CRO
  • 14:40 CROS IN EASTERN EUROPE

    Dr Milen Vrabevski

    Dr Milen Vrabevski, Chief Executive Officer & Medical Director, Comac Medical

  • What legislation already exists for clinical studies?
  • Administration and management of the medical system in Bulgaria
  • Practical aspects of conducting clinical trials in Bulgaria
  • Key ethics and regulatory requirements
  • 15:20 WHAT ARE THE DIFFERENCES IN MANAGING A CRO GLOBALLY VS LOCALLY?

    Dr Werner Feuerer

    Dr Werner Feuerer, Vice President Medical Affairs & Clinical Operations, AAI International

  • Scope of countries: how to manage different procedures and cultures
  • Scope of services: how to co-ordinate multiple services
  • Scope of expertise: how to ensure optimal project related expertise
  • Customers expectation: how to transfer expectations into solutions
  • Communication: which communication structure to use
  • Flexibility: how to manage changes
    Summary
  • 16:00 Chairman's Closing Remarks a followed by afternoon tea

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Julia Lloyd-Parks

    Julia Lloyd-Parks, Senior Consultant, Technomark Consulting Services

    9:10 OUTSOURCING CMC ACTIVITIES

    Dr Patricia Seymour

    Dr Patricia Seymour, Director, Supply Operations, Millennium

  • Defining the need
  • Identifying the contractor options
  • Negotiating the agreement
  • Managing the relationships
  • 9:40 HOW TO GET BEST VALUE OUT OF CRO’S?

    Dr Ian Braithwaite

    Dr Ian Braithwaite, Clinical Development Director, Experimental Medicine, AstraZeneca

  • Is the sponsor committed to outsourcing or are CROs being used to provide additional capacity at peak times?
  • What is the sponsor looking for from CROs? -Has it been in business for a long time or does it have a strong reputation? -Is the company financially stable and will it be available to serve you over the longer term? -Does it have a strong service orientation?
  • Will it provide you with more flexibility? Increase your resources for research? Improve your speed to market?
  • Can the partner you have chosen enhance those competitive advantages?
  • 10:20 OUTSOURCING OF REGULATORY SERVICES

    Béatrice Deprez

    Béatrice Deprez, Senior Director, Regulatory Affairs, Europe, Quintiles & Innovex

  • Role and responsibilities of CRO & sponsor for regulatory activities
  • How is this new Directive affecting sponsors based in the US
  • Practical aspects associated with drug manufacturing and release
  • Integration of DataBases
  • Successful RA outsourcing partnership: brief case study
  • 11:00 Morning Coffee

    11:20 CONTRACT MANUFACTURING OF CLINICAL AND COMMERCIAL PROTEIN PRODUCTS

    Peter Dellva

    Peter Dellva, Senior Director, Manufacturing Management, Pharmacia

  • Have a focused, committed team
  • Choose your contractor well
  • Write good contracts
  • Provide effective communication and project management
  • Have conflict resolution mechanisms
  • Invest in relationship management
  • 12:00 CLINICAL DEVELOPMENT NEEDS OF BIOTECHNOLOGY SPONSORS

    Dr Alan Irvine

    Dr Alan Irvine, Medical Director, Orion Clinical Services

  • Pharmacy requirements - often underestimated
  • Regulatory hurdles can be daunting
  • Indications and their problematics
  • Trial logistics planning and training
  • Monitoring guidelines
  • Reporting requirements
  • 12:40 Lunch

    14:00 THE RESISTORS OF OUTSOURCING

    Dr Michael Gamlen

    Dr Michael Gamlen, Managing Director, Pharmaceutical Development Services

  • Identifying the issues
  • Upfront risk prevention
  • Loss of in-house expertise
  • Lack of contact with the investigators and opinion leaders
  • Loss of intellectual property/ concerns over confidentiality
  • Loss of project control
    Stability of CRO
  • 14:40 THE VIRTUAL PHARMACEUTICAL MODEL

    Dr Jon Court

    Dr Jon Court, Chief Executive Officer, Fulcrum Pharma Developments

  • Virtual development providers – a new type of outsourcing?
  • The business model and how it has evolved
  • The benefits of the virtual pharmaceutical model
  • Evidence that the virtual business model is realistic
  • 15:20 FUTURE PROPOSALS FOR OUTSOURCING

    Dr Ian Dews

    Dr Ian Dews, European Director of Drug Development Programmes, MDS Pharma Services

  • Consolidation of the industry and growth in the number of alliances
  • Portfolio of outsourcing agreements managed in centralised outsourcing departments
  • Increasing use of contract manufacturing
  • Move towards direct distribution
  • Will true virtual pharmaceutical companies become the future?
  • 16:00 Chairman’s Closing Remarks followed by afternoon tea.

    +

    Workshops

    Sponsor & CRO Bid Preparation & Negotiations
    Workshop

    Sponsor & CRO Bid Preparation & Negotiations

    The Hatton, at etc. venues
    9th September 2003
    London, United Kingdom

    Contracting and Negotiating in Outsourcing Research & Drug Development
    Workshop

    Contracting and Negotiating in Outsourcing Research & Drug Development

    The Hatton, at etc. venues
    12th September 2003
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

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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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