Home
overview
Two decades ago, the worlds pre-eminent pharmaceutical companies carried out their own research, development, manufacturing, marketing and sales. Nowadays, there is an array of challenges and opportunities facing both big pharmaceutical and smaller biotech companies as they seek to compete in an ever more challenging marketplace. Therefore, in order to maintain a competitive edge, pharmaceutical companies are adapting their management approaches to cut costs and achieve a higher level of performance. One of the most effective ways of addressing this need is through outsourcing of non-core functions.

Outsourcing - identified by ‘Harvard Business Review’ as one of the most important management ideas and practices of the past 75 years - enables executives to redefine their organisation and focus solutions on their customers with improved accuracy and speed. Indeed, Europe has been identified as fertile ground for both outsourcing and joint venture opportunities, making customer companies able to compete in a global marketplace.

Some 20% of research is already contracted and the CRO market has continued to expand its business by an average of 18% per annum since the beginning of the decade. More than 50% of manufacturing is already contracted and this area will continue to expand as the industry looks for even more ways to create efficiencies.

This conference will provide a comprehensive forum for targeting key aspects of outsourcing within the pharmaceutical industry from both the perspective of both the sponsor and the CRO including: outsourcing global trends, pharmaceutical and biotech outsourcing, detailing critical factors when selecting a partner and sustaining an efficacious partnership, e-business and outsourcing, examining the risks, legal implications and ensuring water-tight contracts. Moreover, the presence of key industry players will provide unique examples of partnership success.

SMi conferences are leading-edge business events offering delegates the opportunity to meet senior industry and government figures and seek their advice and opinions.

Please register now to guarantee your place at this important conference.

Conference programme

8:30 Registration & Coffee

9:00 Chairperson's Opening Remarks

Jean Edwards

Jean Edwards, Head, Clinical Trials Support, Bayer

9:10 MARKET TRENDS IN OUTSOURCING R&D

Dr R Graham Hughes

Dr R Graham Hughes, Scientific Director, Technomark Consulting Services

  • Understanding the value of global outsourcing in pharmaceuticals
  • Size of outsourcing market in N. America/Europe /Asia-Pacific Regions
  • Outsourcing trends
  • Future direction of outsourcing in the pharmaceutical industry
  • Lessons from the Key Players
  • 9:40 THE REGULATORY ASPECTS OF OUTSOURCING

    Dr David Jordan

    Dr David Jordan, Associate Director, Quintiles Scotland

  • Partnership requirements for regulatory inspections
  • Defining responsibilities
  • Strategy-setting for Pre-Approval Inspections by FDA
  • Joint Quality Assurance requirements relating to inspections
  • Contractual obligations
  • Ensuring best outcome of PIAs
  • 10:20 INTELLECTUAL PROPERTY RIGHTS IN PHARMA OUTSOURCING

    Kathy Minter

    Kathy Minter, Associate, Blandy & Blandy Solicitors

  • What are intellectual property rights?
  • Ownership of IP rights
  • Outsourcing: the importance of contracts, assignments and licences
  • IP vs. confidentiality
  • 11:00 Morning Coffee

    11:20 LEGAL IMPLICATIONS OF OUTSOURCING R&D

    Dr Mark Fowler

    Dr Mark Fowler, Contracts Manager, Pfizer

  • Relationship structure: obtaining a balanced deal by ensuring Good Contract Practices
  • Complying to EU directives
  • Product liability risk allocation
  • Intellectual property issues
  • Getting out!: the importance of break clauses
  • 12:00 ENHANCED INNOVATION THROUGH STRATEGIC OUTSOURCING

    Sarah Brooks

    Sarah Brooks, Principal, World Class International

  • Defining rate limiting steps in the discovery process
  • New paradigms to accelerate drug discovery through novel informatics
  • Choosing the ‘best in class’ development candidate
  • Capturing the creative synergy in collaborative outsourcing alliances
  • Rewarding and managing innovative research at outsourcing companies
  • 12:40 Lunch

    13:40 ESSENTIALS OF THE OUTSOURCING SELECTION PROCESS

    Lisa Felkins

    Lisa Felkins, Project Manager, Cardiovascular, Genentech

  • Outsourcing Strategies; At what stage should you outsource?
  • Defining accurate study specifications to ensure outsourcing success
  • Selecting an outsourcing partner; Core competencies of outsource partner
  • Can potential partner meet quality, capacity, technology and cost constraints?; Managing the sponsor/outsourcing partner relationship
  • Defining roles and responsibilities; Objective performance metrics; Communication and decision making-models; Lessons learned; Analysing return on investment
  • Outsourcing partner evaluation and sponsor self-evaluation; Case study
  • 14:20 BUILDING SUCCESSFUL AND SUSTAINABLE PARTNERSHIPS

    Alistair Henderson-Begg

    Alistair Henderson-Begg, Director, Outsourcing Consultancy, TBI Europe

  • Outsourcing: a strategic management tool for sponsor and provider
  • The six key areas to manage
  • The role of the retained team
  • Dealing with change
  • The role of third parties to support the relationship
  • Culture change: move from vendor to partners
  • 15:00 OPTIMISING THE BIDDING PROCESS

    Elizabeth Hall

    Elizabeth Hall, Director, Contracts and Proposal Development, PPD Development

  • The right questions to ask - clear specs and assumptions
  • Key cost drivers
  • Common misunderstandings
  • Critical path for proposal development
  • Value of historic data
  • Sponsor specific budget grids
  • 15:40 Afternoon Tea

    16:00 OUTSOURCING PLANNING AND PROVIDER SELECTION

    Ellis Wilson

    Ellis Wilson, Medical Program Coordinator, Merck

  • Strategic directions and the future of pharmaceutical outsourcing
  • Asking the right questions, with a focus on strategic rather than tactical approaches
  • Using knowledge management as a platform for optimal CRO selection
  • Leveraging the vertical portal concept to facilitate outsourcing
  • 16:30 WEB-ENABLED OUTSOURCING AND E-BUSINESS STRATEGIES

    Dr Kevin Johnson

    Dr Kevin Johnson, Senior Director of Strategy, Inceutica.com

  • The ‘Infomediary’ Role of B2B Marketplaces
  • Web-facilitated business management
  • Lessons from other markets
  • Benefits of pharmaceutical/biotechs and CROs
  • Examples of value-added services
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    17:10 Networking Drinks Reception

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Prof John Kennedy

    Prof John Kennedy, Director, Business Development, Chembiotech

    9:10 WE HAVE LOTS OF NEW SCREENS BUT WHERE DO WE FIND THE LEAD MOLECULES? EXPLOITING EXTERNAL SOURCES OF CHEMICAL DIVERSITY

    Dr David Langley

    Dr David Langley, Compounds Acquisition Manager, GlaxoWellcome

  • Background to current opportunities and issues in high throughput screening
  • What are the options for choices of compounds to screen?
  • Why look outside?
  • Who is out there and what can they offer?
  • How GlaxoWellcome have used compound acquisition to extend their compound collection
  • Where do we go next?
  • 9:40 THE HISTORY OF OUTSOURCING AT ABBOTT

    Dr Robert Miller

    Dr Robert Miller, Program Manager, Abbott Laboratories

  • Approximately 15 years of outsourcing history
  • Increased manufacturing flexibility/expanded effective capacity
  • Efficient use of technology, experience and capital assets
  • Establish synergies with suppliers and contract manufacturers
  • 10:20 RESTRUCTURING YOUR OUTSOURCING PROCESS

    Maria MacGarvey

    Maria MacGarvey, Clinical Development Outsourcing Manager - Europe, Amgen

  • Requirement of ‘Shared Vision’ with partners
  • Development of long term relationships
  • Analysis of proposals
  • Establishing your preferred partners
  • Analysing success of partnership: performance contract
  • 11:00 Morning Coffee

    11:20 BIOTECH OUTSOURCING OF DEVELOPMENT FUNCTIONS

    Dr Alan Irvine

    Dr Alan Irvine, Medical Director, Orion Clinical Services

  • Special outsourcing requirements of biotech firms
  • Trends toward development outsourcing
  • Analysing your current research capabilities
  • Choosing the service provider: is bigger better?
  • Why do it in house when you can outsource? - The economic benefits of outsourcing vs. in-house
  • 12:00 IMPROVING THE CONTRACTING PROCESS

    Dr Alan Davies

    Dr Alan Davies, European Medical Director,Clinical Development , Kendle

  • Novel approaches: is progress being made
  • What does the future hold
  • 12:40 Lunch

    13:40 MANAGING THE RISKS

    Felix Redmill

    Felix Redmill, Principal Consultant, Redmill Consultancy

  • Identifying and assessing risks
  • Strategies for risk management
  • Planning risk-management activities
  • Supporting Examples
  • ‘Risk’ as a way of thinking
  • 14:20 VIRTUAL PHARMACEUTICAL DEVELOPMENT

    Dr Gareth Walters

    Dr Gareth Walters, Director, Regulatory Affairs and Knowledge Management, Fulcrum Pharmaceutical Dev

  • Virtual development as a flexible outsourcing approach
  • Tailoring terms to meet the need of project and sponsor
  • Empowering suppliers to set new development standards
  • Knowledge management tools and processes to support rapid and focussed development
  • 15:00 VIRTUAL PHARMACEUTICAL COMPANIES

    Dr David Cavalla

    Dr David Cavalla, Chief Executive Officer, Arachnova

  • Strategies in virtual drug discovery: type of virtuality
  • Limiting the risk by effective management of outsourced work:
  • Technical ability and understanding
  • Communication methods and channels
  • Developing Networks: the ’Technology Web’ Explained
  • Therapeutic switching
  • 15:40 Afternoon Tea

    16:00 E-SOURCING: EXPLOITATION OF NEW TECHNOLOGIES IN OUTSOURCING

    Rob Whewell

    Rob Whewell, Senior Manager, Supply Networks, Cap Gemini Ernst and Young Life Sciences and Chemicals Group

  • E-business defined
  • Key characteristics of the supply network
  • Traditional Barriers to exploiting the opportunities
  • Assessment of profits growth and supply chain efficiency
  • Cap Gemini - leveraging power relationships using e-technologies: key examples
  • The e-revolution: are you ready?
  • 16:20 WHAT DOES THE FUTURE HOLD FOR OUTSOURCING

    Kim Brown

    Kim Brown, Director, Director, Project Management, CNS, SmithKline Beecham

  • The evolution of a key facet in pharmaceutical research and development: outsourcing
  • Weighing up the risks and rewards of outsourcing
  • How will the sponsor/CRO relationship develop in the future?
  • The changing face of the CRO: how will CROs adapt to these changes?
  • How will outsourcing change in the future?
  • 17:00 Chairman's Closing Remarks and Close of Conference

    +

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    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.