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Benefits of Attending:
· BIOSTATISTICS: Maximise the potential of your trial using innovative statistical methodologies
· EMERGING TECHNOLOGIES: Learn about the technologies that may improve clinical trial operation
· PATIENT RECRUITMENT: Understand strategies to improve recruitment for oncology trials
· PHARMACOGENOMICS: Gain insight into drug response prediction and understand how this can impact making go/no go decisions
· IMAGING: Evaluate the role imaging in oncology trials

A unique opportunity to learn from leading industry experts including:
¨ Dr Lee F Allen, Executive Director, Site Therapeutic Area Leader, Oncology, Pfizer
¨ Dr Binh Nguyen, Medical Director, Eli Lilly
¨ Dr Bruno Osterwalder, Vice President, Global Head, Early & Strategic Oncology, F Hoffman-La Roche
¨ Dr Sunil Gupta, Senior Director, Clinical Development, Oncology, Sanofi-Synthelabo
¨ Dr Alan Lewis, President, Celgene
¨ Dr Murray Yule, Senior Medical Advisor, Oncology, Eisai
¨ Dr John Whittaker, Director, Oncology, ICON Clinical Research
¨ Dr Marc Buyse, Executive Director, International Drug Development Institute
¨ Dr Adrien Tinetti, Executive Director, Europe, Quintiles Oncology Therapeutics

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Dr Alan Lewis

Dr Alan Lewis, President, Celgene

9:10 KEYNOTE ADDRESS

Dr Bruno Osterwalder

Dr Bruno Osterwalder, Vice President, Global Head, Early & Strategic Oncology, F Hoffman La Roche

  • Common mistakes and problems in cancer trials
  • The need to improve efficiency
  • New developments in cancer trials
  • Current ethical considerations in cancer trials
  • 9:40 BRINGING A MOLECULE TO TRIAL: TRANSLATIONAL BIOLOGY

    Dr Jonathan Lewis

    Dr Jonathan Lewis, Chief Medical Officer & Chairman, Antigenics

  • Goals: translational biology: safety and efficacy
  • Methodological design
  • Markers of efficacy
  • Strategies to improve development
  • Satisfying regulatory authorities
  • 10:20 STRATEGIES FOR DRUG DEVELOPMENT IN ONCOLOGY

    Dr Francois Thomas

    Dr Francois Thomas, Senior Advisor, Atlas Venture

  • The present cancer portfolio of the biotech industry
  • Portfolio strategy: balancing risks and rewards
  • Clinical development and strategic alliances
  • 11:00 Morning Coffee

    11:20 CHOOSING THE BEST TRIAL DESIGN FOR YOUR DRUG

    Dr S Murray Yule

    Dr S Murray Yule, Senior Medical Advisor, Oncology, Eisai

  • Methodology options
  • The role of preclinical studies
  • Understanding the mechanism of action and matching this with the correct trial design
  • Choosing the best design
  • 12:00 PATIENT RECRUITMENT

    MaryAnn Guerra

    MaryAnn Guerra, Executive Vice President, Matthews Media Group

  • General strategies in patient recruitment
  • Specific strategies for recruiting in oncology trials
  • The steps, sequences and timing in clinical trial execution
  • How to enhance trial recruitment
  • Identifying appropriate target audiences and reaching these audiences
  • The importance of careful PI and site selection
    The importance of geographic location
  • 12:40 Networking Lunch

    13:40 THE ROLE OF THE CRO IN DRUG DEVELOPMENT

    Dr John Whittaker

    Dr John Whittaker, Director, Oncology, ICON Clinical Research

  • What should a biopharmaceutical company expect from a CRO?
  • A range of services
  • Global trials
  • Strong centralised management
  • Creating a successful strategy
  • Partnering
  • 14:20 TIMING THE TRIAL

    Christine Pierre

    Christine Pierre, President & Chief Executive Officer, Rx Trials

  • The various aspects of starting up a trial - the sites’ perspective
  • Things that have and have not worked in the past
  • Meeting the various timelines
  • The communication chain
  • What a site should do and what should the sponsor expect?
  • Red flags and hiccups: short term slide or long term problem: recognising the difference
  • 15:00 TIMING IN CANCER TRIALS AND REGULATORY SUBMISSIONS

    Dr Sunil Gupta

    Dr Sunil Gupta, Senior Medical Director, Clinical Development Oncology, Sanofi-Synthelabo

  • The time line problem
  • Strategies to enhance recruitment through marketing and advertisement
  • Keeping patients on trials
  • Expedited preparation of documents for regulatory submissions
  • Case study: well timed trials
  • 15:40 Afternoon Tea

    16:00 GO/ NO GO DECISIONS

    Dr Colin Love

    Dr Colin Love, Director, Development, BioVex

  • Moving biological compounds through the pipeline
  • Making a go/ no go decision
  • Integrating non-clinical factors in the decision
  • Determining the response of drugs
  • Continual risk management
  • 16:40 INFORMING PHASE II STUDY DESIGN BY A FOCUSSED APPROACH IN PHASE I

    Dr Stephen Wright

    Dr Stephen Wright, Senior Vice President, Clinical Research & Development, Beaufour Ipsen

  • Addressing the issue of flat dosing
  • Identifying predictors of toxicity
  • Relationships between pharmacokinetics and activity
  • 17:20 IDENTIFYING AND OVERCOMING THE BARRIERS

    Dr Adrien Tinetti

    Dr Adrien Tinetti, Executive Director, Europe, Quintiles Oncology Therapeutics

  • Medico-scientific barriers: preclinical data, protocol aspects, feasibility, patient selection criteria
  • Administrative barriers
  • Operational barriers: project management, clinical monitoring, safety, drug supplies
  • Communication
  • 18:00 Chairman's Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Dr Lee F Allen

    Dr Lee F Allen, Executive Director, Site Therapeutic Area Ledaer, Oncology, Pfizer

    9:10 KEYNOTE ADDRESS

    Dr Binh Nguyen

    Dr Binh Nguyen, Medical Director, Eli Lilly

  • Rate of success
  • Current problems in cancer trials and regulatory approval
  • Future directions in cancer trials and regulatory approval
  • Guiding products to regulatory approval
  • 9:40 DRUG RESPONSE ASSESSMENT

    Dr Lee F Allen

    Dr Lee F Allen, Executive Director, Site Therapeutic Area Ledaer, Oncology, Pfizer

  • Modalities for assessing ‘biologic activity’
  • Efficacy endpoints
  • Role of pharmacogenomics
  • Unpredictable nature of cancer
  • Impact on the design of cancer drug development programs
  • 10:20 MEDICAL IMAGING FOR CLINICAL TRIALS IN CANCER

    Dr Sandra Chica

    Dr Sandra Chica, Medical Director, Perceptive Informatics

  • Overview of roles and applications of medical imaging for clinical trials of oncology
  • Outline of imaging requirements and necessities along the cancer drug development lifecycle, from drug discovery to post-marketing
  • 11:00 Morning Coffee

    11:20 APPLYING NEW TECHNOLOGIES IN EARLY CLINICAL TRIALS OF NON-CYTOTOXIC AGENTS

    Dr Athos Gianella-Borradori

    Dr Athos Gianella-Borradori, Director, Medical Affairs, Cyclacel

  • Proteomics
  • Micro assays
  • Apoptotic markers
  • QPCR on whole blood
  • 12:00 INTEGRATION OF GENOMICS AND BIOINFORMATICS FOR CANCER RESEARCH AND DRUG DISCOVERY

    Eric Eastman

    Eric Eastman, Senior Vice President, Chief Scientific Officer, MetriGenix

  • Use of DNA microarray technology in clinical trials
  • Developing new standards for disease classification, prognosis and therapeutic outcomes
  • Use of the 4D array™ in clinical trials
  • 12:40 Networking Lunch

    13:40 EXPANDING THE POTENTIAL OF EXISTING DRUGS

    Dr Jerome Zeldis

    Dr Jerome Zeldis, Chief Medical Officer , Celgene

  • S.T.E.P.S distribution system
  • Role phase IV program played in the drug’s development
  • Use of phase IV Thalidomide data for the development of successor compounds
  • 15:00 CASE STUDY: TARCEVA

    Dr John Slack

    Dr John Slack, Vice President, Development, OSI Pharmaceuticals

  • Background to Tarceva: - Scientific - Clinical - Commercial
  • Clinical trial issues
  • Current development options
  • 15:40 Afternoon Tea

    16:00 CLINICAL CHALLENGES IN DEVELOPING A ‘CYTOSTATIC’ DRUG

    Dr Scott Freeman

    Dr Scott Freeman, Vice President, Clinical Development, Onyx Pharmaceuticals

  • Background
  • Validation of target
  • Discovery of BAY 43-9006
  • Preclinical data
  • Clinical data
  • Summary
  • 16:40 THE FUTURE OF CLINICAL TRIALS

    Dr Miroslav Ravic

    Dr Miroslav Ravic, Chief Clinical Officer, Antisoma

  • Agents in development
  • What changes are possible to trial design?
  • Influence of new technology on clinical trials
  • The future of anti-cancer agents
  • 17:20 Chairman’s Closing Remarks and Close of Conference

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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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