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Clinical Trials in Cancer
20 June - 21 June 2005
Clinical Trials in Cancer
In cancer, clinical trials are most commonly used to try out new forms of treatment such as surgery, radiotherapy or chemotherapy, to control symptoms such as pain and sickness. At the present time only about 1 in 9 cancer patients take part in clinical trials.  If this was to increase cancer research would be able to move forward more quickly. 

This year’s Clinical Trials in Cancer event will assess the latest advancements in the clinical development of anti-cancer drugs.  The Conference will feature discussion on the current challenges in clinical development including complexities in clinical trial design, from Phase I-IV, medical imaging in oncology, the discovery and validation of biomarkers, how to integrate anti-cancer therapies and the future of cancer drug development.  Consideration will also be given to the development of novel compounds and where certain clinical trials differ from more traditional methodologies. The event will also analyse the new paradigm in cancer drug development. 

Speaker at this year’s Clinical Trials in Cancer include:

  • Dr Steven Hamburger, Senior Director & Compound Development Leader, DOXCIL/CAELYX, Johnson &
  • Johnson
  • Dr Iman El-Hariry, Senior Director, Oncology Medicines Centre, GlaxoSAE Media GroupthKline
  • Dr Binh Nguyen, Senior Medical Director, Global Oncology Platform Team, Eli Lilly
  • Dr Ian Braithwaite, Clinical Development Director, AstraZeneca
  • Dr Debasish Roychowdhury, Medical Director, Regulatory Affairs, Eli Lilly
  • Dr Philip Murphy, Associate Director, Pfizer
  • Dr Jeanette Wood, Head, Angiogenesis, Translational Pharmacology, Oncology Research, Novartis Institute for Biomedical Research
  • Prof Karol Sikora, Professor of Cancer Medicine, Imperial College, HammerSAE Media Groupth Hospital, London, & Scientific Director, Medical Solutions
  • Dr Francesco Bertolini, Laboratory Head, Co-Director, European Institute for Oncology

Conference agenda

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8:30

Registration & Coffee

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9:00

MRI perfusion imaging

  • MR perfusion imaging is a manifold and powerful tool in the clinical diagnosis and treatment of different pathologies affecting the vascular system.
  • Changes in characteristic parameters of the micro-vascularity like permeability can be revealed in a very early state of tumor treatment using dynamic-contrast enhanced MRI (DCE-MRI).
  • The use of MR Imaging and image analysis in oncology phase 1 and 2 studies will be discussed and exemplified.
  • The use of MR Imaging and image analysis in oncology phase 1 and 2 studies will be discussed and exemplified.
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    10:00

    Morning coffee

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    10:15

    Positron Emission Tomography in Anti-cancer drug development

  • Overview of PET imaging, PET Pharmacokinetic imaging, and PET as a biomarker of drug effect,
  • Incorporating PET into clinical studies, standards for reporting PET data, PET and other imaging modalities
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    11:15

    Imaging in phase 3 oncology studies for FDA submission

  • Imaging derived surrogate endpoints such as response rate and time to progression are more and more used as Primary Endpoints for FDA submission.
  • The presentation will discuss the management of the imaging study component including the imaging charter, the independent image review and submission of imaging databases to the FDA.
  • The presentation will discuss the management of the imaging study component including the imaging charter, the independent image review and submission of imaging databases to the FDA.
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    12:15

    Discussion and Questions – review of the session

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    12:30

    Close of Executive Briefing

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Binh Nguyen

    Binh Nguyen, Senior Medical Director, Global Oncology Platform Team, Eli Lilly & Co

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    9:10

    KEYNOTE ADDRESS

    Binh Nguyen

    Binh Nguyen, Senior Medical Director, Global Oncology Platform Team, Eli Lilly & Co

  • "Small" market value for each individual indication
  • First indication usually in refractory patient population with limited market value
  • Need for broad development programmes to identify activity
  • Increasing fragmented market with individualised treatment in the future
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    9:50

    PRE-CLINICAL MODELS OF METASTASIS

    Ellen Filvaroff

    Ellen Filvaroff, Senior Scientist , Genentech Inc

  • Establishing clinically relevant model systems
  • Quantifying internal tumours
  • Testing potential therapeutics
  • Understanding possible mechanisms of action
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    10:30

    Morning Coffee

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    10:50

    PRECLINICAL MODELS TO DEVELOP BIOMARKERS AND PREDICT CLINICAL DOSE OF ANTI-ANGIOGENIC AGENTS

    Jeanette Wood

    Jeanette Wood, Head, Angiogenesis, Translational Pharmacology, Oncology Research, NIBR, Basel, Novartis

  • Does efficacy in angiogenesis models predict efficacy in tumour models?
  • Which tumour models respond and how do they respond?
  • PD biomarkers: physiological vs tumour responses?
  • PD biomarkers: what can be measured by imaging techniques?
  • Do PK/PD relationships in rodent models predict clinical dose?
  • Can biomarker response also be used to stratify patients?
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    11:30

    ACCELERATING THE TRANSLATIONAL PATH IN DRUG DEVELOPMENT

    Zvia Agur

    Zvia Agur, Chair & Chief Scientific Officer, Optimata

  • Learn how to simulate long-term drug-patient dynamic interactions
  • Rapid virtual clinical trials and optimal mono/combo treatment – how does this affect the number of effectuated clinical trials?
  • Facilitating animal-to-phase I transition - rodents, non-rodents and humans
  • Case study: TPO drug salvage
  • Case study: a multi-centre clinical validation in breast cancer patients
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    12:10

    Networking Lunch

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    13:40

    APPLICATIONS OF RNA INTERFERENCE IN CANCER DRUG DISCOVERY AND DEVELOPMENT

    William Marshall

    William Marshall, Executive Vice President, Research & Operations, Site Manager, Dharmacon

  • RNA Interference: a fundamental biological process
  • Identifying novel targets for therapeutic intervention
  • MicroRNA manipulation and characterisation in cancer biology
  • Use in personalised care strategies and biomarker development
  • Potential utility as a cancer therapeutic approach
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    14:20

    EARLY DECISION MAKING (PHASE 0-II)

    Ian Braithwaite

    Ian Braithwaite, Director, Clinical Development, AstraZeneca

  • Design options
  • Appropriate deployment of biomarkers
  • Choice of study populations
  • Practicalities of programme management
  • Limitations on extrapolation of early data
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    15:00

    DESIGNING CLINICAL TRIALS IN PHASES I-IV

    Jantien Wanders

    Jantien Wanders, Therapeutic Area Expert, Oncology, Eisai

  • The use of different designs
  • Methodologies in designing clinical trials
  • Recent failures in phases I-IV
  • Potential solutions to current problems
  • Challenges in clinical trial design
  • Focusing approaches in earlier phase stages
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    15:40

    Afternoon Tea

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    16:00

    USE OF CA125 IN NEW DRUG DEVELOPMENT

    Gordon Rustin

    Gordon Rustin, Director, Medical Oncology, Mount Vernon Hospital

  • CA125
  • Ovarian Cancer
  • EXPERIENCE WITH TRIALS OF VASCULAR DISRUPTIVE AGENTS

  • Vascular disruptive agents
  • Combretastatin
  • CA4P
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    16:40

    CLINICAL RESEARCH NETWORKS IN THE UK

    Jonathan  Ledermann

    Jonathan Ledermann, Director, Cancer Research UK

  • National cancer research networks
  • Development of clinical trials
  • Trial recruitment
  • Challenges
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    17:20

    Chairman’s Closing Remarks and Close of Day One

    Binh Nguyen

    Binh Nguyen, Senior Medical Director, Global Oncology Platform Team, Eli Lilly & Co

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

    Richard Sullivan

    Richard Sullivan, Head, Clinical Programmes, Cancer Research UK

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    9:10

    A NEW PARADIGM FOR DRUG DEVELOPMENT

    Iman El-Hariry

    Iman El-Hariry, Senior Director, Oncology Medicines Centre, GlaxoSmithKline

  • Novel therapeutics as an integral part of cancer treatment
  • Rational drug design
  • ErbB1 and ErbB2 receptors as targets for cancer therapy
  • Lapatinib is a dual inhibitor of both EGFR and ErbB2
  • Preclinical and clinical rationale for lapatinib in the clinic
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    9:50

    TISSUE BIOMARKERS IN CANCER DRUG DEVELOPMENT

    Karol Sikora

    Karol Sikora, Professor, Cancer Medicine, Imperial College, Hammersmith Hospital, London and Scientific Director, Medical Solutions , Medical Solutions Plc

  • New technology for tissue analysis
  • Need for effective biomarkers to determine PD endpoints in phase I
  • Use of surrogates to increase efficiency of phase III studies
  • Developing companion diagnostics for targeted therapies
  • Integrating novel therapies into clinical practice
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    10:30

    Morning Coffee

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    10:50

    THE DEVELOPMENT OF REVLIMID (LENALIDOMIDE)

    Jerome Zeldis

    Jerome Zeldis, Chief Medical Officer, Vice President, Medical Affairs, Celgene Corporation

  • Potential activity of thalidomide in hematology/oncology
  • Development of the IMiDsÒ
  • Development of REVLIMID in:
  • MDS
  • Multiple myeloma
  • Other neoplasms
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    11:30

    MECHANISM FOR ONCOLOGY DRUG APPROVAL

    Steven Hamburger

    Steven Hamburger, Senior Director, Oncology & compound development, Johnson & Johnson

  • Recent FDA regulatory approvals for products used to treat patients with cancer and the various mechanisms for receiving initial approvals (either regular or accelerated), supplemental approvals and phase IV commitments related to approvals
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    12:20

    Networking Lunch

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    13:40

    THE KEY FEATURES OF ENDPOINTS

  • Endpoints in tumour related symptoms
  • Examples of endpoints in oncology
  • The pro’s and con’s of endpoints
  • Classical and non-classical endpoints
  • FDA alternative endpoints for shorter development times
  • Debasish  Roychowdhury

    Debasish Roychowdhury, Medical Director, Regulatory Affairs, Eli Lilly

    Debasish Roychowdhury

    Debasish Roychowdhury, Vice President, Oncology MDC , GlaxoSmithKline

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    14:20

    MEDICAL IMAGING IN ONCOLOGY

    Philip Murphy

    Philip Murphy, Associate Director, Pfizer

  • The role of medical imaging in oncology clinical trials
  • From radiology to quantitative biomarkers
  • Managing the imaging component
  • Currently used imaging derived endpoints
  • Developing novel imaging approaches for improved decision making
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    15:00

    SUCCESSFUL INCORPORATION OF VOLUMETRIC & DYNAMIC IMAGING IN CLINICAL TRIALS

    Edward Ashton

    Edward Ashton , Vice President, Product Development , VirtualScopics

  • Potential advantages of volume measurements for early decision making
  • Dynamic imaging: relative advantages of DCE-CT and DCE-MRI
  • DCE-MRI in clinical trials: pitfalls and solutions
  • Recommendations for future trials
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    15:40

    Afternoon Tea

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    16:00

    CIRCULATING ENDOTHELIAL CELLS AS SURROGATE MARKERS OF ANTI-ANGIOGENIC ACTIVITY IN CANCER

    Francesco  Bertolini

    Francesco Bertolini, Laboratory Head & Co-Director, European Institute of Oncology

  • Circulating endothelial cells (CEC) are increased in cancer patients
  • CEC viability is modulated in cancer patients
  • CEC number and viability is correlated with anti-angiogenic drug activity
  • CEC number and viability predicts survival in breast cancer patients treated with metronimic chemotherapy
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    16:40

    ACTIVE IMMUNOTHERAPY OF CANCER

    David Urdal

    David Urdal, Chief Scientific Officer, Dendreon

  • Targeting antigen presentation
  • T-cell immunity and cancer
  • Clinical development and evidence of benefit
  • Finding new targets for active immunotherapy
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    17:20

    Chairman’s Closing Remarks and Close of Conference

    Richard Sullivan

    Richard Sullivan, Head, Clinical Programmes, Cancer Research UK

    Workshops

    Imaging in Oncology Drug Development

    Imaging in Oncology Drug Development

    Regus City Point
    22 June 2005
    London, United Kingdom

    Mayfair Conference Centre

    17 Connaught Mews
    London W2 2EL
    United Kingdom

    Mayfair Conference Centre

    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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