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Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks Prof Mike Smith, Co-Director, CoMIR

9:10 APPLICATIONS OF IMAGING TO CLINICAL DRUG DEVELOPMENT

Dr Colin Miller

Dr Colin Miller, Vice President, Business Development, BioImaging Technologies

  • The path taken from preclinical studies into the clinical evaluation of drug candidates using imaging modalities
  • What is the value added in early phase trials of drug candidates
  • Application of imaging in clinical evaluation
  • Benefits of imaging in early phases
  • The issues surrounding imaging data in trial management
  • 9:40 THE USE OF IMAGING TO ACCELERATE CLINICAL TRIALS

    Dr Peter Steiger

    Dr Peter Steiger, Chief Executive Officer & President, Synarc

  • How to choose the best technology to achieve your clinical trial goals
  • Does the expense of the technology justify the savings to be made in real time?
  • Development and validation of new imaging end points and surrogate markers
  • Where is the technology going to take the drug development process: what is the next step?
  • 10:20 .

    11:00 Morning Coffee

    11:20 THE VALUE OF IMAGE DATA

    Dr Sanjay Santi

    Dr Sanjay Santi, Associate Professor of Radiology, Harvard Medical School

  • New developments in Oncologic Radiology -Multislice CT -PET -Perfusion imaging
  • Trends in data analysis and management -Tumor volumes -Electronic image management
  • Critical success factors -Up-to-date imaging protocols -Early radiologist involvement
  • 12:00 SURROGATE ENDPOINTS IN MEDICAL IMAGE DATA

    Dr John Waterton

    Dr John Waterton, Director, Imaging, Discovery Enabling Science Technology & Information, AstraZeneca

  • Better choice of drug targets in discovery
  • Earlier go/no decisions on compounds
  • Determine the right dose
  • Shorten time to market
  • 12:40 Networking Lunch

    14:00 MEDICAL IMAGE ASSESSMENT

    Dr Donald Rosen

    Dr Donald Rosen, Chief Technology Officer & Co-Founder, RadPharm

  • Pitfalls in oncology imaging in clinical trials
  • What are the differences between RECIST (Response Criteria in Solid Tumours) and WHO (World Health Organisation) standards for tumour evaluation by imaging
  • State of the art imaging technology
  • 14:40 RADIOTRACER DEVELOPMENT

    Dr David Dutka

    Dr David Dutka, Senior Research Fellow, PET Imaging Centre, Hammersmith Hospital, London, UK

  • The ability of PET to obtain information on drug distribution and binding in the living human
  • The individual challenges presented by PET chemistry -short half-life -the need for specific radioactives
  • The design or choice of radioligands for imaging particular target cardiac receptors
  • Possible future applications of PET
  • 15:20 Afternoon Tea

    15:40 MYCOCARDIAL PERFUSION IMAGING

    Dr Luiz Belardinelli

    Dr Luiz Belardinelli, Vice President, Drug Research and Pharmacological Sciences, CV Therapeutics

  • Pharmacology of adenosine receptors
  • Rationale of adenosine (Adenoscan) in mycocardial and perfusiin imaging studies
  • Features of the ideal pharmacological agent for mycocardial perfusion imaging
  • Pharmacological principles applied to the development of CVT-3146
  • Pharmacological characterisation of CVT-3146
  • 16:20 THE REGULATORY BOTTLENECKS

    Dr Jim Sumner

    Dr Jim Sumner, President, WorldCare

  • What are the regulatory requirements unique to medical imaging in clinical trials
  • How to design your imaging trial to survive an audit: what to expect from the FDA
  • What does the FDA guidance document mean to industry?
  • How to work within the “rules” to speed up your clinical trial programs
  • 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

    Dr Sandra Chica

    Dr Sandra Chica, Associate Medical Director, Perceptive Informatics

    9:10 QUANTITATIVE IMAGING

    Dr Venkatesan Thangaraj

    Dr Venkatesan Thangaraj, Chief Technology Officer, Enmed

  • Clinical benefits of developing imaging technology to diagnose disease
  • Implementing quantitative imaging protocols
  • Cross platform protocol validation whilst maintaining quality assurance
  • Data analysis and archival
  • 9:40 INTEGRATION OF COMPUTER MODELING AND MEDICAL IMAGING TECHNOLOGIES

    Dr David Steinman

    Dr David Steinman, Senior Scientist, The John P. Robarts Research Institute

  • Techniques currently being used to elucidate the biophysical factors involved in atherosclerosis development
  • Determine whether local blood flow patterns can be used to better predict the risk of stroke and optimize bypass grafting surgical techniques
  • The implications of including medical imaging in trial design for drug development
  • The increasing need for digitalisation of images and centralised laboratory analysis
  • 10:20 ADVANCES IN CLINICAL TRIAL DESIGN TO YIELD EFFECTIVE THERAPIES TO TREAT CARDIOVASCULAR DISEASES

    Dr Claudio Marelli

    Dr Claudio Marelli, Clinical Research Director, Nycomed Amersham

  • Overview of imaging in cardiology -Current status and future perspectives
  • Integrating cardiac imaging techniques into the drug discovery process
  • Value of cardiac imaging in clinical trials -preclinical development -clinical trials
  • 11:00 Morning Coffee

    11:20 SPEEDING UP DRUG DEVELOPMENT

    Dr Ian Wilding

    Dr Ian Wilding, Chief Executive Officer, Pharmaceutical Profiles

  • Using scintigraphic imaging to visualize product performance in the gastrointestinal tract and lungs
  • Candidate drug selection using human absorption studies
  • Bridging the gap between in vitro and full clinical development using human imaging studies
  • Targeting drug delivery through product visualization
  • 12:00 IMAGING IN NEUROLOGY

    Speaker to be confirmed

    Speaker to be confirmed, ,

    12:40 Lunch

    14:00 MRI MONITORING OF FEMALE SEXUAL RESPONSE

    Dr Ken Maravilla

    Dr Ken Maravilla, Principal Investigator, University of Washington

  • Rationale for using MRI to assess response
  • Early studies to evalute feasibility of MRI
  • MRI response versus other methods
  • Studies for evaluating reproducibility of MRI method
  • Possible future role of MRI for clinical trial evaluations of new drug therapies for female sexual response
  • 14:40 3D ULTRASOUND

    Dr Leonard Avecilla

    Dr Leonard Avecilla, Director, Education Services, BioImaging Technologies

  • What is 3D ultrasound and how will it impact on the clinical trial sector?
  • The new modalities being developed in non traditional imaging areas
  • The therapeutic areas that make use of 3D imaging technologies
  • Cost effectiveness of using ultrasound techniques as a diagnostic tool
  • 15:20 Afternoon Tea

    15:40 THE PARTNERSHIP ISSUES

    Prof Mike Smith

    Prof Mike Smith, Co-Director, CoMIR

  • Overview of the NHS and University policy on R&D
  • IPR issues with public sector organisation
  • Available knowledge base to support drug development
  • Potential resource base in terms of equipment and expertise
  • Existing trial facilities and clinical networks to support clinical trials
  • 16:20 EXPLORING THE LOGISTICAL ASPECTS OF IMAGE ASSESSMENTS

    Dr David La Point

    Dr David La Point, Executive Director of Business Development and Strategic Planning, Intelligent Imaging

  • What is the role and responsibility of a core laboratory, regulatory personnel, CRO and sponsor?
  • The need to have immediate clinical information from the imaging modality in order to properly care for the patient but not compromise the study (i.e. bias from ‘preliminary’ reads)
  • The feasibility of maintaining blinded personnel performing image acquisition but still insure complete image acquisition which provides adequate data
  • 17:00 Chairman's Closing Remarks and Close of Conference

    +

    Workshops

    Medical Imaging in Clinical Trials: The current picture.
    Workshop

    Medical Imaging in Clinical Trials: The current picture.

    The Hatton, at etc. venues
    15th June 2001
    London, United Kingdom

    The Hatton, at etc. venues

    51/53 Hatton Garden
    London EC1N 8HN
    United Kingdom

    The Hatton, at etc. venues

    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, 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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