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With the public eye becoming increasingly more focussed on and preoccupied with the threat of cancer, The SMi Group’s 6th Annual Clinical Trials in Cancer Conference comes at a vital time within the industry.

We invite you to join your peers and hear cutting edge presentations from senior speakers from the pharmaceutical industry and those involved in cancer research. Key issues such as the importance of biomarkers within clinical development will be addressed as will suggestions on how to optimise the value of cancer drug portfolios.

Industry experts will update you on new regulatory issues in global cancer clinical trials and expert speakers will deliver evidence from successful attempts at improving patient recruitment and motivating adolescents to take part in clinical trials.

This is an essential opportunity for you to take part in a focused, interactive forum. If you wish to stay abreast of developments within this ever-changing industry and not take the risk of falling behind your competitors then your attendance is a must.

OUR EXCEPTIONAL PANEL OF SPEAKERS INCLUDES:
  • Dr Elena Colajori, Executive Director, Clinical Research Oncology, Pfizer
  • Dr Binh Nguyen, Vice President, Clinical Development and Chief Medical Officer, Tigris Pharmaceuticals
  • Dr Iman A El- Hariry, Senior Director, Oncology, GlaxoSmithKline
  • Mikael von Euler, Therapeutic Area Expert, Oncology, F. Hoffman-La Roche
  • Dr Glen Clack, Associate Director, Discovery Medicine, AstraZeneca
  • Dr Peter MacLennan, Director of Project Development and Scientific Affairs, Orion Clinical Services
  • Dr Karl-Heinz Thierauch, Therapeutic Research Oncology, Bayer-Schering
  • Dr Michael Lahn, Medical Advisor, Eli Lilly
  • Dr Shethah Morgan, Research Clinical Scientist, Clinical Development-Discovery Medicine, AstraZeneca
  • Professor David Cameron, Director, National Cancer Research Network
  • Professor Tim Eden, President, The International Society of Paediatric Oncology (SIOP) and Teenage Cancer Trust Professor of Teenage and Young Adult Cancer, The University of Manchester
  • Dr Paul Pharoah, Cancer Research UK Senior Clinical Research Fellow, Department of Oncology, The University of Cambridge
  • Chris Carrigan, National Coordinator, Cancer Registration, NHS
  • Dr Geoff Boxer, Laboratory Manager and UCL Business Fellow, Department of Oncology, University College London

BY ATTENDING THIS CONFERENCE, YOU WILL HAVE THE OPPORTUNITY TO:
  • HEAR EXPERT ADVICE on effective clinician and patient recruitment within oncology trials
  • OBSERVE EARLY RESULTS of biomarkers in early clinical development
  • LEARN VITAL TOOLS for successful trial design
  • UNDERSTAND THE CRUCIAL ROLE of imaging in oncology
  • EVALUATE the importance of Patient Recorded Outcomes in cancer trials

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Michael Lahn

Michael Lahn, Medical Advisor, Eli Lilly

9:10 MEETING CLINICAL TRIALS CHALLENGES AND OPTIMISING THE VALUE OF ONCOLOGY PORTFOLIOS

Elena Colajori

Elena Colajori, Executive Director, Pfizer

·                      Optimising the pipeline of projects
·                      The creation of an ever increasing portfolio of R&D projects through internal and external innovation

9:50 PRECLINICAL MODELS AND TRANSLATABLE PRECLINICAL BIOMARKERS IN ONCOLOGY

Iman El-Hariry

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

·                      Biomarkers emerging into clinical trials
·                      Translation from preclinical to clinical studies
·                      Application in clinical trials - including patient selection and clinical pharmacology
·                      Case studies - leveraging biomarkers in accelerating and streamlining clinical trials
·                      Implementation in drug and diagnostic development
·                      Discovering, validating and developing assays for biomarkers

10:30 Morning Coffee

11:00 BIOMARKERS IN EARLY CLINICAL DEVELOPMENT OF NOVEL ANTI-CANCER THERAPEUTICS

·                      Goals of biomarkers in early phase clinical trials (pharmacodynamic and safety biomarkers)
·                      Development of novel biomarker assays prior to starting early phase clinical trials
·                      Application of biomarkers during phase II clinical development
Michael Lahn

Michael Lahn, Medical Advisor, Eli Lilly

11:40 EARLY DECISION MAKING (PHASE 0-II)

Glen Clack

Glen Clack, Associate Director, AstraZeneca

·                 Design options
·                 Appropriate deployment of biomarkers
·                 Choice of study populations
·                 Practicalities of programme management
·                 Limitations on extrapolation of early data

12:20 Networking Lunch

13:50 ANGIOGENESIS INHIBITORS AND HYPOXIA- A ROLE FOR LDH

Karl-Heinz Thierauch

Karl-Heinz Thierauch, Therapeutic Research Oncology, Bayer-Schering Pharma

14:30 Flow cytometry & Single cell analysis in drug discovery and clinical trials

Dirk Van Bockstaele

Dirk Van Bockstaele, Director , Esoterix Inc.

15:10 Afternoon Tea

15:40 THE CONSTRUCTION OF A NATIONAL CANCER INTELLIGENCE NETWORK

Chris Carrigan

Chris Carrigan, National Coordinator, Cancer Registration, NHS

Chris Carrigan

Chris Carrigan, National Coordinator, National Cancer Action Team

17:00 Chairman’s Closing Remarks and Close of Day One

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Shethah Morgan

Shethah Morgan, Research Clinical Scientist, AstraZeneca

Chris Womack

Chris Womack, Principal Clinical Histopathologist, AstraZeneca

9:10 REGULATORY ISSUES IN GLOBAL CANCER CLINICAL TRIALS

Binh Nguyen

Binh Nguyen, Vice President and Chief Medical Officer, Tigris Pharma

·                European versus FDA regulatory procedures
·                Normal marketing authorization/full approval versus accelerated/conditional approval
·                Role of biomarkers in the regulatory process
·                The European innovative platform for medicines strategy
·                The US FDA Critical Path Initiative

9:50 TARGETING THE HER FAMILY OF RECEPTORS-CURRENT AND FUTURE CHALLENGES

Mikael von Euler

Mikael von Euler, Therapeutic Area Expert, F. Hoffmann-La Roche

·                      Overview of the HER family of receptors
·                      MOA of HER receptor modulators
·                      Clinical application of anti HER targeted approaches
·                      Scientific challenges for the future        

10:30 Morning Coffee

11:00 Clinical Development in Oncology - A collaborative process

Peter MacLennan

Peter MacLennan, Director, Orion Clinical Services

·                      Clinical development of biological products – special features
·                      The role of oncology clinicians, pre-clinical specialists, clinicians specializing in drug development and regulatory affairs professionals
·                      The contribution of an oncology specialist CRO – some real life experiences

11:40 CHALLENGES IN CLINICAL TRIAL DESIGNS FOR TARGETED THERAPY IN ONCOLOGY

Geoff Boxer

Geoff Boxer, Laboratory Manager & UCL Business Fellow, University College London

·                Development of designer antibody molecules with multiple functionality, for Phase I Trials
·                Design of early development clinical trials: hypothesis driven better than empirical? Is MTD still the goal?
·                Use of biologic surrogate markers as endpoint for efficacy in phase Ia/II: how reliable are they?
·                Endpoints for phase II trials: what can we use when response rate is not applicable?
·                Designing combination therapies for Phase I Trials in cancer

12:20 Networking Lunch

13:50 EXPLORING GERMLINE GENETICS IN ONCOLOGY CLINICAL TRIALS

Dr Paul Pharoah

Dr Paul Pharoah, Cancer Research UK Senior Clinical Research Fellow,, The University of Cambridge

·                      What do we know about the role of germline genetic variation and outcome after a diagnosis of cancer?
·                      How can clinical trials contribute to this knowledge?
·                      What are the potential implications for patients and clinical practice?

14:30 CLINICAL RESEARCH NETWORKS IN THE UK; DOUBLING PATIENT RECRUITMENT

David Cameron

David Cameron, Director, National Cancer Research Network

·                      National cancer research networks
·                      Development of clinical trials 
·                      Trial recruitment 
·                      Challenges

15:10 Afternoon Tea

15:40 THE CHALLENGES IN OPTIMISING CANCER TREATMENT IN YOUNG PEOPLE

·                      Raising awareness  in adolescents

·                      Addressing the ‘feeling of invincibility’

·                      Making GP’s aware of the problem of recruiting adolescents

Tim Eden

Tim Eden, President, The International Society of Paediatric Oncology (SIOP) and Teenage Cancer Trust Professor of Teenage and Young Adult Cancer,, The University of Manchester

Shethah Morgan

Shethah Morgan, Research Clinical Scientist, AstraZeneca

16:20 PHARMA RESEARCH & CLINICAL TRIALS - ENGAGING PATHOLOGISTS

Shethah Morgan

Shethah Morgan, Research Clinical Scientist, AstraZeneca

·        Tissue acquisition for target validation/TMAs to support drug discovery & development
·        Creating tissue banks and an internal resource
·        Clinical trials and biomarker work

17:00 Chairman’s Closing Remarks and Close of Day One

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Workshops

COVERAGE, REIMBURSEMENT AND MANAGEMENT OF CANCER MEDICATION
Workshop

COVERAGE, REIMBURSEMENT AND MANAGEMENT OF CANCER MEDICATION

The Hatton, at etc. venues
27th June 2007
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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