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In 2007 the market for anti-cancer drugs was worth around $35 billion, and is predicted to rise much further in coming years.

Developing and commercialising oncology drugs to take a part of this market requires extensive clinical research to prove safety and efficacy. SMi’s 7th Annual Clinical Trials in Cancer Conference provides a great opportunity to hear from leaders in this field. This year’s event will have two main focuses:

Adaptive Designs in Oncology

60% of respondents to a recent survey said they either were planning on implementing or had already implemented adaptive methods into their clinical trials. With a number of presentations and case studies on this exciting topic, the conference will be a great place to learn the latest thinking on the specific application of Bayesian methods to oncology drug development.

Biomarkers, imaging and diagnostics

Using biomarkers to measure pharmacokinetics and drug response is an increasingly necessary part of many clinical trials. Surrogate endpoints enable efficacy to be proved more easily and cheaply, and imaging technologies are becoming an increasingly useful quantitative tool. Diagnostics technologies are also allowing the possibility of personalised medicine for cancer treatment. Presentations on these topics will set out the latest technical advances and applications to clinical research.

New Speaker Confirmed!

  • Vinka Ljubimir, Oncology MDC Clinical Operations, GlaxoSmithKline

Confirmed Speakers Include:

  • Mark Rolfe, Vice President, Discovery Oncology, Millennium Pharmaceuticals
  • Brian Schwartz, Senior Vice President and Chief Medical Officer, Ziopharm Oncology
  • Leon Terstappen, Senior Vice President of Research and Development, and Chief Scientific Officer, Immunicon Corporation
  • Karl-Herman Schlingensiepen, CEO, Antisense Pharma
  • Garrett Hampton, Executive Director, Molecular and Medical Sciences, Celgene Corporation
  • William Gallagher, Associate Professor, Cancer Biology, University College Dublin, and CEO OncoMark Ltd.
  • Karol Sikora, Medical Director, CancerPartners UK, and Professor of Cancer Medicine, Imperial College
  • Shethah Morgan, Research Clinical Scientist, Clinical Development - Discovery Medicine, AstraZeneca
  • Andy Grieve, Professor, Kings College London
  • Nikki Fernandez, Global Product Statistician, AstraZeneca
  • Michala Worrell, Clinical Project Manager, AstraZeneca
  • David Huckle, Chief Executive, Adams Business Associates
  • Geoff Boxer, Laboratory Manager & LTN Business Fellow (Oncology), Cancer Research UK Targeting and Imaging Group, UCL Cancer Institute
  • Dana Ghiorghiu, Associate Research Physician, Imaging, AstraZeneca

This Conference is aimed at Directors, heads and managers of:

  • Clinical Research
  • Discovery Medicine
  • Cancer & Infection
  • Pharmacology
  • Clinical Technology
  • Clinical Diagnostics
  • Oncology
  • Diagnostic/Oncology/Molecular/Biomedical Imaging
  • Specialized Therapeutics
  • Oncology technology
  • Clinical strategy
  • Biostatistics
  • Translational Medicine

If you’re interested in speaking opportunities at this event, please contact Robin Walsh on +44 (0) 20 7827 6086 or rwalsh@smi-online.co.uk. If you’re interested in exhibiting at this event, please contact Alia Malick on +44 (0) 20 7827 6168 or amalick@smi-online.co.uk

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Brian Schwartz

Brian Schwartz, Senior Vice President and Chief Medical Officer, Ziopharm Inc

9:10 OPENING KEYNOTE – FUTURE PROSPECTS FOR CANCER DRUG DEVELOPMENT

Karol Sikora

Karol Sikora, Medical Director, CancerPartners UK

  • The scale of drugs now in clinical development
  • Biomarkers and surrogates in trial design
  • Novel imaging technology and the concept of virtual biopsy
  • The payers perspective in the EU
  • Value based pricing and its effect on clinical R&D
  • 9:50 USING BAYESIAN ADAPTIVE DESIGNS IN CANCER DRUG TRIALS

    Andy Grieve

    Andy Grieve , Professor, Kings College London

  • A basic introduction to Bayesian techniques
  • Advantages over traditional trial models
  • Potential disadvantages
  • 10:30 Morning Coffee

    11:00 CASE STUDY

    Brian Schwartz

    Brian Schwartz, Senior Vice President and Chief Medical Officer, Ziopharm Inc

    11:40 ADAPTIVE TRIAL DESIGN IN ONCOLOGY

  • What is a seamless adaptive trial?
  • Benefits: Why consider a seamless adaptive design?
  • Firewalls: Who gets to see what and when?
  • Interim analyses and go/no-go decisions
  • The hidden costs
  • Nikki Fernandez

    Nikki Fernandez, Global Product Statistician, AstraZeneca

    Michala Worrell

    Michala Worrell, Clinical Project Manager, AstraZeneca

    12:20 Networking Lunch

    13:50 TISSUE MICROARRAYS, DIGITAL SLIDES AND BIOMARKER DEVELOPMENT: CASE STUDIES IN BREAST CANCER

    William Gallagher

    William Gallagher, Associate Professor of Cancer Biology, University College Dublin

  • Tissue microarrays and digital slides as translational research tools
  • Bridging from omic discovery to validation
  • Manual and automated image analysis
  • Case studies in breast cancer, including retrospective analysis of clinical trial-derived samples
  • 14:30 TRANSLATIONAL MEDICINE IN CANCER CLINCAL TRIALS

    Garret Hampton

    Garret Hampton, Executive Director, Molecular and Medical Sciences, Celgene Corporation

  • Integrating preclinical and clinical research: Making informed, intelligent decisions at the right moment
  • The integrated development landscape: How to create it, how to nurture it, how to bring it to maturity
  • Impact of bench to bedside thinking on future clinical research: Developing Oncology drugs in the 21st century
  • 15:10 Afternoon Tea

    15:40 CHALLENGES IN CLINICAL TRIAL DESIGNS FOR TARGETED THERAPY IN ONCOLOGY

    Geoff Boxer

    Geoff Boxer, Laboratory Manager & UCL Business Fellow, UCL - Cancer Institute

  • Development of designer antibody molecules with multiple functionality, for Phase I/II Clinical Trials
  • Design of early development clinical trials: Defining mechanism of action
  • Use of biologic surrogate markers as endpoint for efficacy in Phase I/II: how reliable are they?
  • Endpoints for phase II trials: what can we use when response rate is not applicable?
  • Rational design of combination therapies for Phase I Trials in cancer
  • 16:20 GLOBAL CLINICAL TRIALS IN CANCER - CASE STUDIES

    Vinka Ljubimir

    Vinka Ljubimir, Oncology MDC Clinical Operations, GlaxoSmithKline

  • Details to be confirmed
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Mark Rolfe

    Mark Rolfe, Vice President, Discovery Oncology, Millennium Pharmaceuticals

    9:10 FROM DISCOVERY TO PHASE I CLINICAL TRIALS

    Mark Rolfe

    Mark Rolfe, Vice President, Discovery Oncology, Millennium Pharmaceuticals

  • Understanding the PK/PD/efficacy relationship in preclinical models
  • Investing in target, pathway and terminal outcome markers
  • Predicting an efficacious human dose/exposure
  • Translating pre-clinical markers to the clinical setting
  • 9:50 ROLE OF BIOMARKERS IN ONCOLOGY CLINICAL TRIALS

    Shethah Morgan

    Shethah Morgan, Research Clinical Scientist, AstraZeneca

  • Pharmacodynamic biomarkers - proof of mechanism &/or proof of principle
  • Biomarkers as surrogates for efficacy
  • Patient selection biomarkers – a personalised medicine approach
  • 10:30 Morning Coffee

    11:00 USE OF CIRCULATING TUMOR CELLS AS BIOMARKERS IN ONCOLOGY DRUG STUDIES

    Leon Terstappen

    Leon Terstappen, Senior Vice President of Research & Development and Chief Scientific Officer, Immunicon Corp

  • Celltracks technology of CTC isolation and enumeration
  • Evaluation of prospective and predictive value of CTC in metastatic cancer
  • CTC as biomarker in drug development studies
  • Protein expression and FISH on CTC
  • CTC in pre-clinical animal models
  • 12:20 Networking Lunch

    13:50 USING IMAGING TECHNOLOGY IN ONCOLOGY

    Dana Ghiorghiu

    Dana Ghiorghiu, Associate Research Physician - Imaging, AstraZeneca

  • An overview of the latest imaging methods
  • PET, MRI and CT
  • Novel techniques
  • Quantitative analysis
  • Endpoints in imaging
  • 14:30 TGF-BETA 2 INHIBITOR AP 12009: TARGETED THERAPY FOR MALIGNANT TUMORS

    Karl-Hermann Schlingensiepen

    Karl-Hermann Schlingensiepen, Chief Executive Officer, Antisense Pharma G Mb H

  • Targeted therapy with TGF-beta 2 inhibitor AP 12009
  • Risk mitigation in clinical trials Phase I and Phase II in oncology
  • Successful proof of concept in active-control and dose finding Phase IIb study in recurrent or refractory high-grade glioma
  • Phase III to start in 2008: active-control clinical study in recurrent or refractory anaplastic astrocytoma
  • 15:10 APPLYING PHARMACOGENETICS TO CANCER TREATMENT

    David Huckle

    David Huckle, Chief Executive, Adams Business Associates

  • Using diagnostic testing to avoid adverse drug reactions
  • Pharmacogenomic analysis of molecular markers in tumors to increase efficacy
  • Developing a companion diagnostic for a drug - case study of Herceptin
  • Analysing cancer suceptability through its genotype
  • 15:50 Chairman's Closing Remarks and Close of Conference, Followed by Afternoon Coffee

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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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