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Market opportunities for cancer treatments are at an all-time high but the publication rate of clinical trials is disturbingly low. Factors such as flawed study design and failure to meet endpoints have consistently hindered the drug development processes and need to be considered in more depth. SMi's Clinical Trials in Cancer conference will feature presentations from industry professionals and academic experts on managing clinical development in this crucial therapeutic area.

Now in its 9th year, Clinical Trials in Cancer has become an essential event for all those working in oncology in the pharmaceutical sector. Attend to discover the latest thinking in adaptive trial designs, gain insight into cancer biomarkers, understand the challenges of translational medicine and hear case studies on the logistical and operational issues of conducting clinical trials in Europe.

 

  • Hear about the latest targeted cancer therapies in personalised medicine
  • Identify factors affecting attrition rates of oncology compounds in clinical trials
  • Understand regulatory requirements for adaptive designs
  • Learn about epidermal growth factor receptor inhibitors in cancer treatments
  • Explore the potential use of novel transcriptomic-based biomarkers
   

 

This annual event has been attended in previous years by representatives of the folowing organisations:

  • Amgen
  • Genzyme
  • Ferring Pharmaceuticals
  • Merck Serono
  • Johnson & Johnson
  • Boehringer Ingelheim
  • AstraZeneca
  • Scimega Research
  • GeneQuest Diagnostics
  • Spirogen
  • Fulcrum Pharma Developments
  • IMS HealthCharing Cross Hospital
  • Trion Pharma
  • Roche Products
  • Cancer Research UK
  • Glaxo Smith Kline
  • Munipharma
  • King's College  London
  • Glycotype GmbH
  • GlaxoSmithkline
  • Takeda Pharma Europe

 

Conference programme

8:30 Registration and Coffee

9:00 Chairman's Opening Remarks

Mike Lau

Mike Lau, Principal Clinical Development Scientist, Oncology, GlaxoSmithKline

9:10 Use of Academic Laboratories in Oncology Trials to Foster Collaborative Biomarker Research

Mike Lau

Mike Lau, Principal Clinical Development Scientist, Oncology, GlaxoSmithKline

  • Use of biomarkers in clinical research
  • Outsourcing to commercial laboratories
  • Collaborations with academic laboratories in clinical research
  • Case study/example in oncology trials
  • 9:50 Clinial Trials in Oncology - From Design to Decision-Making

    Panteli Theocharous

    Panteli Theocharous, Senior Clinical Project Scientist, Ortho Biotech Oncology Research & Development

  • Project management of clinical trials
  • Team management and leadership
  • Problem solving and addressing challenges
  • From design into practise
  • 10:30 Pharmaceutical Perspectives on Drug-Radiation Interactions

    Ozlem Ataman

    Ozlem Ataman, Oncology Research Physician and Radiation Oncology Combinations Clinical Lead, AstraZeneca

  • The role of radiotherapy in cancer treatment
  • When to start preclinical testing
  • What clinical data is required?
  • Is registration possible?
  • 11:10 Morning Coffee

    11:30 Biomarkers – The RBM Approach: A Successful Strategy for Drug Development and Diagnostics

    Sabine Küsters

    Sabine Küsters, Director of Scientific Relations, Rules-Based Medicine

  • The application of quantitative Multi-Analyte Profiles (MAPS) for protein biomarker discovery and monitoring 
  • New MAP for oncology applications
  • Ex-vivo immune biomarker monitoring: applications for pharmacodynamics and safety
  • 12:10 Developing Novel Targeted Cancer Therapies: Promises and Pitfalls

    Jeff Evans

    Jeff Evans, Professor of Translational Cancer, Centre for Oncology and Applied Pharmacology Cancer Research, UK Beatson Laboratories Research, University of Glasgow

  • Challenges developing targeted therapies in personalised medicine
  • Refining preclinical models to allow better clinical trial design
  • Use of biomarkers for key decisions in drug development
  • 12:50 Networking Lunch

    14:00 Positron Emission Tomography and Its Application to Drug Development in Oncology

    Julian  Matthews

    Julian Matthews , Senior Lecturer, School of Cancer and Enabling Sciences, University of Manchester

  • Overview of Positron Emission Tomography
  • Use of PET in drug development
  • Pharmacokinetic (bio-distribution) studies
  • Occupancy studies
  • Pharmacodynamic studies
  • 14:40 The Role of the NCRN in Supporting the Feasibility Assessment and Delivery of Commercial Cancer Trials in the UK

    Rick Kaplan

    Rick Kaplan, Associate Director, UK Cancer Research Network

  • Background to the NCRN
  • How the NCRN is supporting Industry to deliver commercial cancer trials in the UK
  • The feasibility and adoption process for commercial trials
  • Engagement with industry to date
  • 15:40 An Analysis of Continued Attrition Rates of Oncology Compounds in Phase 3 Clinical Trials

    Ridwaan Jhetam

    Ridwaan Jhetam, Clinical Operations Head for Oncology and Senior Director, Johnson & Johnson

  • Assessment of the situation and comparisons across the Industry
  • Root causes of high late-stage attrition
  • Lessons learned
  • Models to predict likely failures in future
  • 16:20 Academia and Industry Collaborations to Speed up the Evaluation of New Approaches to Treatment

    Max Parmar

    Max Parmar, Head of Cancer Group, MRC Clinical Trials Unit, National Cancer Research Network

  • Disappointing failure rates for phase 3 trials in academia and industry
  • The concept of multi-arm multi-stage trials
  • A practical example of such a trial (STAMPEDE)
  • The concept of introducing a 'new arm' to a clinical trial
  • 17:00 Chairman's Closing Remarks and Close of Day One

    8:30 Re-registration and Coffee

    9:00 Chairman's Opening Remarks

    Tim Friede

    Tim Friede, Professor of Biostatistics and Chair of Medical Statistics, University Medical Center Göttingen

    9:10 Bayesian Adaptive Randomization as a Tool for Early Development Oncology Studies

    Giacomo Mordenti

    Giacomo Mordenti, Senior Expert Biostatician Team Leader, Merck Serono

  • Challenges in early development oncology trials
  • Adaptive randomization process
  • Simulation results from a case study
  • 9:50 Adaptive Designs for Clinical Trials in Oncology

    Tim Friede

    Tim Friede, Professor of Biostatistics and Chair of Medical Statistics, University Medical Center Göttingen

  • A practitioners’ guide to adaptive designs
  • Adaptations of interest in oncology
  • Logistical issues involved in the implementation of adaptive designs
  • Regulatory requirements for adaptive designs
  • 10:30 Morning Coffee

    11:00 Realising the Potential of Targeted Therapies in Haematological Malignancies

    Charles Craddock

    Charles Craddock, Professor of Haemato-oncology , Leukaemia & Lymphoma Research

  • Increased availability of novel drug therapies in haematological malignancies as a consequence of billions of dollars of research
  • Therapies are not matched by adequate trial activity, particularly in phase I/II arena
  • Patient accrual and completion of trials is unacceptably slow and commercially damaging to biopharma
  • Establishing the UK as leader in translational research for the rapid assessment of novel therapies
  • Leukaemia and Lymphoma Research have made a commitment to deliver a Therapy Acceleration Programme in the UK
  • 11:40 Combining Novel Targeted Agents with Chemotherapy – The Case of EGFR

    Daniel Hochhauser

    Daniel Hochhauser, Professor of Medical Oncology, UCL Cancer Institute

  • Epidermal growth factor receptor (EGFR) inhibitors in targeted cancer treatment
  • Combining chemotherapy and EGFR inhibitors in preclinical models
  • Combining chemotherapy and EGFR inhibitors in the clinic
  • Importance of understanding mechanism in trial design
  • 12:20 Networking Lunch

    13:40 Clinical Development Partnerships – The Cancer Research UK Model

    Ian Walker

    Ian Walker, Licensing Manager, Clinical Partnerships, Cancer Research Technology Ltd

  • Bringing promising anti-cancer agents back into development
  • Early-phase trials conducted at no upfront cost to the company
  • Innovative business model with established track record
  • 14:20 Companion Diagnostics for Cancer Drugs

    Steen Knudsen

    Steen Knudsen, Chief Scientific Officer, Medical Prognosis Institute

  • Novel transcriptomic-based approaches
  • Implications for clinical trials
  • Regulatory implications
  • Market implications
  • 15:00 Chairman’s Closing Remarks and Close of Conference followed by Afternoon Tea

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    Workshops

    Challenging Times – Designing Early Phase Oncology Trials
    Workshop

    Challenging Times – Designing Early Phase Oncology Trials

    Crowne Plaza Hotel - St James
    7th July 2010
    London, United Kingdom

    Crowne Plaza Hotel - St James

    Buckingham Gate 45/51
    London SW1E 6AF
    United Kingdom

    Crowne Plaza Hotel - St James

    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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