Agenda

10.00 - 10.20 Registration and coffee

10.20 - 10.30 Welcome - Herbie Newell (Cancer Research UK) & Jane Cope (NCRI)

10.30 – 10.40 Introduction - Peter Parker (King’s College London ECMC)

“Biomarkers in Late Phase Clinical Trials” - Chair: Peter Parker

10.40 – 11.00 “Aromatase Inhibitors vs Tamoxifen: prognosis or prediction”
Mitch Dowsett (The Royal Marsden, London)

11.00 - 11.20 “An Industry perspective: Biomarkers in oncology drug development”
Corrado Gallo Stampino (Pfizer)

Case studies of biomarkers in late phase clinical trials

11.20 - 11.40 “Genomics profiling in the context of phase 3 clinical trials”
Carlos Caldas (University of Cambridge)

11.40 - 12.00 “The translational research programme in the COIN trial: maximizing opportunity”
Tim Maughan (Wales Cancer Trials Network, Cardiff)

12.00 - 12.20  “Update on BR12 translational study”
Peter Collins (University of Cambridge)

12.10 - 12.40 “Myeloma IX”
Gareth Morgan (The Royal Marsden, London)

12.40 - 14.00 Networking Lunch (in the Edward Lumley Hall)

14.00 - 16.00 Afternoon session: Parallel workshops

Workshop 1 - Genomics and proteomics in sample analysis
Lecture Room 2
(View Details)

Coordinators:
Roz Banks (Cancer Research UK Clinical Centre, Leeds)
James Brenton(Cancer Research UK Cambridge Research Institute)

The aims of this session are to understand the potential impact and the limitations of the current genomic and proteomic technologies, and in particular to gain insight into the practical issues involved in using these approaches in clinical trials.

  • 14.00 - Current status of global proteomic profiling technologies and realistic expectations
    Rob Tonge (AstraZeneca)
  • 14.15 - Targeted pathway profiling using proteomic arrays (protein, antibody, peptide, aptamers)
    Paul Ko Ferrigno (University of Leeds)
  • 14.30 - Sample handling issues – impact on results and feasibility in trials using ICON7 as an example
    Roz Banks (Cancer Research UK Clinical Centre, Leeds)
  • 14.45 - GCLP and biomarker endpoints: lessons from early phase studies
    Richard Sugar (Scientific Drug Development, Cancer Research UK)
  • 15.00 - Obtaining multiple frozen biopsies in NeoTango
    Linda Jones (University of Cambridge)
  • 15.15 - CancerGrid tools for genomic studies in clinical trials
    Peter MacCallum (University of Cambridge)
  • 15.30 - Panel Discussion
    led by James Brenton (Cancer Research UK Cambridge Research Inst)

Workshop 2 - Bio-banking and tissue resources
Committee Room 1 & 2
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Coordinators:
David Cameron (National Cancer Research Network)
Brian Clark (onCore UK)
Louise Jones (Cancer Research UK)

The aims of the session are to illustrate what can be achieved within the context of a phase 3 trial, and to give sufficient information about statistical, ethical, legal and practical aspects of prospective bio-banking as a key part of a randomized clinical trial to allow attendees to go and do likewise.

  • 14.00 - How to build fresh frozen tissue bank from all 1800 patients in a phase 3 clinical trial whose primary end point is biomarker treatment interaction
    Hervé Bonnefoi
    (Chair, European Organisation for Research and Treatment of Cancer Breast Cancer Group (EORTC BCG)     )
  • 14.20 - How to determine the sample size for biomarker research
    Doug Altman
    (Director of Centre for Statistics in Medicine and Cancer Research UK Medical Statistics Group, Oxford    )
  • 14.45 - Panel discussion
  • 15.05 - Research ethics committee approval, patient information, generic and enduring consent - opportunities for tissue banking for translational research
    Brian Clark
    (Chief Executive Officer, onCore UK)
  • 15.25 - Wales Cancer Bank: a pragmatic approach to tissue banking at the national level in the UK
    Malcolm Mason
    (Director, Wales Cancer Bank and Professor of Clinical Oncology, University of Cardiff)
    Gerry Thomas
    (Professor of Molecular Pathology, Hammersmith Hospital, London and Director of Scientific Services, Wales Cancer Bank, Cardiff     )
  • 15.45 - Panel discussion

Workshop 3 - Biomarkers in development of EGFr/ErbB inhibitors
Webb Johnson Room
(View Details)

Coordinator: John Bartlett (University of Edinburgh)

The aims of this workshop are to provide a discussion forum on the development of predictive tissue biomarkers and disease biomarkers in late phase clinical trials in oncology. Examples of current and future applications for predictive biomarkers and a statistical view of validation of biomarkers will be included. There will be time for discussion and formulation of working concepts for the future development of clinical biomarkers relating to inhibitors of the type I receptor tyrosine kinase family.

  • 14.00 - Chairman’s introduction: A roadmap for biomarker development?
    John Bartlett
    (Reader in Molecular Pathology, University of Edinburgh    )
  • 14.20 - Lessons learnt in the ISEL study
    Brian Holloway
    (Global Director Discovery Medicine (Preclinical), AstraZeneca     )
  • 14.40 - Circulating HER2 as a biomarker for response prediction in breast cancer
    John Robertson
    (Professorial Unit of Surgery, Nottingham City Hospital     )
  • 15.00 - ERCC1 directed therapy for advanced non-small cell lung cancer
    Siow Ming Lee
    (Consultant Medical Oncologist, University College Hospital)
  • 15.20 - Statistical considerations when developing a biomarker study
    Janet Dunn
    (Head of Cancer Trials, Warwick Medical School Clinical Trials Unit)
  • 15.35 - Discussion and points for future action