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SMi is proud to present their 3rd annual conference on Biomarkers in Clinical Trials. With the 2011 event aiming to explore the use of biomarkers in Cancer drug development.

Concerns over efficacy, cost, and drug safety have stimulated a need for personalized medicine; and to increase the predictability of clinical research to reduce development cost and time. The use of biomarkers in no longer limited to whether a patient will respond to a treatment, but has extended to aid drug development in all its forms.

As a result biomarkers have now gained significant attention in the R&D process. Which are seen as an emerging but lucrative segment that is opening up new development opportunities, and attracting much commercial interest.

The global biomarker market is estimated to be £12.7 billion by 2014, and driven by the high demand for the biomarkers in the field of drug discovery.

In addition the increasing use of biomarkers in clinical services is boosting the overall biomarker service provider market. 
 

 

"Over 10 million new cancer cases will be diagnosed worldwide over the next year and there is an unmet need for effective, less toxic cancer therapeutics. Our rapidly expanding understanding of how cellular immortality contributes to cancer progression offers an opportunity for the exploitation of the underlying molecular mechanisms into safe and effective new therapies."

Nicol Keith, Professor of Molecular Oncology, Centre for Oncology & Applied Pharmacology

 

 

Interested in speaking at the conference?  

We are always on the look-out for new speakers and interested projects for our upcoming conferences.  Let us know if you would like to participate by emailing smiproduction@smi-online.co.uk

For event sponsorship and exhibiting opportunities, please contact sponsorshipdept@smi-online.co.uk 

 


 

        

What our previous delegates had to say

  

“Good relevant content, very well chaired, good presentations”

Group Leader, UCB 

 

“It was very interesting for me as I have recently moved from translational research to more clinical – translational and diagnostic research. There was a good overview of the field of biomarkers in clinical trials.”

Scientific Co-ordinator for Molecular Pathology, UCL Cancer Institute 

 

"Great mix of Pharma and Non-Pharma" 

Biomarker Logistics Manager, Merck Serono

 

Conference highlights include;

  • A focussed agenda addressing the use of biomarkers in Oncology drug development
  • New developments in Biomarker Validation, Qualification, and Clinical Applications
  • Personalised Medicine and Companion Diagnostics
  • Pharmacology Biomarkers and PK/PD modelling
  • The application of informatics to biomarker usage in clinical trials

 

Vice Presidents, Heads, Directors, Scientists and Project Leaders of

 

  • Research and Development
  • Drug Safety Assessment
  • Biomarker Discovery/Validation
  • Diagnostics
  • Imaging
  • Clinical Pharmacology
  • Toxicology                                          

 

  • Oncology                                              
  • Experimental Medicine
  • Translational Medicine
  • Drug Metabolism
  • Pharmacokinetics
  • Clinical Pathology
  • Molecular and Cell Biology
 

  

Previous delegates came from a wide range of high level positions and international locations

Breakdown by seniority 

Breakdown by region 

 

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Fred Zheng

Fred Zheng, Research Clinical Scientist, Astrazeneca

9:10 Intergrating various fit-for-purpose biomarker studies in oncgology early phase clinical trialsI, their benefits and challenges

Fred Zheng

Fred Zheng, Research Clinical Scientist, Astrazeneca

  • Biomarkers in early phase clinical studies in the oncology therapeutics
  • Challenges in both the design and execution of studies including biomarkers
  • Value added by the inclusion of biomarkers in a specific clinical trial
  • The AstraZeneca Clinical Biomarker Group (CBG)
  • 9:50 Development of oncologymap™ : A public-private partnership dedicated to proviging a powerful new tool for discovery of biomarker patterns in cancer

    Mike Spain

    Mike Spain, VP and Chief Scientific Officer, Myriad RBM Inc

  • OncologyMAP is the newest service offering in Rules-Based Medicine’s portfolio of Multi-Analyte Profiles (MAPs). 
  • Developed in partnership with the National Cancer Institute’s Proteomics Initiative, OncologyMAP contains 101 quantitative, multiplexed immunoassays for measuring cancer-related proteins in serum, plasma or tissue extracts.
  • This novel tool offers an unparalleled platform to aid in the discovery and development of novel therapies and diagnostics in oncology.
  • The OncologyMAP is powered by RBM’s data-driven approach to efficiently and cost-effectively discover useful biomarker patterns.
  • 10:30 Morning Coffee

    11:00 Biomarkers development: Relevance to commercialisation of new products?

    Lincoln Tsang

    Lincoln Tsang, Partner, Arnold and Porter

    How the current policy would influence the current and future development of new products?

    Would biomarkers development be relevant to product approval and market access?

    Would biomarkers be relevant to current thinking of post-approval drug safety monitoring?

    11:40 Intratumoral immune reaction: a novel paradigm for cancer

    Jerome Galon

    Jerome Galon, Research Director, INSERM

  • The importance of the anatomic extent of tumour (TNM) classifications
  • The impact of immune responses on patient prognosis
  • Analysis of patients with early-stage colorectal cancer
  • Investigation of the primary tumour microenvironment
  • Four major immune coordination profiles identified
  • Recent advances analyzing mechanisms responsible for lymphocytic infiltration
  • Tumour invasion is statistically dependent on the host-immune reaction
  • 12:20 Networking Lunch

    13:20 Identification of Markers of Efficacy in Cancer Patients Treated with TroVax (MVA-5T4)

    Richard Harrop

    Richard Harrop, Senior Scientist, Oxford Biomedia (U K) Limited

    14:00 Image Analaysis as an enabling technologyfor the development of drug diagnostics

    Florian Leiss

    Florian Leiss, Trainer & Marketing Specialist, Definiens

  • Imaging is essential to the development of biomarkers and their application in personalised medicine
  • Fast, accurate and consistent image analysis is required to systematically exploit the full content of biomedical images
  • Definiens develops software solutions for image analysis and data mining in cancer research and clinical decision support
  • Very detailed and accurate readouts concerning morphology and biomarker expression profiles from H&E, IHC and IF histology are provided, allowing correlations with patient outcome data
  • Case studies demonstrating applications and improved patient stratification will be presented
  • 14:40 Afternoon Tea

    15:00 Blockbusters or niche products - the lure of personalised medicine

    Karol Sikora

    Karol Sikora, Medical Director, CancerPartners UK

  • New commercial strategies for the biomarker age
  • Incorporating molecular signatures of response into marketing strategy
  • Rescuing trash can drugs
  • Cancer as a chronic illness
  • 15:40 A core microRNA signature of lung inflammation in rat and man

    Sterghios Moschos

    Sterghios Moschos, Reader in Industrial Biotechnology, University of Westminster

    Introduction to microRNAs
    Overview of methodologies in querying the miRnome for biomarker signatures
    Case study: translational experiments in rat and COPD patientsIntroduction to microRNAs

    15:45 Chairman’s Closing Remarks and Close of Day One

    Fred Zheng

    Fred Zheng, Research Clinical Scientist, Astrazeneca

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Robert Brown

    Robert Brown, Chair in Translational Oncology, Head of Epigenetics Unit, Faculty of Medicine, The Hammersmith Hospitals NHS Trust

    9:10 Use of biomarkers as translational sciences and exploratory medicine tools for decision making in drug development

    Taoufik Ouatas

    Taoufik Ouatas, Senior Scientist, Exploratory Development, Astellas Pharma Europe Ltd

  • Role of biomarkers & PK/PD modelling in optimizing clinical development & trial design
  • Biomarker qualification for decision making in clinical development
  • The three questions towards clinical Proof-Of-Concept: positive, negative and landscape
  • 9:50 Biomarker for early assessment of response to therapy

    Rudolf Oehler

    Rudolf Oehler, Senior Scientist, Surgical Research Laboratories, Medical University of Vienna

  • Immediate effects of chemotherapy on the tumour and its microenvironment
  • Preclinical serum biomarker discovery
  • Clinical utility of early assessment of response to therapy
  • 10:30 Morning Coffee

    11:00 Advanced bioinfromatics tools for clincial trials, biomarker discovery to co-therapy management

    Adam Gouldsworthy

    Adam Gouldsworthy, Business Development Manager, CompanDX Ltd.

  • Molecular data gathered from clinical trial can approach gigabytes per patient with high dimensionality simple statistical methods cannot handle this complexity
  • Tools to reduce the complexity and deliver workable biomarker panels are the key to unlocking this data
  • CompanDX will introduce its "Distiller" bioinformatics tools covering biomarker discovery, systems biology tools, "time to event"  biomarker panels and single perspective genome scanning
  • Examples of stratified patient cohorts, systems biology tools identifying key regulatory genes and "time to metastasis" signatures will be outlined
  • 11:40 Forward and reverse translational studies of epigenetic biomarker for old and new drugs

    Robert Brown

    Robert Brown, Chair in Translational Oncology, Head of Epigenetics Unit, Faculty of Medicine, The Hammersmith Hospitals NHS Trust

  • DNA methylation as prognostic/predictive biomarker for identifying aberrant regulation of key pathways in ovarian cancer
  • Epigenetic regulation as driver of acquired drug resistance
  • Potential and pitfalls of demethylating agents in clinical trials of solid tumours
  • Challenges of targeting tumour sustaining/stem cells with epigenetic therapies
  • 12:20 Networking Lunch

    13:40 Epigenetic profiling - enabling personalized medicine?

    Mark Eccleston

    Mark Eccleston, Consultant, Belgian Volition

  • Chromatin structure, the epigenome and personalized medicine
  • The histone code; an accessible source of diagnostic and prognostic biomarkers
  • Blood based epigenetic biomarkers for treatment response monitoring
  • Genome wide hypersensitive site mapping for patient stratification and treatment selection
  • 14:20 Analyses of a biomarker in an oncology phase 2 program

    Vincent Haddad

    Vincent Haddad, Biostatistician Manager, Amgen Ltd

  • Definition and statistical power of: Prognostic effect & predictive effect 
  •  Statistical method within each study
  •  Robustness analyses
  •  Consistency between endpoints and between studies
  •  Recommendations
  • 15:00 Chairman’s Closing Remarks and Close of Day Two

    Robert Brown

    Robert Brown, Chair in Translational Oncology, Head of Epigenetics Unit, Faculty of Medicine, The Hammersmith Hospitals NHS Trust

    15:10 Afternoon Tea

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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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