Developing strategies to optimise the role of biomarkers in by vqx13199


									           Developing strategies to optimise the role of biomarkers in drug development
ACI’s 2nd Biomarkers in Drug Development Conference will explore methodologies and technologies to enhance the drug
development process through early successful translation of biomarkers into the clinical phase. The programme addresses the
challenges of biomarker validation, promoting a more predictive preclinical model and incorporating biomarkers in first human trials.
Enhance your decision making process through the successful implementation of biomarkers.
                                                                                                       SPEAKERS INCLUDE:
                                                                                                       Michael Stocum,
Throughout the 2 days you will have the opportunity to hear from your industry peers and               Managing Director
discover the hottest developments in the employment of biomarkers to “bridge the gap”                  Personalized Medicine
between preclinical and clinical trials:                                                               Partners LLC

    •   Accelerate the introduction of drugs to market                                                 Erik Foehr,
    •   Understand how to utilise biomarkers in the clinical phase to reduce the length and            Associate Director,
        size of trials                                                                                 Pharmacology and
    •   Examine the role of biomarkers as safety indicators in clinical trials to reducing attrition   Toxicology,
    •   Discover how to successfully implement biomarkers into the decision making process
    •   Identify fit for purpose biomarkers
    •   Learn how to increase cost efficiency and productivity through reduced attrition               Robert Wilkinson,
                                                                                                       Discovery Medicine, In
                                                                                                       vivo Pharmacology
AN INTERACTIVE 2 DAYS                                                                                  Capacity Leader,
    •   ACI’s meetings offer the perfect opportunity to discover the latest updates and to
                                                                                                       Richard Margolin,
        discuss your own research challenges and cutting edge solutions with your
                                                                                                       Director, Early Clinical
        peers through an interactive and informative 2 day programme
                                                                                                       Research and
    •   Interact with top level researchers and decision-makers from the pharmaceutical and            Experimental Medicine,
        biotechnology industries                                                                       Schering-Plough
    •   Learn more about your peers’ research, network with key industry leaders and your              Research Institute
        industry colleagues
    •   Discuss the latest challenges and developments in this rapidly changing and growing            Klaus Steensgaard
        sector of the industry                                                                         Frederiksen,
    •   Participate in roundtable sessions – giving you the chance to discuss the latest issues        Department Of Molecular
        with your colleagues – and the speakers – in an open, informal and intimate setting            Genetics,
                                                                                                       Novo Nordisk

                                                                                                       Jochen Theis, Global
Who will attend?                                                                                       Head Biomarkers and
                                                                                                       Experimental Medicine,
All ACI’s events attract a targeted group of senior level researchers and decision-makers from         Hoffmann La-Roche, Inc.
industry. Our meetings are strictly end-user focussed. Only a select group of companies are
invited to sponsor the event – to ensure the emphasis is on the industry participants, and making
sure our delegates have a valuable and positive experience.                                                 Co-Sponsor:
Delegates will be drawn from pharmaceutical and biotechnology companies and include VPs,
Directors and Managers of: Biomarkers, Translational/Experimental Medicine, Clinical
Research/Development, Pharmacology, Toxicology and Safety Assessment, Clinical PK/PD,
Molecular Medicine and Diagnostics
                                                                                                          Other Sponsors:

        Testimonials from ACI’s Previous Biomarkers in Drug Development Conference

                       “The meeting was informative and well organized”

                  “The talks were interesting and covered the topic broadly”

                           “A productive meeting for all participants”

Companies can gain direct access to our senior level audience and have an increased level of
visibility through branding and networking at the conference. For information on available
sponsorship and commercial opportunities, please contact on 44 207 981 2505 or
DAY ONE: 9th April 2008
08.00   Registration and Coffee                                                     Selecting Fit for Purpose Biomarkers

        Eddie Blair, Director, Integrated Medicines                    11.40   CONFERENCE PRESENTATION
                                                                               Identifying a Viable Analysis Model for Surrogate
                                                                               Biomarkers – Improving the Efficacy of Clinical
                                                                               Surrogate End Points
                Characterising Biomarkers                                          •     Encouraging cross departmental cooperation to
                                                                                         bolstering clinical and analytical confidence and
                                                                                         aid marker selection
09.10   KEYNOTE ADDRESS                                                            •     Securing in- house consistency in biomarker
        Understanding the Prerequisites Crucial to the                                   evaluation
        Successful Discovery and Evaluation of Biomarkers                      Jochen Theis, Former Global Head Biomarkers and
        The presentation will focus on how to progress novel                   Experimental Medicine, Hoffmann La-Roche, Inc.
        biomarker programs from their conception to successful         12.20
        endpoints, up to and including potential companion                     CONFERENCE PRESENTATION
        diagnostics. It will briefly review options for strategic              Optimising the Use of Biomarkers in Alzheimer’s
        design and tactical implementation of de novo biomarker                Disease Drug Development
        programs and provide summary examples of recent
        programs, then discuss how to assess the value of these                    •   Imaging for Alzheimers Biomarkers
        biomarker programs in the context of product
                                                                                   •   Assessing the role of chemical markers
        development programs and potential for novel products
                                                                               Richard Margolin MD, Director, Early Clinical Research
        Michael Stocum, Managing Director, Personalized
                                                                               and Experimental Medicine, Schering-Plough
        Medicine Partners LLC
                                                                               Research Institute
        Enhancing Biomarker Prioritisation through Imaging
        Technology to Identify Successful Targets                      13.00   Lunch
        From a commercial standpoint, main problems in drug
        research are the large number of potential drugs that fail,
        and the long trajectory it takes to bring                      14.20   CONFERENCE PRESENTATION
        succesful substance on to the market. Scintigraphic                    Assessing the Utility of Preclinical Disease Models in
        imaging techniques (PET, SPECT) have the potential for                 Biomarker Selection
        early discrimination between successful and failure in
        man and animal. Evenmore, when it is realized that both
                                                                                   •     Debating the importance of preclinical models
        techniques not only provide images, but also have
                                                                                         in translational science and the development of
        quantification properties. In the presentation the potential
                                                                                         drugs in oncology
        of the techniques will be outlined, and a number of
        examples given.                                                             •    Developing strategies to align the critical steps
        Jan Pruim, Medical Coordinator and Deputy Head of                                from in vitro to human
        Department of Nuclear Medicine and Molecular Imaging,                  Robert Wilkinson, Discovery Medicine, In vivo
        University Medical Centre Groningen                                    Pharmacology Capacity Leader, AstraZeneca
10.30   CONFERENCE PRESENTATION                                        15.00   CONFERENCE PRESENTATION
        Improving the Translation of Biomarkers through the                    Identifying Efficacy Biomarkers to Aid Decision
        Application of Cell Culture Systems in Pre Clinical                    Making: Identification of AK-1 for cancer and AK-2
        Assessments                                                            for protection against a broad-spectrum viral
        Working towards the identification of biomarkers that
        could act as generic molecular “red flags” capable of
        predicting adverse reactions induced by new molecules                      •   Applying pharmacogenomics to identify new
        entering the clinical pipeline. We propose that molecular                      drug targets
        characterisation of the “secretome” of human primary                       •   Improve early detection of weak compounds
        skeletal myoblasts exposed to cerivastatin in vitro                    Grace Wong, Chief Scientific Officer, ActoKine
        provides an objective, manipulable and reproducible test               Therapeutics
        bed for the identification of surrogate secreted
        biomarkers of adverse drug reactions in vivo.
                                                                       15.40   Afternoon Refreshments
        Gary Coulton, Director, St. George's Medical Biomics
        Centre, St George’s Hospital, University Of London
                                                                       16.00   “Interactive” ROUNDTABLE DISCUSSIONS
                                                                               TABLE 1
11.10   Morning Refreshments and Exhibition Showcase                           CHAIR: Michael Stocum
                                                                               Assessing the value of biomarker programmes

                                                                               TABLE 2
                                                                               CHAIR: Eddie Blair
                                                                               Optimising the application of biomarkers to improve
                                                                               decision making

                                                                       17.00   Drinks Reception and End of Day One
DAY TWO: 10th April 2008
08.30   Registration and Coffee                                                       Biomarkers for First in Human Trials

        Eddie Blair, Director, Integrated Medicines                  14.00   CONFERENCE PRESENTATION
                                                                             Establishing a “Bridging Model” for Biomarkers in
                                                                             Drug Development – Encouraging cooperation
                                                                             between preclinical and clinical research
        Developing a More Predictive Preclinical Model
                                                                                 •    Selecting translational biomarkers to improve
09.10   KEYNOTE ADDRESS                                                           •   Integrating biomarker data with clinical data
        Preclinical Paradigms for the Identification of                      Jeff Evans, Leader, Translational Cancer Therapeutics,
        Predictive Biomarkers                                                Beatson Institute for Cancer Research

             • Understanding the challenges in predictive
               biomarker discovery                                   14.40   CONFERENCE PRESENTATION
            •  Developing a translational strategy for                       Examining the Advantages of a Pharmacogenomical
               predictive biomarkers                                         Assessment of Biomarkers to Determine Clinical
        David Wholley, Director, The Biomarkers Consortium                   Dose

                                                                             Interleukin-21 (IL-21) is a recently discovered class-I
09.50   CONFERENCE PRESENTATION                                              cytokine which is currently in clinical development. In a
        Managing Translational Research for Novel Cancer                     phase-1 trial where recombinant IL-21 was administered
        Therapies                                                            to patients with metastatic melanoma, microarray
                                                                             analyses of peripheral CD8+ T-cells were used to monitor
             •   Preclinical discovery of relevant biomarkers                the biological response and to identify relevant
             •   Biomarkers for developing a logical discovery               biomarkers. Examples of how these markers have
                 strategy                                                    supported the decisions regarding dose selection and
                                                                             further clinical development will be presented.
            •    Developing molecular response signatures to
                                                                             Klaus Steensgaard Frederiksen, Department Of
                 guide patient selection
                                                                             Molecular Genetics, Novo Nordisk
            •    Personalised medicine - a 10 year perspective
            •    The economics of cancer drug development
        Karol Sikora, Medical Director, Cancer Partners UK           15.20   Afternoon Refreshments

10.30   CONFERENCE PRESENTATION                                      15.50   CONFERENCE PRESENTATION
        Adopting Cost Effective Drug Development through                     Reducing Clinical Trial Costs and the Chances of
        the Application of Attrition Analysis Systems                        Attrition through Smaller Targeted Phase I Trials
             •  Application and impact of biomarkers on the                  The presentation will provide the audience with case
                effectiveness of drug discovery and                          studies that illustrate the challenges and successes of
                development                                                  using biomarkers in clinical trials. BioMarin
            •   Overview of technologies for protein biomarker               Pharmaceutical Inc. focuses on orphan disease
                discovery                                                    indications and has leveraged biomarker information to
            •   Overview of technologies for protein biomarker               facilitate rapid and efficient drug development.
                development and validation                                   Erik Foehr, Associate Director, Pharmacology And
            •   Case studies in oncology and neuroscience                    Toxicology, Biomarin Pharmaceuticals
        Jean-Pierre Wery, Ph.D. ,Chief Scientific Officer,           16.30   CONFERENCE PRESENTATION
        Monarch LifeSciences                                                 Strategies to Improve the Measurement of
                                                                             Biomarkers for Drug Trials
11.10   Morning Refreshments
                                                                             The presentation will discuss ALL the possible issues
11.40   “Interactive” ROUNDTABLE DISCUSSIONS                                 that require careful consideration when contemplating
        TABLE 1                                                              measuring biomarkers in a drug trial – regardless of the
        CHAIR: Jean-Pierre Wery                                              use of that Biomarker (safety, efficacy, PD, R&D,
        How can we implement biomarker strategies that will                  discovery). Case studies will be used to demonstrate
        improve the efficiency of drug discovery and                         both positive and negative outcomes due to oversights or
        development                                                          poor decisions – whether from drug trial organisation and
                                                                             management, or inadequate or inappropriate experience
        TABLE 2                                                              in the laboratory. Consensus of requirements from a
        CHAIR: Erik Foehr                                                    regulatory perspective will also be covered.
        Improving the application of biomarkers in clinical trials           John L Allinson, Director, Veeda Clinical Research
12.40   Lunch
                                                                     17.10   Closing remarks & End of conference
Tel: +44 20 7981 9800                                                 Web:
Fax: +44 20 7593 0071                                                 Mail: ACI Europe, 5/13 Great Suffolk Street, London, SE1 0NS

How to Register
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About ACI
ACI, a UK owned company, have been running successful conferences for the last 10 years in the USA. Headquartered in Chicago
with offices all around the States, they run forums in varied fields and are market leaders in Healthcare business conferences. Opening
their European head office at the end of 2005, they have expanded rapidly and are launching a series of events covering emerging
markets, the maritime industry and now the pharmaceutical industry.
Venue:                                                                The cost of accommodation is not included in the event fee.
Central London, UK. Details to be confirmed.                          Preferential rates will be arranged with or near the event venue,
                                                                      and all confirmed delegates will be given details of how to book
                                                                      accommodation at this rate in due course.
Prices and Payment Information
Conference (Includes Documentation Packet)            9th – 10th April 2008                              £1,495 (+ VAT)
Documentation Packet                                  Copies of all conference proceedings               £295
Documentation Packet Available                                        Discounted Registrations
You can purchase the 2 Biomarkers in Drug Development                 Members and customers of all supporting organisations are
papers at just £295. Simply tick the box on the booking form, send    entitled to a 20% discount off their conference package.
it with payment and your copy will be on its way to you after the     For more information please call +44 20 7981 9800.
meeting. This important manual will be a source of invaluable
reference for the future.
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