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SAE Media Group are proud to announce the 11th annual Adaptive Designs in Clinical Trials conference and exhibition will return to London from the 1st – 2nd April 2019. With the growing popularity in use and acceptance of adaptive designs in clinical trials - demonstrated most recently with the new  FDA  draft guidance on adaptive designs – there is a pressing need for a forum which explores this increasingly normalized medical methodology.


Hosting in depth presentations from regulatory agencies, researchers and biostatisticians, the meeting will cover how personalized medicine, platform trials, response-adaptive randomization, signature designs, estimand framework, bayesian methods and digital innovation are revolutionizing the drug development process both in Europe and North America.

At this years conference there will once again be an array of networking opportunities:

  • Meet and network with key industry and thought leaders shaping state of the art adaptive design techniques
  • More than 4 hours of networking during the conference days
  • Engage with an array of vendors, with leading solution providers, Mevia and GCE Solutions among those exhibiting last year


Key reasons to attend:

  • See how the regulatory environment for adaptive drug design is shifting across the continent with insights from the MHRA, Amgen, AstraZeneca and Berry Consulting
  • Explore the therapeutic potential of  adaptive designs with real-world examples from H.Lundbeck, GSK Vaccines, Pfizer and Novartis 
  • Listen to how the latest platform trial case studies – such as that of  the EPAD project and the MS Society  initiative, are impacting pharmaceutical development
  • Delve into the long-standing discussion of  Bayesian vs. frequentist designs
  • Discover the latest research in response-adaptive designs: trials for rare diseases and looking forward
     

Who should attend:

  • Biostatisticians
  • Clinical project managers
  • Clinical research advisors
  • Clinical Trials Directors
  • Clinical scientists
  • Statisticians
  • Quantitative scientists

     

Almac Clinical Technologies LLC; Amgen; AstraZeneca; BeiGene; Berry Consultants, LLP; Boehringer-Ingelheim; Chiesi Farmaceutici; DEBIOPHARM INTERNATIONAL SA; Dr. Willmar Schwabe GmbH & Co. KG; Eli Lilly International Corporation; European Medicines Agency (EMA); Ferring Pharmaceuticals A/S; Fraunhofer Institute for Algorithms and Scientific Computing; GCE Solutions; Glenmark Pharmaceuticals; GSK; Highbury Regulatory Science; Janssen; Lundbeck Pharma; Medtronic; Menarini Ricerche SpA; Merck & Company; Mevia; MHRA; MRC Biostatistics Unit; National Institute of Allergy and Infectious Diseases ; Orion Corporation Orion Pharma; Oslo University Hospital; Roche Products Ltd; Sanofi Aventis; SDS; TFS Trial Form Support; TFS, S.L. (CIF: B-60569175); Transgene SA; UCB Pharma Limited; University Of Bath; University of Reading; Lancaster University

Conference agenda

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8:30

Registration & Coffee

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9:00

Chairman's Opening Remarks

Tom Parke, Director of Software Solutions, Berry Consultants, LLP

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9:10

An industry outlook on adaptive designs in clinical trials

Tom Parke, Director of Software Solutions, Berry Consultants, LLP

  • Innovations of adaptive designs in clinical trials
  • How has the use of adaptive designs in clinical trials developed?
  • Views on the draft FDA guidance on adaptive designs
  • Heads of Medicines Agencies: Clinical Trials Facilitation Group practical implications
  • clock

    9:50

    Adaptive designs in multiple sclerosis clinical trials

    Emma Gray, MS Society - Head of Clinical Trials, MS National Centre (MSNC)

  • Initiative to establish platform trial
  • The practicalities of setting up platform trials
  • Methodological challenges in MS trial design
  • Ethical and patient perspective on adaptive designs

     

  • clock

    10:30

    Morning Coffee

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    11:00

    Adaptive signature designs for cancer vaccines

    Andrea Callegaro, Senior Manager, Biostatistician, GSK Vaccines

  • Mage-A3: a double-blind, randomised, placebo-controlled, phase 3 trial
  • The practical and operational considerations of immunotherapeutic adaptive designs
  • Futility for subgroup analyses in adaptive signature design
  • The future of adaptive designs for cancer vaccines
  • clock

    11:40

    The European Prevention of Alzheimer’s Disease platform trial

    Philip Hougaard, Vice President, Biometrics, H. Lundbeck A/S

  • EPAD is a public-private partnership running two connected trials:
  • A longitudinal cohort study identifying subjects with biomarker evidence of early Alzheimer’s
  • An adaptive platform trial for Proof-of-concept testing of new preventive treatments, recruiting from the first trial
  • Advantages and disadvantages of testing drugs in this setup compared to classical one-drug trials
  • clock

    12:20

    Networking Lunch

    clock

    13:20

    Forecasting and adaptive adjustment of trial operational design

    Vladimir Anisimov, Principal Data Scientist , Amgen

  • The problems and uncertainties in the operational design of adaptive trials
  • Forecasting trial operational characteristics at interim look and the impact of stochastic variation on the operational design
  • Risk-based monitoring of different metrics of trial performance
  • Interim data-driven re-projection and adaptive adjustment of trial operation
     
  • clock

    14:00

    A regulatory perspective of adaptive design trials

    Beatrice Panico , Medical Assessor , Medicines and Healthcare Products Regulatory Agency

  • Initial Clinical Trial Authorisation (CTA): points to consider
  • Regulatory points to consider for submissions with substantial amendments
  • Safety considerations
  • clock

    14:40

    Afternoon Tea

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    15:10

    Using Estimand Framework in Adaptive Designs: The implication of ICH E9 R(1)

  • ICH E9(R1) and adaptive clinical trials
  • Using estimand framework in adaptive clinical trials
  • Design challenges that ICH E9(R1) might bring to adaptive designs
  • Impact of ICH E9(R1) on the analysis of adaptive clinical trials
  • Steven A. Gilbert, Senior Director Statistics, Pfizer

    Macaulay Okwuokenye

    Macaulay Okwuokenye, Syros Pharmaceuticals, Principal Biostatistician, Syros Pharmaceuticals

    clock

    15:50

    Chairman’s Closing Remarks and Close of Day One

    Tom Parke, Director of Software Solutions, Berry Consultants, LLP

    clock

    8:30

    Registration & Coffee

    clock

    8:50

    Chairman's Opening Remarks

    Alex Sverdlov, Director, Statistical Scientist, Novartis

    clock

    9:00

    Statistical and design considerations in personalised medicine

    Sandeep Menon, Vice President, Pfizer Inc

  • Identifying genetic, genomic and clinical characteristics to predict patient susceptibility
  • Biomarkers and the challenges in their use for diagnostics
  • Selecting appropriate designs to determine biomarker performance, reliability and regulatory acceptance
  • Case studies for biomarker driven trials
  • clock

    9:40

    Implementing cost-efficient randomization designs in clinical trials with heterogeneous treatment costs

    Alex Sverdlov, Director, Statistical Scientist, Novartis

  • Optimal allocation designs minimizing study cost under statistical efficiency constraints
  • Restricted randomization procedures to implement optimal allocation in practice
  • Statistical inference following these procedures, using population-based and randomization-based approaches
     
  •  

    clock

    10:20

    Extrapolation in clinical trials and beyond

    Simon Wandel, Associate Director Statistical Methodologist, Novartis Pharmaceuticals

  • Basics of extrapolation: when is it applicable - and when not
  • Extrapolation from adults to children: “adaptive” borrowing
  • Bridging studies
  • Beyond individual studies: extrapolation via mixture models for meta-analysis
  • clock

    11:00

    Morning Coffee

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    11:30

    Considerations and Experiences in a Randomized Clinical Trial for Treatment of Ebolavirus Disease in Western Africa

    Michael Proschan, Mathmatical Statistician, National Institute of Allergy and Infectious Diseases

    • Bayesian design to seamlessly accommodate adaptations through calculation of posterior probability of superiority
    • Skeptical prior distribution to prevent a self-fulfilling prophecy of benefit, yet less conservative than Fisher’s exact test at interim analyses
    • Resistance to Bayesian presentation among clinical trial community: “But what was the p-value?”
    • Why alternative designs such as the triangular test were not used
     

    clock

    12:10

    Applying adaptive designs in industry

    Frank Fleischer, Team Leader Clinical Biostatistics, Boehringer-Ingelheim

  • Overview of adaptive designs at BI
  • Joint escalation models in oncology dose finding
  • Early phase basket designs and GoNoGo decision making
  • Blinded sample size reassessment – is there a future?
  • clock

    12:50

    Continuous decision making within a clinical trial

    Paul Frewer, Early Clinical Development, AstraZeneca

  • Overview of Decision Making in Early clinical development at AstraZeneca
  • Incorporating continuous decision making into the framework
  • Standardizing tools/ figures to convey the information
  • Statistical risks and considerations in adopting this approach
  • clock

    13:30

    Networking Lunch

    clock

    14:30

    Response-adaptive designs

    Sofia Villar, Senior Statistician, MRC Biostatistics Unit (University of Cambridge School of Clinical Medicine)

  • The benefits of forward looking response-adaptive randomisation in adaptive designs
  • Trials for rare diseases & finding treatments that work subgroups
  • Type 1 error inflation due to an unknown time trend over the course of the trial
  • clock

    15:10

    Panel Discussion: Bayesian vs. frequentist designs incorporating multiple treatment arms

  • Response-adaptive randomisation
  • Triangular tests
  • Dropping poorly-performing arms in multi-arm multi-stage designs
  • Flexibility in Bayesian vs. frequentist designs
  • Michael Proschan, Mathmatical Statistician, National Institute of Allergy and Infectious Diseases

    Kaspar Rufibach, Principal Statistical Scientist, F. Hoffman-La Roche AG

    Alex Sverdlov, Director, Statistical Scientist, Novartis

    Sofia Villar, Senior Statistician, MRC Biostatistics Unit (University of Cambridge School of Clinical Medicine)

    clock

    15:50

    Afternoon Tea

    clock

    16:20

    MIRROS: Phase 3 trial with time-to-event endpoint, cure proportion, and futility interim analysis using response

    Kaspar Rufibach, Principal Statistical Scientist, F. Hoffman-La Roche AG

  • Phase 3 trial in AML with overall survival as primary endpoint which is currently running
  • Sample size based on a cure proportion model
  • Operating characteristics of futility interim analysis explored based on mechanistic simulation model
  • Discussion of statistical and operational aspects of this trial
  • clock

    17:00

    Defining decision rules based on simulated development programs

    Heiko Goette, Biostatistician, Merck

  • Go/no go decision after phase 2 and futility analysis in phase 3 trials based on estimated probability of success
  • Probability of success is estimated using simulations taking into account observed association between short-term and long-term endpoint from phase 2
  • Simulation of complete phase 2 and 3 development program allows to define appropriate decision boundaries
  • clock

    17:40

    Chairman’s Closing Remarks and Close of Day Two

    Alex Sverdlov, Director, Statistical Scientist, Novartis


    Director, Statistical Scientist
    Novartis
    Senior Manager, Biostatistician
    GSK Vaccines
    Medical Assessor
    Medicines and Healthcare Products Regulatory Agency
    MS Society - Head of Clinical Trials
    MS National Centre (MSNC)
    Team Leader Clinical Biostatistics
    Boehringer-Ingelheim
    Biostatistician
    Merck
    Principal Statistical Scientist
    F. Hoffman-La Roche AG
    Syros Pharmaceuticals, Principal Biostatistician
    Syros Pharmaceuticals
    Mathmatical Statistician
    National Institute of Allergy and Infectious Diseases
    Early Clinical Development
    AstraZeneca
    Vice President, Biometrics
    H. Lundbeck A/S
    Vice President
    Pfizer Inc
    Associate Director Statistical Methodologist
    Novartis Pharmaceuticals
    Senior Statistician
    MRC Biostatistics Unit (University of Cambridge School of Clinical Medicine)
    Senior Director Statistics
    Pfizer
    Director of Software Solutions
    Berry Consultants, LLP
    Director of Software Solutions
    Berry Consultants, LLP
    Principal Data Scientist
    Amgen

    Sponsors and Exhibitors

    Supporters

    Workshops

    The FDA – a new guidance on adaptive designs
    Workshop

    The FDA – a new guidance on adaptive designs

    Holiday Inn Kensington Forum
    1 April 2019
    London, United Kingdom

    Design and analysis of clinical trials evaluating novel digital technologies
    Workshop

    Design and analysis of clinical trials evaluating novel digital technologies

    Holiday Inn Kensington Forum
    3 April 2019
    London, United Kingdom

    VENUE

    Holiday Inn Kensington Forum

    97 Cromwell Road , London, United Kingdom

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    A number of our clients have been approached by third party organisations offering to book hotel rooms. We would advise that you do not book through them as they are not representing the SMi Group. SMi Group books all hotel rooms directly. If you are approached by a third party organisation then please contact us before making any bookings. If you have already booked a hotel room using a third party organisation, we would highly recommend contacting the hotel you were booked into to ensure a booking has been made for you. We would also advise you to please check the terms and conditions of the booking carefully.
    HOTEL BOOKING FORM

    2019 ATTENDEES

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    Interview with Dr. Sandeep Menon, Pfizer

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    Interview with Alex Sverdlov (Chair)

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    Letter from the Chairs

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    Interview with Heiko Goette, Merck

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    Interview with Kaspar Rufibach, Principal Statistical Scientist, F. Hoffman-La Roche AG

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    An interview with Sofia Villar, MRC Biostatistics Unit

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    Speaker Line-up

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    2018 ATTENDEES

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    2019 Programme

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    Workshop B

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    Workshop A

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    Presentation by M.Beatrice Panico, Medical Assessor, MHRA

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    Presentation by Professor Sue Todd, University of Reading, UK

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    Presentation by Bob Clay, Managing Director, Highbury Regulatory Science

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    Presentation by Dr. Frank Fleischer, Boehringer Ingelheim

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    Presentation by Christine Fletcher, Amgen

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    Sponsors and Exhibitors


    GCE Solutions

    Sponsors and Exhibitors
    https://www.gcesolutions.com

    Since 2006, GCE Solutions has operated as a biometrics-focused CRO. We are a global clinical research services and solutions organization specializing in all aspects of clinical data. Innovation is the company’s key driver as GCE’s Innovation Team continues developing processes, tools, and technology that accelerate data gathering, analysis, and the submission phases.

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    Drugdevelopment-technology.com covers every aspect of the drug development and research process, from conception to pre-FDA approval. Our global network of journalists updates the site with the latest and most significant industry developments. This coverage allows us to provide everyone - from senior management through to research and QA staff – with in-depth reviews of the latest projects, advance notice of new product releases and analysis of the latest procedural and legislative developments.


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    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


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    Holiday Inn Kensington Forum

    97 Cromwell Road
    London SW7 4DN
    United Kingdom

    Holiday Inn Kensington Forum

    Holiday Inn Kensington Forum is perfectly situated in one of London’s most luxurious and beautiful areas within South Kensington. 

    The hotel is just 2 minutes walk from Gloucester Road tube station for convenient travel to Hyde Park, London Eye, Tower Bridge plus more of London’s top attractions. There are also easy and direct links to some major transport hubs including Victoria, Kings Cross St Pancras, Paddington and Heathrow. 

    This distinctive hotel in south London has so much to offer to make all guests really feel at home. The latest Holiday Inn relaunch is not just about the new look and feel for the hotel but to offer guests more benefits during their stay including a pillow menu for extra comfort during their sleep and a curved shower rail for more spacious feel. 

    In addition to our 906 rooms, all business guests can take advantage of our meeting and conference facilities including High Speed Internet Access and unlimited Starbucks coffee at The Academy. Our hotel’s professional event planners are on board to help take the hard work and stress away from planning your next event. 

    So whether you in London on business or pleasure, make the Holiday Inn London Kensington Forum your first choice of hotel and book your accommodation for our lowest internet rate guarantee. 

    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, SAE Media 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@saemediagroup.com

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