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Experimental approaches to adaptive designs are bcoming more popular as a way to improve the efficiency of drug and medical device development. With adaptive design protocols becoming ever more complex, Adaptive Designs in Clinical Trials 2018 will equip you with the latest knowledge about the changing attitudes of the regulatory bodies to adaptive designs, how technology and experimentl approaches will enrich your adaptive trials and how to ameliorate risks and errors in your adaptive designs.
 

With more case studies and more talks from leading industry experts, Adaptive Designs in Clinical Trials is a must have event for your 2018 calendar.

Benefits of attending 

  • Transform your company by learning how the latest technology and experimental adaptions can optimise your trials.
  • Listen to exciting new case studies from industry experts from a variety of fields and learn how you can apply this practical knowledge to your own trials.
  • Learn how adaptive designs are applied to develop personalised medicines.
  • Gain knowledge of how to optimise your adaptive designs for more efficient clinical trials.
     

Hear from the experts, with presentations from:

  • Amgen
  • Novartis
  • Boehringr-Ingelheim
  • H.Lundbeck
  • Sanofi-Aventis
  • UCB pharma
  • AstraZeneca
  • Biogen
  • Roche
  • Orion  R&D



 

Who should attend
- Biostatisticians
- Clinical project managers
- Clinical research advisors
- Clinical Trials Directors
- Clinical scientists
- Statisticians
 

Amgen; AstraZeneca; Berry Consultants, LLP; Blueberry Therapeutics Ltd. ; Boehringer-Ingelheim; Debiopharm International SA; European Medicines Agency (EMA); GaBI Journal ; Grunenthal Gmbh; H. Lundbeck A/S; IPSEN; Ipsen Innovation; Johnson & Johnson; Kings College London; Livanova; Medicines Assessment; MHRA; MS Society; Novartis; Orion Pharma; Pfizer; Pfizer Global Pharmaceuticals; Roche Deutschland Holding Gmb H; Sanofi; Sanofi Aventis; Servier; Sigma-Tau Pharmaceuticals Inc; TFS, S.L. (CIF: B-60569175); Tillotts Pharma A G; Universitair Ziekenhuis Antwerpen; University College London; University Of Bath;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

9:10 Innovations in clinical trial design: Lessons learnt from adaptive designs

Christine Fletcher

Christine Fletcher, Executive Director Biostatistics, Amgen
View Bio

  • Why are adaptive designs used in clinical trials?
  • What have we learnt from adaptive designs?
  • What does the future of adaptive deigns look like?
  • Other innovations in clinical trial design
  • 9:50 Real-life examples from an industry perspective: Boehringer-Ingelheim

    Frank Fleischer

    Frank Fleischer, Expert Statistician Methodology , Boehringer-Ingelheim
    View Bio

  • A confirmatory enrichment design using group-sequential and interleaving techniques
  • Comparing different adaptive enrichment designs
  • A selection design for determining the most equivalent drug formulation
  • Adaptive randomisation for cut-off determination in the early phase
  • Future areas of interest for adaptive designs in clinical development
     
  • 10:30 Morning Coffee

    11:00 Evaluating digital technology in adaptive clinical trials: promises and challenges

    Alex Sverdlov

    Alex Sverdlov, Director, Statistical Scientist, Novartis
    View Bio

  • Use of digital devices (including wearables) in clinical research
  • How to make sense of the data collected from digital devices
  • What experimental designs are appropriate for evaluating digital therapeutics
  • Examples of adaptive trials
  • 11:40 How does the increased use of technology and novel clinical trial design impact regulatory advice and shape development of new medicines

    Bob Clay

    Bob Clay, Managing Director, Highbury Regulatory Science
    View Bio

  • How does the increased use of technology in adaptive trials impact regulatory guidance?
  • What are the regulatory bodies’ attitudes to novel adaptive clinical trials?
  • What are the challenges and opportunities with novel adaptive designs
  • How will in vitro diagnostic regulations impact the application of adaptive trials?
  • What does the future for adaptive designs, in the context of other approaches to obtaining evidence on the safety, efficacy and effectiveness look like?
     
  • 12:20 Networking Lunch

    13:20 Confirmatory Adaptive Designs involving Selection

    Sue Todd

    Sue Todd, Professor of Medical Statistics, University of Reading
    View Bio

  • Summary of options for trials with treatment selection
  • Consideration of trials with subpopulation selection
  • Overview of examples of trials in practice
  • 14:00 A Case Study: Sequential trials in the context of competing risks

    Corine Baayen

    Corine Baayen, Senior Biostatistician, Lundbeck Pharma
    View Bio

  • How can we evaluate competing risk data in group sequential trials?
  • A case study illustrating the state of the art, typical challenges and open issues
  • A discussion of remaining open questions
     
  • 14:40 Afternoon Tea

    15:10 MHRA: Adaptive Designs and the future of the industry

    15:50 Case Study: A Phase 2/3 Adaptive Seamless Study Design in Patients with Chronic Obstructive Pulmonary Disease (COPD).

    Daniela Casula

    Daniela Casula, Biostatistician, GSK

  • Study design and comparison with standard approach
  • The ‘issue’ with the interim analysis
  • Simulation plan and results
  • 17:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    9:10 Platform studies in drug development

    James Matcham

    James Matcham, Head of Biometrics, Early Clinical Development, AstraZeneca
    View Bio

  • The use of Basket and Umbrella Studies
  • Benefits of a Platform Study approach in Oncology
  • Practical challenges with Platform Studies
  • Applications in other therapeutic areas
  • 9:50 Regulatory perspectives for the planning and assessment of umbrella and basket trials

    Olivier Collignon

    Olivier Collignon, Biostatistician, European Medicines Agency (EMA)
    View Bio

  • Evaluation of the consistency of response across several sub-studies based on different conditions, pooling of the sub-studies and impact on regulatory assessment
  • The debatable necessity to control for multiplicity
  • Additional issues relating to biomarker development and integration of historical controls
     
  • 10:30 Morning Coffee

    11:00 Design and analysis of platform trials assessing multiple treatments and biomarkers

    James Wason

    James Wason, Group Leader, MRC Biostatistics Unit
    View Bio

  • How traditional trial design could be improved when treatments are expected to have different efficacy in different groups
  • A review and comparison of designs available for testing multiple treatments in multiple subgroups
  • An overview of methodology work done to address statistical issues arising when new treatments and biomarkers can be added in, including error rates, use of non-concurrent controls, planning confirmatory studies
  • A description of future research directions in this area
  • 11:40 Panel Discussion: experimental and novel approaches in adaptive designs

    Olivier Collignon

    Olivier Collignon, Biostatistician, European Medicines Agency (EMA)
    View Bio

    James Matcham

    James Matcham, Head of Biometrics, Early Clinical Development, AstraZeneca
    View Bio

    Ros Walley

    Ros Walley, Statistician, UCB Pharma
    View Bio

    12:20 Networking Lunch

    13:20 Self adapting priors

    Ros Walley

    Ros Walley, Statistician, UCB Pharma
    View Bio

  • Incorporating relevant historical information though a Bayesian informative prior is increasingly used in Early Clinical Development
  • Concern about potential prior-data conflict can lead to heavy discounting of this information
  • Instead “self-adapting priors” can be used which alter the down-weighting depending on the discrepancy between the prior and the data
     
  • 14:00 Right Patient, Right Design : Facilitating Personalised HealthCare with Adaptive Designs

    Chris Harbron

    Chris Harbron, Principal Statistical Scientist , Roche Products Ltd

  • Personalised HealthCare (PHC),  targeting therapies to those patients most likely to benefit is becoming increasingly important
  • During development there can be uncertainty on the optimal PHC strategy, both on the need for a biomarker and the exact definition of a biomarker
  • Adaptive designs provide an efficient way of mitigating this uncertainty whilst still maintaining the overall rigour and operating characteristics of the trial
     
  • 14:40 Latest developments in adaptive designs: a company's perspective - Sanofi-Aventis

    Loic Darchy

    Loic Darchy, Head of Statistical Methodology Group, Sanofi Aventis

  • Overview of the latest research at Sanofi
  • Examples of how Sanofi is currently using adaptive designs in their clinical trials 
  • Current issues being faced and challenges ahead
  • 15:20 Afternoon Tea

    15:50 The Role of Re-randomization Tests in Adaptive Methods with Planned or Unplanned Changes

    Michael Proschan

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

    16:20 Adequate decision making in development programmes for targeted therapies

    Heiko Goette

    Heiko Goette, Biostatistician, Merck & Company

  • Development programmes for targeted therapies usually consist of early phase trial for identifying a target subgroup among several biomarker candidates followed by a confirmatory trial
  • Design options for confirmatory trial: targeted subgroup enrichment design or adaptive enrichment design
  • Results from early phase trial influence go/no go decision, choice of confirmatory trial design as well as interim decision rule of adaptive design
  • Early phase results need to be adjusted for data-driven selection to allow adequate decision making
     
  • 17:00 Chairman’s Closing Remarks and Close of Day Two

    +

    Workshops

    Unlocking the potential of platform trials
    Workshop

    Unlocking the potential of platform trials

    Copthorne Tara Hotel
    11th April 2018
    London, United Kingdom

    VENUE

    Copthorne Tara Hotel

    Scarsdale Place, Kensington, London, United Kingdom

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

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    Copthorne Tara Hotel

    Scarsdale Place
    Kensington
    London W8 5SR
    United Kingdom

    Copthorne Tara Hotel

    The Copthorne Tara Hotel London Kensington is an elegant contemporary four-star hotel in prestigious Kensington, located just a two minutes walk from High Street Kensington underground station, making exploring easy. The hotel offers well-appointed and comfortable guest rooms combining Standard, Superior and Club accommodation. Club rooms offer iconic views over the city and include Club Lounge access for complimentary breakfast and refreshments. Guests can sample the authentic Singaporean, Malaysian and Chinese cuisine at Bugis Street, traditional pub fare at the Brasserie Restaurant & Bar or relax with a delicious drink at West8 Cocktail Lounge & Bar.

    The Copthorne Tara Hotel boasts 745 square meters of flexible meeting space, consisting of the Shannon Suite and the Liffey Suite, ideal for hosting conferences, weddings and social events. Facilities include access to the business centre 24 hours a day, fully equipped fitness room, gift shop, theatre desk and Bureau de Change. With ample onsite parking outside the London congestion charge zone and excellent transport links via Heathrow Airport, the hotel is the perfect location for business or leisure stays. The hotel is within close proximity to the shops of High Street Kensington, Knightsbridge and Westfield London, Olympia Conference Centre, Royal Albert Hall, Kensington Palace and Hyde Park.

     

    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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