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SMi is proud to present its 8th Annual conference on Adaptive Designs in Clinical Trials taking place on 18th - 19th April in London

In recent years, the use of adaptive design methods has become very popular due to its flexibility for identifying clinical benefits of the testing drug. Adaptive designs offer the potential to reduce timelines and patient exposure while maximising the probability for successful outcomes. However, along with these benefits come challenges: additional complexity, needs for advanced statistical models and increased operational demands.

The 8th annual Adaptive Clinical Trials conference is designed to highlight an array of topics, including adaptive designs within the context of a development programme, Bayesian analysis in adaptive design, biomarker-driven trials, regulatory issues associated with adaptive design, and more.
 

A series of practical case studies, interactive roundtables and panel discussion facilitated by leading industry experts will provide executives with useful tools and best practices to:
• Explore the use of adaptive design methods in clinical trials
• Adapt clinical development for immunotherapies in oncology
• Evaluate adaptive designs and Bayesian statistic
• Improve covariant adaptive designs
• Seamless Phase I/II Dose Finding Designs with Efficacy and Safety Endpoints

• Discuss the European regulatory framework and approaches to novel designs
• Evaluate the role of biomarker adaptive designs in oncology
• Examine the role of an independent data safety monitoring board
• Learn adaptive design in Bayesian statistic
• Explore the impact of adaptive changes in clinical trials
• Study the development of new drugs in orphan diseases
• Optimise dose finding design on oncology

 

   

Clinical trial managers & associates
Biostatisticians
Directors of business developement
Data managers
Senior statisticians
Professors of statistics
Directors of Clinical trials
Medical doctors
PhD students
Clinical scientists

AstraZeneca; Bays Consulting; Cancer Research UK; Celleron Therapeutics Ltd; EMD Serono, Inc.; Enabling Research ; European Medicines Agency; Excelya; Future Science Group; German Breast Group; Hays Life Sciences; Highbury Regulatory Science?; Institute of Clinical Trials and Methodology; Janssen Pharmaceutica NV; London School Of Economics; Lumos Pharma, Inc.; Medical Research Council ; MHRA; MRC Centre; National Inst Of Pharmacy; National Institute of Pharmacy, Hungary; NDA Group AB; Novartis Pharmaceuticals; Patients Know Best; Queen Mary University Of London; Queen Mary, University of London; Quintlies Ltd.; Sanofi Aventis; Synthon BV; Takeda Development Centre Europe Ltd.; The Cure Parkinsons Trust; UCB GmbH; UCL MRC Clinical trails unit; UCLH NHS Foundation Trust; University of Pisa; Warwick Medical School ;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Loic Darchy

Loic Darchy, Senior Statistician, Sanofi Aventis

9:10 Adaptive Designs in Practice

Frank Fleischer

Frank Fleischer, Principal Methodology Statistician, Boehringer-Ingelheim

  • Case studies of adaptive designs in practice
  • Transforming a Phase II trial into a Phase II/III adaptive design
  • Usage of historical and within trial information for decision making
  • Adaptive trial examples in the early phase
  • 9:50 Seamless phase I/II dose finding designs with efficacy and safety endpoints

    Alex Sverdlov

    Alex Sverdlov, Associate Director of Biostatistics, EMD Serono, Inc

  • Advantages of pursuing seamless phase I/II trial designs in the oncology setting
  • Optimal and sequential adaptive designs to achieve experimental objectives of phase I/II trials
  • A simulation study to compare various state-of-the-art phase I/II designs for bivariate binary efficacy-toxicity outcomes
  •  Incorporating covariates to enable personalized dose-finding
  • Statistical software, information technology, and regulatory aspects
  • 10:30 Morning Coffee

    11:00 Biomarker driven early phase oncology trials; opportunities and challenges

    Sidath Katugampola

    Sidath Katugampola, Biomarker Development Specialist, Cancer Research UK

  • Pharmacodynamic biomarkers in early phase trials
  • Immune monitoring
  • Challenges in biomarker driven trials
  • 11:40 Panel discussion: The role of biomarker-driven adaptive designs in clinical development

    Loic Darchy

    Loic Darchy, Senior Statistician, Sanofi Aventis

    Alex Sverdlov

    Alex Sverdlov, Associate Director of Biostatistics, EMD Serono, Inc

    12:20 Networking Lunch

    13:30 Opportunities of adaptive enrichment designs in the era of precision medicine

    Bo Huang

    Bo Huang, Director of Biostatistics, Pfizer Global Pharmaceuticals

  • Opportunities and challenges in the era of biomarker-driven targeted therapies
  • Overview of enrichment designs in statistical literature
  • Case study 1: Bayesian predictive probability design for a phase 2 POC study
  • Case study 2: Adaptive enrichment with sample size re-estimation for a phase 3 oncology study
  • 14:10 Designing and planning seamless Phase 2/3 studies: Tools, justification and a case-study

    Tom Parke

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

  • Seamless phase 2/3 adaptive trials - the mother lode of adaptive trial design?
  • Elements of a seamless phase 2/3 design - new aspects to adaptive trial simulation
  • Is it worth it? Comparing the value of different drug development strategies
  • Case study: AWARD 5 the Eli Lilly Dulaglutide study
  • 14:50 Afternoon Tea

    15:20 Adaptive clinical trials: A DSMB perspective

    Bruce Turnbull

    Bruce Turnbull, Professor of Statistics, Cornell University

  • A series of vignettes will be presented based on the speaker’s experiences from serving on the DSMB for adaptive trials.
  • Pitfalls that may occur during the conduct of an adaptive trial; how they might be avoided.
  • How members with differing interests interact at DSMB meetings with each other, with the sponsor, with a CRO, and with a "firewall"
  • 16:00 Optimising clinical trials in neuroscience

    Richard Wyse

    Richard Wyse, Director of Research and Development, The Cure Parkinsons Trust

  • Adaptive designs in neurology
  • Integrating new biomarkers into clinical development
  • Developing new strategies for testing multiple therapeutics
  • 16:40 Point estimates and confidence intervals for phase II/III clinical trials when multiple endpoints are used to make treatment selection

    Peter Kimani

    Peter Kimani, Assistant Professor in Medical Statistics, Warwick Medical School

  • Multi-arm and multi-stage
  • Treatment selection
  • Multiple endpoints
  • Point estimation
  • Confidence intervals
  • 17:20 Sequential design for a categorical endpoint in a single-arm clinical trial: application to tumor response

    Pierre Colin

    Pierre Colin, Statistical Sciences and Modelling, Sanofi Pharma

  • Sequential design
  • Single-arm Phase II clinical trial in oncology
  • Categorical endpoint
  • 18:00 Chairman’s Closing Remarks and Close of Day One

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Alex Sverdlov

    Alex Sverdlov, Associate Director of Biostatistics, EMD Serono, Inc

    9:10 Adaptive designs in proof-of-concept studies (Phase IIa) and dose-finding studies (Phase IIb)

    Philip  Hougaard

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

  • Simultaneously doing proof-of-concept and finding the dose(s) for future studies
  • Finding the single best dose or a treatment window with several acceptable doses?
  •  Choosing the most informative doses or the most promising doses (the conflict between individual and collective ethics)?
  • Joint consideration of efficacy and safety
  • 9:50 Early dialogue with regulatory agencies during development and impact on programme and study design

    Robert Clay

    Robert Clay, Consultant Highbury Regulatory Science Chief Regulatory Officer Kinapse Board Director TOPRA, Highbury Regulatory Science

  • Facilitate the development of therapeutics that are available to all patients across the EU
  • Increase early dialogue between different stakeholders
  • Increase patients' involvement
  • 10:30 Morning Coffee

    11:00 Adaptive designs and Bayesian statistic

    Sophie Carr

    Sophie Carr, Bayesian Analyst, Bays Consulting

  • Sub group analysis
  • Challenges of sample size estimation
  • The design of Bayesian Methods in clinical trials
  • 11:40 Seamless phase II/III designs - challenges and opportunities

    Fredrik Ohrn

    Fredrik Ohrn, Statistical Science Director, AstraZeneca

     

  • Case study of a phase II/III trial in oncology
  • Control of type I error
  • Efficiency gains vs operational complexity
  • 12:20 Networking Lunch

    13:30 Improving adaptive designs

    Christopher Jennison

    Christopher Jennison, Professor of Statistics, University of Bath

  • Decision making during an adaptive design
  • Deriving an efficient rule for sample size modification
  • Optimising adaptive designs with treatment selection or subset selection
  • Assessing the benefits of an adaptive design – when are these worthwhile?
  • 14:10 Software solutions for exploratory and confirmatory trials

    Silke Jörgens

    Silke Jörgens, Senior Statistical Consultant, ICON Clinical Research

  • ADDPLAN BASE/MC/PE for confirmatory trials, including comparisons of multiple treatments against control and subgroup selection at interim analyses
  • ADDPLAN DF for exploratory trials, including dose escalation methods and MCPMod
  • Future plans
  • 14:50 Improving covariate-adaptive designs

    Steve  Coad

    Steve Coad, Reader in Statistics, Queen Mary, University of London

  • The elements of covariate-adaptive randomisation
  • Maintaining the type I error rate
  • Likelihood-based inference following the designs
  • Marginal and global balance
  • Incorporating information on responses
  • 15:30 Afternoon Tea

    15:50 Adaptive designs in clinical trials from scientific advice to marketing authorisation: lessons learnt from submissions to the European Medicine Agency

    Olivier Collignon

    Olivier Collignon, Statistics consultant, European Medicines Agency (EMA)

  • Presentation of several EMA case studies
  • Analysis of the adaptive elements used in the design and their impact on trial success
  • Analysis of time from scientific advice to approval for those products
  • Impact of the scientific advice on the design
  • Discussion of the potential regulatory concerns
  • 16:30 Smart and living implant equipped with active therapeutics and stem cells for regenerative nano-medicine

    Nadia Jessel

    Nadia Jessel, Research Director, INSERM

  • Nanoreservoirs technology for regenerative medicine
  • Active and living implant for osteoarticular regenerative nanomedicine
  • Bone and cartilage regeneration

     

     

  • 17:10 Diagnosis and treatment of neurodegenerative dementia: a clinical dilemma

    Filippo Baldacci

    Filippo Baldacci, Medical Doctor, Neurologist , University of Pisa

  • Overview and classification of degenerative dementia
  • Diagnosis and overlaps of degenerative dementias
  • Vascular cognitive impairment and its relationship with degenerative dementias
  • Pre-dementia stadium is the ideal target for treatment: When and how
  • 17:50 Chairman’s Closing Remarks and Close of Day Two

    +

    FEATURED SPEAKERS

    Alex Sverdlov

    Alex Sverdlov

    Associate Director of Biostatistics, EMD Serono, Inc

    Alex Sverdlov

    Associate Director of Biostatistics, EMD Serono, Inc
    Alex Sverdlov

    Bo Huang

    Director of Biostatistics, Pfizer Global Pharmaceuticals
    Bo Huang

    Bruce Turnbull

    Professor of Statistics, Cornell University
    Bruce Turnbull

    Christopher Jennison

    Professor of Statistics, University of Bath
    Christopher Jennison

    Filippo Baldacci

    Medical Doctor, Neurologist , University of Pisa
    Filippo Baldacci

    Frank Fleischer

    Principal Methodology Statistician, Boehringer-Ingelheim
    Frank Fleischer

    Fredrik Ohrn

    Statistical Science Director, AstraZeneca
    Fredrik Ohrn

    Loic Darchy

    Senior Statistician, Sanofi Aventis
    Loic Darchy

    Nadia Jessel

    Research Director, INSERM
    Nadia Jessel

    Olivier Collignon

    Statistics consultant, European Medicines Agency (EMA)
    Olivier Collignon

    Peter Kimani

    Assistant Professor in Medical Statistics, Warwick Medical School
    Peter Kimani

    Philip Hougaard

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

    Pierre Colin

    Statistical Sciences and Modelling, Sanofi Pharma
    Pierre Colin

    Richard Wyse

    Director of Research and Development, The Cure Parkinsons Trust
    Richard Wyse

    Robert Clay

    Consultant Highbury Regulatory Science Chief Regulatory Officer Kinapse Board Director TOPRA, Highbury Regulatory Science
    Robert Clay

    Sidath Katugampola

    Biomarker Development Specialist, Cancer Research UK
    Sidath Katugampola

    Silke Jörgens

    Senior Statistical Consultant, ICON Clinical Research
    Silke Jörgens

    Sophie Carr

    Bayesian Analyst, Bays Consulting
    Sophie Carr

    Steve Coad

    Reader in Statistics, Queen Mary, University of London
    Steve  Coad

    Tom Parke

    Director of Software Solutions, Berry Consultants, LLP
    Tom Parke

    Official Publication

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    Wireless Internet is available throughout the hotel, and you can invite up to 300 people to events at the Academy Conference Centre, with an IT technician and break-out zones. Holiday Inn London-Regent's Park is a 10-minute walk from Santander's offices and businesses in the BT Tower. Stroll 5 minutes to Regent's Park, where you'll find London Zoo and pretty Primrose Hill. We're a 10-minute walk from Bond Street boutiques and 20 minutes from Buckingham Palace and cruises on the River Thames.

    Ask our Concierge to plan your day out and book West End theatre tickets. Room Service is available 24 hours at Holiday Inn London-Regent's Park, or dine in the vibrant Junction Restaurant. Our Junction Bar has a menu of light bites, and a hot breakfast buffet is served daily.

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    Preliminary list of 2016 attendees

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    Interview with Silke Jörgens, Senior Statistical Consultant, ICON plc

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    Interview with Alex Sverdlov, Associate Director of Biostatistics, EMD Serono

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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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    Contact SMi GROUP LTD

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SMi Group Ltd, 2nd Floor South, Harling House, 47-51 Great Suffolk Street, London, SE1 0BS, United Kingdom, Link to Map
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smi-online.co.uk Email: events@smi-online.co.uk
    Registered in England No: 3779287 VAT No: GB 976 2951 71




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