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Due to major changes that have been applied to clinical trials over recent years by both biotech and pharmaceutical companies, the importance of adaptive designs to clinical trials has become more apparent to the industry. The time and cost reductions in the early phase of clinical trials enables less recruitment of patients and improves the general accuracy in clinics. Successful implementation of adaptive designs into a trial however requires unmatched coordination between clinicians, trial managers, statisticians and those involved in the regulation process.


Hear through case studies how all sizes of pharmaceutical companies have successfully implemented trials incorporating adaptive designs. This conference is the only in Europe that focuses on adaptive designs specifically, providing delegates with updates on recent developments in enrichment design, dose response modelling, computer simulation, internal and external regulatory expectations and new data on evaluating adaptive dose ranging studies.
 

Adaptive Designs in Clinical Trials 2014 aims to show you how you can quickly and accurately implement an adaptive design clinical trial for your drug development - from initial processes in managing trials to choosing the right time to implement change.


 

  • The only conference in Europe to focus specifically on adaptive designs in clinical trials
  • Benefit from the first-hand experiences of speakers whose organisations have recently made breakthroughs in adaptive designs
  • Hear the very latest on predicative analytical techniques for increasing efficiency of drug development
  • Learn how to develop a normal standing clinical trial in an adaptive trial
  • Discover FACT software that supports the ever-increasing complexity of adaptive clinical trials by attending the post-conference workshop
     

You should attend this event if you are a Director, Chief Executive, Chief Scientific Officer, Vice President, Head of Department, Principal Scientist or Statistician within the Pharmaceutical or Healthcare industry with responsibilities in the following areas:
 

• Biostatistics
• Adaptive Trials Design
• Regulatory Affairs
• Clinical Drug Development
• Contract Research
• Clinical Operations
• Research and Development
• Intellectual Property
• Legislation & Policy Advice
• Drug and Safety Assessment
• Clinical Pharmacology
• Experimental Medicine
• Clinical Trials
• Business Development
 

Aptiv Solutions ; Astra Zeneca; Berry Consulting; Biopharm Insight; Boehringer Ingelheim; Boehringer Ingelheim Pharma GmbH & Co. KG; Boehringer-Ingelheim; Canbex; Cancer Rearch UK; Catenion; Celgene; Cytel Corporation; Cytel Pharmaceutical Research; Deva Pharmaceuticals; Durham University; Eisai; Hoffmann La-Roche; IPSEN; Jazz Pharmaceuticals Inc; Johnson & Johnson; Lancaster University; MedImmune; MHRA; Novartis; Novartis Pharmaceuticals; Office Of Health Economics; Oxford University; PPD; Propharma Partners Ltd; Quintiles; Roche Products Limited; Sanofi Aventis; Takeda; Takeda Chemical Industries Ltd; Tessella Support Services; UCB Pharma ; UCB-Celltech; Université Catholique de Louvain (Bruxelles); University College London; University Of Bath; University Of Oxford; University of Sheffield; Voisin Consulting;

Conference programme

8:30 Registration & Coffee

9:00 Chairman's Opening Remarks

Michael Krams

Michael Krams, MD, Global Head, Quantitative Sciences, Janssen Pharmaceutical Companies of Johnson & Johnson

9:10 Application of Adaptive Design in PPP’s

Michael Krams

Michael Krams, MD, Global Head, Quantitative Sciences, Janssen Pharmaceutical Companies of Johnson & Johnson

9:50 Case Study: Re-engineering Phase 2

Graeme Archer

Graeme Archer, ADD Statistics Director, GlaxoSmithKline

  • Phase 2 - the critical pivot point between discovery and full development
  • Phase 2 studies designed for their true purpose: as gate-keepers to Phase 3 investment decision-making
  • Introduction to the GSK R&D wide initiative called Re-engineering Phase 2 (RP2)
  • Dose-response modelling, the formal incorporation of historical data into trial designs; making futility analyses routine within P2 studies and using those P2 data to make formal (Bayesian) predictions of potential Phase 3 outcomes; department-wide quantitative peer review
  • The experience of trying to shift an organisation – both within Clinical Statistics and beyond
  • Examples from GSK studies where the RP2 principles have been embedded (“before” and “after” examples), and descriptions of the educational material developed and used inside GSK
  • 10:30 Morning Coffee

    11:00 Simulations: Barriers for routine use and how to overcome them

    Jurgen Hummel

    Jurgen Hummel, Associate Statistical Science Director, PPD

  • Benefits of simulations are well known and often referenced; however, many companies still do not perform them
  • With the main advocates of simulations in statistics departments, how can we engaging people from other departments in the process
  • Case studies to show what has and has not worked well
  • 11:40 The Collaborative Adaptive Clinical Trial Design Process: Teamwork Informed by Simulation

    Roger Lewis

    Roger Lewis, MD, PhD, Senior Medical Scientist , Berry Consulting

  • Adaptive trial designs leverage the incoming stream of new information that arises during clinical trial conduct to improve the statistical efficiency, validity, and safety of a clinical investigation;
  • Identifying the most powerful ways to use this incoming information stream is the “art” of adaptive design and requires, in each case, a detailed and quantitative understanding of the threats to trial validity and success; and
  • The best adaptive clinical trial designs are created in a collaborative, iterative process involving statisticians, clinical domain experts, and trial implementers and are informed be detailed trial simulations.
  • 12:20 Networking Lunch

    13:20 Afternoon Chairman Remarks

    Baldur Magnusson

    Baldur Magnusson, Senior Principal Statistical Scientist, Novartis International AG

    13:30 Advances in Methodology for Phase II/III Clinical Trials

    Sue Todd

    Sue Todd, Professor of Medical Statistics, University of Reading

  • Recent developments in design
  • Methods of analysis for phase II/III trials
  • Examples of implementation
  • 14:10 Using simulation and Biomarkers to speed phase I - II development: A case study

    Pantelis Vlachos

    Pantelis Vlachos , Principal Biostatistician, Strategic Consulting, Cytel

  • The Development Scenario
  • Bayesian Modelling Overview
  • Simulation Cases
  • Selected Results
  • Conclusions
  • 14:50 Afternoon Tea

    15:10 Designing a trial to find the minimum inhibitory concentration of an anti-infective drug

    Baldur Magnusson

    Baldur Magnusson, Senior Principal Statistical Scientist, Novartis International AG

    15:50 Cytel sponsored panel discussion: Barriers and the Future

  • Critical appraisal of adaptive designs: where are the real gains?
  • Is wider acceptance linked to how the methods fare in the public sector?  To become common practice more people need to be using the approach – not just the pharmaceutical industry
  • Has there been a collective "undue advocacy" of adaptive trials by proponents?  Have we unintentionally created unrealistic expectations of improving outcomes and/or efficiencies?
  • Will the adjective "adaptive" be dropped some day, as all trials will be adaptable (in one form or another)?  
  • How will trends toward modeled patients (physically and virtual) change the future of trials?  Will we see trials without humans in our lifetime?
  • Christopher Jennison

    Christopher Jennison, Professor of Statistics , University of Bath

    Pantelis Vlachos

    Pantelis Vlachos , Principal Biostatistician, Strategic Consulting, Cytel

    Loic Darchy

    Loic Darchy , Head of Statistical Methodology Group , Sanofi R&D

    Sue Todd

    Sue Todd, Professor of Medical Statistics, University of Reading

    Baldur Magnusson

    Baldur Magnusson, Senior Principal Statistical Scientist, Novartis International AG

    16:30 Chairman’s Closing Remarks and Close of Day One

    Baldur Magnusson

    Baldur Magnusson, Senior Principal Statistical Scientist, Novartis International AG

    8:30 Registration & Coffee

    9:00 Chairman's Opening Remarks

    Loic Darchy

    Loic Darchy , Head of Statistical Methodology Group , Sanofi R&D

    9:10 Revisiting the Biomarker Adaptive Threshold Design (BATD): is there a need for enrichment?

    Loic Darchy

    Loic Darchy , Head of Statistical Methodology Group , Sanofi R&D

  • The BATD design was recently proposed and assessed by the US National Cancer Institute
  • The present work used as a starting point their landmark publication in Journal National Cancer Institute, 2007
  • The limitations of the design will be discussed and naturally led us to consider an extension to the BATD design ; that extension consists of an extension phase focusing on the particular subset of interest as identified by the testing procedure underlying their approach (if any) when the initial study is statistically inconclusive
  • Go/no go criteria for such an extension are discussed
  • 9:50 Designing an Adaptive Trial using a Combination Test for a Survival Endpoint

    Christopher Jennison

    Christopher Jennison, Professor of Statistics , University of Bath

  • A clinical trial with a survival endpoint and treatment selection
  • Protecting the type I error rate in an adaptive design
  • Problems in applying a combination test to survival data
  •  A new combination test for an adaptive design with survival data
  • 10:30 Morning Coffee

    11:00 Designing multi-arm multi-stage trials with a safety and an efficacy endpoint

    Lisa Hampson

    Lisa Hampson, MRC Career Development Award Fellow in Biostatistics, University Of Lancaster

  • Multi-arm clinical trials that compare several active treatments to a common control have as an efficient means of making an informed decision about which treatment should be evaluated further in a confirmatory study
  • The constraint that selection and formal testing should be based on a single efficacy endpoint, despite the fact that in practice, safety considerations will often play a central role in determining selection decisions
  • Multi-arm, multi-stage design for a trial with an efficacy and a safety endpoint considering the situation where a minimal safety requirement is to be fulfilled and the treatment yielding the best combined safety and efficacy trade-off satisfying this constraint is selected for further testing
  • Selections made at the first interim analysis while the whole trial is allowed to comprise of J analyses
  • 11:40 Biomarker-adaptive designs in oncology: can confirmatory studies tackle sub-population finding?

    Lilla Di Scala

    Lilla Di Scala, Director - Senior Expert Statistician, Biostatistics, Actelion Pharmaceuticals

  • Bio/immune-markers potentially predictive of treatment benefits
  • Examples of threshold identification as well as an example of an already dichotomized marker and the subsequent decision on the testing hierarchy
  • Strategic concerns and implications of including a biomarker-defined sub-population in a confirmatory study
     
  • 12:20 Networking Lunch

    13:20 Afternoon Chairman Remarks

    Christopher Jennison

    Christopher Jennison, Professor of Statistics , University of Bath

    13:30 Optimum Adaptive Design for Dose Finding in Early Clinical Trials Incorporating PK Information

    Barbara Bogacka

    Barbara Bogacka, Reader in Statistics, Queen Mary, University of London

  • Efficient and ethical dose allocation
  • Population variability accounted for in optimum PK sampling times
  • Dose finding targeted at desirable drug exposure
  • 14:10 Flexible Designs in Phase I Pharmacokinetic Trials

    Frank Fleischer

    Frank Fleischer, Principal Statistician, Boehringer-Ingelheim

  • Basic concepts of Phase I PK trials
  • Adaptive and flexible approaches to Phase I bioequivalence trials
  • An evaluation of flexible designs vs pilot/main study approaches
  • Case studies of group sequential designs in Phase I bioequivalence trials
  • 14:50 Adaptive elements in clinical pharmacology trials

    Arne Ring

    Arne Ring, Principal Statistician, University of Leicester, Professor in Statistics, University of the Free State, South Africa

  • Adaptations in first in human trials
  • Efficient planning of bioavailability and bioequivalence trials
  • The role of pilot and feasibility trials in particular in academic research
  • 15:30 Chairman’s Closing Remarks and Close of Day Two

    Christopher Jennison

    Christopher Jennison, Professor of Statistics , University of Bath

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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.

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    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.

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