• Network Meta Analysis (NMA) for Statisticians

    Dates: 07 – 08 Mar, 2019

    presented by Georgia Salanti (ISPM, Bern)

    This intensive course will cover all basic and advanced aspects of synthesis of evidence from studies comparing competing treatments for the same health condition. By the end of this course participants will have an understanding of the role and potential of network meta-analysis, the principles, steps and statistical methods involved; the biases that can distort indirect comparisons and network meta-analysis.

    This course is aimed at statisticians, epidemiologists and other quantitatively-minded researchers who are involved or may be involved in the future in the preparation of HTA submissions. Knowledge of systematic reviews and the fundamentals of meta-analysis is expected of all participants.

    The course will consist of lectures, practical examples and discussions. Participants will gain practical experience in performing analyses in R software and the freely available web application CINeMA.

    Key Topics:

    • Assumptions underlying indirect comparisons
    • Statistical methods in network meta-analysis 
    • CINeMA: a framework and software to evaluate Confidence in Network Meta-Analysis 

    Course runs from:

    Day 1: 10:30 – 18:00 
    Day 2: 8:30 – 15:30

    Click here to view the flyer

    Registration:

     Registration on or before 4th February 2019:
    PSI Member £595 + VAT 
    Non-Member £690 + VAT
    Registration after 4th February 2019:
    PSI Member £695 + VAT
    Non-Member £790 + VAT


    Please click here to register. Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 6th and 7th March which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room. 

  • PSI Webinar: Statistical Engagement with Commercial Activities

    Dates: 12 – 12 Mar, 2019
    Time: 13:00 - 14:30 UK time

    An interesting webinar with three speakers looking at how pharmaceutical statisticians can engage with their commercial and other business teams. Camilo Zapata will introduce the field of “business analytics” in the context of pharmaceuticals, Helena Baptista will talk about how we can measure the effectiveness of our communications and Lucy Frith will speak about communicating efficacy data in a manner appropriate for health care professionals.

    Abstracts

     Camilo Zapata
    Camilo Zapata (Alkermes)
    Abstract: Business analytics is the “discipline” in charge of identifying and leveraging meaningful patterns in data to drive or inform business decisions. It is multidisciplinary in nature as it operates at the intersection between mathematics/statistics, computer science and management.  In this talk we will discuss how these three areas converge to deliver impactful results and share some relevant examples. We will also talk about what characteristics an organization requires in order to leverage this discipline as in the business world the ability to impact decisions is not only determined by the quality of the analyses, but also the robustness of the processes, the skills of the decision makers and the approachability of the results. 

    Bio: Camilo is a data scientist that currently leads the advance analytics organization at Alkermes. He focuses on everything that is not clinical, with special emphasis on the commercial side of the business.  Before Alkermes he led the compliance analytics efforts at Pfizer and the Text mining and Natural language processing hub at Lilly.  He also co-led the creation of the advanced business analytics group at Lilly and he was responsible for building the analytical capabilities of Lilly’s clinical trial supply chain organization.

    Camilo is an engineer by training with M.S. degrees in Chemical and industrial engineering and a PhD in Chemical engineering from Purdue University. In spite of these titles is fair to say that as an engineer he wouldn’t survive.

    Helena Baptista
    Helena Baptista (Lilly)
    Abstract: We have been measuring the efficacy and safety of our medicines for a long time. What are we doing to measure the efficacy of our promotional strategies? Developing great medicines is key, but if we fail to let the scientific community know when and why they should use our products, patients that would benefit the most will hardly get access to them. We need to provide directions to the marketing teams on how, when and how often to reach the interested health care providers. On top, in Europe, we need to do that with limited access to data. We will discuss what we can do and where do we have the biggest challenges.

    Bio: 
    • Education: PhD in statistics. NOVA University of Lisbon – Portugal
    • Professional experience: Finance, Market Research, Operations management, Forecasting, Advanced Commercial Analytics (actual)
    • Teaching undergraduates and Mastery courses on Forecasting Methods and Statistics for Enterprise Data Analysis
     Lucy Frith
    Lucy Frith (GSK) 
    Abstract: Working with a commercial organisation provides a varied array of tasks that often need complex analyses explained in a very concise but transparent way. This can lead to re-use of study data to present the results in a manner that meets the specific needs of different external groups such as health care professional (HCPs). Two such examples will be presented here. Firstly, overlaying the costs of treatments and patient care onto patient outcomes to support discussions with payer groups. Secondly, using Markov Chain modelling to utilise long-term data and provide Health care professionals a presentation of the data that aligns to the probability of a patient changing health status in a given period of time. To give further context to how these presentations of data could be used, such work is reviewed using data collected in a traditional efficacy study and in a pragmatic effectiveness situation.

    Bio:
    Lucy is currently working in the late phase respiratory research and supports a range of marketed products. She has a keen interest in re-using data appropriately to maximise the value of information collected during the development of a medicine. This is to further understand the products, the disease areas of interest and presenting this information in a practical way to external groups such as health care professional (HCPs).  

    Lucy is a statistician with 26 years’ experience in the industry; where she has been involved in the clinical program design, taking products all the way through to submission and regulatory approval. She has a M.S. degrees in Medical Statistics and a MBA.

     

    Please click here to view the flyer.

    Registration:

     Registration
     PSI Member  Free
     Non-member  £20 (plus VAT) 

    Please click here to register.

  • PSI One Day Meeting: New Starters SIG

    Dates: 28 Mar, 2019

    This is the inaugural meeting of the recently relaunched New Starters Special Interest Group. The aim of this meeting is to provide a relaxed environment for early career statisticians to network and interact with their peers across the industry. We will provide a program of informal talks alongside breakout and ice-breaker sessions in order to facilitate discussion amongst attendees. For this one-day meeting the audience will be peers with similar levels of experience and sessions will include content of interest to statisticians early in their careers. In addition to presentations from fellow statisticians there will be a workshop on estimands and ample opportunity to connect with colleagues across the industry.

    If you’re interested in presenting at this event, please send a brief description of your proposed presentation to Sam Hadlington by 22nd February 2019. We’re compiling a New Starters email distribution list so that we can let members know about future events and ideas for New Starters. Please click here to join the mailing list.

     

    Registration

    PSI Member  £25 + VAT
    Non-Member £120 + VAT (This includes PSI membership for 2019)

    Please click here to register.
  • PSI Toxicology SIG Workshop 2019

    Dates: 02 – 03 Apr, 2019

    The Toxicology SIG provides a forum for statisticians working in regulatory and investigative toxicology to discuss issues and interact with one another.

    This 1.5-day workshop will involve approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types.

    The cost will be £205 including VAT per delegate, inclusive of food and one night’s accommodation.  The workshop is being held at the Crowne Plaza Hotel, Heathrow.

    The agenda and topics that will be discussed are yet to be finalised, but please get in touch with gareth.thomas@envigo.com if you have suggestions.  Full details will be circulated in the coming weeks.

    Registration Costs
     £205 incl VAT Inclusive of food and one night’s accommodation  

    Please click here to register. Registration will close on on 28th February 2019.
  • Webinar: MCP-Mod – Theory, Implementation and Extensions

    Dates: 08 – 08 May, 2019

    Cytel sponsored webinar in association with PSI

    Time: 14:00 - 15:30 UK time

    MCP-Mod (Multiple Comparisons & Modelling) is a popular statistical methodology for model-based design and analysis of dose finding studies. This webinar will describe the theory behind MCP-Mod (plus extensions), and how to implement it within available software. Pantelis Vlachos (Cytel) will provide a brief introduction to the methodology and illustrate the MCP-MoD capabilities in EAST 6.5. Saswati Saha (University of Brehem) will discuss new variations and alternatives to MCP-Mod and show how to implement them in R. Neal Thomas (Pfizer) will present further technical details of MCP-Mod by evaluating the method using results from least squares linear model theory.

    Abstracts


    Pantelis Vlachos
    Pantelis Vlachos
    (Cytel Inc.) 

     

    MCP-Mod in East®:  Early development dose-finding design and analysis

    Selection of a dose (or doses) to carry into a confirmatory phase III study is among the most difficult decisions in drug development. A prerequisite for informed decision making and dose selection at the end of phase II is a solid characterization of the dose-response relationship(s).The MCP-Mod method combines principles of multiple comparisons with modelling techniques to provide an efficient alternative to traditional dose-finding studies which are either designed and analyzed based on multiple comparisons of active doses vs placebo within an ANOVA framework, of assume a functional relationship between response and dose according to a certain parametric model. We illustrate MCP-Mod design and analysis capabilities with East®.   

     

    Bio: Pantelis is Director/Strategic Consultant for Cytel, Inc. based in Geneva. He joined the company in January 2013. Before that, he was a Principal Biostatistician at Merck Serono as well as a Professor of Statistics at Carnegie Mellon University  for 12 years. His research interests lie in the area of adaptive designs, mainly from a Bayesian perspective, as well as hierarchical model testing and checking although his secret passion is Text Mining. He has served as Managing Editor of the journal “Bayesian Analysis” as well as  editorial boards of several other journals and online statistical data and software archives.

     

    Saswati Saha
    Saswati Saha
    (University of Bremen)

     

    Model based dose-finding methods in Phase II clinical trials

    The primary objective of this presentation is to discuss dose-finding methods in Phase II clinical trials that can simultaneously establish the dose-response relationship and identify the right dose. MCP‐Mod is one of the pioneer approaches developed within the last 10 years. Though MCP-Mod is identified as an efficient statistical methodology for model-based design and analysis of Phase II dose finding studies under model uncertainty, a major disadvantage of MCP-Mod is that the parameter values of the candidate models need to be pre-specified a priori for the PoC testing step. This may lead to loss in power and unreliable model selection. Off late several new variations and alternatives to MCP-Mod are explored where the parameter values need not be pre-specified in the PoC testing step and can be estimated after the model selection step. We will briefly introduce four such state-of-art dose-finding methods, show how to implement the methods in R software and present a numerical comparison between the different new methods and the MCP-Mod approach.

     

    Bio: Saswati completed her Ph.D as a part of IDEAS network on December 2018 from the Competence Center for Clinical Trials (KKSB) at University of Bremen under the supervision of Professor Werner Brannath. Her primary areas of research during her PhD were dose response modelling, multiple testing, drug combination studies, dose finding and confidence interval estimation for target doses in drug development.

    Saswati studied at the Indian Statistical Institute, where she completed her Bachelor’s degree (2011) and Master’s degree (2013) in Statistics. After her masters she worked on credit risk modelling in two renowned financial institutions, Ernst & Young and Genpact, for two years and dealt with time series modelling for stress testing and logistic regression modelling for building scorecards.

     

    Neal Thomas
    Neal Thomas
    (Pfizer Inc.)

     

    Understanding MCP-Mod dose finding as a method based on linear regression

    MCP-MOD  is a testing and model selection approach utilizing contrast-based test statistics and p-values adjusted for multiple comparisons. The MCP-Mod procedure can be alternatively represented as a method based on simple linear regression, where 'simple' refers to the inclusion of an intercept and a single predictor variable, which is a transformation of dose. It is shown that the contrasts are equal to least squares linear regression slope estimates. The test for each contrast is the usual t-statistic for a null slope parameter, except that a variance estimate with fewer degrees of freedom is used in the standard error. Selecting  the model corresponding to the most significant contrast p-value is equivalent to selecting the predictor variable yielding the smallest residual sum of squares. Many of the properties of MCP-Mod procedure can be understood and quantified using results from least squares linear model theory.

    Bio: Neal received a PhD in Statistics from the University of Chicago.  He is the  leader of the Statistical Research and Innovation center at  Pfizer working on clinical and non-clinical applications in several therapeutic areas. Previous work experience includes sample surveys, educational statistics (ETS), and health policy applications.  Statistical research interests include design of observational studies, dose response, missing data methods, matrix sampling, psychometric models, and Bayesian statistics.


    Please click here to download the details.

    Registration

    This webinar is free to attend. Please click here to register.

  • Estimands and Sensitivity Analysis in Clinical Trials

    Dates: 22 – 23 May, 2019

    Topics Include 

    • Estimand Framework
    • Description, strategies, and construction of estimands
    • Impact on trial design, conduct, analysis and documentation
    • Estimand case studies

    Presenters

    • Chrissie Fletcher   
    • Frank Petavy
    • Frank Bretz
    • Rob Hemmings

    Registration

     
    Early Bird (Up To & Including 24th April)  After 24th April
    PSI Member £495 + VAT £595 + VAT
    Non-Member £570 + VAT (This includes PSI membership for 2019) £670 + VAT (This includes PSI membership for 2019)

    Please click here to register.

    Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms on 21st and 22nd May which will be allocated on a first come first served basis. Please contact psi@mci-group.com to reserve a room. Rooms are charged at £109.00 inc VAT per room including breakfast.
  • PSI Conference 2019

    Dates: 02 – 05 Jun, 2019

    PSI are pleased to announce that the countdown to the 2019 Conference has begun! The theme for the conference is “Data Driven Decision Making in Medical Research”.  The 2019 PSI Conference will take place at the Queen Elizabeth II Centre (QEII), London, from 2nd to 5th June 2019.

    Registration will open in November 2018, with the early bird deadline for registrations on the 20th March 2019.

    The conference will consist of a variety of plenary and parallel sessions, as well as breakout discussion sessions, workshops, a poster session and the Annual General Meeting. Please note that the conference will run over three full days from Monday to Wednesday, with an optional half day training course on the  Sunday afternoon (can booked during registration at an additional cost). 

    Sessions will include early phase innovative trial design, industry best practice - 10 years on, statistical issues in safety drug labelling, model based dose finding designs, an update from Transcelerate and much more, with speakers from industry, academia and regulatory agencies.  A draft agenda will be released later this year.

    Abstract submissions for the 2019 Conference are now open! We welcome abstracts on any subject but are interested in the following topics; decision making, bayesian topics within early or late phase, causal inference, future trends, pre-clinical statistics, patient reported outcomes, and patient-centric data. To view the full list of topics and for information on how to submit an abstract, click here

    Finally, sponsorship and exhibition opportunities are already ongoing. Thank you to those who have already signed up. We will be allocating exhibition spaces in the order in which exhibitors sign-up, so get in early to secure the best spot!

    Should your company be interested in the sponsorship opportunities available, please contact Alex Currie (alexander.8.currie@gsk.com) or Chris Watton (chris@wattonhall.com).

    We hope you will join us in building on the huge success of this year’s event in Amsterdam, to make the 2019 Conference in London an even greater event!

    Kate Taylor

    PSI Conference Chair

    For more information on the conference, please click here.

  • Introduction To Industry Training Course 2019

    Dates: 01 Oct, 2019

    Are you a PSI member with approx. 1-3 years experience as a Statistician or a Statistical Programmer within the industry?

    THE INTRODUCTION TO INDUSTRY TRAINING COURSE NEEDS YOU!


    NEXT COURSE STARTS OCTOBER 2019,
    Final dates to be confirmed

    PSI Member: £1,050 + VAT
    Non-Member: £1,145 + VAT

    AIM: To describe the drug development process from research right through to research, toxicology, data management & role of the CRO, clinical trials, product development & manufacture and marketing.

    Places will be assigned on a first come, first served basis. Please ensure you discuss your application with your manager.


     PLEASE CLICK HERE TO VIEW THE FLYER

    CLICK HERE TO DOWNLOAD THE APPLICATION FORM

    For further information contact:

    Alex Godwood & Zelie Bailes

    Heptares Therapeutics Ltd
    Bio-Park
    Broadwater Road
    Welwyn Garden City 
    Hertfordshire AL7 3AX

       Email: alex.godwood@heptares.com ; zelie.a.bailes@gsk.com
    Tel: 01707 448020