• Medical Statistics Taster Day 2018

    Dates: 28 Feb – 28 Feb, 2018

    Our annual careers event, Medical Statistics Taster Day, will be held at the University of Leicester on Wednesday 28th February 2018.  The half-day event will include a series of talks, panel discussion, exhibition stands, and an interactive workshop.

    This event is open for attendance to all students currently studying for a statistics-related MSc or PhD. Final year BSc students studying a statistics-related course are also welcome (although places may be limited depending on demand).

    This event is open for exhibitors to all UK pharmaceutical companies, CROs, CTUs and other organisations working within the field of Medical Statistics. We would also like to welcome any UK-based universities who run an MSc or PhD in Statistics, or have statistical consulting groups. 

    We would like to invite all of the above to run an exhibition stand to promote working or studying further in the field Medical Statistics, so that students can be made fully aware of their options.  We will also be looking for company volunteers to help with the panel discussion, new starter talk and workshop, so please let us know on your registration form if you are able to help.

    For exhibitors - this is an excellent opportunity to raise the profile of your company or university with students who are interested in a career in medical statistics. 

    For students - this is an excellent opportunity to find out more about the field of medical statistics, talk to people from different organisations and make contacts for the future.

    Click here for further details and to register online. 

    We look forward to seeing you there!

    PSI Careers and Academic Liaison Committee (CALC)

  • PSI One Day Meeting: Bayesian Methods for Dose Finding and Biomarkers

    Dates: 28 – 28 Feb, 2018

    Timings: 09:30 - 17:00 UK Time
    Location: Royal Statistical Society
    Address: 12 Errol Street, London

    Bayesian methods are being increasingly used in the design and analysis of trials through all stages of clinical drug development. This meeting will include talks on two areas of application commonly used in early phase trials – dose selection and biomarkers. The meeting will include a range of case studies presented from different therapeutic areas. More details to follow. 

    Click here to register.


    Agenda

    Time

    Agenda

    09.30 - 09.55 Registration

    09.55 - 10.00

    Welcome and Introduction

    10.00 - 10.40

    First-in-Human Studies: Practice or Principle
    Andy Grieve, UCB Pharma

    10.40 - 11.20

    Model based dose escalation: in practice
    Phil Overend, AstraZeneca

    11.20 - 11.40

    Break

    11.40 - 12.20

    A Bayesian information theoretic design for phase I dose finding trials without monotonicity assumption
    Pavel Mozganov, University of Lancaster

    12.20 - 13.00

    Bayesian hierarchical model for dose escalation
    Alessandro Matano, Novartis

    13.00 - 13.50

    Lunch

    13.50 - 14.30

    The use of formally elicited priors to aid the design of a phase 2B dose ranging study
    Doug Thompson, GlaxoSmithKline

    14.30 -15.10

    Bayesian methods for design and analysis of clinical trials assessing multiple treatments and biomarkers
    Prof James Wason, MRC Biostatistics Unit

    15.10 - 15.30

    Break

    15.30 - 16.10

    Error rates control via shrinkage priors in multivariate error-in-variable dose-response models
    Fabio Rigat, GlaxoSmithKline

    16.10 - 16.50

    Prior elicitation and translation of biomarkers to aid clinical development plans and compound selection
    Trevor Smart, Lilly

    16.50 - 17.00

    Close


    Abstracts


    rev bayes 
    Rev Thomas Bayes
    Bayesian methods are being increasingly used in the design and analysis of trials through all stages of clinical drug development. This meeting will include talks on two areas of application commonly used in early phase trials – dose selection and biomarkers. The meeting will include a range of case studies presented from different therapeutic areas. 
    Andy Grieve, UCB First-in-Human Studies: Practice or Principle

    Abstract: 
    The last 12 years has seen two FIH studies hit the newspaper headlines: the study of TGN1412 conducted at Northwick Park Hospital in the UK and the study of BIA 10‐2474 conducted in Rennes in France. Both studies led to catastrophic outcomes for the volunteers involved. As a result of the first study two investigations were established. The first was set-up by the MHRA and their final report, Duff et al (2006), appeared in December 2006. The second was established by the Royal Statistical Society(RSS) to look at statistical issues involved in FIH studies. The resulting report, Senn et al (2007), made 21 recommendations, both practical and methodological. After the second study a sub-group of the RSS working party provide a commentary on statistical issues involved, Bird et al (2017). As a result of the Duff report the Commission for Human Medicines established an Expert Advisory Group (EAG) on Clinical Trials in 2007 to review FIH protocols for three types of new compounds. I was a co-author on the two statistical reports and served on the EAG. In this talk I review practical and methodological issues involved in FIH studies based on my experience serving on these three groups.

    Bird SM, Bailey RA, Grieve AP, Senn S. Statistical issues in first‐in‐human studies on BIA 10‐2474: Neglected comparison of protocol against practice. Pharmaceutical Statistics 2017;16:100-6.

    Expert Scientific Group on Phase One Clinical Trials (Final report of a group convened by UK's Medicines and Healthcare Regulatory Authority and chaired by Professor Sir Gordon Duff), Final report online 6 December 2006, see http://webarchive.nationalarchives.gov.uk/+ /dh.gov.uk/ en/ publicationsandstatistics/ publications/publicationspolicyandguidance/ dh_063117 (acc. Jan 2018).

    Senn S, Amin D, Bailey RA, Bird SM, Bogacka B, Colman P, Garrett A, Grieve A, Lachmann P. Statistical issues in first‐in‐man studies. Journal of the Royal Statistical Society: Series A (Statistics in Society) 2007; 170:517-79.

    Phil Overend, AstraZeneca

    Model based dose escalation: in practice

    Abstract: At AstraZeneca, the implementation of a model based Bayesian dose escalation design in Oncology phase 1 studies has been facilitated by putting practical considerations in place that address the operational challenges that arise due to increased statistical complexity that accompanies the methodology. We will discuss a practical case study, describing the first time that this approach was implemented at AstraZeneca, including the options explored for specifying the prior, the advantages of the approach together with practical and methodological learnings for future studies.  The extension to 2-drug combination dose escalation studies will be introduced.

    Pavel Mozgunov A Bayesian information theoretic design for phase I dose finding trials without monotonicity assumption

    Abstract: Methods for finding the highest dose that has an acceptable risk of toxicity in Phase I dose-escalation clinical trials assuming a monotonic dose-response relationship have been studied extensively in recent decades. The assumption of monotonicity is fundamental in these methods. As a result, such designs fail to identify the correct dose when the dose-response relationship is non-monotonic, for example, in dose-schedules and dose-combinations trials. We propose a dose-escalation method that does not require monotonicity or any pre-specified relationship between dose levels. The design is based on the Bayesian model incorporating an information-theoretic criterion for dose selections. We will discuss the practical aspects of the design such as prior and safety stopping. For small sample size typical for dose-escalation studies we will show in simulations that the proposed method is comparable to well-studied and used methods under the assumption of monotonicity and outperforms them when this assumption is violated. We conclude with an extension of the design which allows to include an efficacy endpoint.

    Biography: Pavel did his undergraduate studies in the National Research University Higher School of Economics, Moscow, Russia. He worked on information-theoretic aspects in statistics in the International Laboratory of Stochastic Analysis. Currently, Pavel is a PhD student in Lancaster University where he works on the project “Dose finding for combination trials with many treatments” under supervision of Professor Thomas Jaki. Pavel is a Marie-Curie Fellow in the IDEAS network. The aim of his project is to develop novel dose finding designs which do not require parametric assumptions and can be applied to various clinical trials. 

    Alessandro Matano Bayesian hierarchical model for dose escalation

    Abstract: Clinical trials with multiple strata (e.g. indication, dose regimen, mutation status) are increasingly used in drug development. In dose escalation trials, where data are often sparse and a multiple strata analysis may be the only option to study a new treatment, good statistical inference and decision-making can be challenging. Inferences from simple pooling or stratification are known to be inferior to hierarchical modeling methods, which build on exchangeable strata parameters to allow borrowing information across strata. However, the standard exchangeability (EX) assumption bears the risk of too much shrinkage and excessive borrowing for extreme strata. This talk will present the exchangeability-nonexchangeability (EXNEX) approach in dose finding studies, as a robust extension of the standard EX approach. It allows each stratum-specific parameter to be exchangeable with other similar strata parameters or nonexchangeable with any of them. A case study from a Phase I trial will also be shown.

    Biography: After the degree in Statistics for biomedicine, environment and technology from the university of Rome “La Sapienza” (2008), Alessandro joined the pharmaceutical industry (Novartis). He is currently working as Associate Director of Biostatistics in the area of Phase I/II Oncology clinical trials in Early Development Biostatistics (EDB) group. Prior to join the EDB Oncology group Alessandro has worked as trainee in the CIS-Methodology Group, supporting the methodological development and implementation of oncology Bayesian single agent/combination dose-finding study design.

    Doug Thompson

    Doug Thompson, GSK
    The use of formally elicited priors to aid the design of a phase 2B dose ranging study

    Abstract: The use of assurance to quantify the probability of success of a proposed parallel group clinical trial is well understood. This framework extends naturally to studies with other designs; including when evaluating dose response is the primary focus. Prior distributions formally elicited about the mean response at certain dose levels can be used to set certain constraints such that a spread of plausible three parameter E-max curves may be generated. In this presentation, we will discuss our experiences in the development of a dose response trial simulator. We illustrate how such an approach may be used to help characterise interim futility rules, dose adaptation and assurance.

    Biography: Doug Thompson has been at GlaxoSmithKline for over three years working on the design, analysis and reporting of clinical trials in rare diseases. He studied statistics at the University of Glasgow as an undergraduate before going on to undertake a PhD at the University of Edinburgh on the development of a risk stratified approach for the treatment of acute stroke patients, funded through the MRC Hubs for Trials Methodology Research.

    James Wason Bayesian methods for design and analysis of clinical trials assessing multiple treatments and biomarkers

    Abstract: Response to treatments is often highly heterogeneous, especially ones that are targeted at specific biological pathways. The increasing availability of biomarkers and targeted treatments has led to the need for trial designs that efficiently test new treatments in biomarker-stratified patient subgroups. Often new treatments are targeted at a specific biomarker subgroup, but may in fact work in a narrower or broader set of patients.

    I will discuss Bayesian adaptive methodology for trials that have multiple treatments and biomarkers. The proposed design incorporates biological hypotheses about the links between treatments and biomarker subgroups, but allows alternative links to be formed during the trial. The statistical properties of the method compare well to alternative designs available.  This design has been developed for trials in ovarian cancer and breast cancer and some methodology issues specific to each application will be discussed. These include the use of continuous biomarker information to allocate patients and adding in new treatments and biomarkers during the trial.

    Biography: James Wason is a Professor of Biostatistics at Newcastle University and a Programme Leader at the MRC Biostatistics Unit. He leads a research group focused on development of statistical methods for more efficient trials. His research interests are adaptive designs, using biomarkers prospectively during trials and analysis of composite endpoints. As well as working on methodology, James is very interested in applying novel methods in real clinical trials and is currently involved in several ongoing trials using novel designs.

    Fabio Rigat, GSK Error rates control via shrinkage priors in multivariate error-in-variable dose-response models

    Abstract: When planning & analysing limited numbers of dose-response data, the risk of false positive results may be considerable. In this case, priors can be used to penalise inferences for dose-response parameters so as to reduce this risk. We demonstrate a simple example of such priors for analysing the multivariate relation between the dose of an investigational asset administered to a cohort of cancer patients and the associated average change in the expression of several target genes. This analysis is further robustified by identifying error terms capturing the technical variability of these biomarker data from those representing sampling variation. 

    trevor smart Prior elicitation and translation of biomarkers to aid clinical development plans and compound selection

    Abstract: The talk will show how prior elicitation of a pharmacodynamic (PD) biomarker can be used to estimate a design prior to be used in designing clinical trials.  In addition, if the translation of the biomarker to efficacy or safety is elicited, then this can help evaluate the benefits of the biomarker and how decisions may be made based on the biomarker.  An example will be given where efficacy and safety biomarkers are used to compare several compounds being considered for the same indication.  The elicitation of the translation allows us to weigh up which biomarker is most relevant in making the decision over which compound to progress first.  When this decision can be made, pre-clinical, Phase 1 or Phase 2, can be compared.

    Biography: Trevor has been the Group Lead for Early Phase Neuroscience Statistics at Eli Lilly since September 2011 covering neurodegeneration, psychiatric illnesses and pain.  This covers the clinical planning after Candidate Identification through to the decision to proceed to Phase 3.  Prior to this he was at Pfizer in Kent from 1998, where he worked on early clinical development as well.  Much of the work was in pain and many biomarker and methodology studies including: fMRI, other imaging biomarkers, healthy volunteer challenge models and patient biomarkers. Trevor has also worked for BioSS in Scotland and at Rothamsted.



    Click here to register. 


     

    Registration Fees

    PSI Member

    £40 + VAT

    Non-Member

    £135 + VAT
    (This includes free PSI membership for the remainder of 2018)



    Please register before Wednesday 21st February 2018. 

    Please contact the PSI secretariat on psi@mci-group.com if you have any dietary requirements or queries about the event.

    Andy Grieve, UCB Pharma

    Andy Grieve, UCB Pharma

    Andy Grieve, UCB Pharma

    Bayesian methods in a seamless Phase 2/3 diabetes trial
    Tom Parke, Berry Consultants

    Error rates control via shrinkage priors in multivariate error-in-variable dose-response models
    Fabio Rigat, GSK

    Error rates control via shrinkage priors in multivariate error-in-variable dose-response models
    Fabio Rigat, GSK

  • A PSI Training Course on Missing Data

    Heathrow | Dates: 06 – 07 Mar, 2018

    The aim of this course is to provide participants with an understanding of missing data, its link with what is to be estimated in a study (the “estimand”), and statistical modelling approaches. The 2 day course includes workshops: participants will undertake a number of practical exercises on missing data in SAS. The course will provide participants the opportunity to gain insight into some of the more useful new methodologies for missing data, with a view to being at the service of the real scientific question of interest. Multiple imputation (MI) will be emphasised – due to this method’s flexibility.

    Attendees will require a laptop with access to SAS.

    The following topics will be covered:

     
    - History of research into missing data
    - Prevention of missing data and impact on study power
    - Missing Data and its relation to the estimand
    - Estimands and their models
    - Multiple imputation I: models for missing data
    - Weighting I: weighting for missing data
    - Multiple imputation II: methods for non-continuous endpoints
    - Weighting II: augmenting weighed data with model estimates
    - Composite endpoints
    - Case studies

    Course runs from:
    10:00 - 17:00 (registration from 09:00) on Day 1
    09:00 - 16:00 on Day 2

    Registration

    Registration costs include lunch and refreshments. PSI are holding a limited number of hotel rooms until the 31st January 2018 which will be allocated on a first come first served basis.

     

    Registration BEFORE 31st January 2018 
     PSI Member  £495 plus VAT
     Non-Member  £590 plus VAT
     Registration AFTER 31st January 2018
     PSI Member  £595 plus VAT
     Non-Member  £690 plus VAT

    Please click here to register.

    Please click here to view the flyer.

  • PSI Webinar: HTA submissions in Germany, what do statisticians need to know to be successful with their GBA dossiers – Part Three

    Dates: 06 – 06 Mar, 2018
    Time: 15:00 - 16:00 UK Time
    Presenter: Dr Carsten Schwenke

    Early benefit assessment was introduced in Germany in 2011 as a basis for price negotiations between payers and pharmaceutical companies. Since then, all new drug substances have to be assessed at the Federal Joint Committee (G-BA), by indication. This series of webinars by Dr C. Schwenke will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG and should be of particular interest to statisticians who work in HTA and those who deal with requests from their local German team.

    Abstract

    The so called early benefit assessment in Germany was introduced in 2011 as basis for price negotiations of the institutionary sick funds and the pharmaceutical company. Since then, all new drug substances are to be assessed at the Federal Joint Committee (G-BA, Gemeinsamer Bundesausschuss) by indication. A new indication always requires a new procedure. In a first step, the additional benefit over a comparator has to be shown based on the rules of evidence based medizine and the available clinical data. The marketing authorization holder has to submit a benefit dossier with all available clinical data for the drug substance in the indication. A template for the dossier is provided by G-BA and defines how the data is to be shown. This template has statistical implications with regards to the presentation of the clinical data including subgroup analyses, surrogate endpoints, direct and indirect comparisons, metaanalyses and others.

    The web-seminar will focus on the statistical implications and how to deal with the requirements by G-BA and their methodological support institute IQWiG. PROs and CONs of certain statistical methods will be discussed in the light of their acceptance by G-BA and IQWiG. The target audience will be statisticians in HTA and statisticians who cope with the requests from their local German affiliate. 

    About the Presenter: Dr. Carsten Schwenk

    _wsb_244x367_foto_carstenDr. Carsten Schwenke studied statistics at the Universities of    Dortmund and Sheffield (UK) with minor subject theoretical  medicine (University of Bochum). He completed his studies with a diploma in statistics and gained the certificate Biometry of the  University of Dortmund. He received his PhD from the Technical  University Berlin in the area public health / health economics at  the Berlin School of Public Health.

    Dr. Schwenke works as a statistician since 1995, first as a  statistical researcher at the statistical consultation center of the University of Dortmund and in the department medical statistics at the University of Göttingen. This was followed by about 10 years as a project biometrician at Chiron-Behring in Marburg, where he headed the biometry, and at Schering AG. After this, he worked as project leader Specialized Therapeutics in the department of Global Health Economics and Outcomes Research at Bayer-Schering Pharma AG in Berlin.

    Dr. Schwenke founded SCO:SSiS in 2007. Main areas of work are clinical development and – particularly since introduction of the AMNOG in 2011 – the area of market access and benefit assessment. A list of publications can be found in Medline (http://www.ncbi.nlm.nih.gov/pubmed/?term=Schwenke+C). 

     

    Registration
    PSI Member Free
    Non-Member £10 (plus VAT)

    Click here to register.
    Registration will close on Thursday 1st March.
  • PSI/EFSPI Webinar: Quantitative benefit-risk assessment using MultiCriteria Decision Analysis (MCDA) and its extensions: practical application

    Dates: 13 – 13 Mar, 2018
    Time: 14:00 - 15:30 UK Time

    Presenters: Gaelle Saint-Hilary and Stephanie Cadour


    Abstract

    Several quantitative methodologies have been proposed to support decision-making in drug development. In particular, MultiCriteria Decision Analysis (MCDA) is a useful tool to assess the benefit-risk balance of medicines according to the performances of the treatments on several criteria, accounting for the preferences of the decision-makers regarding the relative importance of these criteria. The EMA Benefit-Risk Methodology Project suggested that it is one of the most comprehensive among the quantitative methodologies they considered, and it is also recommended by several highly profiled expert groups. While MCDA requires the exact elicitation of the weights of the criteria according to the preferences of the decision-makers, extended versions of MCDA have been proposed, such as Stochastic Multicriteria Acceptability Analysis (SMAA) and Dirichlet SMAA, where the weights are considered as random variables to account for some uncertainty in the weight assignment.

    This webinar proposes a very concrete illustration of MCDA and of the extended models SMAA and Dirichlet SMAA using case-studies. We will present how to derive a benefit-risk utility score for each treatment, how to compare several treatments, how to present the results and how to conduct sensitivity analyses. The differences between the models will be highlighted, and some R code will be presented and shared after the presentation.



    About the Presenter: Gaelle Saint-Hilary

    Stephanie CadourGaelle Saint-Hilary works in statistics for the pharmaceutical industry since 2006. She is currently completing a PhD on “Quantitative Decision-Making in Drug Development”, sponsored by Servier, at the Polytechnic University of Turin (Italy). Before that, she worked as biostatistician in the industry, first at Servier for 5 years and then at Novartis Oncology for 4 years. She was responsible for the clinical development and the licensing of medicinal products in neuropsychiatry and leukemia, and her main scientific interests were benefit-risk assessment, network meta-analyses, multiple test procedures, simulation models of time-to-event data and survival analysis in presence of intercurrent events. The development and the promotion of quantitative methods for drug benefit-risk assessments is one of the major topics she considers during her PhD, with the final goal of enhancing decision-making throughout the drug life-cycle. 





    About the Presenter: Stephanie Cadour

    Gaelle Saint-HilaryGraduated in 2011, Stéphanie Cadour works as a biostatistician at Servier (France) since then. She was initially responsible for the statistical aspects of phase II and III clinical studies conducted in the therapeutic areas of neuropsychiatry and diabetes. She is now working on early phase studies in the field of oncology. In parallel of these activities, Stephanie developed skills on meta-analyses as well as on quantitative approaches for benefit-risk assessment on which she has been working on since 2011.







    The webinar is free to attend.

    Click here to register. 

  • PSI Webinar: What’s the big deal with big data and will it have a big impact on me?

    Dates: 22 – 22 Mar, 2018
    Time: 15:00 - 16:30 UK Time
    Presenters: Dr Joachim Schwarz, PhD Todd Sanger and Richard Pugh


    Dr Joachim Schwarz

    Abstract
    Predictive Modelling in the field of Customer Relationship Management
    The webinar focusses on one main problem of every customer relationship management department: How to identify those customers, which are more likely to e.g. terminate their customer relationship or to buy a new product? One way to solve this is predictive modelling. We will have a look on typical data a company has about their customers, and how it can be used to develop a model to predict a specific customer behaviour.  A special focus will be laid on limitations of this approach and, last but not least, its specific potential to generate or to save money. 

    About the Presenter

    Blog_Schwarz-1-245x300Dr Joachim Schwarz, studied mathematics at the Georg August University in Göttingen and at Trinity College in Dublin. He did his PhD in business administration at the private university of Witten / Herdecke, and afterwards, he has more than nine years working experience as manager and team leader in the analytical CRM department of the Deutsche Telekom, with special focus on data mining and predictive modelling. Since winter term 2013, he is professor for business mathematics and statistics at the FOM university of applied sciences in Bonn.








    PhD Todd Sanger

    Abstract

    Moving from R&D to Sales and Marketing: the business analytics experience of a statistician at Lilly
    Typically, pharmaceutical companies invest more money on sales and marketing than they do on R&D, yet very few statisticians work to support sales and marketing organizations.  At Lilly, we created a group of statisticians to support analytical problems in Sales and Marketing.  This talk will describe the types of issues we encounter and the statistical techniques we use to tackle these issues.

    About the Presenter

    sangerResearch Fellow, Advanced Analytics at Eli Lilly and Company


















    Richard Pugh

    Abstract

    Looking over the fence: What does Data Science mean outside of life sciences and what can we learn?
    The last 10 years have seen significant growth in companies investing in Big Data, Data Science, Machine Learning and AI.  The key driver for organisations investing in these initiatives is to generate insight from data that can be used to drive better decision making.  However, as each industry has different aims and constraints, the adoption of data-driven approaches can vary significantly. 

    This presentation will look at core concepts of data science, such as the 3 Vs of data, and how different industries have looked to implement these concepts.  In particular, we will look at possible opportunities for the pharmaceutical sector to adapt successful approaches from other industries.

    About the Presenter

    rpRichard Pugh is Chief Data Scientist and co-Founder of Mango Solutions, a Data Science consulting company specialised in the pharmaceutical industry.  Richard studied Mathematics and Statistics at the University of Bath before working as a biostatistician within the life sciences industry.  Richard then joined Insightful, working as a Consultant across many industries around the application of statistical methods using the S-PLUS software product.  In 2002, Richard co-founded Mango Solutions to focus on the application of analytics to solve business challenges using technologies such as SAS, S-PLUS and R.  Richard is heavily involved in the R community, co-authoring the book “R in 24 Hours”, and was the first President of the R Consortium.  Richard is an active member of the committee of the RSS Data Science Section.  Today, Richard spends much of his time advising clients across a variety of industries on data-driven approaches, and is a regular speaker at analytic conferences.



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

       
       
       
    Registration
    PSI Member Free
    Non-Member £10 (plus VAT)


    Click here to register.
     
    Registration
    PSI Member Free
    Non-Member £10 (plus VAT)


    Click here to register.
     
    Registration
    PSI Member Free
    Non-Member £10 (plus VAT)


    Click here to register.
     
    Click here to register.
  • PSI Toxicology SIG Workshop 2018

    Stockley Road | Dates: 24 – 25 Apr, 2018

    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 hopefully approximately 20 statisticians, focusing on discussions around “best practice” in the statistical analysis of various data types. 

    The cost will be £225 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 is 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 months.

    Registration Costs
     £225 incl VAT Inclusive of food and one night’s accommodation 


    Please click here to register.

  • Health Technology Assessment (HTA)

    Gothenburg | Dates: 24 – 25 Apr, 2018
    This 2-day course will provide an introduction to the methods of health technology assessment.  There will be a focus on how to estimate the costs and benefits of new interventions and analysis undertaken to support decisions about whether new interventions should be funded by health systems.  The first day will include sessions on policy context and basic economic evaluation methods, as well as lectures on health measurement and valuation for HTA, evidence synthesis and decision analysis.  There will also be exercises to confirm participants’ understanding of key concepts. The second day will focus on sharing case studies and discussing key statistical challenges in HTA such as treatment switching, extrapolation, and network meta-analysis.  Attendees will be encouraged to share their own HTA experiences.  

    Please click here to view the flyer.

    The following topics will be covered:

    • HTA Policy
    • Methods of Economic Evaluation
    • Critical Review of HTA Publications
    • Evidence Synthesis
    • Measuring and Valuing Health
    • HTA Decision Models
    • Industry HTA Case Studies
    • Key Statistical Challenges in HTA

    Presenters:

    • Mark Sculpher, Professor of Health Economics and Director of the Programme on Economic Evaluation and Health Technology Assessment at the University of York.
    • Neil Hawkins, Professor of Health Economics and Health Technology Assessment at the University of Glasgow.
    • Jan McKendrick, Senior Director at PRMA Consulting Ltd.
    • Anja Schiel, Senior Advisor and Statistician and the Norwegian Medicines Agency (NoMA)
    • Jonathan Alsop, Director at Numerus.

    Course runs from:

    Day 1: 09:30 – 17:30 (registration from 9:00)  
    Day 2: 09:00 – 15:30 

    Registration:

    Please click here to register.

    PSI are holding a limited number of reduced price hotel rooms at Gothia Towers until the 23rd March which will be allocated on a first come first served basis.

    Registration costs (includes lunch and refreshments)

     Before 23rd March
     PSI Members £495 + VAT 
     Non-Members  £590 + VAT
     After 23rd March
     PSI Members  £595 + VAT
     Non-Members  £690 + VAT

    PSI are holding a limited number of hotel rooms at Gothia Towers on 23rd and 24th April which will be allocated on a first come first served basis. Rooms will be charged at £115 per room per night including breakfast. Please contact psi@mci-group.com to make a reservation.
  • Introduction To Industry Training Course 2018

    Dates: 01 Oct, 2018 – 01 Nov, 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!

     PLEASE CLICK HERE TO VIEW THE FLYER

    NEXT COURSE STARTS OCTOBER 2018
    PSI Member: £1050 + VAT
    Non-Member: £1145 + 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.

    Limited places available!

    Application forms must be received by 30th June 2018!

    Please discuss your application with your manager
    Final dates to be confirmed.

    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

    Tel: 01707 448020   

     

    Email: alex.godwood@heptares.com
    zelie.a.bailes@gsk.com