Twenty-seventh meeting, 29 May – 1 June, 2018

The PAGE 2018 meeting was held at 2m2c Congress Center, Montreux, Switzerland.

Our sponsors:

Conference location

The PAGE meeting takes place in an informal atmosphere with vivid scientific discussion. PAGE 2018 was held at the Montreux Music & Convention Center. The meeting started with a welcome reception at “Marché couvert” (Covered market) in Montreux city center on Tuesday evening 29 May. The scientific programme started on Wednesday morning 30 May and ended at noon on Friday 1 June. Participants are encouraged to attend all conference days and present their work in the form of an oral presentation or poster.

Abstracts and Apps

The program and abstracts can be downloaded as a single document (in pdf or docx format). Note that no printed abstracts are available at the conference so print them at home or use the special Apps that have been developed for iPhone and Android to view all abstracts off-line on your portable device.

Programme items:

• The Lewis Sheiner Student Session
  The annual Lewis Sheiner Student Session was inaugurated, both to honour the memory of Lewis Sheiner and to highlight his lifetime passion for student education. Students who wish to be considered for this session should submit an extended abstract no later than 26 February 2018.
  • The abstract must be structured with the following subheadings: Objectives / Methods / Results / Conclusion / References.
  • There must be at least 6,000 but not more than 7,000 characters (including spaces) in the abstract text(excluding Title / Authors/ Affiliation and References).
  • The submitted work must have been performed either as part of an MSc or PhD programme and/or will ultimately form part of a PhD thesis.
  • Each year a rotating committee of three members, representative of the PAGE community, will judge who should receive the honour of presenting in the Lewis Sheiner Student Session.
  • If selected, the student will automatically receive a 300 euro travel grant. A permanent list of students, with links to their presentation, will be maintained on the web site.
• The Stuart Beal Methodology Session
  As a tribute to Stuart Beal, the organising committee has instituted the Stuart Beal Methodology Session. The organising committee will choose presenters from the submitted abstracts.
• Special session on Pharmacometrics in dose individualisation – focus on biomarkers. This session will be focused on the combined utilisation of TDM biomarker data and model-based methods in dose individualization. Further presenters will be selected by the organising committee from the submitted abstracts (see abstract categories upon submission).
  • Pr Thierry Buclin (University Hospital of Lausanne) will give an introduction to the theme and emphasize the clinicians’ needs when facing TDM results.
  • Dr Catherine Sherwin (University of Utah) will share her experience in dose individualization approaches using biomarkers.
• Special session on Immunotherapy in oncology. This session will cover a clinical overview and modelling aspects in this area. Further presenters will be selected by the organising committee from the submitted abstracts (see abstract categories upon submission)
  • Dr Scott K. Pruitt (MSD) will give a Clinical overview covering the state of the art in immuno-oncology including therapies and study designs, i.e. a view of how compounds are being developed.
  • Dr Benjamin Ribba (Roche) will present the ideas of the biology and mechanistic PK/PD modelling in this area, including clear applications.
• Special session on Estimands. The purpose of this session is to give a background to Estimands and the potential opportunities from a pharmacometric perspective. The session will encompass the statistical and the pharmacometric viewpoints.
  • Dr Mouna Akacha (Novartis) will give a background on estimands and discuss why they are important.
  • Dr Mick Looby (Novartis) will present a pharmacometric perspective on the matter

Registration

• Registration is only possible at the PAGE website.
• If you have previously registered at the PAGE website, your personal details (address etc.) are still available.
• If this is the first time you will attend PAGE, register first at the PAGE website before enrolling for the meeting.

Please keep our database up to date by editing your existing profile if required!

• If you’ve forgotten your password, a reminder can be requested automatically from the website by e-mail.
• If you’ve forgotten your password and changed your e-mail address then please contact Rik Schoemaker (rs@page-meeting.org).
• Updates of personal details in the website are confirmed automatically by email. Note that if you do not receive a confirmation, you should check that your e-mail address is correctly entered in the designated field.

Registration fees and payment

• Registration fees are:
  • 625 € for participants from industry and commercial enterprises
  • 425 € for academics (including post-doc students), non-profit participants, unemployed or retired professionals, and government employees
  • 125 € for full time students in an MSc or PhD programme at the time of the PAGE meeting (and not otherwise employed) who do not submit and present a poster or oral communication abstract at PAGE 2018
  • 25 € for full time students in an MSc or PhD programme at the time of the PAGE meeting (and not otherwise employed) who do submit and present a poster or oral communication abstract at PAGE 2018
• Fees include coffee, tea and lunch on all days, the welcome reception on 29 May and the social event on 31 May.
• Accompanying persons may attend the welcome reception and the social event for a fee of 125 €
• Participant places are limited and allocated on a first come, first serve basis.
• Registration fees must be paid at the PAGE website by credit card only (Visa, Maestro, MasterCard and American Express) within 14 days after registering at the PAGE website. Visa payments require Verified-by-Visa to be activated, and MasterCard requires SecureCode for your and our own security. Failure to meet this deadline will automatically place your registration on the waiting list.
• Students wishing to qualify for the student registration fee will need to upload, at the time of registration, a scanned copy of a signed letter of support from their supervisor indicating that they will be full time students in an MSc or PhD programme at the time of the PAGE meeting, and a scan of their current student card. If this information (and an abstract if applicable) is not available at the time of the abstract deadline (26 February), non-reduced fees will be charged.

Cancellation policy

No refunds will be given once the registration fee has been paid, not even in the extremely unlikely event that the meeting is cancelled due to force majeure. Substitution of delegates will be accepted at any time.

PAGE Student Sponsorship

A PAGE Student Sponsorship to support travel and accommodation expenses (kindly supported by Certara, ISoP, LAP&P, BAST, and Occams), is available to a number of students unable to obtain any other financial support. This will be judged on a case-by-case basis by a selection committee. Please see here to download a form with criteria and details on how to apply. Applications need to be submitted by the time of the abstract deadline (26 February), so make sure you receive confirmation of receipt when sending your application.

Abstract submission

Deadline for Lewis Sheiner Student Session abstracts: 26 FEBRUARY 2018
Deadline for regular abstracts: 26 FEBRUARY 2018

The abstract submission deadline is the same for all abstracts: Lewis Sheiner Student Session abstracts, oral session abstracts, and poster abstracts and there will be no option for late submissions. The reason is that the PAGE organising committee cares about the quality of all abstracts, and that means that sufficient time is required for judging the abstracts. In particular, abstracts without results will be rejected. Statements such as “…will be shown…”, or “…will be available at the time of the conference…” are not acceptable. Furthermore, abstracts for an anonymous drug (drug X) will not be accepted unless the work clearly describes a new methodology/new disease model for a specific therapeutic area (or similar), i.e. is of value to the pharmacometric community without the identity of the drug. Accordingly, a 2-compartment population PK model for drug X will not be acceptable. Also note that the abstract length (both minimum and maximum) has been increased significantly compared to previous years, to allow a better assessment of the intended presentation.

• Please follow these instructions carefully regarding format and length of the abstracts or download them in either Word/RTF or Adobe/PDF format. Abstracts that do not comply with these guidelines will not be accepted.
• Each participant is only allowed to submit one abstract, i.e. either in an oral or in a poster category
• If your request for an oral presentation is not granted, you will be contacted to change your abstract category from an oral to a poster category
• Submission of abstracts is only possible online through the PAGE website. Log in, click on ‘Register/submit abstract’ and click the link on the bottom of your personal info page.
• To facilitate the review of abstracts and to help structure the poster sessions, please select an abstract category when you submit your abstract.
• The abstract must be structured with the following headings: Objectives / Methods / Results / Conclusion / References.
• There are strict limits with a minimum of 3,000 and a maximum of 4,500 characters (including spaces) for the abstract text (excluding Title/ Authors/ Affiliation and References).
• When you click “Submit” you will immediately receive an email with your abstract attached. This e-mail will also be sent to the committee responsible for peer review in the selected category. Therefore, only click “Submit” when you have finished editing!
• Abstracts will remain invisible until release of the final programme (anticipated date: between 5 and 15 April).

Posters

The poster boards will accommodate an A0-size portrait poster (118.9 cm high and 84.1 cm wide/46.8 by 33.1 inches). Material for mounting your poster to the boards will be available on-site.

The local organisers have provided the possibility of having your poster printed on-site at the cost of CHF 55 for paper quality and CHF 75 for fabric quality. Prepare your poster in A0 portrait layout in pdf format, and upload your file here. The deadline for file-submission and payment is May 18.

Slides for the oral sessions

Slides for the oral session should be provided as PowerPoint or pdf and are recommended to have a layout in the 16:9 widescreen format for projection. No personal laptops are allowed for presenting slides.

Software demonstrations

Software companies, Academic Software Application Developers and Contract Research Organisations are welcome to present their products and services during PAGE. The cost for one commercial table is 1700 euros including dedicated high speed wifi connection. Please visit the conference secretariat webpage for further details.

SATELLITE MEETINGS

Several events will be held before and after the PAGE meeting. If you are interested in organising such a satellite meeting, please fill in the online form and the local organising agency Swiss Backstage will get in touch. Please note that PAGE itself is not involved in organising satellite workshops or booking venues, etc, and satellite meetings cannot be booked through the PAGE or local organisers web-site.

• Simcyp Limited (a Certara company) is running a one-day Parameter Estimation and Pharmacodynamics (PE/PD) hands-on workshop on Tuesday 29 May. The workshop covers the concepts and application of combining the top-down and bottom-up approaches to build fit for purpose PBPK models and the further linking of PBPK models to PD models to provide insight into covariate effects through a combination of lectures and hands-on sessions. The major topics covered are:
  • Data entry, fitting and interpretation of results
  • Simultaneous fitting of PK and PD parameters
  • Covariate recognition
  • Using built-in and custom scripted pharmacodynamic models in Simcyp
  • PD driven by the concentration at the relevant site of action e.g. liver
  • Running the Simcyp Simulator through the R package.

  Cost: Academics £75.00, Simcyp Consortium members £75.00, and Non Members £150.00. To register please click here or email Kelly on events@simcyp.com

• Simcyp Limited (a Certara company) is running a one-day hands-on workshop on Bridging PBPK with POPPK for Paediatrics on Tuesday 29 May. The workshop covers predicting the age-related changes to pharmacokinetics and drug-drug interactions including associated variability and linking this information to drug response in the preterm and full term paediatric population. Examples of “how this informs the design of POPPK studies” will be presented during the course. The major topics covered are:
  • Age-dependent physiological PK models for small molecules and large molecules
  • Prediction of drugs pharmacokinetics using IVIVE approach
  • Handling Age-varying covariates during simulation
  • Prediction of DDI in paediatrics
  • Linking PK variability to drug response in children
  • Strategies for optimal study design using combination of PBPK and POPPK

  Cost: Academics £75.00, Simcyp Consortium members £75.00, and Non Members £150.00. To register please click here or email Kelly on events@simcyp.com

• Simcyp Limited (a Certara company) is running a one-day workshop on physiological modelling of therapeutic proteins and antibody-drug conjugates on Tuesday 29 May. The workshop will combine lectures and hands-on sessions and focuses on both the considerations needed to model the ADME and target binding properties of therapeutic proteins, mAbs, antibody drug conjugates, and bispecific antibodies in a systems pharmacology context, using minimal and full PBPK models, and model applications in drug development. The major topics covered are:
  • Physiological models of protein (subcutaneous) absorption and distribution
  • Clearance mechanisms of therapeutic proteins
  • Physiological models of Antibody Drug Conjugates
  • Modelling of target mediated drug disposition (TMDD) of protein and ADCs including techniques to account for target shedding and binding kinetics of bispecific antibodies.

  Cost: Academics £75.00, Simcyp Consortium members £75.00, and Non Members £150.00. To register please click here or email Kelly on events@simcyp.com

• The nlmixr team will be running a one-day hands-on workshop on simulation (RxODE) and parameter estimation using the free and open-source R-based nonlinear mixed effect modelling platform nlmixr on Tuesday 29 May. The course will consist of a mixture of lectures and hands-on exercises. Contact info@nlmixr.org for further information, and visit this link for registration. Cost: 180 euro to cover the workshop room, lunch and coffee/tea. We have a limited number of reduced fee spaces available if you can argue a strong case.
• IntiQuan is running a full day hands-on workshop on Using R and Shiny to support efficient PK/PD and QSP modeling, parameter estimation, simulation, and reporting in Word on Monday 28 May. The workshop is designed as a hands-on tutorial, allowing participants to work through all examples under guidance of the presenters. All material (slides, example models, R code, required R libraries, and additional software) will be shared with the participants. No prior knowledge of either NONMEM, MONOLIX, SAEMIX, or NLMIXR is required. Basic knowledge of ODE and NLME modeling and R is of advantage. Cost: Standard rate 180 EUR, academics & non-profit organization employees 90 EUR. For more information and registration, please click here or email Henning on info@intiquan.com.
• SGS Exprimo is running a two-day Clinical Trial Simulation course on Monday and Tuesday 28-29 May.
  • The course on Monday will introduce attendees to Simulo, a PK-PD-Disease model simulator developed for 6 years and now available to the public. The user-friendly interface can specify complex behavior (adaptive trials, interim analysis, complex dose adaptation, adverse events) in a flexible way, as the simulation uses an R backend. The resulting R-script may be applied outside of Simulo in any R environment. After this session, you will be capable of running your own clinical trial simulations. You will receive a free license to the software.
  • The course on Tuesday presents a theoretical framework on all aspects of model simulation: model selection, adaptation, evaluation, clinical trial simulation and clinical trial optimization. All practical examples will be demonstrated using Simulo.

  Cost: 180 euro per day to cover the room, lunch and coffee breaks. Only 30 places will be available for both sessions. Priority will be given to attendees registering for both sessions. For more information and registration, please contact nancy.smets01@sgs.com.

• Certara University is running a two-day Phoenix NLME course on Monday and Tuesday 28-29 May. Phoenix NLME is a “full package” software that can be used during the entire drug development stage for optimal PK/PD modeling and simulation performance. Phoenix NLME is the only program that dynamically uses 3 different connected modes of analysis (built-in, graphical and textual). Built-in models are library models that can automatically be transformed into graphical and/or textual mode for use if needed. Graphical models are also automatically translated into textual mode for use. In other words, users can chose a model from an extensive model library (Built-in mode), draw the model using a graphical editor (graphical mode) or write it using code (textual mode). In the background, all model building modes in Phoenix NLME use the Phoenix Modeling Language (PML), similar to the NONMEM control stream. These unique characteristics make the Phoenix NLME software the easiest program to be used for optimal model building strategy.The 2 days course will on the first day introduce the main concepts of Population PK/PD with hands on based on case studies but that focus on standard PK/PD continuous responses (Drug, biomarkers, etc,). On the second day, basic theory on categorical responses, count data and time to events will be taught. We provide a unique opportunity to bring your own complex PK/PD model based data and get private consulting during the hands on part of the advanced course: after a half day focusing on the population analysis theoretical aspects, the instructor will provide a private consulting type of service during the hands on part of the workshop. Cost will be $995 USD; please email info@CertaraUniversity.com to register.
• ICON will present a one-day NONMEM 7 course on Monday 28 May. Workshop attendees will be instructed on how to implement the FAST FOCEI algorithm (new in NONMEM 7.4), how to use Monte Carlo importance sampling, stochastic approximation E-M methods, and full Bayesian methods, both traditional Gibbs Bayesian and Hamiltonian no U-turn sampling (new in NONMEM 7.4). Parallel computing and dynamic memory allocation for efficient memory usage will also be described as well as additional new features of NONMEM 7.4. The features of PDx-POP 5.2, the graphical interface for NONMEM 7, will also be demonstrated. Cost will be $500 for industry, $250 for academia, and $100 for students. For details and registration contact Lisa Wilhelm-Lear @ Lisa.Wilhelm@iconplc.com. The details can be found here.
• Metrum Research Group will present a one-day workshop entitled Advanced Use of Stan, rstan and Torsten for Pharmacometric Applications on Tuesday 29 May 2018. We will provide a guided hands-on experience in the advanced use of Stan, rstan, and Torsten, for Bayesian PKPD modeling. Stan is a flexible open-source software tool for Bayesian data analysis using Hamiltonian Monte Carlo (HMC) simulation – a type of MCMC simulation. Torsten is a Stan extension containing a library of functions to simplify implementation of PKPD models. This workshop builds on the foundations presented in our previous introductory Stan workshops. Topics include model evaluation and comparison, models with systems of ODEs, optimizing Stan code, using MCMC results for population and trial simulations, and more. You will execute Bayesian data analysis examples using Stan. Via the examples you will learn to implement population PKPD models including those involving censoring, numerical solution of ODEs, and user-defined probability distributions and likelihoods. Cost will be $600 for industry, $300 for academia/government/non-profit and $150 for students. Click here for details and registration.
• Metrum Research Group will present a one-day hands-on workshop entitled Simulation from ODE-based population PK/PD and systems pharmacology models in R using mrgsolve on Saturday 2 June 2018. After a brief review of simulation principles and planning strategies, we will provide a guided hands-on experience in the use of the R package mrgsolve. mrgsolve is a free, open source, validated R package to facilitate simulation from hierarchical, ODE-based PK/PD and systems pharmacology models frequently employed in pharmaceutical research and development programs. You will code, execute, and summarize PK, PK/PD and systems pharmacology model simulations using mrgsolve and R. Through many examples, you will learn to implement model-based simulations to help address questions at a variety of stages of a development program. Cost will be $600 for industry, $300 for academia/government/non-profit and $150 for students. Click here for a more detailed workshop description.
• Uppsala Pharmacometrics will give a 2.5-day course on Advanced methods for population model building and evaluation in NONMEM for intermediate and advanced users from the 26th – 28th of May. The course presents model building and evaluation strategies, techniques and implementations in population models. The course will consist of both lectures and hands-on computer exercises using NONMEM 7, PsN and Xpose 4. Click here for more details and information on registration.
• Lixoft is running a 1 day hands-on workshop on Target Mediated Drug Disposition models with the MonolixSuite on Monday the 28th of May. The workshop is intended to pharmacometricians wishing to have an introduction and an overview of TMDD. No prior experience of the MonolixSuite nor population PK modeling of biologics is required. It will provide an overview of the characteristics of the PK of therapeutic proteins, introduce TMDD modeling concepts (equations, approximations, underlying assumptions), and discuss guidelines for the development of TMDD models. Hands-on lectures to explore the behavior of TMDD models, as well as to model step by step a TMDD PK data set, will be included. More information and registration here.
• Lixoft is running a 1 day hands-on workshop on parametric modeling of time-to-event data with the MonolixSuite on Monday the 28th of May. We will provide a general introduction to the concepts related to time-to-event data, followed by guided hands-on to exemplify parametric time-to-event modeling in practice. Repeated time-to-event, covariate modeling and joint modeling of PK-TTE or PD-TTE data sets (including informative dropouts) will also be covered. The participants will learn how to format a time-to-event data set, write a model, estimate the parameters, interpret the results to step wise improve the model, and finally run simulations of time-to-event models. No prior experience of the MonolixSuite is required. More informations and registration here.
• Lixoft is running a 1 day hands-on workshop on advanced Monolix on Tuesday the 29th of May. The course is designed for modelers with already a good knowledge of Monolix, who wish i) to better understand the methods, the algorithms and their options, ii) learn how to implement complex models, iii) improve their strategy for model building. The course will consist of both lectures and hands-on sessions with Monolix. A dedicated Q&A hour session will be proposed. More information and registration