Nineteenth meeting, 8-11 June, 2010

The PAGE 2010 meeting was hosted by Martin-Luther-Universität Halle-Wittenberg (MLU) and the Arbeitsgemeinschaft für Angewandte Humanpharmakologie (AGAH) and was held at the Langenbeck-Virchow-House.

View of the central stair case of the Langenbeck-Virchow-House

Our hosts

PAGE meetings take place in an informal atmosphere with vivid scientific discussion. The meeting will start with the Welcome reception on Tuesday evening June 8. The scientific programme will start on Wednesday morning June 9 and will end at noon on Friday June 11. Participants are encouraged to attend all conference days and present their work in the form of an oral presentation or poster.

The program plus abstract titles and oral and software abstracts can be downloaded as a single document (pdf or rtf) and all poster abstracts can be downloaded as a single document (pdf or rtf). The location and dates of the posters, software demonstrations and exhibitions can be downloaded here.

Components of the program:

• 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 (equivalent to 2 pages of typed A4) of their intended presentation for the PAGE meeting. 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 elected, the student will automatically receive a PAGE-sponsored 300 euro travel grant (on top of potential other grants, see below). 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 abstracts submitted under the category "Oral presentation: Methodology".
• Tutorial
  Stephen Senn will present a tutorial on "covariate complications in clinical trials" 
• Invited speakers
  Jonathan French on "When and how should I combine patient-level data and literature data in a meta-analysis?"
  Wilhelm Huisinga on "Physiologically based pharmacokinetic-dynamic modelling"

Registration
The registration procedure will deviate significantly from previous years. Registration will open on January 15 2010 at 8:00 in the morning, Berlin time (GMT+1). When you log in at the PAGE web-site by clicking on 'Register/submit abstract' under Berlin, Germany on the left hand-side menu, you can update your personal information first and then the registration procedure will take you directly to the web-site of the organising agency (Intercom GmbH). Here you will be asked to pay your registration fee directly by credit card (accepted credit cards: American Express, VISA, Master Card) or to request an invoice to be paid within 4 weeks. You will remain on the PAGE web-site waiting list until we have updated your payment information at the PAGE web-site.

Your personal details (address etc) are still available if you have registered at the PAGE website before. 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 (). If you update your information, an automatic e-mail will be sent to you; if you do not receive this mail then please re-check your e-mail address. If you have never visited this website before, you need to fill in your personal details first and then log in again to register for the meeting.  

Registration fees are 450 EUR for participants from industry, 250 EUR for academics and non-profit participants and 50 EUR for students (in an MSc or PhD program). Fees include coffee, tea and lunch on all days (except Friday June 11), the welcome reception on June 8 and admission to the social event on June 10. Accompanying persons can attend the social event for a fee of 120 EUR. According to §4, para. 22, German Turnover-Tax Law registration fees are exempt from VAT. All Places are limited to a number of participants on a first come first serve basis. After receiving a written confirmation including the remark “Account balanced” by INTERCOM the booking is binding. Please bring your confirmation letter (or if you have not received one, your payment slip) to the registration desk.

Cancellation policy
The General Terms of Bussiness can be downloaded here. All changes or cancellations must be submitted to INTERCOM Dresden GmbH in writing. In case of cancellation received before April 10, 2010, 70% of the registration fee will be refunded (315 EUR for participants from industry, 175 EUR for academics and non-profit participants), if received before May 10, 2010, 50% of the registration fee will be refunded (225 EUR for participants from industry, 125 EUR for academics and non-profit participants). Student fees will not be refunded aside from the exceptions specified below. If cancellation is received after May 10, 2010 or if the participant fails to attend (“no show”) the entire registration fee has to be paid. Registered persons whose abstracts are rejected and not joining the meeting are eligible for a full refund. Changing an abstract category from oral to poster by the selection committee is not considered a rejection and is therefore not grounds for a refund. Registered students without granted PAGE-Pharsight Student Sponsorship are eligible for a full refund if not joining the meeting. All refunds will be settled within 6 weeks after the conference. Substitutes will be accepted at any time.

Hotel reservation
INTERCOM offers accommodations in different Hotel categories at special rates on a first come first serve basis. An overview of the hotels (pdf) can be obtained here. You will be able to select and book your hotel and see prices and room types directly from the organisers web-site that is accessible via the registration link.
We strongly recommend that you reserve a hotel room as early as possible because of an expected limited availability of hotel rooms in Berlin due to several other events that take place in parallel to the PAGE2010 meeting.

Social events
The welcome reception will be on Tuesday evening (June 8) at the Langenbeck-Virchow-House and the social event will take place on Thursday evening (June 10). All places are limited to a number of participants on a first come first serve basis. The Registration Fee includes the Social Evening and has to be paid by credit card or bank transfer in advance. After receiving a written confirmation by INTERCOM the booking is binding.
If you would like to cancel the social evening only, please submit to INTERCOM Dresden GmbH in writing. Please note that there will be no refund for a cancellation of this part.

In celebration of the World Cup and European Championships coinciding with PAGE once every two years, the inaugural EU-vs.-REST OF WORLD PAGE Football Biannual Championship is planned for Berlin on Wednesday June 9th (download flyer here)!

Berlin
Berlin is the capital city and one of 16 states of Germany. Located in northeastern Germany, it is the center of the Berlin-Brandenburg Metropolitan Area, comprising 5 million people from over 190 nations. Berlin is a major center of culture, politics, media, and science in Europe and home to world-renowned museums like the Pergamon Museum and the Old National Gallery. Geographically embedded in the European Plains Berlin is influenced by a temperate seasonal climate. Around one third of the city´s territory is composed of forests, parks, gardens, rivers and lakes.
Please visit the tourism site of Berlin to learn more (www.visitberlin.de). For information on how to reach Berlin please visit this site. Public transportation: The Berliner Verkehrsbetriebe (BVG) is the largest municipal public transportation company in Germany. Together with the S-Bahn Berlin GmbH the BVG ensures that Berlin enjoys the mobility essential for a metropolis; all information including an online route-planner can be found here. Please note that the Langenbeck-Virchow-Haus is located opposite the Charité. As a large University Hospital, the Luisenstr. is a very busy street with scarce car park options (as in the whole area), but the bus stop of Bus 147 is just in front of the conference venue.

Satellite meetings
Several events will be held before and after the PAGE meeting:

• Pharsight Corporation will present a hands-on workshop on Phoenix NLME – A Next Generation Tool for Population PK/PD Analysis (June 8, registration Fee: $795). Instruction will be given on basic data management and exploratory graphical and tabular data analysis methods, as well as model building, comparison and evaluation of methods for nonlinear mixed effects modeling. Using the integral Phoenix Connect function, attendees will be able to include NONMEM, SAS and S-Plus scripts in graphical workflows along with Phoenix NLME. For details, check here.
• PODE 2010 is a workshop on the theory of optimum experimental design for non-linear mixed effects models and its applications in drug development. The workshop will take place on Friday afternoon, June 11 and Saturday morning, June 12. For details, check here.
• Mango Solutions will present a 2 day workshop entitled R for Pharmacometrics on the 7th and 8th of June. This training course will teach the basic concepts of the R language using familiar PKPD data and tasks. The training then progresses to more advanced functionality invaluable to pharmacometricians, such as importing and graphing NONMEM information, simulation-based analyses and modelling. This will be a hands-on training course, using exercises and interactive sessions in order to reinforce skills gained. Every course attendee will also qualify for 3 months’ consultative R support from Mango Solutions. For details, check here.
• Uppsala Pharmacometrics with Mats Karlsson and colleagues will give a 3-day course on Pharmacokinetic-Pharmacodynamic modeling of continuous and categorical data in NONMEM 7 for intermediate and advanced users from 6th to 8th of June. The course presents modeling strategies, techniques and implementations (using NONMEM 7) for the handling of PK-PD information in population models. PD models for continuous data as well as binary, ordered categorical, count and time to event data will be discussed. The course will include explanations and comparisons of the different estimation methods available in NONMEM 7. Model diagnostics for PK-PD models including diagnostics for the new estimation methods offered in NONMEM 7 will also be covered. The course will consist of both lectures and hands-on computer exercises using NONMEM 7, PsN and Xpose 4. For details, check here.
• ICON will present a one-day NONMEM VII course on 7 June. This one day workshop will cover the description and use of new features in NONMEM 7. Workshop attendees will be instructed how to specify gradient precision for the improved FOCE algorithm,and will also be instructed on how to use the new estimation methods, such as iterative two stage (ITS), importance sampling (IMP) expectation maximization (EM), Markov chain Monte Carlo (MCMC) stochastic approximation EM (SAEM), and three hierarchical stage MCMC Bayesian method using Gibbs and Metropolis-Hastings algorithms. The new features of PDx-POP 4.0, the graphical interface for NONMEM 7, will also be demonstrated. If you would like to attend the NONMEM 7 Workshop please contact IDSSoftware@iconplc.com for more information and registration.
• Bayer Technology Services (www.systems-biology.com) will present a 1 day workshop on Mechanistic Modeling - From ADME prediction to Physiologically-Based Population Analysis (June 12, registration fee €300/€100 for industry/academia). Starting with an introduction to the fundamentals of physiologically-based pharmacokinetic modeling, examples for classical applications in pharmaceutical R&D will be given. These include prediction of ADME properties, the optimization of formulation design and the support of First in Man. The workshop will then focus on current applications such as clinical trial simulation, physiologically-based Bayesian analysis and physiologically-based PK/PD. Modeling demonstrations will complete the workshop program. For details, check here.
• Simcyp Limited will be running a hands-on workshop on 7 June to showcase the ‘Parameter Estimation’ module of the Simcyp Population-based ADME Simulator. The course is free for Simcyp licence holders and £225/£100 for other attendees from industry/academia. The course focuses on the contrasts between common POP-PK analyses of clinical data and ’bottom-up’ PBPK approaches, and highlights how the strengths of the two techniques can be combined. This bridging helps with rationalising covariate model building and the design of studies.
  The examples include fitting mechanistic drug-drug interaction, PBPK-derived concentration-time profiles and absorption models. Attendees will learn about the use of genetic algorithms and maximum likelihood approaches in optimising objective functions. Only a rudimentary knowledge of PBPK is assumed and the concepts and practical applications of integrating available in vitro data and physiological knowledge with clinical observations for estimating unknown/uncertain drug or physiological parameters will be reviewed. For further details, check here. 
• A 1.5 days MONOLIX 3.2 workshop presented by Marc Lavielle will be given on the 7th and 8th of June. The course is designed for both beginners in PK-PD modelling as well as more advanced ones. The course will present several features available in MONOLIX 3.2: libraries of PK-PD models, MLXTRAN for continuous and discrete data models, MLXTRAN for complex administrations, mixture models, graphs and tables, IOV,...
  It will emphasize hands on training, with the participants working on their own computers. For details, check here.

Abstract Submission
In order to facilitate review of abstracts and to aid in a structured presentation of posters, a number of categories has been created:

- Oral Presentation: Lewis Sheiner Student Session
- Oral Presentation: Clinical applications
- Oral Presentation: Physiology-based modelling
- Oral Presentation: Covariate model building
- Oral Presentation: Integration of literature data
- Oral Presentation: Methodology
- Oral Presentation: Other topics
- Poster: Applications- Anti-infectives
- Poster: Applications- Biologicals/vaccines
- Poster: Applications- Coagulation
- Poster: Applications- CNS
- Poster: Applications- CVS
- Poster: Applications- Endocrine
- Poster: Applications- Oncology
- Poster: Applications- Other topics
- Poster: Methodology- Algorithms
- Poster: Methodology- Design
- Poster: Methodology- Model evaluation
- Poster: Methodology- PBPK
- Poster: Methodology- Other topics
- Software demonstration

A category should be selected when submitting the abstract. For abstract submission click on 'Register/submit abstract', log in if necessary and click the link on the bottom of your personal info page. Submission of abstracts is only possible online through this website. 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 will require re-submission. Upon submission of an abstract, an e-mail will be sent to you with your abstract. This e-mail will also be sent to the committee responsible for peer review in the selected category and abstract-updates may be requested. Abstracts will remain invisible until release of the final program.

Posters
The poster boards will accomodate an A0-size portrait poster (118.9 cm high and 84.1 cm wide). Material for mounting your poster to the boards will be available on-site.

PAGE-Pharsight Student Sponsorship
Students in and MSc or PhD program who submit an abstract for a poster or oral presentation may apply for sponsorship (between 200 and 300 euro, depending on the total number of submissions), by sending an e-mail (after submitting an abstract) to Rik Schoemaker (). The deadline for requesting sponsorship coincides with the deadline for abstract submission: 15 March 2010. Students that want to qualify for a sponsorship should require hotel accommodation for the meeting and should bring proof of their academic status (a letter from their supervisor), to be presented at registration for the meeting. Applications for this sponsorship should be limited to students who have no other funding source (e.g. industrial funds, professional societies). This means that the applicant's trip cannot be fully funded by someone else; sponsorship can only be requested if a substantial amount of personal funds is required to finance the trip to Berlin.

Deadline for Lewis Sheiner Student Session abstracts: 1 MARCH 2010
Deadline for regular abstracts: 15 MARCH 2010
Deadline for requesting PAGE-Pharsight Student Sponsorship: 15 MARCH 2010

Software Demonstrations
Software companies, Academic Software Application Developers and Contract Research Organisations are welcome to present their products and services during PAGE. Please contact our conference secretariat for further details .

Conference secretariat
For matters related to the PAGE meeting:


For matters related to payment of registration fees, hotel reservation, tourist information etc:
Diana Berthold
INTERCOM Dresden GmbH
Zellescher Weg 3 
01069 Dresden / Germany 
phone: +49 (351) 32017340
fax: +49 (351) 32017333
e-mail: dberthold@intercom.de 
web: www.intercom.de

Conference location:
Langenbeck-Virchow-Haus
Luisenstr. 58/59
10117 Berlin, Germany
Please follow this link "How to get to the conference venue, the Langenbeck-Virchow-Haus".