EUFEPS Conference on
Optimising Drug Development
together with
European Biosimulation Network of Excellence:
Biosimulation - A New Tool in Drug Development

Effective Integration of Systems Biology, Biomarkers, Biosimulation and Modelling in Streamlining Drug Development

A Unique Discussion Forum for Scientists from the Pharmaceutical Industry, Regulatory Agencies and Academic Institutions

November 29 - December 1 • 2006 • Basel Convention Center • Basel • Switzerland

Organised by the European Federation for Pharmaceutical Sciences (EUFEPS) and the European Biosimulation Network of Excellence (BioSim)
Co-sponsored by the American College of Clinical Pharmacology (ACCP), the European Center for Pharmaceutical Medicine (ECPM), and the Swiss Society of Pharmaceutical Sciences (SGPhW)

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The Conference opens on Wednesday, November 29, 2006, at 08:15 (Pre-registration on Tuesday, November 28) and it closes on Friday, December 1, at 14.15.

Scope and Aim
To increase the efficiency and productivity of new drug development, new tools for predictive human models of disease and efficient drug discovery, development and evaluation are necessary. Among these new technologies, “modelling”, “biomarkers”, “biosimulation“ and “systems biology” are gaining increasing attention. The aim of this Conference is to present and discuss both visionary and effective integration of them all, also to develop a foundation for further research, development and utilisation of them.

For example, modelling is applied in drug development to predict the outcome of the next steps to be taken in various processes. Biomarkers will enable translational data from preclinical species to humans, hence helping to understand drug effects, side effects and toxicity in a more predictive manner. Quality in data is a must for successful submission to regulatory authorities, arrived at by careful study design and validation. Biosimulation is, furthermore, an old dream of in silico pharmaceutical sciences. Core activities would include translation of experimental insights into consistent mathematical frameworks, including formal models to predict the course of physiological processes under varying conditions. Systems biology approaches are expected to link genomic, proteomic and metabolomic data and bioinformatics, to provide better understanding and simulation of function and dysfunction of living systems. New insights will change paradigms of drug discovery, development and evaluation.

The Conference is intended for drug discoverers, developers and evaluators, including in silico, in vitro and in vivo scientists, clinical pharmacologists and other scientists exploiting modelling, biomarkers, biosimulation and systems biology, as well as for academic researchers who want better insight into industry use of these approaches, e.g. to become aware of urgent training needs, and for regulator and patient group scientists evaluating today’s and tomorrow’s medicines therapy.

Sessions will include

• Model-Based Drug Development (I):
  Role of Systems Biology in Drug Discovery
• Model-Based Drug Development (II): Pharmacokinetic/Pharmacodynamic Principles in Preclinical Development
• Model-Based Drug Development (III):
  Case studies in Drug Discovery & Preclinical Development
• Model-Based Drug Development (IV):
  Modelling & Simulation in Clinical Development – The Concept
• Model-Based Drug Development and Biomarkers (I):
  Case Studies in Clinical Development
• Model-Based Drug Development and Biomarkers (II):
  Clinical Trial Designs and Statistical Aspects
• Learning from failures: Could biomarkers and model-based drug development have prevented phase III failures?
• Implementation of Systems Biology, Biomarkers, Biosimulation and Modelling in Pharmaceutical Industry: Current Status and Lessons Learned

Format & Preliminary Programme
Using a similar format to previous EUFEPS conferences, key segments of the process are broken down into a number of sessions, each with lectures and discussions and general discussion sessions for conclusions and recommendations.

Scientific & Planning Committee
Ole J Bjerrum, Copenhagen DK, Fritz R Bühler, Basel CH, Anne Marie Clemensen, Lyngby DK, Meindert Danhof, Leiden NL, Hartmut Derendorf, Gainesville FL USA, Igor Goryanin, Edinburgh UK, Rajesh Krishna, Rahway NJ USA (Co-Chair), Lawrence J Lesko, Silver Spring MD USA, Hans H Lindén, Stockholm SE, Erik Mosekilde, Lyngby DK (Co-Chair), Christian R Noe, Vienna AT, Carl Peck, Washington DC USA, Ian C Ragan, Windlesham UK, Shashank Rohatagi, Bridgewater NJ USA, Malcolm Rowland, Manchester UK, Hans Günter Schäfer, Biberach An Der Riss DE (Co- Chair), Donald R Stanski, Basel CH, Steffen Thirstrup, Copenhagen DK, Hans Westerhoff, Amsterdam NL, Michael Zühlsdorf, Wuppertal DE

Exhibition Information
Companies are welcome to participate as an exhibitor at this Conference.
The Conference delegates are academics, industrialists, regulators and students which will give you a unique opportunity to meet experts in your field. The exhibition offers every opportunity to promote and position your company, your products, your services, your expertise and your specialists, facilitating your contact with them, predicting their needs and shaping future collaboration.

Exhibition Organiser

Health Links has been contracted as the Exhibition Organiser.
Please direct inquiries regarding exhibition or sponsorship to Health Links (channey@health-links.co.uk), Windsor House, 11A High Street Kings Heath, Birmingham B14 7BB, United Kingdom, Tel +44 208 7496471, Fax +44 121 2483390, www.health-links.co.uk

How to apply
Application for stand space must be made on the “Application and Contract” form. Every effort will be made to accommodate exhibitors request for space and position. The exhibition stands and space are assigned on a “first come – first served” basis.

Click for Application and Contract Form.

Sponsorship Opportunities
To sponsor this Conference and by this enable additional quality meetings on key topics, contact the Exhibition Organiser Health Links (channey@health-links.co.uk) or the EUFEPS Executive Director, Hans H Lindén (hans.linden@eufeps.org). Please direct general questions about the conference to the Conference Secretariat (conferences@eufeps.org).

Oral and poster contributions
Scientific contributions relating to the scope and aim of the Conference will be welcome and considered for poster presentations. Abstracts should be submitted to the EUFEPS Secretariat, both as an email attachment and as a hard copy. Submission deadline is October 31, 2006.

Click for Editorial Instructions.

Language
English will be the language of the Conference. No simultaneous translation will be provided.

Organiser
EUFEPS was founded in 1991. Its mission is to advance excellence in the pharmaceutical sciences and innovative drug research, and to represent the interests of scientists engaged in drug research and development, drug regulation and drug policymaking. Currently, it links scientific societies and associations in 24 European countries and there are more than 600 individual members of EUFEPS.

Basel
Basel beats differently is the motto with which Basel wants to draw attention to itself at home and abroad. Special to Basel in fact different is its position in the so-called Dreiländereck, the triangle formed by the three countries of Switzerland, Germany, and France. Basel is known as an open, many-faceted cultural, educational, and economic metropolis. Basel is the centre of northwestern Switzerland, on the border with Germany and France, located at the very core of central Europe. Both its historic townscape and modern architecture are part of Basel’s living present. The choice of leisure facilities available in Basel is much greater than in other town of similar size. This is true not only because of its above-average cultural range, its many high-class museums such as its Kunstmuseum (Museum of Fine Arts), the Beyeler Foundation, or the Antikenmuseum (Museum of Antiquities). Besides culture, Basel also offers many other possibilities for amusing oneself: at sports, walking through the old town, or a stroll to the shops in the inner city. The Basel region also offers many opportunities for enjoying one’s leisure hours. There are many of these, in the parks, the green-belt areas around the city, its rivers, and the nearby recreational areas in the adjacent more rural halfcanton, in the Black Forest, and in Alsace.

Final Programme

Day 1 – Wednesday, November 29, 2006

Day 2 – Thursday, November 30, 2006

Day 3 – Friday, December 1, 2006

Location
The Conference will take place at the Basel Convention Center, Messeplatz 21, CH-4021 Basel, Switzerland. Tel +41 58 2002020; Fax +41 58 2062186

How to get there
from the Airport:

• Taxi, travelling time around 15 minutes at an approximate cost of CHF 40,-
• Airport coach to the Railway station SBB where you embark the tram no 2 in the direction City. Stop ‘Messeplatz’. Travelling time from airport approximately 40 minutes, cost around CHF 3,-

from the Badischer Bahnhof (Railway station):

• Tram no 2 or 6, direction City. Stop ‘Messeplatz’. Travelling time around 5 minutes. Cost approximately CHF 2,-
• Taxi 3 minutes at an approximately cost of CHF 10,-

from the Schweizer Bahnhof SBB (Railway station):

• Tram no 2, direction City. Stop ‘Messeplatz’. Travelling time around 12 minutes. Cost approximately CHF 3,-
• Taxi travelling time around 8 minutes at a cost of around CHF 20,-

Registration
The registration fee (EUFEPS Membership 10% reduction) includes all conference documentation, all coffee breaks, three lunches and one reception buffet. The cost for hotel accommodation and travel is not included in the registration fee.

Click for online registration

Click for Registration Form (PDF)

Students
Participants applying for student fees should include proof of their student status (a photocopy of the university identity card).

Confirmation
In order to receive confirmation of registration by email, please make sure to indicate the email address on the registration form! Confirmation will be sent upon receipt of payment.

Alterations
Alterations to your registration must be made in writing and sent to Congrex Sweden AB by email or fax.

Inquiries
Congrex Sweden AB has been contracted for registration and administration support. Please direct all inquiries regarding registration, accommodation or payment to Congrex at: codd.registration@congrex.com
Tel +46 8 459 66 00
Fax +46 8 661 91 25

Hotel Reservation
Hotel reservations can be made on-line or on the attached hotel registration form. A number of hotel rooms have been reserved at hotels at preferential rates for the Conference. The hotels are both situated in the city centre of Basel and near the Conference venue. The Conference venue is accessible with public transportation or by foot depending on choice of hotel. The rates below are per room, per night, including breakfast, city tax and VAT (7,6 %).

Hotel accommodation will be reserved and confirmed only when Congrex Sweden AB has received your credit card number as a guarantee on the registration form. Congrex Sweden AB reserves the right to book another hotel if the desired accommodation should be fully booked. To ensure that the hotel reservation will be made as required, please indicate your credit card number on the registration form. After October 31, 2006, accommodation and rates will be confirmed according to availability.

The hotel reserves the right to charge you for all nights reserved and guaranteed on the registration form, should you check out before confirmed departure date or in case of no-show.

All reservations are handled by Congrex Sweden AB. Possible changes of your hotel reservation as well as cancellation must be made in writing to Congrex Sweden AB. Please do not contact the hotel directly.

Payment Registration Fee and Hotel Accommodation
Please indicate your name and the payment reference number 0666 on all money transfers.

Congrex Sweden AB will not be responsible for identifying funds transferred directly into the account when the name of the participant or invoice number is not mentioned, nor will Congrex Sweden AB accept charges of bank fees associated with the transfer.

Payment should be made in advance by one of the following methods

• American Express, Visa or Eurocard/Mastercard may be used for all charges.
  Please indicate card number and expiry date on the registration form.
• Transfer to SEB (Skandinaviska Enskilda Banken), SE-106 40 Stockholm, Sweden, BIC/SWIFT-code: ESSESESS, Account no. 5501-8248858, IBAN No SE75 5000 0000 0550 1824 8858 in CHF to Congrex Sweden AB.
• Banker’s draft, which should be sent together with the registration form by ordinary mail. The Banker’s draft should be purchased at your bank and made out in CHF to Congrex Sweden AB, Attn: CODD. Please cross the draft. We are not able to accept personal cheques, company cheques or Eurocheques. Please send the Banker’s draft to: Congrex Sweden AB, Attn: CODD, P.O. Box 5619, SE-114 86 Stockholm, Sweden.
• Scandinavian residents may pay by bank or postal giro transfer. Bank giro 224-7021, or Postal giro 9052-2.

As from 3 weeks before the Conference we only accept credit card as payment. Registrations will be confirmed when Congrex Sweden AB has received payment. Admission to the Conference is granted only if Congrex Sweden AB has received the registration fee. Delegates, who have made late payments, should bring a proof of payment to the Conference. Failure to produce this on request gives Congrex Sweden AB the right to charge the amount to your credit card. Kindly note that Congrex Sweden AB only require payment forthe registration fee. Participants need to provide Congrex Sweden AB with a credit card number to guarantee the accommodation but the payment for the stay will be charged directly by the hotel upon check-out.

Cancellation of Registration
Notification of cancellation must be made in writing and sent to Congrex Sweden AB. Cancellation of registration will be accepted until October 31, 2006, up to which date the total amount will be refunded less CHF 80 for administrative expenses. For cancellations made after October 31, 2006, we regret that no refunds can be made.

Cancellation of Hotel Reservation
Notification of cancellation must be made in writing and sent to Congrex Sweden AB. Cancellation of any hotel reservation will be accepted until October 31, 2006, up to which date the hotel deposit will be refunded less an administration fee of CHF 80. We regret that after October 31, 2006, we will charge you for the whole stay.

General Information
Badges
Each participant will receive a name badge upon registration. For security reasons all participants are requested to wear their name badge during all the Conference activities.

Currency
The currency in Basel is CHF (EUR 1 is equal to approx. CHF 1.5).

Disclaimer/Liability
The Organising Committee and Congrex Sweden AB accept no liability for any injuries/losses incurred by participants and/or accompanying persons, nor loss of, or damage to, any luggage and/or personal belongings.



The Congrex Group works internationally with subsidiaries in the Netherlands, the United States and Sweden as well as licensed partners throughout Europe and Latin America.

Useful Adresses