EUFEPS Conference on
Optimising Drug Discovery and Development
together with
European Biosimulation Network of Excellence (BioSim) and
EU Microdosing AMS Partnership Programme (EuMapp)

Integrating Systems Approaches into
Pharmaceutical Sciences

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

December 5-7 • 2007 • Basel Convention Center • Basel • Switzerland

Index » Preliminary Programme » Click for Registration on-line » Click for Registration Form (PDF) » Click for Editorial Intructions » Click for Final Programme » Click for Additional Information » Useful Addresses   Download the 2nd Announcement To read PDF files you will need the software plug-in Acrobat Reader, which is a free shareware from Adobe. Click here if you wish to download the shareware.

The Conference opens on Wednesday, December 5, 2007 at 08:15 (Pre-registration on Tuesday, December 4) and it closes on Friday, December 7, at 16:00, including the Extra Session on Microdosing.

Scope & Aim
Building on the outcomes of the highly successful 2006 Conference, on how to make use of biosimulation, biomarkers, modelling and systems biology in streamlining drug development, the aim of the 2007 Conference is to further develop visionary and timely integration of systems approaches into pharmaceutical sciences. Objectives of it include:

To present and discuss scientific progress that will support and strengthen cutting-edge research in drug discovery, development and translational medicine, such as:

• Approaching biosystems
• Biosimulation and “virtual” organs
• Model building and components of
• The full clinical trial simulation
• Integration for exploratory development, including simulating drug development plans
• Microdosing
• Other relevant R&D stimulating initiatives

To communicate progress of impacting governmental and public-private initiatives and projects, in improving drug therapy for human, including the:

• InnoMed/IMI JU (Innovative Medicines Initiative Joint Undertaking)
• The Biosimulation Network of Excellence (BioSim)
• The European Microdose AMS (Accelerator Mass Spectroscopy) Partnership Programme (EuMapp)
• The (Dutch) Top Institute Pharma
• US Critical Path Initiative
• Biomedical Innovation and Systems Biology Contributions

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, breakout discussion sessions, poster sessions and general discussion sessions for conclusions and recommendations.

Breakout Session Topics
Time will be devoted to parallel breakout sessions. Discussion topics considered are:

• Translational pharmaceutical sciences
• Modelling and simulation as risk mitigation tool
• Harmonising and sharing quality data management
• Software/libraries/systems for models and simulations
• How to arrive at a global regulatory strategy for model based drug development
• Education and training
• Integration of company research: What and when
• R&D organisation: How and when

Scientific Planning Committee
Ole J Bjerrum, Copenhagen DK
Fritz R Bühler, Basel CH
Anne Marie Clemensen, Lyngby DK
Morten Colding-Joergensen, Bagsvaerd DK
Meindert Danhof, Leiden NL
Hartmut Derendorf, Gainesville FL USA (Co-chair)
Igor Goryanin, Edinburgh UK
Rajesh Krishna, Princeton NJ USA
Lawrence J Lesko, Silver Spring MD USA
Hans H Lindén, Stockholm SE
Erik Mosekilde, Lyngby DK (Co-chair)
Christian R Noe, Vienna AT (Co-chair)
Carl Peck, Washington DC USA
Ian C Ragan, London UK
Malcolm Rowland, Manchester UK
Hans Günter Schaefer, Biberach An Der Riss DE
Thomas Senderovitz, Braine-l’Alleud BE
Donald R Stanski, Basel CH
Steffen Thirstrup, Copenhagen DK
Hans Westerhoff, Amsterdam NL
Michael Zuehlsdorf, Basel CH

Poster Contributions
Scientific contributions relating to the aim and objectives of the Conference will be welcome and considered for poster presentations. Abstracts should be submitted to the EUFEPS Meetings & Events Secretariat, both as an email attachment and as a hard copy. Submission deadline is October 31, 2007.

Click for Editorial Instructions.

Exhibition Contributions
Companies are welcome to participate as exhibitors at this Conference. The Conference delegates are academics, industrialists, regulators and students, which will provide an opportunity to meet experts in this new field. The exhibition offers every opportunity to promote and position companies, relevant products and services, expertise and specialists, facilitating contacts and interactions, including predicting their needs and shaping future collaboration.

Health Links has been contracted as the Exhibition Organiser. Please direct all inquiries regarding exhibition to Health Links (channey@health-links.co.uk), Windsor House, 11A High Street Kings Heath, Birmingham B14 7BB, United Kingdom, Tel No +44 208 7496471, Fax No +44 121 2483390.

Sponsorship Contributions
To sponsor this Conference and by this enable additional quality meetings on key topics, contact the Executive Director, Hans H Lindén (hans.linden@eufeps.org) or the Project Manager Annika Nyman (annika.nyman@eufeps.org).

Organisers
This Conference is organised by the European Federation for Pharmaceutical Sciences (EUFEPS), together with the European Biosimulation Network of Excellence (BioSim) and the EU Microdosing AMS Partnership Programme (EuMapp). It is 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).

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. For more information on EUFEPS and its activities, please visit the Conference Website EUFEPS Online at: www.eufeps.org

BioSim is a Network of Excellence established by the European Commission under its 6th Framework Programme. The main objective of the Network is to demonstrate how the use of modern simulation technique through a deeper and more quantitative understanding of the underlying biological, pathological and pharmacological processes can lead to a more rational drug development process, improved treatment procedures and a reduction in the needs for animal experiments. With its 26 academic, 10 industrial and 4 regulatory partners, the BioSim Network commands a wide range of biomedical expertise.

EuMapp is the European Union Microdose AMS Partnership Programme, funded by the European Commission. It gathers together 10 organisations from 5 different countries (United Kingdom, Sweden, The Netherlands, France and Poland) towards the certification of high and low voltage Accelerator Mass Spectrometry technique (AMS). In microdose studies, trace amounts of candidate substances for new medicines are administered to healthy volunteers and followed in the body. The aim is to evaluate microdosing for drug development and to arrive at recommendations about how and when it could and should be used.

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

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 north-western Switzerland, on the border with Germany and France, and 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 half-canton, in the Black Forest, and in Alsace.

Preliminary Programme

Wednesday, December 5, 2007

Welcome and Introduction

Conference Co-chairs

Session I: Approaching biosystems: How and why

Co-chairs: Christian R Noe, University of Vienna, Vienna AT &
Erik Mosekilde, Technical University of Denmark, Lyngby DK

• Identification and reverse engineering of biological systems:
  What can mathematics contribute?
  Heinz W Engl, University of Vienna, Vienna AT
• Biosimulation: The link between theory and experiment
  Morten Colding Jørgensen, Novo Nordisk A/S, Bagsvaerd DK
• Molecular correlation networks in systems biology and biomarker discovery  
  Robert N McBurney, BG Medicine Inc, Waltham MS USA

Session II: Biosimulation and virtual organs: Contributions and challenges

Co-chairs: Blanca Rodriguez, University of Oxford, Oxford UK &
Hans Westerhoff, Free University of Amsterdam, Amsterdam NL

• Multiscale modelling of drug-induced effects on cardiac activity
  Blanca Rodriguez, University of Oxford, Oxford UK
• CNS functional modelling: Parkinson’s Disease
  Peter Tass, Research Centre Jülich, Jülich DE
• The virtual patient: Biosimulation in anaesthesia
  Samsun Lampotang, University of Florida, Gainesville FL USA

Session III: Model building: The disease component

Co-chairs: Fritz R Bühler, ECPM, Basel CH & Igor Goryanin, The Edinburgh Centre for Bioinformatics, Edinburgh UK

• PhysioLab on Asthma
  Mikhail Gishizky, Entelos, Palo Alto CA US
• Pathway-based strategy for discovering oncology therapeutics: Integrating text mining, modelling and high content assay development
  Carolyn Cho, Pfizer, Cambridge MA USA
• Modelling ageing
  Speaker to be announced

Session IV: Model building: The patient population component

Co-chairs: Amin Rostami-Hodjegan, University of Sheffield and Simcyp Ltd, Sheffield UK & Steffen Thirstrup, Danish Medicines Agency, Copenhagen DK

• Individualised chronotherapy of cancer patients
  Francis Levi, INSERM, Paris FR
• Designing antidepressant clinical trials: The role of placebo response models and imaging biomarkers
  Roberto A Gomeni, GlaxoSmithKline, Verona IT
• Co-morbidity affecting PK: Regulators request and what’s available from modelling
  Steffen Thirstrup, Danish Medicines Agency, Copenhagen DK

Introduction to Breakout Sessions

Breakout Sessions A-B-C-D

Reception Buffet

Thursday, December 6, 2007

Welcome to the Second-Day Programme

Conference Co-chairs

Session V: Model building: The exposure response component (PK/PD)

Co-chairs: Meindert Danhof, Leiden University, Leiden NL &
Hans Günter Schaefer, Boehringer-Ingelheim, Biberach An Der Riss DE

• State-of-the-art PK/PD modelling: Theory and concepts
  Meindert Danhof, Leiden University, Leiden NL
• Using systems models in characterising exposure response
  Mats Karlsson, University of Uppsala, Uppsala SE
• The Industry perspective on pharmacometrics: Past, present and future
  Thorsten Lehr, Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield USA

Session VI: The full clinical trial simulation, incl. the drop-out issue

Co-chairs: Hartmut Derendorf, University of Florida, Gainesville FL USA & Carl Peck, Center for Drug Development Science, Washington DC USA

• Clinical trials simulation in drug approval
  Joga Gobburu, Food and Drug Administration, Silver Spring MD USA
• Trial simulation to facilitate decision  making in drug development
  Marc Pfister, Bristol Myers Squibb Research Institute, Princeton NJ USA
• Clinical trial simulations for anti-infective agents
  Johan W Mouton, Canisius-Wilhelmina Hospital, Nijmegen NL

Extra Session: Contribution of microdose studies

(to be continued in the afternoon of the third day)

Co-chairs: R Colin Garner, Xceleron, York UK &
Malcolm Rowland, University of Manchester, Manchester UK

• Physiologically based pharmacokinetic modelling as a tool to support interpretation of microdose studies
  Simon Thomas, Cyprotex, Macclesfield UK

Session VII: Integration for exploratory development, including simulating drug development plans: The helicopter view

Co-chairs: Thomas Senderovitz, UCB Pharma, Braine-l’Alleud BE & Donald R Stanski, Novartis, Basel CH

• Panel with short contributions and discussion

Breakout Sessions E-F-G-H

Poster Session – Drinks and Snacks

“Speakers Corner” and guided tour
Organisers: Anne Marie Clemensen, Technical University of Denmark, Lyngby DK & David Rand, Warwick University, Coventry UK

Friday, December 7, 2007

Welcome to the Third-Day Programme

Conference Co-chairs

Session VIII: Relevant R&D stimulating initiatives

Co-chairs: Ole J Bjerrum, University of Copenhagen, Faculty of Pharmaceutical Sciences, Copenhagen DK & Hartmut Derendorf, University of Florida, Gainesville FL USA

• InnoMed/IMI JU: Contributions to date and to come
  Representative, European Commission, Brussels BE
• PPP Dutch Top Institute Pharma: Bridging the gap
  Daan J A Crommelin, Top Institute Pharma, Leiden NL
• Visionary thinking about systems biology contributions
  Adriano M Henney, AstraZeneca, Macclesfield UK
• Seeking first to understand and then to be understood: A regulatory policy initiative for a better agency interaction in China
  Zili Li, Merck & Co, Rahway NJ USA
• The US Critical Path Initiative: Progress and plans
  Speaker to be announced
• EMEA initiatives to stimulate and facilitate drug developments
  Hans-Georg Eichler, EMEA, London UK
• How to utilise European and American initiatives for better drug development: Concepts, outcomes, training and plans
  Carl Peck, Center for Drug Development Science, Washington DC USA

Breakout Session Reports Discussion

Co-chairs: Christian Noe, University of Vienna, Vienna AT&
Erik Mosekilde, Technical University of Denmark, Lyngby DK 

• Conclusion and recommendations
• Wrap-up and farewell to those not staying for the Extra Session
  Hans Westerhoff, Free University, Amsterdam NL

Extra Session: Microdosing to learn and confirm quicker

Co-chairs: R Colin Garner, Xceleron, York UK
Rokus de Zeeuw, BEBO Foundation, Assen NL

• Molecular Dosing. NOAEL versus MABEL
  Colin Dollery, GlaxoSmithKline, Harlow UK
• Microdosing: What have we learned so far
  R Colin Garner, Xceleron, York UK
• Key safety issues in microdosing: Call for harmonisation to the regulatory authorities
  Rokus de Zeeuw, BEBO Foundation, Assen NL
• Regulatory aspects on microdosing
  Carolyn Belcher, Constella Group Ltd., Cambridge UK
• Discussion (with above panel) and wrap up
  Co-chairs: R Colin Garner, Xceleron, York UK  & Rokus de Zeeuw, BEBO Foundation, Assen NL
• Closing of the Extra Session

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)

Conference Registration Fees (Swiss Franc)

EUR 1 = CHF 1.5

* Gold Corporate Sponsorship Rate: 10 % reduction of fee/s
(AstraZeneca, GlaxoSmithKline, Pfizer)
* Silver Corporate Sponsorship Rate: 5 % reduction of fee/s
(Bayer HealthCare)

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.

Hotel Reservation

Hotel reservations can be made on-line or on the attached hotel reservation form. A number of hotel rooms have been reserved at hotels at preferential rates for the Conference. The hotels are all situated in the city centre of Basel and the Conference venue is accessible with public transportation or by foot.

The rates below are per room, per night, including breakfast and VAT.

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, 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 0797 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 Handelsbanken, Box 7190, SE-103 88 Stockholm, Sweden, BIC/SWIFT-code: HANDSESS, Account no: 43537979,
  IBAN No SE67 6000 0000 0000 4353 7979 in CHF to Congrex Sweden AB.
• Scandinavian residents may pay by bank transfer.
  Bank giro 224-7021.

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.

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, 2007, up to which date the total amount will be refunded less CHF 80 for administrative expenses. For cancellations made after October 31, 2007 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, 2007, up to which date no charge will be made less an administrative fee of CHF 80. We regret that after October 31, 2007, 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 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.

Website

For the latest information about the Conference, please see e.g. circulating announcements and updates on this website.

Alternatively, contact
EUFEPS Meetings and Events
PO Box 1136
SE-111 81 Stockholm
Sweden
Tel +46 8 7235000
Fax +46 8 4113217
Email conferences@eufeps.org

Useful addresses

EUFEPS Member Societies