EUFEPS Conference on

October 8-10 • 2008 • Uppsala • Sweden

Scope & Aim & Objectives
Building on the outcomes of previous successful EUFEPS Conferences on drug transporters, compound profiling and lead optimisation, respectively, the scope of this new conference is drug transport and delivery and impact on the whole drug discovery and development process. It will focus on a number of critical issues in drug discovery and development of both small and large molecules. Special concerns for presentation and discussion during this meeting will be interpretation of data and how they are used to develop new molecular entities; when should certain methods and information be applied; what are the limitations of predictive tools today; and when do they make a difference in discovery and/or development. A particular aim of the conference is to provide a critical review of issues with respect to drug discovery, development and regulatory decision making processes.

The Conference opens on Wednesday, October 8, 2008, at 08:45 (Pre-registration on Tuesday, October 7) and it closes on Friday, October 10, at 13:30.

Conference Sessions
The Conference Programme includes Speaker and Breakout Sessions. Speaker Sessions are:

• What is the recent progress in understanding transport
  processes?
• How successful is drug (organ) targeting of small drugs
  and biologics?
• How to utilise preclinical data mining including on
  drug transport in decision-making for the clinical phase?
• What is there to help to assess the impact on cellular,
  organ and whole body PK-PD?
• Clinical Assessment: What are the needs for the
  successful development of new therapies (medicines)
  under consideration of transport processes?
• Bringing it all together towards future challenges (panel
  discussion with delegates)

Specific objectives
To present and discuss scientific progress in the application of cutting edge technologies and processes in drug discovery and development such as:

• Active and passive transport processes of small and
  large molecules
• Early ADMET understanding
• Drug and specific tissue targeting, including
  nanotechnologies and delivery of RNAs
• In vivo imaging techniques and applications and
  interpretation in development
• Information management and data mining, as key
  elements in physiological based modelling and systems
  biology
• Discovery-development interface and regulatory
  challenges, including quantity-quality success
• and decision making in a complex environment

To contribute to common understanding of achievements, needs and trends in more successful discovery and development of innovative drugs

• Experiences with new R&D models: Learning and
  confirming
• Bridge building between R&D and academia
• Governmental initiatives

Scientific and Advisory Committee
Manfred Kansy (Co-chair), F Hoffmann-La Roche, Basel CH
Hans Lennernäs (Co-chair), Uppsala University, Uppsala SE
Patrick Couvreur, Paris-Sud University, Paris FR
Monica Edholm, Medicinal Products Agency, Uppsala SE
Bernard Faller, Novartis, Basel CH
Jörg Huwyler, University of Basel, Basel CH
Roeline Jochemsen, IRIS, Paris FR
Karin Jorga, F Hoffmann-La Roche, Basel CH
Sverker Ljunghall, AstraZeneca, Södertälje SE
Malcolm Rowland, University of Manchester,
Manchester UK
Dennis Smith, Pfizer, Sandwich UK
Geoffrey T Tucker, University of Sheffield, Sheffield UK

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.

Click for Editorial Instructions.

Abstract submission deadline will be August 25, 2008.

Exhibition and Sponsorship Options
Companies are welcome to participate as exhibitors at this Conference, providing an opportunity to meet experts in this new field. It also offers every opportunity in facilitating contacts and interactions, including predicting needs and shaping future collaboration. Supporting this Conference by sponsorship will furthermore, enable additional useful initiatives and events on this and additional key topics by EUFEPS.

To exhibit and/or sponsor, contact the EUFEPS Project Manager, Annika Nyman (annika.nyman@eufeps.org),
or the EUFEPS Executive Director, Hans H Lindén
(hans.linden@eufeps.org), or Health Links directly for exhibition (full address below).

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

Organiser
EUFEPS (European Federation for Pharmaceutical Sciences) was founded 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. In addition, there are member institutions and around 500 Individual Members of EUFEPS.

Additional Informations
For more information, see circulating announcements and updates on the Conference Website (see top of column). 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

Preliminary Programme

Wednesday, October 8, 2008

Welcome, Introduction and Opening Remarks
Hans Lennernäs, Conference Co-Chair, Uppsala University, Uppsala SE
Daan JA Crommelin, EUFEPS President, Leiden NL

Session I: What’s the recent progress in understanding transport processes?

Session Co-Chairs: Bernhard Faller, Novartis, Basel CH
Hans Lennernäs, Uppsala University, Uppsala SE

• Transporters and enzyme interplay
  Brian Houston, University of Manchester, Manchester UK
• Mechanistic modelling of hepatic transport from cells to whole body: Application to napsagatran and fexofenadine
  Agnès Poirier, F Hoffmann-La Roche, Basel CH
• Novel cell-based models for studying the interactions of drugs with transporters
  Ismael Hidalgo, Absorption Systems, Exton PA USA
• Multidrug resistance: Insights with thermodynamics
  Anna Seelig, University of Basel, Basel CH
• Passive permeability and active transport models to predict oral absorption
  Per Artursson, Uppsala University, Uppsala SE
• How important are the influences of BBB transporters in determining CNS drug penetration and potency?
  David Begley, Kings College, London UK
• Discussion

Session II: How successful is drug organ targeting of small drugs and biologics?

Session Co-Chairs: Jörg Huwyler, University of Basel, Basel CH Gert Fricker, University of Heidelberg, Heidelberg DE

• Brain targeting of biotherapeutics and non-viral gene therapies
  Ruben J Baodo, ArmaGen Technologies Inc, Santa Monica CA USA
• Strategies for intracellular delivery of nucleic acids and proteins
  Enrico Mastrobattista, Utrecht University, Utrecht NL
• Overcoming the blood brain barrier: Dreams and facts
  Gert Fricker, University of Heidelberg, Heidelberg DE
• Focal therapy of prostate cancer
  Hans Lennernäs, Uppsala University, Uppsala SE
• Pulmonary drug delivery
  Thomas Kissel, Philipps-Universität Marburg, Marburg DE
• Discussion

Parallel Breakout Sessions

Poster Session

Welcome Reception Dinner Buffet

Thursday, October 9, 2008

Welcome to the Second-day Programme
Manfred Kansy, Conference Co-Chair, F Hoffmann-La Roche, Basel CH

Session III: How to utilise preclinical data mining including on drug transport in decision-making for the clinical phase?

Session Co-Chairs: Manfred Kansy, F Hoffmann-La Roche, Basel CH
Dennis Smith, Pfizer Sandwich UK

• Biomolecular networks and transport: From massive data and information to relevant knowledge
  Johannes van Beek, Free University, Amsterdam NL
• On the increasing importance of data mining in drug discovery and development
  Manfred Kansy, F Hoffmann-La Roche, Basel CH
• From model generation to knowledge creation: Current challenges and tailor-made solutions to improve the PD-PK and safety profile in drug discovery
  Holger Fisher, F Hoffmann-La Roche, Basel CH
• Constraints of drug-like properties
  Paul D Leeson, AstraZeneca R&D, Charnwood UK
• Regions of ADME space occupied by transported compounds
  Dennis Smith, Pfizer, Sandwich UK
• Discussion

Session IV: What is there to help to assess the impact on cellular, organ and whole body PK-PD?

Session Co-Chairs: Roeline Jochemsen, IRIS, Paris FR
Bengt Långström, GE Health Care, Uppsala SE

• The use of in vitro models to understand the importance of transporters in drug disposition: A pharmaceutical industry perspective
  Tommy B Andersson, AstraZeneca, Södertälje SE
• Imaging techniques for drug transport: Pros and cons
  Bengt Långström, GE Health Care, Uppsala SE
• Microdosing in early prediction of PK in human
  Roeline Jochemsen, IRIS, Paris FR
• PK/PD predictions for monoclonal antibodies and biotherapeutics
  Frank-Peter Theil, Genentech Inc., San Francisco CA USA
• Translational magnetic resonance imaging and spectroscopy MRI/MRS in pharmaceutical R&D
  Marcus von Kienlin, F Hoffmann-La Roche, Basel CH
• Discussion

Parallel Breakout Sessions

Poster Session

Friday, October 10, 2008

Welcome to the Third-day programme
Clive G Wilson, Strathclyde University, Glasgow UK

Session V: Clinical Assessment: What are the needs for the successful development of new therapies (medicines) under consideration of transport processes?

Session Co-Chairs: Monica Edholm, Medicinal Products Agency, Uppsala SE
Clive G Wilson, Strathclyde University, Glasgow UK

• Windows of absorption
  Clive G Wilson, Strathclyde University, Glasgow UK
• Impact of transporters in early development: Lessons learnt
  Olivier Luttringer, Novartis Pharma AG, Basel CH
• Company and academia drug development
  Pekka Männistö, University of Helsinki, Helsinki FIN
• Regulatory aspects on drug transporters
  Monica Edholm, Medicinal Products Agency, Uppsala SE
• Strategies for new compartments
  Heyo K Kroemer, Greifswald University, Greifswald DE
• Discussion

Session VI: Bringing it all together towards future challenges (panel discussion with delegates)

Moderators: Monica Edholm, Medicinal Products Agency, Uppsala SE
Manfred Kansy, F Hoffmann-La Roche, Basel CH
Hans Lennernäs, Uppsala University, Uppsala SE

Closing Remarks

Registration & Accomodatioon
The registration fee includes all conference documentation, all coffee breaks, two lunches and the Welcome Reception Buffet. The cost for travel and hotel accommodation is not included in the registration fee.

Conference Registration Fees (SEK)
1 SEK = 0.10 EUR

• Gold Corporate Sponsorship Rate: 10 % reduction of
  fee/s (AstraZeneca, GlaxoSmithKline, Pfizer)
• Silver Corporate Sponsorship Rate: 5 % reduction of
  fee/s (BayerHealthCare)
• Exchange rate as of June 25, 2008

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

Useful Addresses

EUFEPS Member Societies

EUFEPS Sponsors

Conference Co-sponsors