EUFEPS Conference on

When Poor Solubility Becomes an Issue:
From Early Stage to Proof of Principles


April 26-27 2006 Centro Congressi GSK Verona Italy

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

Index

» Final Programme
» General Information (PDF)
» Click för Final Programme (PDF)
» Click for Registration on-line
» Click for Registration Form (PDF)
» Click for Hotel Registration Form (PDF)
» Click for Exhibition and Sponsorship Application (PDF)
» Useful Addresses
 
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The Conference opens on Wednesday, April 26, 2006, at 09:00 (Pre-registration on Tuesday, April 25) and it closes on Thursday, April 27, 2006, at 17.30.

Invitation
This Conference is a new initiative by the EUFEPS Committee on Industrial Relations (CIR). Obviously, it will address an important issue in the development of new medicines. It is intended for all those struggling with such problems, as well as for students and young scientists entering the field.

Scope and Aim
The pressing challenge pharmaceutical scientists (product-development scientists) have to face is the poor solubility of drug candidates. In a scenario where an increasing number of drug molecules are generated (high-throughput discovery screening methods, combinatorial synthesis, etc.), the impact of biopharmaceutical properties, including solubility, on drug development tend to be underestimated. Nonetheless, water insolubility can hamper or completely halt new drug development.

This Conference will explore the physicochemical and biopharmaceutical properties important in order to have a ”drugable” candidate together with formulation strategies to overcome insolubility-related hurdles during “hit-to-lead” research. In this EUFEPS conference highly experienced leaders from industry and academia in areas of preformulation, product development (pre-clinical and clinical) and in silico modelling will walk participants through the key tools available in order to recognise if a solubility problem would be an issue in the developability of a drug substance. Discussion sessions will facilitate open dialog among participants from drug discovery and development.

Conference Objectives and Attributes

  • Bring together scientists from industry and academia and PhD students from diverse disciplines of pharmaceutical sciences, physical pharmacy, biopharmaceutics, pharmacokinetics and modelling and clinical pharmacology
  • Understand the relevance of preformulation in processes of drug discovery and drug development
  • Review current techniques and strategies for drug candidate selection and formulation
  • Explore the linkage of in vitro and preclinical in vivo data to formulation performance in humans
  • Contribute to the development of tools for the prediction and measurement of drug-like properties and application in discovery
  • View Posters offering unique experience and insight
  • Meet in a learning environment conducive to thoughtful consideration and interaction

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.

Scientific & Planning Committee
Hendrik de Jong, I.R.I.S. Servier International Research Institute, Courbevoie FR; Dionigio Franchi, GlaxoSmithKline, Verona IT; Franck Leveiller, AstraZeneca R&D, Lund SE; Hans H. Linden, EUFEPS, Stockholm SE; Sven Stegemann, Capsugel, Bornem BE

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.

Click for Application and Contract form.

Sponsorship Opportunities
To sponsor this Conference and by this enable quality meetings on key topics, contact the Exhibition Organiser, Chris Hanney at Health Links (chrishanney@btclick.com) or the EUFEPS Executive Director, Hans H Lindén (hans.linden@eufeps.org).


To find out more about sponsorship and exhibition opportunites, please visit our partner Health Links.

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 February 20, 2006.

Click for Editorial Instructions.

Student Attendance Package
Funds are being raised for a Student Attendance Package. It is a new EUFEPS initiative, which would provide a substantial number of qualified students from all European countries to attend this Conference. The package would include free registration and free accommodation (3 nights). The minimum target number of participating students would equal one student per European country (42), but more would be welcome (up to 1/4 to 1/3 of the total number of delegates at the conference). Also, should EUFEPS Member Societies want to support some student(s), i.e. pay for student registration and accommodation, this would entitle the same society to an additional student for free. If more money would be raised than actually needed, this money would be saved for new initiatives, along the same lines, in a “EUFEPS Fund for Research Training and Education”.

To qualify for this Conference, students should be PhD or Master Degree Students, who submit a recommendation letter from supervisor + a short biography + an up to one page poster abstract or an up to one page description of interest area and work performed by the student as part of the PhD or Master Programme, by January 31, 2006, to the EUFEPS Secretariat, attention Annika Nyman (for address, see ”Useful Addresses”). Review of documents received and selection of students will be done, by a special committee, during February 2006.

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 around 600 individual members of EUFEPS.

Verona
We would like to welcome you to Verona, which is the city of the most famous lovers in history: Romeo and Juliet. Verona has much more to offer and one of the most famous monuments in town is the Roman Amphitheatre, commonly known as The Arena. This Roman theatre is one of the biggest (and best preserved) theatres from the Roman Empire times. There are place for more than 22,000 spectators. Nowadays world famous operas are performed in the Theatre every summer. Although the building is now used for operas and other cultural shows, its original use was crueller: the famous Gladiators fights. In front of the Arena you will find the ’Piazza Bra’ and in front of this square you have the ’Palazzo Barbieri’ which is the Town Hall finished in 1883. Other interesting buildings are the ’Gran Guardia’ Palace, a 1610 Sanmicheli inspired building, and the ’Palazzo Guastaverza’, a Sanmicheli work.

Final Programme

Wednesday, April 26, 2006

Welcome, Introduction and Opening Remarks
Christian R Noe, EUFEPS President, University of Vienna, Vienna AT; Franck Leveiller, Conference Chairman, AstraZeneca R&D, Lund SE

Keynote presentation: Overview on solubility and bioavailability issues
Gordon L Amidon, University of Michigan, Ann Arbor MI USA

Session I: Physical/chemical properties of the drug substance
Chairman: Hendrik de Jong, Servier International Research Institute, Courbevoie FR

  • Understanding solubility of the molecules
    Andrea Casazza, GlaxoSmithKline, Verona IT
  • Crystal structure, polymorphism
    Ingvar Ymen, AstraZeneca R&D, Södertälje SE
  • Structural aspects of salt formation: Salt as supramolecular entities
    Dimitris Papoutsakis, Novartis Institutes for BioMedical Research, Cambridge MA USA
  • Crystal engineering and particle design
    Peter York, University of Bradford, Bradford UK

Session II: Biopharmaceutical evaluation focused on drug substance selection
Chairman: Valentino J Stella, University of Kansas, Lawrence KS USA

  • In vitro absorption models to assess drug absorption
    Brian Henry, Pfizer Global R&D, Sandwich UK
  • Prediction of human oral absorption, in drug discovery, using in silico models
    Ronnie Patersson, AstraZeneca R&D, Charnwood, Leicestershire UK
  • Simulation of GI tract absorption
    GlaxoSmithKline, Hertfordshire UK
  • Biopharmaceutical tools to assess developability of poorly soluble drug substances
    Jan Van Gelder, Lilly Development Centre, Mont-Saint-Guibert BE
Session III: Drug candidate selection
Chairman: Sven Stegemann, Capsugel, Bornem BE
  • Influencing candidate selection to minimise development impact
    Christopher Spancake, GlaxoSmithKline, Research Triangle Park NC USA
  • Strategies for lead drug substance optimisation: Drug delivery concepts
    Ward Smith, Pfizer Global R&D, Groton CT USA
  • Approaches for the rapid transition of drug substances and formulations into human studies
    Ian Wilding, Pharmaceutical Profiles, Nottingham UK

Panel Discussion
Chairmen: Hendrik de Jong, Servier International Research Institute, Courbevoie FR, Sven Stegemann, Capsugel, Bornem BE, Valentino J Stella, University of Kansas, Lawrence KS USA

Bus shuttle from Conference Center for a Welcome Dinner at the ’Restaurant Teodorico’ – located on a hill in town with a striking view of Verona.

Thursday, April 27, 2006

Welcome and introduction of keynote presentation
Dionigio Franchi, GlaxoSmithKline, Verona IT

Keynote presentation: Strategies to overcome poor solubility
Valentino J Stella, University of Kansas, Lawrence KS USA

Session IV: Successful formulation strategies for bioenhancement
Chairman: William Charman, Monash University, Parkville Victoria AU

  • Nano-particles formulation of poorly soluble drugs
    Lennart Lindfors, AstraZeneca R&D, Mölndal SE
  • Cyclodextrins to enhance solubility
    Marcus Brewster, Janssen Pharmaceutica NV, Beerse BE
  • Lipids and the absorption of lipophilic drugs
    William Charman, Monash University, Parkville Victoria AU
  • Micellisation and microemulsions
    Jayne Lawrence, Kings College London, London UK
  • Self emulsified systems as drug delivery
    Hassan Benameur, Capsugel, Colmar FR
  • Sugar glass dispersions enhancing the dissolution rate of lipophilic drugs
    Erik HW Frijlink, Groningen University, Groningen NL
  • Modulation of bioavailability of carotenoids in humans
    Myriam Richelle, Nestle Research Center, Lausanne CH

Session V: Biopharmaceutical evaluation of drug delivery systems
Chairman: Peter York, University of Bradford, Bradford UK

  • In vitro dissolution systems: Bio relevant dissolution tests and a priori prediction of plasma profiles
    Jennifer B Dressman, Goethe University, Frankfurt DE
  • Evaluation of the in vivo performance of formulation principles:
    What to learn from imaging studies?
    Werner Weitschies, Ernest Moritz Arndt University, Greifswald DE
  • In vitro/in vivo correlation: Regulatory perspectives
    Carla Caramella, University of Pavia, Pavia I

Panel Discussion
Chairmen: William Charman, Monash University, Parkville Victoria AU, Jennifer B Dressman, Goethe University, Frankfurt DE, Dionigio Franchi, GlaxoSmithKline, Verona IT

Location
The Conference will take place in the Centro Congressi GSK, Centro Ricerche, Via A. Fleming 4, Verona IT.

Public transport from Verona Airport
Verona airport is situated just 12 km from the centre of town. It is accessible via car, bus, rail and taxi.

A shuttle-bus operates to and from Verona Railway Station and the Airport every 20 minutes from 06:10-23:35.

Taxi, travelling time around 15 minutes at an approximate cost of EUR 25.

During the Conference, a shuttle-bus service from the city center to the Centro Congressi GSK will be available.

Registration
The registration fee (EUFEPS Membership 10% reduction) includes all conference documentation, all coffee breaks, two lunches and one conference dinner. 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 (EUR)
(incl.VAT 20%)

EUFEPS EUFEPS
EUFEPS
EUFEPS
Members
before
February 20, 2006
Standard Fee
before
February 20, 2006
Members
after
February 20, 2006
Standard Fee
before
February 20, 2006
Industrial delegate
1080
1200
1400
1550
Academy delegate
630
700
840
930
Government delegate
630
700
840
930
Student delegate
270
300
360
400

See also ’Student Attendance Package’.

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 by email or fax.

Inquiries
Please direct all inquiries regarding registration or payment to Congrex at: E-mail wpsbi.registration@congrex.se Phone +46 8 4596600. Fax +46 8 6619125

Hotel Reservation
Hotel reservations can be made on the attached hotel reservation form. The hotels are all situated in the city centre of Verona and the Conference venue is accessible with shuttle bus transportation.

 Hotel Rates
  Single room Double room Breakfast Rate available until
****
EUR 120
EUR 143

included

March 15 , 2006
***
EUR 110
EUR 120
included March 15 , 2006
**
EUR 80
EUR 90
included March 15 , 2006


Send the enclosed hotel accommodation form to Iantra Viaggi sas, P.zza Donatori di Sangue, 5 - 37124 Verona (Italy), Phone +39-045 8303306, Fax +39-045 8388581, E-mail info@iantra.it

Click for Hotel Registration Form (PDF)

The deadline for hotel reservation is March 15, 2006. Requests received after this deadline will be taken into consideration, but accommodation in the chosen hotel category cannot be guaranteed. Iantra Viaggi will suggest other suitable accommodations. Iantra Viaggi will send a confirmation voucher only after receiving the hotel accommodation form and the payment of the hotel deposit + reservation fee. The voucher will specify the name and the address of the hotel, the amount already paid and the balance due. Please do not forget to indicate in the form an e-mail address or fax number where the confirmation can be sent to. Forms received without the corresponding payment will not be taken into consideration.

Payment Hotel Accommodation
For methods of payment, please see hotel accommodation form.

Payment Registration Fee
Please indicate your name and the payment reference number 0624 on all money transfers.

Congrex 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 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. 5936-8253269
    IBAN no SE68 5000 0000 05936825-3269
    in EUR to Congrex Sweden AB, Attn: WPSBI
  • 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 EUR to Congrex Sweden AB, wpsbi.registration@congrex.se. 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: WPSBI, 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, Congrex only accepts credit card as payment. Registrations will be confirmed when Congrex has received payment. Admission to the Conference is granted only if Congrex 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 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.
Cancellation of registration will be accepted until March 1, 2006, up to which date the total amount will be refunded less EUR 50 for administrative expenses. For cancellations made after March 1, 2006 we regret that no refunds can be made.

Cancellation of Hotel Reservation
Cancellations of the hotel accommodation must be sent in writing to Iantra Viaggi. Cancellations received by April 5, 2006 will be entitled to a complete refund (reservation fee excluded). There will be no refund for cancellations received after April 5, 2006.

General Information
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 Italy is EUR.

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.


Iantra Travel and Events is a young and dynamic company located in Verona, in Northern Italy. IANTRA is specialised in incentive trips, car launches, congresses and special events organisation. Iantra was born in October 1997 by the will of the Director of the congress and incentive department of a big Italian company, leader in the organisation of services and travels on national and international levels. The company is now formed by a multilingual group of experienced people, who have been working in this field for more than 15 years.


Founded in 1998, Health Links is a full service event organising company with a wealth of experience within the health, social and environmental sectors.

Useful Addresses

Registration
EUFEPS Secretariat Conference Venue
Congrex Sweden AB
Attn: WPSBI
PO Box 5619
SE-114 86 Stockholm, Sweden
Phone +46 8 4596600
Fax +46 8 6619125
Email wpsbi.registration@congrex.se
Website http://www.congrex.com

Attn: Annika Nyman
PO Box 1136
SE-111 81 Stockholm, Sweden
Phone +46 8 7235000
Fax +46 8 4113217
Email conferences@eufeps.org

Website www.eufeps.org

Facilities of the GlaxoSmithKline
Via A Fleming 4
IT-37135 Verona
ITALY
Hotel Reservation Exhibition and sponsorship information packages etc.  
IANTRA Viaggi s.a.s.
Piazza Donatori di Sangue, 5
IT-37124 Verona, Italy
Phone +39 045 8303306
Fax +39 045 8388581
Email info@iantra.it
Website http://www.iantra.it
Health Links
Attn: Chris Hanney
3rd Floor, Windsor House, 11A High Street
Kings Heath, Birmingham B14 7BB, United Kingdom
Phone +44 208 7496471
Fax +44 121 2483390
Email chrishanney@btclick.com
Website http://www.health-links.co.uk
 


The European Federation for Pharmaceutical Sciences – EUFEPS
SE-175 72 Järfälla (Stockholm) Sweden
Tel +46 8 50582040   Fax +46 8 4113217   Email secretariat@eufeps.org