When Variability Becomes an Issue in Drug Development:
How to Understand, Predict and Manage?

May 13-14 • 2008 • Centro Congressi GSK • Verona • Italy

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The Conference opens on Tuesday, May 13, 2008, at 09.00 (Pre-registration on Monday, May 12, 2008) and it closes on Wednesday, May 14, 2008, at 17.00.

Invitation
This Conference has been initiated by the EUFEPS Committee on Industrial Research Relations (CIRR) as a follow up of the very successful conference:
’When poor solubility becomes and issue: From early stage to proof of principles’, held in Verona on April 26-27, 2006. This 2008 conference addresses another important issue in the development of new medicines and it is intended for all those facing and dealing with variability problems and issues, including students and scientists entering onto this area.

Scope & Aim
Phase I/II clinical studies are designed to understand and predict the pharmacokinetic profile of a drug candidate in healthy volunteers and patients. However, many drug candidates show intra- and inter-subject variability in the pharmacokinetic and or pharmacodynamic profile raising critical questions concerning the achievable safety and efficacy profile of a drug candidate within the targeted broad patient population. Because the variability can have several reasons (e.g. poor or variable absorption, pre-systemic, first pass or systemic metabolism, drug-drug interaction, disease state, genetic predisposition etc.) it is of most importance to understand early on which variability can be managed within the drug development process and which cannot and, consequently, are at major risk to be discontinued in the later clinical development programme.

This EUFEPS conference will raise awareness of the variability in the pharmacokinetic profile and drug response, which becomes already visible in early clinical trials as a potential source and risk for the drug candidate developability. In this conference leading experts from the academia, pharmaceutical industry and regulatory bodies will provide insight into the various sources of variability, their measurements, predictions, risk assessments and practical approaches to overcome the variability. Furthermore, the variability is discussed from the view points of the different disciplines involved in the drug discovery and development process (clinicians, pharmaceutical scientists, regulatory bodies). Followed by some true cases studies from the industry the speakers including DMPK clinicians, pharmacologists, clinicians, formulation scientists and experts of regulatory authorities, who are dealing with and highly experienced in the understanding and assessing the risk of PK/PD variability of a drug candidate, provide the audience with the latest tools and guidance on drug discovery and development.

Conference Objectives and Attributes

• Bring together scientists from industry and academia and regulatory authorities and PhD students from the different disciplines of pharmaceutical sciences, preclinical development, biopharmaceutics, pharmacokinetics, clinical pharmacology, clinical trials design and statistics and in-silico modelling
• Raise awareness of variability in pharmacokinetic and drug response as an issue in drug discovery and development
• Review the various sources of variability and their impact on the developability of a safe and effective new medicine
• Discuss the existing tools to measure, understand its underlying root causes and predict (in-silico) the variability of a drug candidate
• Identify strategies to minimize and manage variability in a medicinal product
• Contribute to the understanding and integration of variability in drug candidate selection early on
• Encourage an open dialog and transfer of relevant knowledge between pre-clinical, clinical, formulation and regulatory scientists
• View posters offering unique experience and insight
• Meet in a learning environment, get conductive to thoughtful
  considerations and use the opportunity for scientific exchange

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 and Planning Committee
Dionigio Franchi, GlaxoSmithKline, Verona IT (Co-chair)
Malcolm Rowland, Manchester University, Manchester UK (Co-chair)
Sven Stegemann, Capsugel, Bornem BE (Co-chair)
Douwe D. Breimer, LACDR, Leiden NL
Henk de Jong, IRIS, Courbevoie FR
Mats Karlsson, University of Uppsala, Uppsala SE
Franck Leveiller, Novartis, Basel CH
Hans H. Lindén, EUFEPS, Stockholm SE
Yuichi Sugiyama, University of Tokyo, Tokyo JP
Geoffrey Tucker, University of Sheffield, Sheffield UK
Göran Westerberg, Sienabiotech, Siena IT

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.


Health Links has been contracted as the Exhibition Organiser.
Please direct all inquiries regarding exhibition and 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. Website www.health-links.co.uk

How to Apply for Space
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 Executive Director, Hans H Lindén (hans.linden@ eufeps.org) or the Project Manager Annika Nyman (annika.nyman@eufeps.org)

Poster contributions
Scientific contributions relating to the scope and aim of the Conference will be welcome and considered for poster presentations.

Click for Editorial Instructions.

Submission deadline is April 4, 2008.

Student Attendance Package
Funds are being raised for a Student Attendance Package, the objective of which would be to offer a substantial number of qualified students recruited from all (42) European countries, preferably, including free registration and free accommodation (3 nights) in Verona to participate in this Conference (up to 1/4 to 1/3 of the total number of delegates of 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 an additional student for free. If more money would be raised than actually needed, this money would be saved for new initiative, along the same lines, in a “EUFEPS Fund for Research Training and Education”. In any case, support for travel would have to be provided by the institution of the student and/or other local sources.

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 March 31, 2008, 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 April 2008.

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. For more information on EUFEPS and its activities.

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.

Preliminary Programme

Tuesday, May 13, 2008

Welcome and introduction
Daan JA Crommelin, Conference Co-Chair and EUFEPS President, Leiden NL
Malcolm Rowland, Conference Co-Chair, Manchester UK

Session I: Perspectives on variability in drug response
Co-chairs: Malcolm Rowland, University of Manchester, Manchester UK
Roberto A Gomeni, GlaxoSmithKline, Verona IT

• Quantifying variability: A basic introduction
  Mats O Karlsson, University of Uppsala, Uppsala SE
• How do clinicians perceive and act on variability in drug response?
  Jeffrey K Aronson, University of Oxford, Oxford UK
• How does an industrialist perceive variability in drug response and product performance?
  David Tainsh, GlaxoSmithKline, Harlow UK

Session II: Sources of variability in drug response
Co-chairs: Dionigio Franchi, GlaxoSmithKline, Verona IT
Mats O Karlsson, University of Uppsala, Uppsala SE

• How much does pharmacogenetics explain?
  Michel Eichelbaum, Institute For Clinical Pharmacy, Stuttgart DE
• What influence of the GI transit on sources of variability?
  Werner Weitschies, Ernst Moritz Arndt University of Greifswald, Greifswald DE
• How to put together a ‘systems approach’ to integrate sources of variability?
  Geoffrey T Tucker, University of Sheffield, Sheffield UK

Session III: Judging variability in clinical drug development
Co-chairs: Jeffrey K Aronson, University of Oxford, Oxford UK
David Tainsh, GlaxoSmithKline, Harlow Essex UK

• Is it possible to predict variability?
  Amin Rostami-Hodjegan, University of Sheffield and Simcyp Ltd, Sheffield UK
• Impact of pharmacokinetic and pharmacodynamic variability on clinical study design and program decision making
  Don Nichols, Pfizer, Sandwich UK
• Managing variability: How to use a model-base approach to improve clinical trial design?
  Roberto A Gomeni, GlaxoSmithKline, Verona IT
• Electronic monitoring of dosing histories usefully explains residual variability in PK/PD and delivers novel insight for therapeutic decision making
  Bernard Vrijens, University of Liège, Liège BE
• How can biomarker and co-variates be used in understanding and managing variability?
  Niclas Jonsson, Exprimo NV, Mechelen BE

Session IV: Variability in the regulatory review process
Co-chairs: Hendrik de Jong, I.R.I.S. Servier International Research Institute, Courbevoie FR
Michel Eichelbaum, Institute for Clinical Pharmacy, Stuttgart DE

• Variability in drug response: A European regulator’s view
  Bruno Flamion, University of Namur, Namur BE

Panel Discussion
Co-chairs: Douwe D Breimer, Leiden University, Leiden NL
Franck Leveiller, Novartis, Basel CH

Bus shuttle from Conference Center for a Welcome Dinner in Verona

Wednesday, May 14, 2008

Welcome to the Second-Day Programme
Daan JA Crommelin, Conference Co-Chair and EUFEPS President, Leiden NL
Malcolm Rowland, Conference Co-Chair, Manchester UK

Session IV – to be continued: Variability in the regulatory review process
Co-chairs: Hendrik de Jong, I.R.I.S. Servier International Research Institute, Courbevoie FR
Michel Eichelbaum, Institute for Clinical Pharmacy, Stuttgart DE

• How do EU regulators view personalised medicines?
  Gunnar Alvan, Medical Products Agency, Uppsala SE

Session V: The impact of dosage form and route of administration on variability in drug response
Co-chairs: Dionigio Franchi, GlaxoSmithKline, Verona IT
Werner Weitschies, Ernst Moritz Arndt University of Greifswald,
Greifswald DE

• Variability in oral administration: What is the formulator’s perspective?
  Oskar Kalb, Novartis Pharma AG, Basel CH
• How to reduce variability in gastro-intestinal absorption of poorly water soluble compounds through self-emulsifying formulations?
  Jan Vertommen, Capsugel, Bornem BE
• How to select physical form of a drug candidate to reduce variability?
  Erik Söderlind, AstraZeneca, Mölndal SE
• Performance of biopharmaceuticals: Sources of variability
  Daan J.A. Crommelin, Top Institute Pharma, Leiden NL

Session VI: Case Studies & Panel Discussion
Co-chairs: Malcolm Rowland, University of Manchester, Manchester UK
Sven Stegemann, Capsugel, Bornem BE

• Case 1:I s changing the administration route an option for reducing variability? A case study on a HIV-drug.
  Lieven Baert, Tibotec, Mechelen BE
• Case 2: Overcoming PK variability of poorly soluble compounds: A case study
  Marcel Schmid, F Hoffmann-La Roche, Basel CH
• Case 3: Wondering about dosage form impact variability: Case studies for discussion and identification of a way to get through
  Patrizia Ghiotti, GlaxoSmithKline, Verona IT

Panel Discussion including Outcomes
Sven Stegemann, Capsugel, Bornem BE
Clive G Wilson, Strathclyde Institute For Biomedical Science, Glasgow UK

Closing of the Workshop
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)

• See also ’Student Attendance Package’
• 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.

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

Inquiries
Please direct all inquiries regarding registration or payment to Congrex Sweden AB at: E-mail wvbi.registration@congrex.com
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.

Click for Hotel Registration Form (PDF)

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

The deadline for the receipt of the hotel reservation form is April 4, 2008. Requests received after this deadline will be taken into consideration but accommodation in the chosen hotel category cannot be guaranteed. Iantra will suggest other suitable accommodation.

Booking procedures and payment
For payment by Credit Card
The accommodation form must be sent to Iantra by fax, e-mail or post, quoting in the proper space the credit card data for the payment of the hotel reservation fee (€ 30,00 per room). The credit card data are necessary to guarantee the reservation.

Iantra will provide to charge the reservation fee on the card and pass the card data to the chosen hotel. No charge will be made on the card by the hotel unless cancellations after the deadline (April 12, 2008) or no-shows occur. In this case the hotel will provide to charge the card for the amount corresponding to one night stay. The payment of the complete stay will have to be settled at the hotel when checking-out. Accepted credit cards: VISA, MASTERCARD (see details in the accommodation form).

For payment by Bank-to-bank Transfer
The accommodation form must be sent to Iantra by fax or post accompanied by the bank transfer payment of the hotel deposit (corresponding to 1 night in the chosen hotel category) + reservation fee (€ 30.00 per room). The balance of the hotel accommodation must be settled directly at the hotel at check-out. The deposit will be deducted from the final payment. See bank data in the accommodation form.

Forms received without the corresponding payment or without credit card data will not be considered.Invoice for the reservation fee will be issued by Iantra S.r.l. Invoice/receipt for the complete stay will be issued by the hotel.

Payment Registration Fee
Please indicate your name and the payment reference number 0858 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. 6137-0434 84239, IBAN No SE24 6000 0000 0000 4348 4239 in EUR to Congrex Sweden AB.
• 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 Sweden AB only accepts 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 March 31, 2008, up to which date the total amount will be refunded less EUR 50 for administrative expenses. For cancellations made after March 31, 2008 we regret that no refunds can be made.

Cancellation of Hotel Reservation
Cancellations of the hotel accommodation must be sent in writing to Iantra S.r.l. Cancellations received by April 12, 2008 will be entitled to a complete refund (reservation fee excluded). There will be no refund for cancellations received after April 12, 2008.

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.

The IANTRA S.r.l. is a local company specialised in incentive trips, meetings, congresses and special events. The company is formed by a group of multilingual staff who made experiences through years of congress organisation, local and abroad.

Website
Forthe 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

EUFEPS Sponsors