EUFEPS 2nd MAB Workshop on:

June 3-5 • 2008 • Crowne Plaza • Heidelberg • Germany

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The Workshop opens on Tuesday, June 3, 2008, at 09:00 (Pre-registration on Monday, June 2) and it closes on Thursday, June 5, at 16:00.

Scope & Aim
Monoclonal antibodies are one of the most important classes of therapeutic proteins. Moreover, numerous monoclonal antibodies are under clinical evaluation for a broad range of important therapeutic areas including cancer, rheumatoid arthritis and infectious diseases. Significantly, classical Biotech companies are no longer the only players and traditional large Pharma companies have now also recognised the potential of monoclonal antibodies.
 
This Workshop will cover a broad spectrum of topics from the design and engineering of monoclonal antibodies, through process development (e.g. cell line optimisation and down stream processing), analytics, formulation aspects and manufacturing up to clinical applications. An important element of the Workshop will be the attention paid to current regulatory requirements for the introduction of monoclonal antibodies. Trends towards antibody fragments and aspects of safety and immunogenicity including protein aggregation will also be discussed.

Workshop Sessions

• Design of antibodies and antibody mimetics
• Upstream development
• Downstream development
• Physical characterisation and protein analytics
• Pharmacokinetics
• Safety and immunology
• Pharmaceutical aspects, protein aggregation and formulation by immobilization
• Clinical aspects
• Regulatory aspects
• New trends/Market development

Format and Preliminary Programme
Key segments of the processes are broken down into a number of sessions, each with lectures and discussions, as well as podium discussions on each day. Posters and exhibitions of related technologies. 

Scientific Planning Committee
Karoline Bechtold-Peters, Boehringer-Ingelheim Pharma GmbH &Co KG, Biberach an der Riss DE (Co-Chair)
Daan J.A. Crommelin, Dutch Top Institute Pharma, Leiden NL
Wayne Gombotz, Omeros Corp., Seattle WA USA
Wim Jiskoot, Leiden/Amsterdam Center for Drug Research, Leiden NL
Hans H. Lindén, EUFEPS, Stockholm SE
Barry D Moore, XstalBio, Glasgow UK
Sven Stegemann, Capsugel, Bornem BE
Jan van de Winkel, Genmab, Utrecht NL

Poster Contributions
Scientific contributions relating to the scope and aim of the Workshop 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 April 30, 2008.

Student Bursaries
There will be a number of bursaries for Students at this Workshop, in the amount of EUR 350 each for which sponsorship is being sought. To qualify, 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 April 30, 2008, to the EUFEPS Secretariat, attention Annika Nyman (for address se ‘Useful Addresses’). Review of documents received and selection of students will be done by a special committee during May 2008.

Exhibition and Sponsorship Options
Companies are welcome to participate as exhibitors at this Workshop, 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 Workshop by sponsorship will, furthermore, enable additional useful initiatives and events on this and additional key topics, by EUFEPS and EAPB.

To exhibit and/or sponsor, contact the EUFEPS Project Manager, Annika Nyman (annika.nyman@eufeps.org), the Executive Director, Hans H Lindén (hans.linden@eufeps.org) or the President, Daan J.A. Crommelin (daan.crommelin@tipharma.com).

Organisers
EUFEPS (European Federation for Pharmaceutical Sciences) 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.

EAPB (The European Association of Pharma Biotechnology) is a non-profit association dedicated to the advancement of biotechnology in pharmaceutical sciences, specifically as applied to industrial materials, processes, products and their associated problems. Its members constitute scientists employed in industry, government and university laboratories, biotech companies and scientific organisations.

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

Photo: German National Tourist Board/Mayer, Heidelberg/Neckar: historical ’’Zum Seppl’’ student pub

Heidelberg
Heidelberg is located in Southeastern Germany along the Neckar river, in the region of Baden Wurttemberg, an hour south of Frankfurt. Heidelberg is part of Germany’s ”Castle Road.” Flanked by major rivers, Heidelberg is conveniently located between the majestic Langeberg mountains and the sea. This beautiful country town, on the banks of the Duivenhoks River, is a small, tranquil town with friendly people, good schools and a modern infrastructure. With its population of 6415, Heidelberg offers a quiet, rustic atmosphere in an area that is still unexplored by many.

Preliminary Programme

Tuesday, June 3, 2008

Welcome, Introduction and Opening Remarks
Karoline Bechtold-Peters, Co-Chair, Boehringer-Ingelheim Pharma GmbH & Co KG, Biberach an der Riss DE
Wim Jiskoot, Co-Chair, Leiden/Amsterdam Center for Drug Research (LACDR), Leiden NL
Daan JA Crommelin, EUFEPS President, Leiden NL

Keynote presentation

• Evolving technologies of antibody engineering
  Michael Neuberger, Trinity College Cambridge, Cambridge UK

Session I: Design of antibodies and antibody mimetics
Chairman: Jan GJ van de Winkel, Genmab A/S, Utrecht NL

• SMIP, highly-specific, single-chain polypeptide therapeutics
  Alan Wahl, Trubion Pharmaceuticals Inc., Seattle WA USA
• Single domain camel antibodies
  Serge Muyldermans, Free University of Brussels, Brussels BE

Session II: Upstream development
Chairman: Sven Stegemann, Capsugel, Bornem BE

• Automation in antibody discovery and development
  Patrick van Berkel, Genmab BV, Utrecht NL
• Plant derived antibodies and how to overcome current challenges in post-translation
  Rainer Fischer, Fraunhofer-Institut für Molekularbiologie und Angewandte Oekologie, Aachen DE

Session III: Downstream development
Chairmen: Wayne R Gombotz, Omeros Corporation, Seattle WA USA
Wim Jiskoot, Leiden/Amsterdam Center for Drug Research, Leiden NL

• Use of membrane adsorbers for impurity removal
  Lee Allen, Lonza Biologics In, Slough UK
• Viral safety studies – Current views
  Klaus Kellings, NewLabs, Düsseldorf DE

Podium Discussion
(Prepared questions, participants to forward questions on cards, panel discussion)

Welcome Reception 
Bus shuttle from  the Crown Plaza for a Welcome Dinner at the ’Castle of Heidelberg’ –  a famous ruin in Germany and  landmark of Heidelberg. It is located 80 m (262 feet) on the hillside of the Königstuhl hill and from there it dominates the sight of the town....

Wednesday, June 4, 2008

Session IV: Physical characterisation and protein analytics
Chairman: Barry D Moore, XstalBio, Glasgow UK

• Mass spectrometry for assessment of protein hererogeneity during process development
  Niklas Engler, F Hoffmann – La Roche, Basel CH
• Rapid assay development for high throughput antibody development
  Bob Bailey, Amgen Inc, Seattle WA USA

Session V: Pharmacokinetics
Chairman: Jan GJ van de Winkel, Genmab A/S, Utrecht NL

• Predicting the exposure and effect of monoclonal antibodies using PK-PD modelling
  Bart Ploeger, LAP&P Consultants BV, Leiden NL
• Antibody transport across biological barriers
  Mark Gumbleton, University of Cardiff, Cardiff UK 

Session VI: Safety and immunology
Chairman: BKaroline Bechtold-Peters, Boehringer-Ingelheim Pharma GmbH & Co Kg, Biberach an der Riss, DE

• Immunogenicity of cytokine-modulating biopharmaceuticals –
  an inconvenient truth
  Klaus Berndtzen, Laboratory of Medical Immunology, University Hospital, Copenhagen DK
• Report on the Tegenero case
  Nicki Panoskaltsis, Imperial College London, Northwick Park & St Mark’s Campus UK

Session VII: Aggregates and protein immobilization
Chairman: Wim Jiskoot, Leiden/Amsterdam Center for Drug Research, Leiden NL

• Aggregation of monoclonal antibodies – mechanism, thermodynamic driving forces and kinetics
  Eva Y Chi, University of Chicago, Chicago IL USA
• Exploiting precipitation and crystallization of monoclonal antibodies for drug development
  Karoline Bechtold-Peters, Boehringer-Ingelheim Pharma GmbH & Co KG, Biberach an der Riss DE

Podium Discussion
(Prepared questions, participants to forward questions on cards, panel discussion)

Wine Reception 
Poster Session and Exhibition

Thursday, June 5, 2008

Session VIII: Pharmaceutical aspects
Chairman: Barry D Moore, XstalBio, Glasgow UK

• High Throughput Formulation of monoclonal antibodies
  Tudor Arvinte, University of Geneva, Geneva CH
• Formulation of biologics in relation to bulk storage options
  Satish K Singh, Pfizer Global Biologics Inc, Chesterfield MO USA

Session IX: Clinical aspects
Chairman: Heiko E von der Leyen, Hannover Clinical Trial Center GmbH, Hannover DE

• Transition from early phases to phase III
  TBA
• Development of a novel therapeutic antibody directed against MRSA
  Knut Ohlsen, University of Würzburg, Würzburg DE

Session X: Regulatory aspect
Chairman: Sven Stegemann, Capsugel, Bornem BE

• Monoclonal antibodies and high-risk medicinal products
  Jan Müller-Berghaus, Paul-Ehrlich-Institut, Langen DE
• Is the biosimilar paradigm applicable to monoclonal antibodies?
  Huub Schellekens, Department of Pharmceutical Sciences,
  Utrecht University, Utrecht NL

Session XI: New trends/Market development
Chairman: Inge Mühldorfer, Rentschler Biotechnologie GmbH, Laupheim DE

• Therapeutic antibodies: Trends and future developments
  Jan GJ van de Winkel, Genmab A/S, Utrecht NL

Podium Discussion
(Prepared questions, participants to forward questions on cards, panel discussion)

Concluding remarks

Location 
The Workshop will take place at the Hotel Crowne Plaza which is situated right in the heart of the picturesque city of Heidelberg, Kurfuerstenanlage 1, D-69115 Heidelberg, Germany.
Tel  +49 6221 917661, Fax +49 6221 917659

How to get there  
From the International Airport Frankfurt Main

• 80 km distance to the Hotel Crowne Plaza
• Bus shuttle (leaving every hour between 08.00-22.30 from Terminal 1), travelling time 60 minutes at an approximate cost of EUR 20
• Taxi , travelling time around 60 minutes at an approximate cost of EUR 100
• Train, travelling time around 55 minutes at an approximate cost of EUR 22

From  the International Airport Stuttgart

• 125 km distance to the Hotel Crowne Plaza 
• Train, travelling time around 90 minutes at an approximate cost of EUR 25

Train
1 km distance from the Heidelberg Main Station to the Hotel Crowne Plaza. Taxi, travelling time around 5 minutes at an approximate cost of EUR 5

Registration 
The registration fee (EUFEPS Membership 10% reduction) includes all workshop 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 Workshop 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: E-mail mab08.registration@congrex.com
Phone +46 8 459 66 00 Fax +46 8 661 91 25

Workshop Registration Fees (EUR)  

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

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 Workshop. The hotels are all situated in the city centre of Heidelberg and the Workshop 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 full pre-payment of the total cost of the accommodation. Congrex Sweden AB reserves the right to book another hotel if the desired accommodation should be fully booked. After April 30, accommodation and rates will be confirmed according to availability.

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.

Click for Hotel Registration Form (PDF)

Payment Registration Fee and Hotel Accommodation 
Please indicate your name and the payment reference number 0859 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.
• Swedish residents may pay by bank transfer. Bank giro 224-7021.
  As from 3 weeks before the Workshop we only accept credit card as payment. Registrations will be confirmed when Congrex Sweden AB has received payment. Admission to the Workshop 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 Workshop. 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 April 30, 2008, up to which date the total amount will be refunded less EUR 50 for administrative expenses. For cancellations made after April 30, 2008 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 April 30, 2008.

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 Workshop activities.

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 addresses 

Workshop Registration and Hotel Reservation Congrex Sweden AB Attn: MAB08 PO Box 5619 SE-114 86 Stockholm, Sweden Phone: +46 8 4596600 Fax: +46 8 6619125 Email: mab08.registration@congrex.com Website: http://www.congrex.com	Workshop Venue Hotel Crowne Plaza Kurfuerstenanlage 1 D-69115 Heidelberg, Germany. Phone: +49 6221 917661 Fax: +49 6221 917659 Website: http://crowneplaza-heidelberg.de
EUFEPS Secretariat Attn. Annika Nyman PO Box 1136 SE-111 81 Stockholm, Sweden Phone: +46 8 7235000 Fax: +46 8 4113217 Email: conferences@eufeps.org	EAPB Secretariat Attn: Karoline Bechtold-Peters Kelchstrasse 31 D-12169 Berlin, Germany Phone: +49 30 83850696 Fax: +49 30 83850616 Email: info@eapb.org Website: http://www.eapb.org

EUFEPS Member Societies

EUFEPS Sponsors