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International Pharmaceutical Federation (FIP)
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Endorsing Organisation

Patron Category
Congress Secretariat
International Pharmaceutical
Federation
FIP Congress & Conferences
P.O. Box 84200
NL-2508 AE The Hague
The Netherlands
Tel +31 70 3021982
Fax +31 70 3021998
Email congress@fip.org
Website www.fip.org
© FIP & EUFEPS, 2006-2007

Post-Satellite by EAPB and EUFEPS

EAPB and EUFEPS Workshop on

Monoclonal Antibodies

April 26-27 • 2007 • Amsterdam • The Netherlands

To register to this Workshop, click:
MAB Workshop Online Delegate Registration Form

Scope and Aim

Monoclonal antibodies are one of the most important classes of therapeutic recombinant proteins. They 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 recombinantly manufactured 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 modification of antibodies by conjugation or subsequent glycosylation as well as their reduction in size to antibody fragments such as domain or single chain antibodies will also be discussed.

Topics Covered

  • New technologies for design of antibodies and engineering
  • Latest advancements in ustream development including expression systems and feed strategies
  • Downstream development including purification and recovery optimisation
  • Physical characterisation, formulation and delivery systems
  • Scale-up issues and production scale manufacturing
  • Analytics and specs
  • Clinical update (new antibody therapies), commercial impact and new trends
  • Pharmacokinetic and safety
  • Armed antibodies and new classes of antibodies or antibody derivatives
  • Future of antibody therapeutics: What are the next steps?

Scientific Planning Committee

Karoline Bechtold-Peters, Boehringer-Ingelheim, Germany (Co-Chair)
Wim Jiskoot, Leiden/Amsterdam Center for Drug Research (LACDR), The Netherlands (Co-Chair)
Daan J.A. Crommelin, Dutch Top Institute Pharma, The Netherlands
Hans H. Linden, EUFEPS, Stockholm, Sweden
Barry Moore, XstalBio, United Kingdom
Wayne Gombotz, Omeros Corp., USA
Jan van de Winkel, Genmab, The Netherlands
Sven Stegemann, Capsugel, Belgium


EAPB www.eapb.org

EAPB is a professional association dedicated to the advancement of biotechnology in pharmaceutical sciences, specifically as applied to industrial materials, processes, products and their associated challenges. Its members constitute scientists employed in industry, government and university laboratories, biotech companies and scientific organisations.



EUFEPS www.eufeps.org

Founded in 1991, the mission of EUFEPS 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, EUFEPS links 24 Member Societies in 24 European countries.





AAPS www.aaps.org

AAPS is a professional scientific society of more than 12,000 members employed in academia, industry,  government and other research institutes worldwide.  Founded in 1986, AAPS provides a dynamic international forum for the exchange of knowledge among scientists to enhance their contributions to public health.



FIP www.fip.org

FIP, founded in The Hague, more than 90 years ago, is the worldwide federation of national pharmaceutical, professional and scientific, associations, with a mission to represent and serve pharmacy and pharmaceutical sciences around the globe.  Through its member association, FIP connects, represents and serves more than a million pharmacists and pharmaceutical scientists around the world.

Preliminary Programme

Index

» Thursday
» Friday


Thursday • April 26, 2007

Welcome, Introduction and Opening Remarks
Keynote Presentation: Past, Present and Future of Antibody Therapeutics
Sir Gregory Winter, University of Cambridge, UK

Session I: New technologies for design of antibodies and engineering
Chairman: Jan van de Winkel, Genmab, NL

Glycoengineered therapeutic antibodies with increased FcgRIII binding affinity and enhanced biological activity
Pablo Umana, F. Hoffmann-La Roche, CH

Engineering antibody effector funtion
Carl Webster, Cambridge Antibody Technology, UK
Generating novel immuno-therapeutics for small bioactive compounds (haptens)
Andy Porter, Haptogen, UK
Session II: Latest advancements in upstream development including expression systems and feed strategies
Chairman: Sven Stegemann, Capsugel, BE
Human antibodies from transgenic birds
Robert Etches, Origen Therapeutics, USA
Qualitative and quantitative comparison of protein expression systems for the manufacturing of Mabs
Rainer Fischer, Frauenhofer-Institut für Molekularbiologie und Angewandte Oekologie, DE
Cell culture points-to-consider; a commercial perspective
Ben Bulthuis, Centocor, NL
Session III: Downstream development including purification and recovery optimisation
Chairman: Karoline Bechtold-Peters, Boehringer-Ingelheim, DE
Re-usable and disposable concepts in the chromatographic purification of Monoclonal Antibodies
Uwe Gottschalk, Sartorius, DE
Development of economic and robust downstream processes for therapeutic antibodies using platform technologies
Alexander Jacobi, Boehringer Ingelheim Pharma GmbH & Co. KG, DE
Bulk freezing/thawing technology
Gaël Péron, Stedim Biosystems, F
Session IV: Physical characterisation, formulation and delivery systems
Chairmen: Barry Moore, XstalBio, UK, and Wim Jiskoot, Leiden/Amsterdam Center for drug Research (LACDR), NL
Rapid physical characterisation tools in early development phase
Patrick Garidel, Boehringer-Ingelheim, DE
High concentration processing and formulation of Mabs – New and state-of-the-art approaches
Wolfgang Friess, University of Munich, DE
Novel dry powder antibody formulations
Jan Vos, XstalBio, UK
Case studies of antibody aggregation and high throughput formulation approaches
Tudor Arvinte, University of Geneva, CH
End of day I and panel discussion

Friday • April 27, 2007

Session V: Scale-up issues and production scale manufacturing
Chairman: Wayne Gombotz, Omeros Corp., USA
How to make successful technology transfers in Mabs production
Tim Clayton, Serono, CH
Implementing PAT (Process Analytical Technologies) in Mabs production
Jochen Strube, Bayer Technology Services, DE
Production of human monoclonal antibodies on the human cell-line PER.C6
Erik Hack, Crucell, NL
Session VI: Analytics and specs
Chairman: Daan JA Crommelin, Top Institute Pharma, NL
Setting specifications for Mabs – Regulatory perspective
Bernd Liedert, Paul Ehrlich Institute, DE
Application of analytical ultracentrifugation as an orthogonal method for protein size distribution analysis
James Andya, Genentech Inc., USA
Aggregates in biotech products – Regulatory expectations for aggregates
Elizabeth Leininger, StemCells, USA
Session VII: Clinical update (new antibody therapies), commercial impact and new trends
Chairman: Jan van de Winkel, Genmab, NL
Anti-IL12p40 antibody development and clinical data
Trudi Veldman, Abbott, USA
Ofatumumab, a novel human CD20 antibody for treatment of lymphoid malignancies and inflammation
Jan van de Winkel, Genmab, NL
Commercial impact and potential of Mab products and Mab production
Andreas Werner, Boehringer Ingelheim, DE
The next generation of recombinant immunotoxins
Stefan Barth, Fraunhofer Institute IME-MB, DE
Session VIII: Pharmacokinetics and safety
Chairman: Wim Jiskoot, Leiden/Amsterdam Center for Drug Research (LACDR), NL
Clinical consequences of development of antibodies to therapeutic monoclonal antibodies
Lucien Aarden, Sanquin, NL
Global immunogenicity assessment of antibody therapeutics
Philippe Stas, Algonomics, BE
Safety assessment of monoclonal antibody products – Perspective on preclinical requirements to support the determination of safe use conditions
Jim Green, Biogen Idec, USA
Session IX: Armed antibodies and new classes of antibodies or antibody derivatives
Chairman: Wayne Gombotz, Omeros Corp., USA
Conjugated antibodies – Overview and case study on Mylotarg
Boris Gorovits, Wyeth, USA
A novel therapeutic antibody format
Paul Parren, Genmab, DK
Potent immunoconjugates for cancer therapy
Peter Center, Seattle Genetics, USA
Discussion Forum: Future of antibody therapeutics/what are the next steps?
(Prepared questions, participants to forward questions on cards, panel discussion)

Location

Hotel Park Plaza Victoria Amsterdam
Damrak 1-5, 1012 LG Amsterdam

Language

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

Poster contributions

Scientific contributions relating to the scope and aim of the Workshop are welcome and will be considered for poster presentations. Abstracts should be submitted via this website. The maximum length of the abstract text is 2000 characters. Submission deadline is February 28, 2007.

Click here for online Abstract Submission


Exhibition Information

Exhibitors are welcome to participate in this Workshop. The Workshop 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. For exhibition information, please contact

Chris Hanney
Health Links Inc.

3rd Floor, Windsor House
11A High Street
Kings Heath, Birmingham B14 7BB
United Kingdom
Tel +44 121 2483399
Fax + 22 121 2483390
Email chrishanney@btblick.com
Website www.health-links.co.uk

Sponsorship Information

To sponsor this Workshop, and by this enable additional quality meetings on key topics, contact
Hans H. Linden
EUFEPS
PO Box 1136
SE-111 81 Stockholm
Sweden
Tel + 46 8 7235025 or +46 708 799813
Email hans.linden@eufeps.org
Website www.eufeps.org

 

Registration

For registration fee, see table below (including 19 % VAT). EAPB or EUFEPS Members will receive 10% reduction. Should they – or other – also register to the PSWC2007, there is an additional reduction. The fee includes all Workshop documentation, all coffee breaks and meals. The cost for hotel accommodation and travel is not included in the registration fee.

To register to this Workshop, click:

MAB Workshop Online Delegate Registration Form

Workshop
Registration Fees
EUR
(Incl. VAT 19%)
EAPB & EUFEPS EAPB & EUFEPS PSWC2007 Delegates EAPB & EUFEPS EAPB & EUFEPS PSWC2007 Delegates
Members
before
February
28, 2007
Standard before
February
28, 2007
Registered to PSWC 2007 as well
before
February
28, 2007
Members
after
February
28, 2007

Standard
after
February
28, 2007

Registered to PSWC 2007 as well
after
February
28, 2007
Industrial Delegate € 1060 € 1180 € 965 € 1430 € 1605 € 1180
Academy Delegate € 560 € 620 € 490 € 740 € 810 € 620
Government Delegate € 560 € 620 € 490 € 740 € 810 € 620
Student Delegate € 200 € 225 € 165 € 250 € 300 € 225


Payment

Please indicate your name and 0752 (Payment reference number) on your money transfer.
 
Account holder: Congrex Sweden AB, Att: EUFEPS MAB 2007, 
P.O.Box 5619, SE-114 86 Stockholm, Sweden
 
Bank: Handelsbanken, Box 7190 SE-103 88 Stockholm, Sweden
Swift/BIC-code: HANDSESS
Account no: 6137-043484239
IBAN no: SE24 6000 0000 0000 4348 4239
 
Please note that you need to send a copy of your bank transfer when made later than March 30th 2007.

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, accommodation and administration support. Please direct all inquiries regarding registration, accommodation or payment to Congrex Sweden AB at: mab.registration@congrex.com
Tel +46 8 4596600
Fax +46 8 6619125

Hotel Reservation

For accommodation, please take advantage of the Hotel Reservation procedures of the PSWC 2007, provided by the RAI Hotel & Travel Service.
For online hotel reservation, click: Hotel booking PSWC2007 online


Useful addresses

European Federation for Pharmaceutical Sciences
EUFEPS Secretariat

PO Box 1136
SE-111 81 Stockholm
Sweden
Tel +46 8 7235000
Fax +46 8 4113217
Email conferences@eufeps.org
Website www.eufeps.org

European Association of Pharma Biotechnology
EAPB Secretariat

Kelchstraße 31
DE- 12169 Berlin
Germany
Tel +49 30 838 506 96
Fax +49 30 838 506 16
Email info@eapb.org
Website www.eapb.org

 

Organisers and Co-sponsors
Organisers of this PSWC 2007 Post-Satellite are the European Association of Pharma Biotechnology (EABP) and the European Federation for Pharmaceutical Sciences (EUFEPS), and it is co-sponored by the American Association of Pharmaceutical Scientists (AAPS) and the International Pharmaceutical Federation (FIP).