Your Hosts |
International Pharmaceutical Federation (FIP)
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Board of Pharmaceutical Sciences (BPS)
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Endorsing Organisation
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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
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© FIP & EUFEPS,
2006-2007 |
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To register to this Workshop, click:
MAB
Workshop Online Delegate Registration Form
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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.
- 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?
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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. |
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» Thursday
» Friday
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| 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 |
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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) |
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Hotel Park Plaza Victoria Amsterdam
Damrak 1-5, 1012 LG Amsterdam
English will be the language of the Workshop. No simultaneous
translation will be provided.
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
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
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
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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 |
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. |
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Participants applying for student fees should include
proof of their student status (a photocopy of the university identity
card).
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 to your registration must be made in
writing and sent to Congrex Sweden AB by email or fax.
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
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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
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
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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). |
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