EUFEPS Conference
on
Optimising Biotech
Medicines:
Rational development of therapeutic proteins
Pre-satellite symposium
of the EUFEPS 2004 Conference
An unique discussion forum for scientists from the pharmaceutical
industry, regulatory agencies and academic institutions
October 14-15 •
2004 • Brussels Marriott Hotel
• Brussels •
Belgium
Scope
and aim
The pipeline for pharmaceutical proteins under development is
well filled. A recent survey indicated that, in particular,
a large number of therapeutic monoclonal antibodies and vaccines
are on their way to the market. In a number of aspects the development
process for these proteins is different from conventional, low
molecular weight active substances. But, what exactly, makes
pharmaceutical proteins different? Why do they stand out?
Pharmaceutical proteins are high molecular weight molecules,
with a secondary, tertiary and, sometimes, quaternary structure
mainly stabilised by rather weak physical forces. Moreover,
the many amino acids that make up the protein can readily undergo
chemical degradation reactions. The development process has
to be designed in such a way that these delicate structures
are stable during fermentation, purification, formulation, storage
and administration to the patient. The structure of the whole
molecule (not only the receptor binding site) should be preserved
during all stages ensuring the proper pharmacokinetic profile
and lack of immunogenicity (except for vaccines, of course).
At present, the parenteral route (‘stick to the needle’)
is the predominant route of administration for the majority
of proteins as bioavailability through other routes of administration
is still too low and too variable. But, now methods are emerging
to deliver pharmaceutical proteins through controlled delivery
technologies and to use needle-free and pulmonary inhaler systems
for protein administration.
Finally, therapeutic proteins may need special exploratory and
human development programmes, e.g. because many show a highly
species-specific therapeutic effect or bear a high similarity
to endogenous molecules.
In this EUFEPS conference different aspects of pharmaceutical
protein development will be discussed by experts, who actually
have developed pharmaceutical proteins and guided them through
the regulatory process. Emphasis will be put on new findings
and insights in the development process. To set the stage, present
and future of biotech medicines will be discussed in the opening
contribution. There will be break out sessions to give the delegates
the opportunity to discuss particular issues in detail with
their colleagues and invited experts. A conference report e.g.
highlighting issues for further discussion will be drawn up
and used by EUFEPS in support of its broad initiative ‘New
Safe Medicines Faster’
Sessions
of the Conference include:
-
Optimisation of the production process
-
Optimisation characterisation of therapeutic proteins
-
Delivery and formulation aspects
-
Rational exploratory and human development
-
Design and performance of antibodies as therapeutics
-
Regulatory issues and Conclusions
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. In the breakout sessions, the
session topics will be discussed further in smaller groups and
supplementary information added from the participants of the
session. Rapporteurs will present the breakout sessions summary
reports on the second morning of the Conference.
Scientific
& Planning Committee
Chair: Daan JA Crommelin, Utrecht NL
Additional Members: Tudor Arvinte, Geneva CH; Fritz
R. Bühler, Basel CH; Hendrik de Jong, Courbevoie
FR; Leo GJ de Leede, Leiden NL; Jim Faulkner,
Beckenham UK; Sven Frøkjaer, Copenhagen DK;
Claus-Michael Lehr, Saarbrücken DE; Hans H.
Lindén, Stockholm SE;
Exhibition
Information
Companies are invited to exhibit at the Conference. For information
on layout, costs etc., as well as an exhibition registration
form, please contact the EUFEPS Secretariat.
Call
for Posters
Scientific contributions relating to the conference topic will
certainly be welcome and considered for poster presentation.
Abstracts should be submitted to the EUFEPS Secretariat both
as an email attachment and as a hard copy, before August 16,
2004.
Clic for Editorial
instructions.
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 25 Member Societies in 24 countries.
Thursday,
October 14, 2004
Welcome
and Introduction
Ole J Bjerrum, EUFEPS President, Copenhagen DK
Daan JA Crommelin, Conference Chair, Utrecht NL
Setting
the Stage
Session
I: Optimisation of the production process
Moderator: Tudor Arvinte, Geneva CH
-
Value
through process optimisation - Fast track high quality development
Helmut Hoffmann, Biberach DE
-
Process
analytical technology (PAT) for biotech products: Relevance
to manufacturing optimization
Rick E Cooley, Indianapolis IN USA
Session
II: Optimisation characterization of therapeutic
proteins
Moderator: Daan JA Crommelin, Utrecht NL
- Analytical techniques
to establish therapeutic activity:
Progress in spectrometry
Tudor Arvinte, Geneva CH
- Analytical techniques
to establish therapeutic activity:
Progress in electrophoretic techniques
Michel Faupel, Basel CH
- Techniques to establish
therapeutic activity:
Progress in bio-assays
Ashvin K Patel, Beckenham UK
Session
III: Delivery and formulation aspects
Moderators: Jeroen Bezemer, Leiden NL, and Claus-Michael
Lehr, Saarbrücken DE
-
Protein
formulations: Bottlenecks and challenges
Daan JA Crommelin, Utrecht NL
-
Peptide
and protein PEGylation for an improved therapeutic value
Francesco M Veronese, Padua IT
-
Overcoming
cellular barriers with large molecules
Claus-Michael Lehr, Saarbrücken DE
-
Development
of a stable, long acting interferon alpha 2b formulation
Jeroen Bezemer, Leiden NL
-
Technologies
for protein delivery: Perspectives from industry
Pierandrea Esposito, Ivrea IT
Buffet
Dinner
-
Downstream
industrial processing aspects
-
Analytical,
delivery and formulation aspects including stability, route
of administration, specification setting
-
Human
clinical development/Regulatory aspects: Testing for immunogenicity
-
Antibodies
Friday,
October 15, 2004
Session
IV: Rational exploratory and human development
Moderator:
Ole J Bjerrum, Copenhagen DK
-
Transitional Research – the new bridge from Discovery
to Development
Samson Fung, Bagsvaerd DK
-
Comparability and bioequivalence issues regarding pharmaceutical
biologicals
Ralf Gleixner, Geneva CH
-
Leachables from uncoated rubber stoppers and their effect on
immunogenicity of proteins
Fred Bader, NJ USA
-
Immunogenicity of biotech products
Huub Schellekens, Utrecht NL
Short
reports of the Break-out Sessions
Session
V: Design and performance of antibodies
as therapeutics
Moderator: Fritz R Bühler, Basel CH
-
Human
antibodies as next generation therapeutics
Jan GJ van de Winkel, Utrecht NL
-
Case
study E:25
Steven J Shire, San Francisco CA USA
Session VI: Regulatory
issues and Conclusions
Moderator: Hendrik de Jong, Courbevoie FR
-
Similar
biological medicinal products: Where are we going?
Jacques Mascaro, High Wycombe UK
- Small molecules and
biologicals contrasting development issues
C Richard Jones, Basel CH
-
Regulatory
aspects
John Purves, London UK
Closing
of the Conference
Conference Chair: Daan JA Crommelin, Utrecht NL
Location
The Conference will take place at the Brussels Marriott Hotel,
Rue A. Orts 3-7, Brussels, BE-1000 Belgium. Tel no +32 2 5169090,
Fax no +32 2 5169000
How
to get there
To reach the Brussels Marriott Hotel from the Airport:
-
Taxi, travelling time around 25 minutes at an approximate
cost of EUR 30,-
-
Airport City Express train (four times per hour), to the Central
Station. Travelling time from airport approximately 20 minutes,
cost around EUR 3,-. From Central Station 10 minutes walking
distance to the Brussels Marriott Hotel.
-
Bus coach (three times per hour), to the Brussels Railway
Station, takes around 40 minutes to an approximate cost of
EUR 3,-
Registration
and Payment
Registration Online
or by Form.
Click
for Online Registration.
Or use the Registration
Form for the EUFEPS 2004, and return it to Congrex Sweden
AB, P.O. Box 5619, SE-114 86 Stockholm, Sweden, Fax No: +48
8 661 91 25, Email: eufeps2004.registration@congrex.se
The registration
fees on the Form, include all Conference documentation, all
coffee breaks, two lunches and one Buffet Dinner. The cost for
hotel accommodation and travel is not included in the registration
fee.
Reduced
Fee
Delegates attending this Conference on Optimising Biotech Medicines,
October 14-15, 2004, and the EUFEPS 2004, October 18-20, 2004,
will receive a discount of the Conference on Optimising Biotech
Medicines registration fee. The discount fee is specified in
the table, see below, as well as on the Registration Form.
| Conference
Registration FeesEUR
Excl. 21% VAT |
EUFEPS
Standard Fee
|
EUFEPS
Individual Member
|
EUFEPS
Standard Fee
|
EUFEPS
Individual Member
|
| Paid
until
July 1, 2004
|
Paid
until
July 1, 2004
|
Paid
after
July 1, 2004
|
Paid
after
July 1, 2004
|
Industrial
delegate
|
800
|
720 |
1000 |
900 |
If
also registering for EUFEPS 2004
|
400 |
360 |
500 |
450 |
Government/Academy
|
350 |
315 |
450 |
400 |
If
also registering for EUFEPS 2004
|
175 |
155 |
225 |
200 |
Students*
|
130 |
115 |
200 |
180 |
| If
also registering for EUFEPS 2004 |
65 |
55 |
100 |
90 |
| Conference
Registration FeesEUR
Incl. 21% VAT |
EUFEPS
Standard Fee
|
EUFEPS
Individual Member
|
EUFEPS
Standard Fee
|
EUFEPS
Individual Member
|
| Paid
until
July 1, 2004
|
Paid
until
July 1, 2004
|
Paid
after
July 1, 2004
|
Paid
after
July 1, 2004
|
Industrial
delegate
|
970
|
870 |
1200 |
1100 |
If
also registering for EUFEPS 2004
|
485 |
435 |
605 |
545 |
Government/Academy
|
425 |
380 |
545 |
485 |
If
also registering for EUFEPS 2004
|
210 |
185 |
275 |
245 |
Students*
|
160 |
140 |
240 |
220 |
| If
also registering for EUFEPS 2004 |
80 |
70 |
120 |
110 |
Please note that
the above registration fees (excluding VAT) are for VAT taxable
persons established in Belgium or VAT taxable persons identified
for VAT purposes in Belgium through an individual fiscal representative.
* A copy of your student ID must be enclosed.
Hotel
Reservation
A number of rooms have been reserved at specially reduced rates.
For hotel categories and rates (including VAT), see other side
of the Reservation Form. Complete as needed and send to Congrex
Sweden AB, P.O. Box 5619, SE-114 86 Stockholm, Sweden, fax:
+46 8 6619125, not later than September 1, 2004.
Cancellations
Pre-registered delegates who are unable to attend the Conference
will be refunded, except for an administrative fee of EUR 50,
provided the Conference Secretariat receives a written notice
of non-attendance, before September 1, 2004. No refunds can
be made for cancellations received after this date. Substitutions
may, however, be made at any time. The name of the substitute/s
should be forwarded to the Conference Secretariat.
Cancellation of hotel reservation will be accepted until September
1, 2004, up to which date the hotel deposit will be refunded.
We regret that the hotel deposit cannot be refunded after September
1, 2004.
Additional
Information
Contact the EUFEPS Secretariat (address below) for copies of
this or the EUFEPS 2004 announcements, the Preliminary Programme
and Registration Form. Also, inform your colleagues about this
important Conference.
Conference
Secretariat
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
|
Conference
Venue
Brussels Marriott Hotel
Rue A. Orts 3-7
1000 Brussels
BELGIUM
Phone +32 2 5169090
Fax +32 2 5169000
www.marriotthotels.com
|
Registration
and Hotel Reservation
Congrex Sweden AB
P.O. Box 5619
SE-114 86 Stockholm, Sweden
Phone +46 8 4596600
Fax +46 8 6619125
Email eufeps2004.registration@congrex.se
www.congrex.se |
|