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

Download the 2nd Announcement
Download the Conference Registration Form

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
  • Biotech medicines: Present and future aspects
    TBA

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

Break-out Sessions

  • 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


The European Federation for Pharmaceutical Sciences – EUFEPS
Box 1136   SE - 111 81   Stockholm, Sweden
Tel +46 8 7235000   Fax +46 8 4113217   Email secretariat@eufeps.org