EUFEPS
Conference on Optimising Biotech Medicines
Rational Development
of Therapeutic Proteins
May 13-15 •
2002 • Berlin •
Germany
The Conference opens
on Monday, May 13, 2002, at 9:00 am, and it closes on Wednesday,
May 15, 2002, at 13:15 pm.
The
famous Brandenburg Gate in the very heart of Berlin,
a place for major changes a little more than ten years ago.
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 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.
Emphasis
on new findings
In this EUFEPS conference different aspects of pharmaceutical
protein development will be discussed by experts, who actually
have developed pharmaceuticaproteins and guided them through the
regulatory process. Emphasis will be puon new findings and insights
in the development process. In addition, there wilbe a number
of break out sessions to give the delegates the opportunity to
discuss particular issues in detail with their colleagues. A conference
report highlighting issues for further discussion will be drawn
up and used by EUFEPS isupport of its broad initiative “New
Safe Medicines Faster”.
Scientific & Planning Committee
Chair: Ole J. Bjerrum, Copenhagen DK
Co-Chairs: Daan Crommelin, Utrecht NL, Henk
de Jong, Courbevoie FR
and Claus-Michal Lehr, Saarbrücken DE
Additional Members: Tudor Arvinte, Basel CH,
Jim Faulkner,
Beckenham UK, Sven Frøkjær, Copenhagen DK,
Sven Petrén, Södertälje
SE and Rainer Müller, Berlin DE
Format & Preliminary
Programme
Using a similar format to previous EUFEPS Conferences, key segments
of the value chain will be broken down into five sessions, each
with lectures and discussions, together with open discussions
in evening workshops. Workshop summary reports will be integrated
and presented by rapporteurs on the third morning of the conference,
and future perspectives will be discussed before closing the
meeting. A report on the outcome of the meeting will be published.
Call for Posters
and Abstracts
Scientific contributions relating to the conference topic will
certainly be welcome and considered for poster presentation
(Size of Board: 150 cm high; 100 cm wide). Abstracts should
be submitted to the Conference Secretariat (for address, see
below), both as an email attachment and as a hard copy, before
April 5, 2002. Click
for editorial instructions.
Exhibition Information
Companies are invited to exhibit at the Conference. For further
information on layout, costs and such matters, as well as to
request an exhibition application form, please contact the Conference
Secretariat (for address, see below).
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 23 countries. In
addition, there are individual Members and Other Supporting
Organisations.
