Date change !!
Next ACTIP meeting
June 20-21, 2002, Amsterdam
For details and a preliminary agenda, please
contact the ACTIP Secretariat. ACTIP@ACTIP.org
In this issue
ACTIP web still
growing in popularity
News from ESACT
News from the European
Commission
Tough times for trade
associations
Biogenerics &endash;
a challenge
Stem cell news
Business News
Research news
New texts in Pharmacopoiea
On the web
EMBO events in 2002
Agenda
ACTIP
web still growing in popularity
The ACTIP web site is still growing in
popularity. The statistics for the month of January show more
than 16,000 connections, of which 3,411 were requests for specific
pages. The most popular pages were the ACTIP News bulletin, the
pages on monoclonal antibodies, the general information on animal
cell technology and the interesting links page. Of all requests,
30% came from companies.
News
from ESACT
ESACT's take home messages
In the latest ESACT Newsletter (January
2002), there is a report of Hanspeter Amstutz on presentations
of the 17th ESACT meeting 'From Target to Market', held in Sweden
last year. The article is very informative, and also identifies
3 key take home messages:
Apoptosis is the main cause of death in a fermenter culture;
Gene therapy can be successful, if the target indication/population
is chosen appropriately;
Ex-vivo (stem) cell culture and tissue engineering are taking
off.
Recommended for a quick overview of the
meetingís highlights!
Source:
ESACT Newsletter, January 2002.
A copy is available upon request from the ACTIP Secretariat.
News
from the European Commission
Project on bio-informatics tools
As a result of the ëGenomes for human
health initiativeí of the EC, a consortium of the European
Molecular Biology Laboratory (EMBL) and a number of other European
Research centres will develop the next generation bio-informatics
tools which will be used to further work out genomic material.
For this initiative 19,4 million EURO is available.
Source: CF001040404/R4
R&D must rise to 3%
Research Commissioner Philippe Busquin
has called on EU member states to raise their total R&D spending
to 3% of GDP. So far, only two member states (Finland and Sweden)
come near the 3% level.
This is necessary in order to create an effective European Research
Area. One third of this investment should come from public funds
and two-thirds from industry. The recommendation is in the Commissionís
report to the spring EU head of government meeting, due to take
place in March in Barcelona.
Source: Research Europe, Number 114, January 24, 2002.
Framework 6 proposal
The Spanish presidency will be concentrating
on concluding discussion on the Framework 6 proposal which is
expected to have its 2nd reading the European Parliament in April.
In addition, the Spanish will strive to strengthen the role of
innovation and to reinforce links bewteen scientific and industrial
policies. Also, it will promote the role of R&D as the engine
of sustainable and competitive growth.
Meanwhile, the Commission has revised the
proposed rules for participation in FP 6, removing the chapter
on new instruments and an annex on costing.
The Conference launching the FP6 programme,
explaining the objectives and rules for participation, will be
held on November 11-13, 2002 in Brussels
Experts & calls
Experts wanted &endash;
simple forms available!
The European Commission is continuously
looking for independent experts to evaluate research proposals.
For details and how to appy, visit:
www.cordis.lu/expert-candidature/home.html
In the past, the expert application forms
were very difficult indeed, putting many potential experts off.
But now a redesigned interactive application form is available
on the internet. It is a simplified form of only 2 pages!!!
In addition, registered evaluators can
now modify and update their profiles online or via email. See
also:
http://candidature.cordis.lu/expert-evaluators
Monitoring experts wanted
If you are not participating in an EU project,
and have sufficient scientific background, you can propose to
become an independent expert monitoring the EU RTD programmes.
This is: assessing the progress of implementation and whether
objectives, priorities and financial resources are still appropriate.
Deadline for the 2003 monitoring exercise: September 15, 2002.
For more information, visit:
www.cordis.lu/expert-monitoring/home.html
Life Science contracts
Calls for expression of interest for service
contracts in the field of life sciences. Deadline May 31, 2004;
OJ S157-108696 of August 17, 2001, pp 50.
Functional genomics
The European Science Foundation programme
on functional genomics invites proposals for workshops to be
held in 2002 or early 2003. Workshops can be proposed for any
of the areas of the programme.
Contact: Annette Martin, tel + 44 1223 496 246.
Email: annette.martin@bbsrc.ac.uk
. web: www.functionalgenomics.org.uk
Descartes Prize
The European Commission invites proposals
for the Descartes Prize, which will be awarded for outstanding
achievements resulting from European collaborative research.
All scientific fields are eligible. Deadline March 15, 2002.
Contact: European Commission, tel + 32 2 296 70 24.
Web: www.cordis.lu/improving
.
QoL Calls for proposals
In the remaining months, the following
Calls for Proposals are still open:
Deadline April 10: Quality of Life programme: Marie Curie Individual
Fellowships
www.cordis.lu/life
Deadline April 17: Quality of Life programme: SME Measures
www.cordis.lu/life
Deadline June 12: Quality of Life programme: Accompanying measures
www.cordis.lu/life
Deadline April 17: Innovation programme: SME measures
http://www.cordis/lu/innovation-smes
Deadline April 15: Human potential programme: Raising public awareness
of science and technology
http://www.cordis.lu/improving/
Deadline June 15: Human Potential Programme: S&T policy strategy,
accompanying measures
http://www.cordis.lu/improving/
Ministers fail to agree EU patent
EU ministers failed to reach agreement
on the Community patent by the end of December 2001, despite
additional pre-Christmas meetings. Discussions now centre on
whether to persevere with negotiations or offer a patent system
that states can opt into.
The main stumbling block remains language and the cost of translation.
The Belgian presidency had proposed that the system should allow
patents in any of the official EU languages, with the costs of
translation into the official European Patent Organization languages
&endash; French, German and English &endash; to be met by the
Community patent system. However, France and Germany in particular
did not want to back this compromise, saying it had drifted too
far from the original proposal and was no longer centralised
and cost efficient. Since the Spanish presidency would like to
approve a Community patent system, a decision is hoped for at
the next meeting of EU internal market ministers on March 1.
Source: Research Europe, Number 114, January 24, 2002-02-27
Anti-terror group established
Commissioner Busquin has set up a group
of scientific experts on biological and chemical terrorism in
response to a call from EU research ministers on December 10,
2001. The experts come from member state research and defence
ministries and the Commission. A first progress report should
be presented to research ministers on March 11, 2002. The group
will look at questions of research linked to the detection and
identification of biological and chemical agents and the prevention
and treatment of attacks. An inventory will be made of research
activities currently in progress and co-ordination options examined.
Gaps in research will be identified.
Key research subjects
are:
the development of tools for early detection and diagnosis of
attacks
surveillance of biological or chemical agents that could be used
in terrorist attacks
the development of rapid mechanisms to produce and distribute
new vaccines against emerging diseases
studies of potential threats to agriculture and food industries.
Blow to biotech sector
In a ruling published late November 2001,
the influential Scientific Committee on plants stopped short
of condemning Welsh restrictions on an authorised GM crop &endash;
even though it said there was no scientific evidence supporting
the Welsh restrictions. The restrictions prohibit farmers from
planting Aventis T25 maize within 200 meters of other farms growing
conventional maize or organic crops to prevent the spread of
the engineered genes through cross pollination. There are now
national restrictions on growing GM crops in Wales, France, Denmark,
Italy, Greece, Austria and Luxembourg.
Source: European Voice, December 5, 2001
Criticism on EUs indecisiveness on biotech
policy
Agriculture Commissioner, Franz Fischler, criticised the EU for
"muddling-through policy" in the area of biotechnology,
and warned that Europe could be left behind on new technologies.
In an address to the AGRIBEX Food Fair in Brussels on 13 February,
Mr Fischler stated that "it is high time that Europe finds
a way to address questions" dealing with genetically modified
organisms (GMOs). Commissioner Fischler stressed that "Europe
lacks a shared vision and a common objective regarding genetically
modified organisms" and urged the EU to "stop making
decisions on such a difficult issue as biotechnology on a purely
emotional basis". Mr Fischler said that the role of consumers
in the context of this debate was "absolutely paramount".
The Commissioner called for a policy that protects farmers who
grow conventional or organic crops from accidental GMO contamination.
He stressed that consumers must be free to choose between GM
and non-GM products, therefore European farmers will have to
segregate GM and GM-free crops.
Source: EURActive News, February 15, 2002
Tough
times for trade associations
Trade associations face a struggle if they
want to influence EU policy makers. This gloomy conclusion was
reached after interviews with 50 director-generals of EU trade
groups and 150 members and non-members of the European Parliament.
The interviewer found that political fragmentation of the Union
means companies have lots of opportunities to lobby politicians
and officials, thereby bypassing trade associations. In addition,
some lobby groups also loose out on ërepresentativityí
because a few big firms dominate them. Further, lobby groups
suffer because the EU cannot licence certain groups as 'official
and principal partners'. The result is that most business associations
become just one of a number of channels of representation to
political powerbrokers, and tend to organise themselves around
very narrow common interests, explaining the presence of hundreds
highly specialist associations, such as the 'natural sausage
casing manufacturers association', just to name one.
Source: Inside the 'Trade Association'. Justin Greenwood.
Published by Palgrave: http://www.palgrave.com.
Reported in European Voice, October 10, 2001
Biogenerics
&endash; a challenge
Over the next 4 years many pharmaceutical
patents will expire. These are worth an estimated 40 billion
USD in product sales, and include as many as 18 blockbuster drugs.
Several of these are pharmaceuticals that have been biotechnologically
developed and produced. These biopharmaceuticals are also expected
to be launched by generics companies, as they account for about
10 billion USD total sales and represent one of the fastest growing
segments in the pharmaceutical market. The list includes Genentech's
somatotropin (exp. 1991), Eli Lilly's insulin (exp 2001), Schering-Plough's
interferon alpha (exp 2002), Seronoís somatotropin (exp
2003), Biogenís interferon beta (exp 2003), Lilly's somatotropin
(exp 2003), and erythropoietin of Amgen and Roche (exp respectively
2004 and 2005).
Hurdles to overcome
However, it is anticipated that only a
few generic players will successfully occupy the emerging market
niche. There are many hurdles to overcome, including the requirement
of a high level of specialised skills and competencies; the willingness
to dedicate long-term financing, and extensive planning. The
biggest obstacles, though, come from regulatory authorities that
are likely to consider each re-development as a 'new biological
entity' (NBE). Already, the EMEA calls these products 'multisource'
products, and in the US, the situation is similar. Approval will
therefore be dependent on preparing and filing a complete dossier,
including clinical trials, rather than on proving bioequivalence.
Moreover, in Europe approval can only be obtained via a centralised
procedure. This increases development costs by a factor of between
10 and 50 when compared with chemical generics.
Another factor driving up costs will be the need for GMP contract
manufacture.
In order to bring multisource biopharmaceuticals
to market, several business models are emerging: the developer
(mostly biotech start ups such as Rhein Biotech, Cangene, Microbix
and GeneMedix) and the distributor (traditional generics companies
partnering with specialized development companies, i.e. Stada
commissioning DSM). Alternatively, some generics companies have
founded their own centre of excellence (i.e BioGenerix created
by Ratiopharm).
Thus, the generics industry faces the challenge
of a new market segmen which, besides fierce opposition from
the originators, will also offer the chance to shape the industry
and create sustained value.
Source: Adapted from 'The emergence of biogenerics', Klaus
Maleck and Federico Pollano, BioGenerix AG, European Biopharmaceutical
Review, pp 19-21, autumn 2001.
Stem
cell news
Stem cell knowledge
If you are getting confused with the plethora
of terminology surrounding stem cells, I would like to introduce
you to an inaugural article by the new Chief Editor of the ESACT
Newsletter, Dr. Steve Oh. The article starts with common definitions
and explanations of key concepts about stem cells, and ends with
an assessment of how stem cell research might be applied. Highly
recommended.
Source: ESACT Newsletter, January 2002
Another source of stem cell knowledge is
the following site, which contains many stem cell links:
http://europa.eu.int/comm/research/quality-of-life/stemcells/links.html
These include educational sites, permitting
a better understanding of the fundamentals and context, research
sites for news and latest developments, information on ethical
and legal debates, and articles from leading international newspapers.
EU Conference
On the same topic: more information of
the EU Conference on stem cells which was held on December 18-19,
2001 in Brussels can be found on:
http://europa.eu.int/comm/research/quality-of-life/stemcells.html
Business
News
Patent on BSE blood test
On January 30, 2002, the British biotech
company Proteome Sciences has applied for a patent on a blood
test for BSE. Until now, BSE and Creutzfeld-Jakob diseases could
only be demonstrated using brain samples.
Source:
www.agriculture.com/default.sph/AgNews.class?FNC=sideBarMore__ANewsindex_html___47267
Incyte stops with DNA chips
Californian company Incyte Genomics will
stop with the production of DNA chips. Reason: the production
no longer fits the business model and many institutes are making
their own micro-arrays.
Company Agilent, also producer of micro-arrays, has acquired
the patent portfolio of Incyte Genomics and is developing a universal
bioinformatics platform.
Source: BioNieuws Nov 24, 2002
First product Isotis
The first biological product marketed by
Dutch tissue company Isotis is called CellActive Skin. The product
is available to twelve German, Austrian and Swiss hospitals.
The product is an intermediate step toward a fully reconstituted
skin containing a dermis and epidermis.
Source: BioNieuws Nov 24, 2001
Research
news
Cloned cows seem to be healthy
Many cloned animals seem to suffer from
obesity, respiratory problems en circulatory abnormalities. According
to researchers from Advanced Cell Technology, this is not the
case for cloned cows. The scientists cloned 30 cows; 6 died at
birth, the other 24 were perfectly normal. The scientists attribute
earlier reports of immunological and genetic differences to species
differences or to other cloning techniques.
Source: Bionieuws Nov 24, 2001
Note: It has been demonstrated that the
cloned sheep Dolly, who is still quite young, is suffering from
arthritis. It is unusual for a young sheep to suffer from arthritis.
Source: news.bbc.co.uk/hi/english/sci/tech/newsid_1742000/1742838.stm
New
texts in Pharmacopoiea
On January 1, 2002, the 4th edition of
the European Pharmacopoiea replaced the entire 3rd edition. It
is available in book and electronic form (CD-ROM and on-line
versions) in English and French. From now on a collection of
non-cumulative supplements will update the 4th edition: 2 supplements
have already been published for the 1st year and 3 additional
supplements will be published every year during the lifetime
of the 4th edition.
107 new and reviseds text have just been
released for implementation in the European Pharmacopoiea on
July 1, 2002, whereafter they become legally binding.
A number of the new texts merit special attention:
In the monographs on combined human vaccines: the test for residual
toxin in guinea pigs has been replaced by an in vitro method;
in the monographs on water, the medium used for microbiological
monitoring has been changed to improve performance of the test.
On
the web
New IRE network website
The Innovation Relay Centre (IRC)-IRE Central
Unit has launched the new public website of the Innovating Regions
in Europe, providing comprehensive, up to date information about
regional innovation policies and policy initiatives across Europe.
The site includes an updated list of contacts. See:
http://www.innovating-regions.org/
On-line European Research News Centre
This site features developments in European
science, under thematic heading such as ëagricultureí.
Easy to understand style with technical blends. Visit:
http://Europa.eu.int/comm/research/news-centre/index_en.html
Research funding and policy
It is not easy to keep timely track of
European policy news or funding opportunities. The bi-monthly
publication Research Europe (695 EUROs) will help you along.
Highlights from the publication, as well as daily news and jib
opportunities from and in the UK, is now available on-line at:
http://www.ResearchResearch.com
Service of Belgian BioIndustry Association
The BBA can help you to get ready for the
6th Framework Programme, to find appropriate collaboration and
partners in Europe, and prepare applications to the E.C. The
EuropaBio SME project database is available on http://www.bba-bio.be/smes/index2.asp
http://www.bba-bio.be
EMBO
events in 2002
Recently, the ACTIP Secretariat received
a 2002 calendar, featuring all Bioscience in Europe events planned
by EMBO. Here we give a shortlist of activities selected for
ACTIP members. For full information, please view the EMBO website
at: http://www.embo.org
Electrical coupling in
the retina; March 10-16, Practical
Course, Oldenburg, Germany
Crystallization of macromolecular
complexes. April 8-13. Practical Course,
EMBL, Grenoble, France
Gene vectors. April 14-27. Practical Course, Evry, France
Mass spectrometry in proteomics, April 15-26. EMBO course, Havana, Cuba
The functional organisation
of the cell nucleus, April 18-21, Workshop,
Prague, Chech Republic
Signalling and cancer, April 20-23. Conference, EMBL Heidelberg, Germany
Exocytosis, April 20-25, workshop, Tomar, Portugal
Conference on Prokaryotes
in the 3rd millenium: actions and effects of molecular machines, April 26-30. EMBL Heidelberg, Germany
Automated macromolecular
structure solution, May 9-16. Practical
Course, EMBL Heidelberg
Cell death across kingdoms, May 11-15. Jooint CNRS Jacques Monod/EMBO workshop,
Roscoff, France
Genetics after the genome, May 16-19. Special EMBO workshop, Brno, Czech
Republic
Translational control in
development and neurobiology, May 23-26,
Joint Serono Foundation/EMBO workshop, Mallorca, Spain
Genetic recombination and
the maintenance of genome stability,
May 27-31. Workshop, Seillac, France
Functional genomics using
high density oligonucleotide arrays,
June 15-21. Practical course, Aarhus, Denmark
Molecular and genetic tools
for the analysis of medaka and zebrafish development, July 21-31. Practical course, EMBL, Heidelberg
Multidimensional NMR in
structural biology, August 11-16. Practical
course, Il Ciocco, Lucca, Italy
Ribozymes and RNA catalysis, August 23-27. Workshop, Dundee, UK
DNA Microarrays: applications
and data analysis. September 14-21,
Practical Course, EMBL Heidelberg
The biology of heat shock
proteins and molecular chaperones,
September 25-29, Lecture Course, Warsaw, Poland
Frontiers of molecular
biology, October 11-15, EMBO members
workshop, Oslo, Norway
Joint EMBL/EMBO Science
and Society Conference, November 15-17.
EMBL Heidelberg
Protein expression, purification
and crystallization, December 4-11,
Practical Course, EMBL Hamburg
Sectoral meeting in immunology, date to be announced, EMBO, Heidelberg
AGENDA
A number of interesting conferences and
workshops is coming up. Of all the events mentioned here, the
detailed programmes and registration/application forms are available
from the ACTIP Secretariat.
Pharmaceutical products
and viral safety
March 14-15, 2002, Paris France
Organization: Institut Pasteur Euroconferences. Fax: + 33 1 40
61 34 05. http://www.pasteur.fr/applications/euroconf
Biotechnology in the post-genomics
area &endash; impact on science, business & society
March 14-15, 2002, Ede, The Netherlands
Organization: Netherlands Biotechnological Society;
Congress Secretariat: + 31 317 482 954; fax: + 31 317 482 237;
email: nbv.wessels@algemeen.pk.wau.nl
BioTech Israel 2002
March 20-21, 2001, Tel Aviv, Israel
Organization: Biotech Israel 2002 Congress Secretariat, Tel Aviv.
Tel: + 972 35 14 0000; fax: + 972 35 17 56 74; web: http://www.kenes.com/biotech
Excipients: classical quality
requirements and functional related testing
April 4-5, 2002, Brussels
Organization: EDQM, tel + 33 388 41 28 15; fax: + 33 388 41 27
71; web: http://www.pheur.org
First multidisciplinary
theoretical and practical training in virology
April 14-27, 2002 Genopole, Evry, France
Organization: Mauro Mezini, Genethon III, tel: + 33 169 47 10
23; fax: + 33 169 47 19 46;
email: vecteuronet@genethon.fr
EuroConference: the Challenge
of Change in EU Business Associations
May 7-10, 2002, Brussels
Organization: Ernst & Young Association Management, Tel:
+32 2 774 9610,
Fax: +32 2 774 9690 Email: euro.conference@eyam.be
or visit the website
http://www.ey.be/euroconference
Danish Biotech Seminar
May 28-30, Hilton Brussels, Belgium
Organization: BBA and the Danish Chamber of Commerce, Denmark,
the Danish Export Council and the Danish Embassy. Registration
at http://www.bba-bio.be/pages/danish_forum_290502.asp"
BIO 2002-02-27
June 9-12, 2002, Metro Toronto Convention Centre
Organization: Biotechnology Industry Organization, 1225 Eye Street,
NW; Suite 400, Washington, DC 20005-5958
EU Advanced Workshop on
Biotechnology Ethics and Puplic Perceptions of Biotechnology.
June 17-26, 2002, Oxford, UK
Organization: EFB Task Group on Public Perceptions of Biotechnology
efb.cbc@tnw.tudelft.nl
www.kluyver.stm.tudelft.nl/efb/TGPPB/oxford.htm"
Plenary meeting ACTIP
June 20-21, 2002, Amsterdam
Organization: ACTIP Secretariat : ACTIP@ACTIP.org
BIOMED 2002 (9th International Symposium on Biomedical Science
& Technology)
September 19-22, 2002, Antalya, Turkey
Information: http://www.biomed2002.ankara.edu.tr
European Society of gene
Therapy
10th Annual Meeting
October 13-16, 2002, Antibes, France
Organization: Congrex Sweden, Tel: + 46 84 59 6600; fax: + 46
86 61 9125; email: esgt@congrex.se
JAACT 2002-02-27
November 11-15, Fuchu City, Japan
Organisation: JAACT. Web: http://www.tuat.jp/~jaact02/
Launch EUs 6th Framework
Programme
November 11-13, 2002, Brussels
Organization: DG Research, tel + 32 295 99 71; fax: + 32 2 295
82 20;
email: rtd-conference2002@cec.eu.int;
web: http://europa.eu.int/comm/research/conferences/2002
BioTech Helsinki 03
March 24-26, 2003, Helsinki, Finland
Organization: Finish Bioindustries/Sitra/Tekes. Tel: + 358 917
28 43 14.
Web: http://www.biotechhelsinki.com
18th ESACT meeting: animal
cell technology meets genomics
May 11-15, 2003, Granada
Organization: ESACT, http://www.esact.org
or + 34 932 388 777
11th European Congress
on Biotechnology, 25th anniversary of EFB: Building bridges between
biosciences and Bioengineering
24-29 August, 2003, Basel, Switzerland
Organization: ECB11, Tel + 41 61 686 28 28; fax: + 41 61 686
21 85;
email: info@ecb11.ch; web:
http://www.ecb11.ch.
ACTIP Bulletin nr 29, March 2002
For more information:
ACTIP Secretariat. P.O. Box 9143, 3007
AC Rotterdam, The Netherlands
Tel: + 31 10 482 83 06;
fax: + 31 10 482 77 50;
email: ACTIP@ACTIP.org
Web: http://www.actip.org
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