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In this issue:
Abstracts
vaccine projects
1350 Biotech
companies
Germany leading
in patents
Public
perception
On the web
Regulatory
Affairs
Short research
news
Short news
Commission
news
Publications
Available:
Abstracts vacccine projects
The book of abstracts of projects
on vaccine development is available. It covers the projects selected
for funding following the 1st call for proposals in Key Action
2, Control of Infectious Diseases.
If you are interested in one or more projects: first look up
the project titles through the CORDIS database:
http://dbs.cordis.lu/EN-GLOBALsearch.html
and use as search terms the project
numbers, i.e. QLK2. You will then get a list of project titles,
and can click on for more info. Select the project(s) you are
interested in from this list and ask the ACTIP Secretariat to
send you the corresponding abstracts. You may also request the
ACTIP Secretariat for a full copy of the entire book of abstracts.
EU:
more than 1, 350 biotech companies
The rate at which new biotech
companies are being created in Europe is astounding. In 1999,
the number of biotech companies in Europe increased by 15% to
1,351. Much of the recent increase has been focused on Germany,
where the number of biotech companies has risen by over 150%,
demonstrating the impact of the German government's initiatives
to promote biotech. Germany has now surpassed the UK as the country
with the most biotech companies, but UK is still leading in the
product pipeline, reflecting the maturity of its biotech industry.
Some figures will demonstrate the vigour of today's European
biotech companies:
Number of biotech companies:
* Germany: 280
* UK: 270
* France: 180
* Sweden: 140
* Switzerland: 98
* Netherlands, Finland, Belgium, Denmark: 60-70 each
Product pipeline of European
public companies:
* Total Preclinical (45), Phase I (42), Phase II (49), Phase
III (11);
* UK: Preclinical (29), Phase I (28), Phase II (36), Phase III
(11);
* Germany: Preclinical (2);
* France: Preclinical (4), Phase I (5), Phase II (4);
* Sweden: Preclinical (5), Phase I (7), Phase II (2);
* Denmark: Preclinical (5), Phase I (1), Phase II (6);
* Netherlands: Phase I (1), Phase II (1).
Source: Ernst & Young, from
thought to finish. European Life Sciences Report 2000.
A copy is available from the ACTIP Secretariat or from one of
the EU offices of Ernst & Young.
...and
Germany also leading in patents
According to new research from
Derwent Information, Germany is streets ahead of the UK and other
countries in biotechnology innovation. The study addresses patent
applications in 1998 and 1999 in a number of EU countries. For
example, in 1999, the total percentage of biotechnology patent
applications from researchers from the UK was 22%, while the
percentage for German researchers was 40%. Researchers from France
and the Netherlands scored 11 and 8 %, respectively.
This is another indication that Germany's biotech sector is catching
up rapidly. The country's patenting activity increased by 11%
over 1998's figure of 36%.
The research looked at the number
of patent documents in Derwent's Biotechnology Abstracts database.
Patent applications to the European Patent Office, World Patent
Office Patent Co-operation Treaty (PCT) and Regional Patent Offices
are included.
Source: Bioforum International
2, 2000
Public
perception
The public and genomics
Levels of public understanding
of genomics and genome-related issues in the UK are fairly low.
The most important features of public attitudes towards these
areas of research are:
* the public is relatively supportive of explicitly medical applications
of molecular genetics, with the important exceptions of transgenic
animal research and xenotransplantation;
* people tend to distinguish clearly between morally acceptable
apllications (i.e. screening for serious genetic diseases) and
morally unacceptable applications (i.e. eugenic attempts to improve
human nature). At present, the British public has provisionally
classified all forms of human cloning in the 'morally unacceptable'
category.
On a global level, the following
emerges:
* support for genetic testing: 50% in the EU, 51% in the USA
and 48% in Canada;
* support for biotechnological food: 22% in the EU, 37% in the
USA and 38% in Canada;
* support for xenotransplantation: 16% in the EU, 23% in the
USA and 29% in Canada.
Source: European Biopharmaceutical
Review, March 2000, pp 8-12
EU support for biotech
decreases - the New Eurobarometer 2000 study
The previous Eurobarometer study
dated from 1996. Since then, much has happened: Dolly, the first
cloned sheep and discussions about human cloning, xenotransplantation,
failed trials with gene therapy and even deaths, still raging
controversies about genetically modified ('Frankenstein') foods.
The most recent Eurobarometer 2000 study shows that all these
issues have influenced the thinking of Europeans about biotechnology
and its applications: support for biotechnological applications
has fallen even further.
In all, 16,000 Europeans were
interviewed. Below we give the responses, and we compare the
2000 responses with the ones given in 1996.
* modern biotech and food: useful
55% in 1996, 42% in 2000;
* genetically modified plants for insect resistance: useful 68%
in 1996, 55% in 2000;
* human genes in bacteria for vaccine production: useful 80%
in 1996, 68% in 2000;
* genetic tests for detection genetic diseases: useful 80% in
1996, 73% in 2000;
* improvements in quality of life: yes 43% in 1996, 37% in 2000;
* trust in information sources: most trust in consumer organisations
and medical professionals (25% in 2000, an increase). Trust in
universities (7% in 2000) and environmental organisations (14%)
decreased.
Source: Bionieuws 10, May 20,
2000
See also:
www.europa.eu.int/comm/research/press/2000/pr2704en-ann2.html
Worldwide attitude to
biotechnology
Recently, results were published
from a worldwide study on public attitudes towards biotechnology.
The study was performed by the Angus Reid Group and interviewed
2,000 respondents in the USA and Canada, and 3,000 people in
Australia, UK, France, Germany, Brasil and Japan. The study was
conducted in 1998 and in 2000. Results have been published in
the report 'New Thoughts for Food: Consumer Reaction to Biotechnology
in Foods'.
Aversion against genetically modified foods increased from 45%
to 51% in the USA, and in Canada from 45% to 59%. Percentages
for the UK, France, Germany and Japan are respectively 58%, 73%,
73% and 82% negative.
Source: Angus Reid Press Release,
June 8, 2000. See also:
www.angusreid.com/media/content/displaypr.cfm?id_to_view=1040
On
the web
European voice on web
European Voice, the weekly journal
for news on the Commission, Council and EP, is now available
online:
www.European-Voice.com
New website DG Research:
http://europa.eu.int/comm/dgs/research
http://europa.eu.int/comm/research
Submission of project
proposals
The following websites are handy
when submitting a project proposal to the European Commission:
Workprogrammes FP5:
www.cordis.lu/fp5/home.html
Latest calls for proposals FP5:
www.cordis.lu/fp5/src/calls.htm
FP5 proposal submission forms:
www.cordis.lu/fp5/src/forms_a.htm
FP5 infodesk addresses:
www.cordis.lu/fp5/src/cont-cec.htm
Evaluation manual FP5:
www.cordis.lu/fp5/src/evalman.htm
Peer review evaluation process:
www.cordis.lu/life/src/library.htm
Intellectual Property Rights
model contract:
www.ipr-helpdesk.org/en/booka1.htm
External advisory groups Quality
of Life programme:
europa.eu.int/comm/dg12/fp5/advice/hleg-1.html
Job listings on the
web
The ACTIP website now features
a link to BioView, a website with thousands of job listings in
all disciplines, including research, development, regulatory
affairs, validation, manufacturing/production etc. The sites
also features an area where candidates can leave a resume for
review by industry professionals. See:
http://www.bioview.com
Companies involved in
stem cell research
(for a full table with a description
of the activity, please contact the ACTIP Secretariat):
Aastrom Biosciences (USA):
www.aastrom.com
Advanced Cell Technology Inc
(USA):
www.advancedcell.com
Advanced Tissue Sciences (USA):
www.advancedtissue.com
BresaGen Ltd
www.bresagen.com.au
Cell Based Delivery Inc. (USA):
www.cbd-biotech.com
CytoTherapeutics Inc (USA):
www.cyto.com
Geron Corp (USA):
www.geron.com
Ixion Biotechnology Inc. (USA):
www.ixion-biotech.com
Layton Biosciences Inc (USA):
www.laytonbio.com
NeuralStem BioPharmaceuticals
Ltd (USA):
www.neuralstem.com
NeuroNova AB (Sweden):
www.neuronova.com
Nexell Therapeutics Inc (USA):
www.stemcellselection.com
Osiris Therapeutics Inc. (USA):
www.osiristx.com
Stem Cell Sciences Pty Ltd (Australia)
no web address found
Regulatory
Affairs
New vaccine guidelines
approved
In May 2000, a group of experts
representing member states and the EMEA met to discuss key issues
concerning the procedure of batch release of vaccines in Europe.
These guidelines have been prepared by the Official Medicines
Control Laboratory network (OMCL). The following guidelines have
been adopted or approved for consultation:
Adopted guidelines for:
* Hepatitis A vaccine;
* Hepatitis B vaccine;
* combined Hepatitis A and B vaccine.
Approved for consultation:
* tick-borne encephalitis;
* virosomal Hepatitis A vaccine;
* live, oral typhoid vaccine;
* combined haemophilus type B conjugate and Hepatitis B vaccine;
* revised guideline for pneumococcal polysaccharide vaccine;
* revised haemophilus type B conjugate vaccine.
All the adopted guidelines are
published on the website of the European Directorate for the
Quality of Medicines (EDQM) of the European Council:
http://www.pheur.org
Alternatives to potency
testing tetanus vaccines
On June 27, 2000, the EDQM, together
with WHO, organized a scientific symposium on tetanus vaccines
for human use to survey the recent developments in the quality
control of tetanus vaccines and to examine the progress made
for their potency determination.
Current European Pharmacopeia
and WHO potency tests involve tests in animals and a more acceptable
method for routine testing of tetanus vaccines has long been
sought. At the symposium, serological potency models using ELISA
and TOBI techniques were the centre of interest. Data was presented
to show the usefulness of these methods either alone or in conjunction
with methods that are now used. Discussion on common approaches
on how to perform quality controls of these vaccines in the future
based on alternative methods for demonstration of batch consistency
were held.
Source: press release EDQM, June
27, 2000. See also www.pheur.org
Short
research news
Listeria genome sequenced
On April 18, a press release
announced the successful completion of a BIOTECH project to sequence
the Listeria genome. See: europa.eu.int/comm/research/quality-of-life.html
Insect cells interesting
for vaccines
Company Intervet in the Netherlands
(subsidiary of Akzo Nobel Pharma) has chosen for the baculovirus
expression system in insect cells to produce an animal vaccine
against swine fever (hog cholera). Reason: the baculovirus expression
system allows a 100-fold higher production of protein compared
to a system based on animal cells. Current production is in 1,000
litre bioreactors.
Glycosylation in insect cells is slightly different from glycosylation
in mammalian cells, but the small differences do not seem to
have an adverse effect on immunogenicity.
Baculoviruses are also used to
produce virus-like particles. US company Medimmune is currently
conducting clinical tests with a human parvovirus vaccine.
A major advantage is the speed
with which a production system based on the baculovirus expression
system can be developed (within 8 weeks). This speed could be
a major advantage in the developed of anti-flu vaccines. UK company
Protein Sciences is conducting clinical tests with human flu
vaccines produced in insect cells. It is impossible to reach
a similar development speed using mammalian cells, since selection
of recombinant mammalian cells is quite a lengthy procedure.
Source: Bionieuws 9, May 6, 2000.
For more info, see:
www.proteinsciences.com
www.medimmune.com
www.intervet.com
Pharming abandons rabbits
for alpha-glucosidase
Dutch company Pharming is well
known for its use of genetically modified cattle or rabbits for
the production of biopharmaceutical proteins, intended for orphan
diseases.
For 5 years, Pharming has been pioneering a production method
in rabbits of the protein alpha-glucosidase to treat patients
with Pompe's disease. Phase II clinical trials, conducted together
with partner Genzyme, were successful. However, just before the
start of phase III clinical trials, it became evident that researchers
of the US Duke University, together with company Synpac, would
be able to beat Pharming with the presentation of a dossier to
the authorities. Synpac's method is based on the use of CHO cells.
Instead of competing with Synpac, Pharming decided to acquire
the rights to the CHO-based production method from Synpac. Pharming
will continue to develop alpha-glucosidase against Pompe's disease,
but will switch to the CHO-cell based method. Pharming's newly
built Belgium facility for 3,000 genetically modified rabbits
will remain empty for the time being.
Source: Volkskrant April 4, 2000
Short
News
New Secretary-General
for EuropaBio
The Board and membership of EuropaBio
have appointed Hugo Schepens as new Secretary-General. He will
join the association in October as the successor to Anthony Arke.
Hugo Schepens has considerable experience in the pharmaceutical
industry and in health economics.
Source: press release EuropaBio,
August 8, 2000
Tightening TSE prevention
rules
On May 17, 2000, the European
Parliament adopted a proposal for a Regulation creating rules
for controlling and preventing Transmissable Spongiform Encephalopathies
(TSEs). The EP want to urge member states to routinely slaughter
all the animals in a cattle herd when one of them has been infected
by mad cow disease. They also call for wide scale introduction
of BSE screening tests. The rapporteur also wants to extend the
scope to include products so far excluded, such as cosmetics,
pharmaceuticals and other medicinal products. Specified Risk
Material (SRM) is to be dealt with according to special treatment
arrangements, i.e. feeding prohibition, mandatory removal and
incineration of SRMs from live cattle, goats and sheep.
Source: Europe Environment, no.
569, May 30, 2000
US and EU establish
mutual forum
Biotechnology holds great promises
for the future of mankind, but it has also created unease due
to concerns about possible unknown effects and food safety.
To help address these concerns and to study the benefits and
risks of biotechnology, the USA and the EU agreed at their May
31 summit meeting to establish a Biotechnology Consultative Forum.
The Forum includes a carefully selected group of eminent scientists,
ethicists, environmentalists, farmers, businessmen, consumer
representatives and development experts. A report of their findings
will be available at the December 2000 summit.
If you would like to know the
names of the US or EU forum members, please ask the ACTIP Secretariat
for a list of members.
Programme ESACT meeting
Sessions ot the 17th ESACT meeting,
to be held from June 10-14, 2001 in Tylosand, Sweden, will include:
* identification of drugs and drug targets;
* expression systems for target and drug production;
* cell physiology and metabolism;
* production technology;
* changes in the regulatory environment;
* novel technologies for administration of cell derived proteins;
* novel prophylactic and therapeutic approaches based on animal
cells or nucleic acids;
* biotech in the new millennium
Source: ESACT Newsletter July
2000
Biological Weapons Convention
- joint industry position
The global pharmaceutical, chemical
and biotechnology industry, as represented by EFPIA, FEBC and
PHRMA, has issued a joint industry position paper on the Compliance
Protocol to the Biological Weapons Convention. Major points are:
* industry is actively supporting
efforts to strengthen the Convention by the inclusion of effective
measures to help enhance compliance with its objectives and to
reduce the threat of biological warfare;
* industry seeks to ensure that an appropriate balance is achieved
between the objectives of the compliance protocol and the legitimate
rights of private industry facilities, including the protection
of intellectual property and confidential business information.
* industry's concerns with the compliance protocol include the
scope of declarations and on-site activities and the degree to
which the burden of the protocol on legitimate activities is
balanced by its value for arms control purposes.
The full text of the position
paper is available on the ACTIP website, as well as on the EFPIA
website:
www.efpia.org
Commission
News
New Research Director
General
DG Research Director-General
Jorma Routti has stepped down. The DG portfolio is now managed
by Deputy DG Hendrik Tent.
Technical assistants
In 2000, the EC will seek Project
Technical Assistants (PTAs) to help with the implementation of
FP 5 for a number of programmes, including the Quality of Life,
Information Society, SME, INCO and Human Potential Programmes.
For more information, look regularly at:
www.cordis.lu
New EU Health Strategy
On May 16, 2000, the European
Commission, by David Byrne, Commissioner for Health and Consumer
Protection, presented its proposals for the future strategy on
health in the Community. A key part is the new public health
programme, which will run for six years and will cost 300 million
EURO. Focus will be on:
(1) improved health information;
(2) improved capacity to address health threats;
(3) key determinants of health (and disease).
Busquin to 'think big'
on new R&D funding
This autumn, Research Commissioner
Philippe Busquin will unveil plans to focus EU funding for R&D
on large-scale strategic projects, in a bid to help the Union
catch up with its US and Japanese rivals. In his paper, he will
argue that the EU money currently is spread far too thinly on
a raft of small-scale projects. Instead, the Commission should
be prepared to think big with FP6 with priority given to fewer,
bigger projects worth millions of EURO apiece. The projects should
add value to the EU.
The list of key priorities will most likely include:
* genomics;
* nano technology;
* medical research covering the human brain;
* fuel cell research;
* aeronautics;
* information society.
His plans will be closely linked
to separate proposals to build a 'European research area'. The
latter aims to improve coordination of national and Union-level
R&D programmes.
The Commisioner is also examining
ways to encourage R&D through tax breaks for research.
Source: European Voice, Vol 6,
nr 30, July 27 2000.
Scientific big shots
to advice Busquin
On April 27, Commissioner Busquin
announced the establishment of a High Level Group on Biosciences.
The group is composed of 11 eminent scientists in the life sciences
and will advice about current and future developments in biotechnology.
Members of the group have been selected on the basis of both
their scientific merits as well as their ability to communicate
with the lay public. Well known names are Derek Burt, chairman
of the British Committtee for the environmental introduction
of GMOs, and Marc van Montagu, professor in Gent. For more details,
see
http://www.europa.eu.int/comm/research/press/2000/pr2704en-ann1.html
Exploitation responsibility
of specific research programmes
Since 1989, the European Commission
has supported demonstration and dissemination projects as a follow
up to research projects. Often, these innovation projects had
their own funding, and specific innovation programmes existed.
In FP 5, however, the role of
facilitating subsequent exploitation of Community-based research
has been passed to the specific research programmes themselves.
It is now the responsibility of each of the four thematic programmes
to ensure that every FP 5 research project makes concrete plans
for eventual commercialization, and follows these through tthe
licensing of intellectual property in foreign markets.
Source: Innovation & Technology
Transfer, Vol 3, May 2000. For more info, contact Dr. Archibugi,
CNR: archibu@www.isrds.rm.cnr.it
Virtual Technology Parks
In 1998, the European Commission
approved the European Technology Transfer Initiative (ETTI).
Among its recommended elements was a virtual technology park
(VTP). Two approaches have been adopted:
(1) a multisectoral hub, structured as a consortium of 15 SME
platforms, set up at existing business-support institutions with
established client bases. At its core is the ETTN website;
(2) a sectoral hub, modelled on a virtual technology park. It
aims to replicate the services of an ordinary technology park
but without the bricks and mortar. By now, platforms have been
established for the construction, food production and software
sectors, each with its own character.
The project is unique and strong
interest in joining the project has been voiced in the US and
Australia.
Source: Innovation & Technology
Transfer, Vol 3, May 2000. For more information, contact Eklen
Pedersen at ellen.pedersen@cec.eu.int.
Alternatively, visit:
http://ettn.jrc.it
http://www.connet.org
http://www.nice-food.org
http://www.nsaviking.net
Deadlines 2000
The second deadline for the 2nd
call for proposals for funding is
October 11, 2000
The following areas will be open
for this call for proposals:
Key Action 2,
Control of Infectious Diseases:
2.1. Improved or novel vaccines;
2.2. Strategies to identify and control infectious diseases;
2.3. Aspects of public health and care delivery systems;
Key Action 3,
the Cell Factory:
3.1.1. Development of new diagnostics;
3.1.2. Therapeutic strategies;
3.2.2. Bioassays and biosensors;
3.2.4. Biodiversity and ecological dynamics;
3.2.5. Safe use of new biomolecules and bioprocesses;
3.3.4. Identification and sustainable use of metabolic and genetic
doversity as a source of new valuable products;
RTD activities
of a generic nature:
7.1 Pathogenic mechanisms in chronic and degenerative diseases;
8.1. Genome analysis;
8.2. Functional genomics and proteomics;
9.1. Cell communication in Neurosciences;
9.2. Brain theories in neurosciences.
In addition, based on the open
call of March 6, 1999, the following areas are still open:
* support for research infrastructures: deadline October 11;
* Marie Curie Host Fellowships: deadine October 11;
* SME Exploratory Awards, deadline September 13;
* Accompanying Measures, deadline
October 11.
Selection projects
Selection rates and funding levels
of the first call for proposals FP5, Quality of Life, shows the
following:
* Key Action 1 (Food and Health):
selection rate 21.5%, average funding per project 1,684,613 million
EURO;
* Key Action 2, Infectious Diseases (vaccines): selection rate
33.3%, average funding 1,973,974 EURO;
* Key Action 3, Cell Factory: selection rate 10.4%, average funding
1,945,820 EURO;
* Key Action 4, Environment and Health: selection rate 15.7%,
average funding 1,437,871 EURO;
* Key Action 5, Sustainable agriculture etc: selection rate 71%,
average funding 1,331,623 EURO;
* Key Action 6, Ageing Population and Disabilities: selection
rate 13.7%, average funding 1,387,214 EURO
* Generic projects, selection rate 17%, average funding 1,684,404
EURO;
* Infrastructures, selection rate 33.3%, average funding 913,614
EURO
EC
publications
The quarterly RTD info magazine informs on the main developments in
EU funded research activities. Free:
rtd-info@cec.eu.int
http://europa.eu.int/comm/research/rtdinfo.html
Bimonthly CORDIS
focus also provides a review
of the EU's research and innovation activities. Free.
innovation@cec.eu.int
http://www.cordis.lu/focus/en/src/focus.htm
Summaries of
BIOMED 2 research projects
(1994-1998) are available from DG 12:
* vol 1, 713 pp, ISBN 92-828-7426-5
* vol 2, 651 pp, ISBN 92-828-7315-3
Please contact stephane.hogan@cec.eu.int
Catalogue of Central and
Eastern European projects
Since 1992, the EU has intensified
research cooperation with the Central and Eastern European countries
and the new independent states of the former Soviet Union under
the Copernicus programme.
In 1998, 235 projects were selected
(from 1931 proposals) and 1574 teams funded (from 10,236 proposing
teams). An amount of 53 million EURO was allocated for projects
in environmental protection, health research activities, non-nuclear
energy, information technologies, advanced communications and
social sciences.
A catalogue of projects is available
for 12 EURO (551 pages, reference CG-13-98-322-EN-C).
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