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Next
ACTIP meeting
The next ACTIP meeting will
be held in Marburg, Germany
June 3-4,
2004
Please already
reserve the date. Details will follow
soon.
Members:
did you submit your company profile?
At the Montreux
meeting it was decided to extend the membership
listing on the ACTIP website with a short company
profile. You are all kindly asked to write such a
short profile about your company. The profile will
be available when someone clicks on your company
name. From there on the reader will be referred to
your company's website.
Please be so kind
to make such a profile if you have not already done
so and send it to the ACTIP Secretariat as soon as
possible!
In
this issue
Zoonoses
set to increase
The
killer diseases
Biotechnology
and Development Programmes
News
from the Commission
Research
News
Business
news
News
from other organizations:
On
the web
Most
successful Y-chromosomes
Agenda
Zoonoses
set to increase
With global trade
and the worldwide ecological crisis, the danger
from zoonoses (animal diseases which can spread to
human beings) is set to increase in the decades to
come. The recent outbreak of avian flue in Asia is
an example, as was the SARS outbreak last year.
Many specialists believe that zoonoses will
represent a major threat to public health in the
coming century. Certain diseases return at regular
intervals, others strike like bolts out of the
blue, others never disappear.
Below we give some
examples:
- influenza:
comes back yearly, from farm animals to human
beings. Can be deadly, i.e. Spanish flue, 1918,
worldwide 20-40 million deaths.
- Marburg fever:
1967, 7 deaths, violent hemorrhagic fever, green
monkeys brought to German laboratory
- Malaria,
hematozoan transmitted by anopheles
- Brucellosis,
leishmaniosis: endemic in Mediterranean
populations
- AIDS (HIV virus
most likely passed from monkeys to people
through hunting and eating bushmeat)
- Hendra (1994)
and Nipah (1999) viruses, originated in
fruit-eating bats from south-east Asian
forests
- SARS,
coronavirus
- Hanta viruses,
passed by rodents (forestry workers, farmers (in
the Balkans, deadly in 12% of
cases).
- New variant CJD
(spread of TSEs from bovines to
humans)
- Brucellosis
(undulant fever), sheep, Mediterranean
shepherds
Some say that the
fear for zoonoses is overdramatic: have human not
always lived in contact with animals? Has our
immune system over millions of years not learned to
combat these pathogens? Does the species barrier
not provide protection? The answer is no, as the
examples above demonstrate. Also, some 200 zoonoses
are known today.
Zoonoses are
expected to increase since the opportunities for
pathogens to jump across the species barrier have
multiplied in recent decades. The reasons are:
rapid urbanization, population movements, the
clearing of new agricultural land, the growing
trade in meat, milk and other animal products, the
increasing speed and number of vehicles, increased
tourism. Other factors are global warming, which
allows certain species, in particular insects, to
colonize new regions where they propagate new
pathogens. Also, tropical deforestation is bringing
humans into contact with animals they have not
encountered before. Acceleration of international
trade and travel put all world inhabitants at
risk.
In the EU it has
been proposed to set up a European Diseases
Prevention and Control Centre. Its primary missions
will be epidemiological surveillance, including a
network of pathologists who can be called upon 24
hours a day to formulate scientific opinions on
policies and to provide technical assistance. This
independent agency should come into being in
2005.
Several EU-funded
projects are targeting zoonoses. Here are some of
their titles and contact details:
- EU contact:
Isabel.minguez-tudela@cec.eu.int;
anna.lonnroth@cec.eu.int
- Bivalent
hanta-virus vaccine for Europe:
detlev.kruger@charite.de
- Diagnostics and
control of rodent-borne viral zoonoses in
Europe: antti.valeri@helsinki.fi
- Pathogenesis,
diagnosis and control of avian influenza
infections:
j.banks@vla.defra.gsi.gov.uk
- European
surveillance network for influenza in pigs:
G.Koch@id.dlo.nl
- Preparing for
an influenza pandemic: new vaccination
strategies: jwood@nibsc.ac.uk
- Tick-borne
diseases:
philippe.brouqui@medicine.univ-mrs.fr
- RA and
prevention alveolar echinococcis:
peter.kern@medizin.uni-ulm.de
- All EU funded
research into TSEs:
europa.eu.int/comm./research/quality-of-life/tse/index_en.html
- Brucellosis
vaccines: guillote@tours.inra.fr;
imoriyon@unav.es; liautard@univ-montp2.fr; COST
network with 400 researchers:
www.brucella.org
Source:
RTD
Info, November 2003
The
killer diseases
On the topic of
infectious diseases: throughout history they have
had a devastating effects on humanity as well as
society &endash; depleting the workforce, burdening
the health care system, weakening the economy.
Below a table of the WHO, identifying the big
killers of today, yesterday and
yesteryear
Outbreaks
in 2003:
SARS; 7919 cases,
662 deaths
Meningococcal
disease, 7146 cases, 1058 deaths
Ebola, 143 cases,
128 deaths
Big
killers of today:
Malaria, 300-500
million cases/year; 1.5-2 million
deaths/year
Tuberculosis: 8
million cases/year; 2 million
deaths/year
AIDS: 6 million
cases/year; 3 million deaths/year
Big
killers of yesteryear:
6th Century,
Plague: 142 million cases, 100 million
deaths
Bubonic plague, 30
million cases, 12 million deaths
Spanish flue
(1918), 1 billion cases, 21 million
deaths
Source:
WHO,
represented in EBR, winter 2003
Biotechnology
and Development Programmes
All 1889 United
Nations member states have committed to achieving
the Millennium Development Goals by 2015. These
goals are aimed at poverty alleviation, improved
education and health, environmental sustainability
and other development indicators. At first glance
it appears that science and technology have no role
to play in meeting these targets. However, in a
recent report it was shown that there is a very
close match indeed. The authors mapped a list of
'top 10 biotechnologies to improve health in
developing countries' onto the Millennium
Development Goals. This study challenges the common
assumption that high tech solutions are unsuitable
for development goals. Below we reprint the match
between technologies and development
goals:
Combat
infectious diseases; reduce child mortality;
improve maternal health:
Molecular
diagnostics (i.e. dipstick assays)
Recombinant
vaccines (reduced risk vaccines, rational vaccine
design)
Improved vaccine
delivery systems (needle free technologies,
temperature stable controlled release
systems)
Sequencing pathogen
genomes (understanding disease mechanisms; boosts
search for novel drugs and vaccines)
Recombinant
proteins (cheaper synthesis drugs in i.e. E.
coli)
Combinatorial
chemistry (rapid generation compounds (i.e anti
leishmaniosis drugs)
Improving
children's nutrition:
Nutritionally
enhanced GM crops (golden rice with
beta-carotene)
Ensuring
environmental
sustainability
(bioremediation, clear contaminated sites, degrade
pollutants)
Promoting
gender equality
(female controlled protection against sexually
transmitted infections (i.e. novel mandelic acid
condensation polymer blocks)
Source:
Nature
Biotechnology, Vol 21, nr 12, Dec 2003, pp
1434-1436
News
from the Commission
More
funding to combat HIV/AIDS, malaria and
tuberculosis
The EU has stepped
up its AIDS research funding in the developing
world. While the EU has agreed to contribute some
60 million _ towards the 4 billion _ Global Health
Fund, this does not fund R&D activities. To
fill the gap, a separate EU initiative called the
Europe Developing Countries Clinical Trial
Partnership (EDCTP) allocates 600 million _ during
a 5-year period until 2007 to create new medicines
and vaccines against AIDS, malaria and
tuberculosis. EDCTP will initially focus
exclusively on Africa. EDCTOP will get 200 million
_ in EU funds, 200 million _ from EU member states
and 200 million _ from industry, charities and
private research organizations. Moreover, an
additional 200 million _ will be donated via the
Commission's FP6 programmes for 'normal calls for
proposals' which target HIV/AIDS. In fact, 6
projects due to be funded under FP6 will start in
2004. According to the Commission, 19,000 lives are
lost each day to HIV/AIDS, malaria and
tuberculosis.
Prodi:
research has to be key priority
In a recent speech,
knowledge and innovation were highlighted by
Commission President Romano Prodi as the Union's
'key priorities'. Mr Prodi called for a more
proactive approach to the issue by Member State
governments, saying that "The Commission will make
its proposals and the Council will take its
decisions. However, nothing will actually happen
until these decisions become policies at national
level."
Mr Prodi deplored
the fact that there are 400,000 'top EU
researchers' currently working in the US, and
stressed that Europe must create research centres
of excellence that are the best in the world. "They
must become the vital symbol of our belief in the
future, and that here in Europe we are capable of
planning for the future and making it happen," he
said. Echoing previous calls for a 'new European
Renaissance', the president called for Europe to
"become what it was for centuries: the point of
reference for young researchers throughout the
world."
Emphasizing the
urgency of the situation, he claimed that
investment in education and research is not an
"abstract problem", but an issue to be addressed
now, as international competitors are already
overtaking Europe. He concluded his address with a
few words about Europe's researchers of the future,
and their significance for European
competitiveness. "Our young people must be able to
find in Europe the opportunities to study, work and
be successful that are their right. I must stress
that I am not speaking only in their interests;
this is the key to our very survival," he
said.
Source:
CORDIS
News, Jan 19, 2004
EU to be
more active in 'war without guns'
There is a war
without guns between North America, the Far East
(China and Japan) and the EU. According to E. Vizi,
president of the Hungarian Academy of Sciences,
this War refers to the war in science, and he
thinks the EU should do more to promote advances in
crucial areas of research such as genetic
engineering and nanotechnology. He also thinks that
the 'EU should create a knowledge based society and
a knowledge-based economy' if it wants to keep up.
While the EU has made these pledges before, the
transatlantic brain drain is still continuing. Vizi
said EU governments were finally beginning to take
science as seriously as they should, given that
intellectual property rights account for 80% of an
average product's value, while only 100 years ago
it was the other way around, with labor costs and
material costs taking up the lion's share.
Goverdhan Mehta, president elect of the
International Council of Science, said that the
'growth of knowledge' had doubled from the years
AD1 to 1750, between 1750 and 1900 and again
between 1900 and 1950. Today, however, knowledge is
doubling every 3-4 years. Or: more information has
been generated in the last 30 years than in the
previous 5000. All these wise quotes were heard
during the World Science Forum, hosted by Hungary
on November 8-10 last year.
Source:
European
Voice, Nov 13, 2003
Commission:
wake-up call for basic research in
Europe
With the aim of
sparking off a debate on how to promote basic
research in Europe, the Commission on 15 January
2004 published a Communication on "Europe and
fundamental research". Commissioner Busquin said
that the paper was designed to act as a "wake-up
call" for Europe to realize that it is quickly
losing ground in the area compared to the US and
Japan. Fundamental research, he said, is key to
growth, competitiveness and better quality of life,
and must not be neglected.
'Basic research' is
driven by a researcher's interest in a scientific
question with no immediate or obvious commercial
value. Nonetheless, results of basic research have
often led to ground-breaking scientific discoveries
such as the DNA and X-rays and inventions like the
Internet. Basic research also plays a crucial rule
in the training of scientists.
High marks on
publications, lower on citations. In terms of
publications, Europe is in the lead with 41.3% of
the world total compared with 31.4% for the USA. In
terms of number of references, regarded as the best
indicator of the quality of research, Europe is
behind in most disciplines: US researchers account
for about one-third more references. Europe
achieved very good results during the early 20th
century Nobel awards, but performances have been
falling ever since.
The fragmentation
of Europe's research systems due to structural
differences within Member States of the European
Union has had an impact on several aspects: lack of
co-operation and co-ordination, lack of critical
mass, but also more importantly, lack of
competition at the European level.
While the EU held a
leading position in basic research in the early
20th century, this has been overshadowed by other
fields which are seen to be more profitable, such
as applied, market-orientated research.
The Commission's
initiative comes at the time when public research
organizations have showed their dismay at
governments' failures to increase research budgets
despite their pledge to achieve the
three
percent target
as set out by the 2002 Barcelona Council. In
France, more than 5,500 leading researchers have
signed an internet petition threatening to resign
from their positions if their demands for boosting
national research
Source:
CORDIS
News, January 16, 2004
See also:
http://europa.eu.int/comm/research/press.cfm
More on
the ERC
Discussions on the
European Research Council at various meetings have
been summarized in:
European Research
Council &endash; the life scientists'
view'
www.elsf.org/elsfbrochures/elsferc03.pdf
EU
scientists against clinical trials
directive
Thousands of EU
scientists have signed a petition against the EU
clinical trials directive, saying new red tape
could smother independent medical research. Cancer
specialists said the directive, which imposes
strict controls on monitoring and reporting drug
trials, would mean only big companies could afford
to carry out clinical research.
Source:
European
Voice, Jan 22, 2004
.
While Busquin calls on medical researchers to
create a forum
EU Research
Commissioner Philippe Busquin has invited the
opinions of the research community on the
contributions that a forum on academic medical
research could make to European research in this
field. Speaking to the French national institute
for health and medical research (INSERM) on 15
December, Mr Busquin acknowledged that while the
directive on good clinical practice, adopted in
2001 and to have been implemented in 2003, is
necessary, it is, to an extent, problematic for
public sector researchers wishing to carry out
clinical trials.
While ensuring an
appropriate research climate is essential for the
continuation of publicly funded clinical trials, it
is no less so encouraging private companies to
carry out research in Europe. According to Mr
Busquin, 73 per cent of investment by European
pharmaceutical companies was channeled into Europe
in 1990, while this figure had fallen to below 60
per cent in 2000. The answer to the drop in medical
research in Europe is to carry out more research on
a pan-European scale in order to create a genuine
critical mass of resources, and to disseminate
knowledge gained throughout the whole of Europe,
concluded Mr Busquin.
Source:
CORDIS
News
'Europass'
brings together CV, diplomas and training
certificates
The Commission has
recently adopted a proposal on the creation of a
'Europass', designed to improve the transparency
and EU-wide recognition of EU citizens' skills and
qualifications as part of the Union's commitment to
lifelong learning. This booklet (which will be
available online) brings together five existing
documents covering the following skills and
qualifications:
- the European
CV;
- a list of
language skills (the European Language
Portfolio);
- experience of
transnational mobility (the MobiliPass, which
will replace the current
Europass-Training);
- higher
education diplomas (the Diploma Supplement)
and
- vocational
qualifications (the Certificate
Supplement).
The Commission does
not rule out adding further documents to the
'Europass' in the future in order to address
specific sectors or skills in more
detail.
The draft decision
is expected to be adopted by the Parliament and
Council by the end of 2004. The official launch of
the new Europass should take place during a
conference on vocational education and training to
be held in Maastricht in December 2004.
Source:
Commission:
Europass
: a new instrument for better recognition of
qualifications and skills in the enlarged Europe
[FR] [DE]
Focus on
human tissue engineering potential
The European
Commission recently published a report on prospects
for commercial and research activities in the field
of human tissue engineering (regeneration of
tissues). The European Commission is currently
seeking to prepare legislation which will
harmonizes the authorization procedures for
marketing products/processes from human tissue
engineering.
The Commission
report, elaborated by its Institute for Prospective
Technological Studies at the EU Joint Research
Centre (JRC) in Seville, represents the first
comprehensive map of the emerging industry of human
tissue engineering in Europe. The paper makes clear
that the lack of an EU-wide authorization process
is hampering the growth of a nascent
knowledge-based industry.
The European
tissue-engineering sector is characterized by
young, small, research-based and
technology-oriented companies. A total of 113
European companies are now active in tissue
engineering in Europe (EU25), with 54 companies
engaging in in vitro production of tissues. The
European structure is similar to that of the USA,
regarding the number and size of
companies.
The size of the
tissue engineering market development and the
commercial range of applications is still in its
infant phase. Many of the tissue-engineered
products are still in early stages of development.
The small biotech companies involved do not have
the resources for large, long-term clinical trials
to provide information on the cost-effectiveness of
the treatment compared to conventional
alternatives. Lack of cost-effectiveness data is
the main reason for which insurance companies are
reluctant to reimburse treatment with
tissue-engineered products.
The present
regulatory framework applied differs from Member
State to Member State, which presents an obstacle
to free movement of tissue-engineered products and
hampers market growth in the EU. Some measures at
European level are already on the way. A Directive
on standards for quality and safety of human
tissues and cells is now being examined by European
institutions. Measures on marketing of products and
consumer safety are currently under preparation.
This new legislation should cover the marketing of
tissue-engineered products to safeguard consumer
and user protection and enable an effective common
market for these products.
The JRC report
"Human tissue-engineered products. Today's markets
and future prospects" may be downloaded
at:
www.jrc.es/home/toolbar/whats_new.html
Source:
CORDIS
News, January 22 2004
MEPs
approve cell and tissue directive
On Dec 16, 2003,
MEPs adopted the human cells and tissues directive
(503 for, 42 against). The directive sets minimum
standards for the donation, procurement, storage
and processing of human tissues and cells. The
directive holds that donors can be paid for cells
and tissues &endash; but only for loss of earning
or expenses. This compromise was reached to avoid
fears that payment would encourage a trade in body
parts. However, within the directive, human embryos
for stem cell research are not covered, leaving
controversial ethical questions surrounding EU
funding for this type of research in a grey zone of
legal uncertainty. Approval procedures for the
least controversial projects will be started on a
case by case basis after January 1.
Source:
European
Voice, Dec 18, 2003
Research
News
First
human HIV vaccine trial in South
Africa
In a US backed
study, South Africa's first human trial of a HIV
vaccine started early November 2003. The new
vaccine is being tested for safety and its effects
on the human immune system in 48 volunteers in
South Africa and the US. The vaccine is the first
to specifically target the strain of HIV that is
devastating South Africa, as well as India and
other countries. South Africa has a greater number
of AIDS cases than any other nation; the
predominant cause is HIV-1 subtype C. The
predominant subtype affecting the Western world is
subtype B, for which there are a number of vaccine
trials under way.
Source:
European
Voice, November 27, 2003
Good
results gene therapy trial
Schering's AGT-MI
is one of the first projects in the field of gene
therapy, which has entered advanced clinical
trials. Schering is one of the pharmaceutical
companies active in the field of regenerative
medicine.
Recently the
company announced that the results of the AGENT-2
study, part of the clinical development program for
the AGT-MI project, were published in the Journal
of the American College of Cardiology. The study
examined the efficacy and safety of Schering's
product in improving blood flow in the hearts of
patients with ischemic heart disease. The study
showed positive outcomes of its therapeutic
angiogenic product Ad5FGF-4 in the treatment of
patients with chronic stable angina.
The substance of
AGT-MI, Ad5FGF-4, is an adenoviral vector that has
been designed to transport the gene that encodes
for the growth factor FGF-4 into cells of the
heart, leading to the formation of new small blood
vessels (angiogenesis). This procedure is sometimes
referred to as a "microcirculatory bypass". The
product (1010 viral particles [vp)]) or a
placebo was delivered through a subselective
catheter into the coronary vessels of the hearts of
52 patients with coronary blood flow (perfusion)
defects during a minor surgical procedure. Four and
eight weeks later, perfusion of the heart muscle
was measured in these patients with single photon
emission tomography (SPECT) imaging.
Angiogenesis with
Ad5FGF-4 is designed to stimulate new blood vessel
growth which may provide alternate routes for blood
to flow into oxygen-deprived ischemic areas of the
heart due to blocked or narrowed arteries.
Envisioned as a procedure that could be
administered by interventional cardiologists,
Ad5FGF-4 involves a one-time administration of an
adenoviral gene therapy vector containing the human
Fibroblast Growth Factor 4 (FGF4) angiogenic gene
delivered into the coronary arteries through a
standard catheter.
Source:
Schering
AG, Berlin
For more
information, call 973/487-2095, or visit
www.schering.de/eng.
Heart stem
cells found
Researchers have
identified heart cells that meet most of the
criteria for stem cells: rat cardiac cells that are
self renewing and multipotent, with the ability to
differentiate in vivo into myocytes, smooth muscle
cells and endothelial cells.
Source:
Cell
114, 763-776, 2003
Wider
applicability for EPO
Recently, German
researchers concluded that EPO has a wider
applicability then treating severe anemia or
boosting an athlete's performance. It has been
demonstrated to be a good candidate for the
treatment of schizophrenia. The hormone does not
work by affecting the symptoms (paranoia and
delusions), but acts by decreasing the progression
of neurodegeneration. EPO appears to influence
various processes, such as apoptosis and a neuron's
metabolism. In addition, EPO has been shown to
improve cognitive functions in the mouse model.
Furthermore, EPO seems to have favorable effects
following brain seizures. Eight German centers are
involved in experimental treatments of
schizophrenia.
Source:
Bionieuws,
Dec 19, 2003
Business
news
100
million _ for R&D of Eastern
SMEs
The European
Investment Bank (EIB) has pledged 100 million _ in
support of entrepreneurs in Hungary, Slovenia and
Romania. The funds will be allocated to small and
medium-sized enterprises (SMEs), along with public
and private agencies active in the diffusion of
innovation, research and development, and
information and communications networks.
Funds will also be
made available to other sectors, including health
and education, social housing, energy,
environmental protection and general
infrastructure. Philippe Maystadt, President of the
European Investment Bank, spoke of the importance
of developing small and medium-sized enterprises
"in countries where the SME sector is not yet a
deeply-rooted part of the economic
scene."
"Global loan
facility will provide an advantageous source of
finance for the development of this sector that
encourages entrepreneurship and represents an
important source of job creation," Mr Maystadt
added. Additional information about the European
Investment Bank can be found at www.eib.org.
FDA
guidance on pharmacogenomics data
Recently, the FDA
issued the 'Draft guidance for industry:
pharmacogenomics data submission. This document
encourages drug and biologics developers to perform
pharmacogenomics testing during drug development
and clarifies how the FDA will evaluate the
resulting data. The guidance also provides specific
criteria and recommendations on submitting
pharmacogenomics data for investigational new drug
applications (INDs), new drug applications (NDAs)
and biological license application (BLAs). This
includes information on what data are needed and
how FDA will use or not use such data in regulatory
decisions. The draft guidance is available at:
www.fda.gov/cder/guidance/5900dft.pdf
Source:
IVD technology, February 2004
EU should
invest in 'white biotechnology'
The EU must invest
heavily in industrial biotechnology to boost both
environmental and economic growth, say Belgian
scientists in a report for the Royal Belgian
Academy Council of Applied Sciences. The authors
want an EU action plan on environmental
technologies due later this month to provide a
boost for industrial biotechnology. This sector is
called 'white biotechnology' to distinguish it from
'green' (environmental) and 'red' (medical)
biotechnology. The Ghent University researchers say
the EU is already lagging behind the US in the
development of energy saving technologies,
including renewable sources using sugars or
vegetable oils. In America, where the promise of a
new bio-based economy has spurred a long term
strategy and technology road-map to the year 2020,
companies already produce biomaterials for soft
drink cups, bedding and clothing. The white
biotechnology sector already accounts for around 5%
of the EUs chemical production and this proportion
is expected to rise to 20%, saving 11-22 billion _
through lower production costs. For example,
producing vitamin B2 using enzymes instead of a
chemical process cuts costs by 40%.
Source:
European
Voice, Jan 22, 2004
Germany
not innovative on biotech medicines
Peter Heinrich,
president of Emerging Biopharmaceutical Enterprises
(EBE) (representing sSMEs within EFPIA), applauded
EU leaders for pledging to increase research
funding for medical biotechnology. However, he
said, it is like trying to run a bath with the plug
out. You cannot on the one hand commit to
increasing innovation if, with the other hand, you
are not supporting the fruits of that innovation.
With the last remark he refers to Germany's
biopharmaceutical policy (notably health care
reform plans, reference pricing and mandatory 16%
rebates), which have already prompted several firm
to shut down or move their R&D activities
elsewhere.
Source:
European
Voice, December 17, 2003
.
but new funds for German biotech
The German
government has published three measures to boost
its biotechnology industry. The centerpiece is 500
m_ for Germany's venture capital sector to spend
over 5 years to support the formation of funds that
invest in early, developmental and mid-stage
technology companies. This measure is expected to
leverage another 1.2 billion _ in private sector
finance.
The second measure
is competitive programs to encourage collaboration
between academia and industry. Two schemes have
been announced: BioChancePLUS (to fund
collaborative research projects between academic
groups, biotechnology firms and medium-size
pharmaceutical companies; budget 100 m_ over 5
years) and BioFuture (1.5 million _ in total
funding to 7 academic groups engaged in basic
biotechnological research.
Essential is that
in the past projects were focused on bringing back
researchers to Germany; the new approach focuses on
funding of teams that are defining new strategic
research directions.
Despite all these
measures, analysts say a serious flaw still exists:
no tax incentives for R&D intensive young
firms, and no exit routes for investors.
Source:
Nature
Biotechnology, Vol 21, nr 12, Dec 2003, pp
1414
Positive
CPMP opinion for radioimmunotherapy Zevalin in
Europe
Schering has
received a positive opinion from the Committee of
Proprietary Medicinal Products (CPMP) for its
radioimmunotherapy product Zevalin®. Zevalin is
used in the treatment of adult patients with a
particular form of non-Hodgkin's Lymphoma (NHL),
namely those with rituximab relapsed or refractory
CD20+ follicular B-cell NHL . Schering expects the
European Commission's marketing approval for
Zevalin within the next months and is ready to
launch the product shortly after approval in the EU
countries.
Zevalin is the
first commercially available radioimmunotherapy for
low grade B-cell NHL.
Zevalin has proven
to be effective in heavily pretreated patients who
are refractory to prior antibody. Zevalin has also
shown high efficacy in a comparative clinical trial
with overall response rates significantly superior
to antibody treatment alone.
Source:
CORDIS
News nov 6, 2003
Genzyme to
establish research facility in
Europe
Genzyme Corporation
has announced that it will open a research facility
in Cambridge, UK. The new facility will bring
Genzyme into proximity with renowned academic
institutions, a cluster of nearly 200 biotechnology
companies, and a large pool of world-class
scientific talent. The facility is scheduled to
open early in 2004 and to focus initially on
antibody technology and its applications in
oncology, renal disease and immune-mediated
diseases. Genzyme's research activities in
Cambridge will be led by Bruce Roberts, general
manager of Genzyme Science Europe.
In a recent survey
commissioned by the journal Science and the
American Association for the Advancement of
Science, Genzyme was ranked among the top ten most
highly regarded employers for scientists in the
biotechnology and pharmaceutical
industries.
Source:
Pressi,
Jan 19, 2004
European
Association of Pharma Biotechnology (EAPB)
initiative on Regulatory Affairs
Regulatory Affairs
is one of the most important disciplines
accompanying drug development from tube to market.
Regulations governing research, development and
marketing of medicinal products are nowadays
developed in close co-operation between authorities
and pharmaceutical industry. Methods and technology
in pharmaceutical biotechnology are advancing much
faster than the respective regulations. In the EU
as well as elsewhere - and also at ICH
(International Conference on Harmonisation of the
technical requirements for drug registrations) - we
must take into account, that the development of
guidances, directives and regulations takes a long
time before they come into force.
In the meantime,
biotechnology based companies which develop their
new drugs with new technologies, have a regulatory
"black box" concerning the design of their
development program.
Therefore, the
European Association of Pharma Biotechnology (EAPB)
has plans to establish a highly competent and
efficient Special Interest Group of Reg. Aff.
Professionals. The group should
* become
knowledgeable concerning existing biotech related
legislation
* analyse week
points in existing legislation and
* bring case
studies and subjects for discussion
* start
co-operating contacts to EC DG Enterprise, EMEA as
the major
European
authorities re Biotechnology as well as to
ICH
* represent EAPB
and biotech Reg. Aff. in the public in
presentations and publications
Source:
EFB
Newsletter November 2003
News
from other organizations:
News from
EFB
Currently, the
European Federation of Biotechnology (EFB) has
3,800 personal and 190 institutional members. In
2003, 11 EFB regional branch offices have been
established all over Europe (for details please
visit www.efbweb.org/rbo/rboview.htm.
In addition, 2 new EFB Sections on Medicines
Development and NanoBiotechnology have been
established. Please visit www.nsmf.org
and www.efbweb.org/sections/nanobio.htm
for more info or to register as member. These two
new Sections are significant extensions of the
topics covered by EFB thus including activities
related to drug development, medicine and applied
biophysics. The Section on Medicines Development
also represents a platform for a new visionary
European initiative called New Safe Medicines
Faster (www.nsmf.org)
while Section NanoBiotechnology represents the
Nano2Life Consortium.
Young
European Biotech Network (YEBN)
Since September
2003 the EFB has been re-enforced by a new
associated section, the Young European Biotech
Network (YEBN). YEBN is a non-profit organization
with the aim to strengthen the co-operation of
students and young Life Scientists throughout
Europe. YEBN is comprised of presently five
national associations with different focus from
education-improvement or university-industry
linkage to entrepreneurship. YEBN is organized as a
project platform with 'Project0' as a core group.
The flexible structure allows launching independent
projects.
More info on the
YEBN: www.yebn.de/portal/
Cytotechnology:
Special issue on Metabolic
Engineering
ESACT members are
planning to produce a special issue of
Cytotechnology on metabolic engineering: current
status of cellular modification approaches towards
maximization of yield from animal cells. The
editors, Otto Merten and Mohamed Al-Rubeai are keen
to see a special issue of original work right
across the field of metabolic engineering
application in cell culture such as the
modification of apoptosis, proliferation,
glycosylation and other cellular properties. They
are therefore inviting researchers in animal cell
culture to submit their works to this special
issue. The editor and publisher are aiming for a
publication in October 2004. If you are interested
in making a contribution, please contact them
immediately with a title.
This special issue
is aimed at all those involved in, and those
entering or interfacing with metabolic or cell
engineering of animal cells, whether graduate
student or experienced research worker.
Please, contact one
of the editors at their email addresses:
Mohamed Al-Rubeai: m.al-rubeai@bham.ac.uk
Otto-Wilhelm Merten: omerten@genethon.fr
On
the web
RNA
interference
RNA interference
(RNAi) is being harnessed for target identification
and validation and developed as a powerful new
therapeutic class. A lengthy but complete review of
the technology and the key players is given in the
December issue of Nature Biotechnology. It also
lists the following useful websites offering RNAi
selection tools:
Ambion's siRNA
Target Finder: www.ambion.com/techlib/misc/siRNA_design.html
Cold Spring
Harbor's RNAi OligoRetrivere: http://katahdin.cshl.org:9331/RNAi/
Dharmacon's
siDesign Center www.dharmacon.com
Qiagen's siRNA
Target Sequence Design: www.qiagen.com/jp/siRNA/sirna_design.asp
Sirna's Emboss:
www.biobase.de/embossdocs/sirna.html
Tuschl Laboratory
siRNA User Guide: www.rockefeller.edu/labheads/tuschl/sirna.html
The Whitehead RNAi
Selection program: http://jura.wi.mit/edu/pubint
Source:
Nature
Biotechnology, vol 21, nr 12, December 2003, pp
1441-1446
Most
successful Y-chromosomes
The male
Y-chromosome is doomed to disappear: per million
years, 3-6 genes disappear from the Y-chromosome.
It has been sequenced (Nature, June 2003) and
currently contains not more than 78 active genes,
sufficient to produce 27 proteins. The reasons of
this doom and gloom are a lack of recombination and
surprisingly few variations: some Y-chromosomes
occur frequently, others are rare. In a nicely
written article, two examples of the world's most
successful Y-chromosomes are given.
Probably the
world's most successful Y-chromosome is the one
allegedly from the Mongolian leader Genghis Kahn,
ruler of an area encompassing Asia from the Pacific
Ocean until the Caspian Sea. Exactly along the
borders a particular Y-chromosome is found
frequently: it is most likely of Genghis Kahn and
his four sons and one grandson. The reason: all men
were killed and cities destroyed. Each warrior was
free to do as he pleased with one exception: all
pretty women were sent to Genghis Kahn. Currently,
there are 16 million people with the alleged Kahn
Y-chromosome. This particular Y-chromosome is not
found outside the old Mongolian borders. Thus, this
Y-chromosome succeeded to multiply from one copy to
16 million in only 30 generations!
An example closer
to home is that of the Scottish leader Somerled of
Argyll (1100), who is at the root of three Scottish
clans, the MacDonalds, the MacDougallls and the
MacAllisters. At present, there are close to half a
million copies of Somerled's Y-chromosome; after
all, he was rich, powerful, had a lot of land and
attractive sons who later became the founding
fathers of the three clans.
Source:
Bionieuws
Jan 16, 2004, and Nature, June 19,
2003
Agenda
Superbugs
and Superdrugs: a focus on
antibacterials
March 1-2, London, UK
Information: + 44 20 7827 6168
Biologics:
overcoming the challenges of development and
manufacture
March 8-9, 2004, London
Information: www.smi-online.co.uk/bio.asp
BioSquare
2004
March 10-12, 2004, Basel, Switzerland
Information: info@biovalleybasel.com
The
Cures Start Here
The 2004 Annual Meeting of NYBA, the New York
Biotechnology
Association
March 1-2, 2004 New York, USA
Information: www.nyba.org/programs_events/registration.shtml
Advanced
Course on Biotechnology Ethics and Public
Perceptions of Biotechnology
29 March -7 April 2004, St Edmund
Hall,Oxford,UK
Information: www.efbpublic.org
BioVision
Alexandria
April 3-6, 2004, Alexandria Egypt
Information: www.bibalex.org/bioalex2004conf/
Paul
Ehrlich Institute hosts Euregenethy: Gene therapy
2004
April 15-16, 2004, Langen (Frankfurt), Germany
Information: http://euregenethy.org
cGMP
Training for the Biotechnology and Pharmaceutical
Industries in
Europe
April 22-23, 2004, London, United Kingdom
Information: www.spi.pt/seminar/events
Boston Hotel | Boston, Massachusetts
The
Pharmaceutical Alliance Management Congress 2004
April 15-16, Princeton, NJ, USA
Direct: (617)630-1342; eglazer@healthtech.com
Structure-based
drug design
April 26-27, 2004, Boston MA, USA
Information: lisac@healthtech.com
Laser
Capture Microdissection: Enabling High-Throughput
Molecular
Fingerprinting for DNA, RNA & Protein
Analysis
April 28-29, 2004 oston, Massachusetts
Information: lisac@healthtech.com
5th Annual
Recombinant Antibodies, Inaugural monoclonal
antibodies
April 28-29, April 30, Cambridge MA, USA
Information: jenniferl@healthtech.com
The
Williamsburg BioProcessing Conference Europe, 1st
Annual Meeting
Process development and production issues for
eukaryotic cell derived
products
15-17 March, 2004, antibodies, Amsterdam
18-19 March, 2004, Viral Vectors & Vaccines,
Amsterdam
Information: www.wilbio.com
EMBO
40 years of success
1964-2004
June 18-20, 2004, EMBL Heidelberg, Germany
Information: www.embo.org
Quality
on the move: Dynamics of the European
Pharmacopoeia
4-6 October 2004, Hilton Hotel, Budapest,
Hungary
Information: http://www.pheur.org
5th
International Conference on Systems
Biology
October 9-13, 2004, Heidelberg, Germany
Information: www.ICSB2004.org
3rd
Recombinant Protein Production - A comparative view
on host physiology
November 11-13, 2004 Tavira, Algarve, Portugal
Information: IBET, Alexandra Azevedo
e-mail: xana@itqb.unl.pt
phone: +351 21 4469362 (direct);
World
Life Sciences Forum,
BioVision
April 11-15, 2005, Lyon, France
Information: www.biovision.org
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