|
Next
meeting
Please
note that the next ACTIP meeting will take place in
Toulouse,
France on
April
24-25, 2003
Central topics of this
meeting are:
biomanufacturing variations
stem cells as research/screening
tools
Please contact the
actip@wirehub.nl
ACTIP Secretariat if
you would like to receive an invitation and
accompanying documentation
In this issue
2002
European Innovation Scoreboard
The
chipping forecast
stormy
weather ahead
Higher
biology teaching standards
Innovative
medicines used erratically
Stem
Cell news
Research
news
Business
News
On the
web
Publications
Training
courses
Agenda
2002
European Innovation Scoreboard
Last year we reported on the
results in Europe regarding key factors determining
Europe's innovation scores. Here are the main
findings for the year 2002.
As in 2001, smaller Member
States are in the top slots for many factors:
Sweden is in the top 3 11 times, Finland 9 times,
the Netherlands 5 times, Denmark 4 times; This
shows that the EUs innovative leaders are found in
the Nordic countries plus the Netherlands.
For 7 out of 10 indicators, the leading EU
countries are better placed than the USA and Japan.
For example, Finland and Sweden lead in business
R&D expenditure, and Luxembourg, Spain and the
Netherlands in new capital raised. The EUs only
significant lead over Japan is in home Internet
access.
Some relative strengths:
Denmark: lifelong learning, US patents, venture
capital;
Germany: patenting, business R&D, medium/high
tech manufacturing employment;
France: science graduates, home internet
access;
Ireland: science graduates, manufacturing high tech
value added, home internet access;
UK: education, high tech manufacturing value
added;
Sweden: patents, finance, lifelong learning;
Netherlands: new capital raised, patents, lifelong
learning
Spain: new capital raised, US patents, home
internet access
The full report (2002
European Innovation Scoreboard SEC 2002 1349 of Dec
9 2002) can be requested from innovation@cec.eu.int
or downloaded from www.cordis.lu/focus/en/src/supplements.htm
. There is also a dedicated website:
http://trendchart.cordis.lu/Scoreboard2002/index.html
Source: Innovation and Technology Transfer, Special
Edition, February 2003
The
chipping forecast
In December 2002, Nature
Genetics published 'The Chipping Forecast II'. Part
I was published in January 1999 and focused on the
'nuts and bolts' of micro-array technology.
However, 3 years later, the biggest concern is no
longer how to make and use arrays, but how to
design experiments, weed out noise, analyze data
and validate results. Therefore, part II, published
in December 2002, contains a number of articles
focusing on just these issues. Here an example of
some of the reviews:
Fundamentals of experimental design for cDNA
microarrays
Microarray data normalization and
transformation
From patterns to pathways: gene expression data
analysis comes of age
Post-analysis follow up and validation of
microarray experiments
Characterizing the physical genome
The genetics of variations in gene
expression
Protein microarrays and proteomics
Molecular portraits and the family tree of
cancer
Functional exploration of the C.elegans genome
using DNA microarrays
Better therapeutics through microarrays
- Source:
Nature
Genetics, Supplement, Vol 32, December
2002
.......stormy
weather ahead
The 10th Annual BioPartnering
Europe Conference 2002 was attended by over 1,500
delegates. There were several BioPartnering
Leadership sessions, among which a 'Forecaster of
the Future'. The latter featured a keynote address
by Dr. Stuart Henderson, partner at Deloitte &
Touche, who quoted from that firm's Life &
Health Sciences Report. His 10 predictions for the
future of the Life Sciences session are the
following, and they do not make easy
reading:
The general economic conditions are likely to
worsen in the near term;
The capital markets are likely to remain shut
for at least the next four to six quarters,
possibly even until 2005/2006;
Venture capital funds are likely to remain
defensive (= protect their existing portfolios
and remain cautious with respect to new
investments);
The long-awaited and much-heralded M&A
activity (merging and acquisition) will
begin;
There will be a slow down of company formation,
but more collaboration between academic and
licensing groups;
There will be an increase in recycling of
venture capital funds;
Product focus will dominate for investments in
the sector;
Extended enterprise will take centre stage in
the most successful companies going forward
(includes more recognition of mutual
co-dependency);
The pharmaceutical industry will need to take a
pivotal role in stabilizing the industry;
There need to be new EU initiatives to fill
equity gaps (assisting companies to proceed
financially past the seed stage
phase).
Other panel members cited
Europe's problems of 'ack of depth' and 'lack of
quality in senior management teams'. Furthermore,
there was consensus to plan sensibly, refocus
businesses and build what is needed within existing
companies. Quote: "it is our opportunity to do the
right thing that will deliver the value in the
industry in the next 3-4 years".
Source:
European
Biopharmaceutical Review, winter 2002, pp 35. See
also www.techvision.com/bpe
Higher
biology teaching standards
The European Commission is
funding a two-year initiative to create an ongoing
training programme for biology teachers and
scientists, and to develop, archive and distribute
the best available teaching resources throughout
Europe. The project is entitled 'Continuing
Education for European Biology Teachers', and will
be coordinated by the European molecular biology
organization (EMBO), working in collaboration with
the European molecular biology laboratory and the
European Federation of Biotechnology. The
initiative will receive 710,000 euros under the
quality of life and management of living resources
section of the Fifth Framework
Programme.
A key feature of the project
is the organization of one international and eight
national teacher workshops - aimed at increasing
European cooperation and exchange - during which
training materials and teaching resources will be
developed and disseminated. The national workshops
will take place in Hamburg, Copenhagen, Madrid,
Prague, Hinxton, Warsaw, Szeged and Jerusalem, with
the international event being held in
Heidelberg.
The aim of the collaboration
is to create a training programme that will bring
teachers into laboratories for hands-on activities
with qualified students in order to develop new
assets for biology teaching. A dedicated facility
will be established at the EMBL in Heidelberg for
this purpose. The project will also result in an
online resource centre and archive that offers
practical classroom materials to teachers and
students. In addition, the resource centre will
address current ethical and social issues connected
with the impact on society of advances in science,
and suggest how best to introduce these topics into
a classroom setting.
Source:
EMBO at
http://www.embo.org
.
Innovative
medicines used erratically
According to a recent study,
the development and improved application of
innovative medicine is essential to attempts to
improve health care systems throughout Europe. The
study, carried out by Professor Schoffski on behalf
of the European Federation of Pharmaceutical
Industries and Associations (EFPIA), also revealed
a current lack of recognition and erratic use of
innovative medicines among Member States' health
care systems.
The findings of the study
showed that while there are innovative medicines
available for the 20 diseases studied, patients are
in many cases receiving medicines that are proving
less effective or having severe side effects. In
some cases, patients were not given any treatment
at all. Such findings not only suggest worrying
trends in current health systems in Europe, but
also imply a lack of understanding and interest in
the value of innovative medicines, which could, in
turn, have repercussions on the further funding of
research and development in the area of innovative
pharmaceuticals.
The study suggests that by
developing and implementing innovative medicines,
health care systems can become more cost effective,
with higher investment compensated by improved life
expectancy of patients. Professor Schoffski
believes that to stimulate the application of such
medicines, patients and health professionals should
be made more aware of all the treatments available,
and that the pharmaceutical industry has to address
the price differences between new medicines and
older treatments which inevitably lead to the use
of older therapeutic principles for a longer
time.
Source:
EFPIA at
http://www.efpia.org
.
Stem
Cell News
Commercializing
cell therapies
The commercialization of cell
therapy has yet to take off. While some skin and
bone products are leading the way, only a fraction
of the potential of cell therapy has been realized.
A number of companies have started autologous cell
therapy services and are generating revenues.
However, as the barriers to enter these markets are
low, the investment return is unlikely to excite.
Products based on allogenic cell therapy are a much
better commercial proposition: they are scaleable
and can be patent protected, making them a more
desirable goal for companies. Key hurdles
associated with supply, function and control are
being addressed, with technologies like inducible
apoptosis likely to make a real impact. Real
advances are being made on the manufacturing aspect
of product delivery, for instance with the
generation of sophisticated serum-free media.
Cell therapy will start to fulfill its potential
when human cells of defined function for each
specific need can be grown easily in the laboratory
and can be controlled once implanted in the
patients. True stem cell products may still be a
long way off (some even estimate 10 years or more),
whereas those based on more controllable, partially
differentiated cells are likely to become a reality
much sooner. These products have the potential to
displace traditional pharmaceutical and health care
approaches.
Source:
Will West,
CellFactors, European Biopharmaceutical Review,
Winter 2002, pp 56-60
The UK
National Stem Cell Initiative
The UK has adopted a
pragmatic approach combining public acceptance,
government recognition of potential scientific and
commercial value with a clear and open regulation
of stem cell research. This approach has resulted
in the UK National Stem Cell Initiative.
The National Initiative not only provides
additional funding for stem cell projects. As part
of this initiative, the UK Medical Research Council
and the Biotechnology and Biological Sciences
Research Council are jointly funding the
establishment of a National Stem Cell Bank. This
bank will curate existing and newly developed human
embryonic stem cell lines as well as human stem
cell lines derived from fetal and adult tissues.
Cell lines will be available to UK academics and
industry and to overseas academics. It is intended
to eventually follow both a cGMP and a non-GMP
track. Ownership of the cell lines deposited
remains with the depositor, and issues of lines and
materials from the bank to 3rd parties will be
under materials transfer agreements. The presence
of a UK Stem Cell Bank clearly represents a major
opportunity for coordinated UK research on existing
and newly developed cell lines. This should make
the UK an attractive environment for stem cell
research.
Source:
Dr. John Sinden,
ReNeuron, European Biopharmaceutical Review, Winter
2002, pp 62-63
Sweden:
New Stem Cell Institute
Swedish stem cell researchers
in Lund are building a new interdisciplinary
'Center for Stem Cell Biology and Cell Therapy'
through the establishment of a Stem Cell Institute
(SCI). Sweden is one of the few countries to allow
stem cell research and the use of therapeutic
cloning. For the next 6 years 10 million EURO is
available to build up the centre. The centre will
comprise 11 major research groups.
Stem Cell
bank in China, Stem cell Institute in
USA
The Chinese government has
approved the establishment of a stem cell bank in
Tianjin, near Peking. The stem cell bank will be
coupled to a transplant centre, capable of treating
200 patients annually. Also in other life sciences
fields China is particularly active. Three years
ago, the Chinese Genome Centre was established, and
this played a key role in the elucidation of the
genome of rice. Furthermore, the Chinese are
pioneering human-animal cell hybrids for the
production of tissues.
Also in Europe and the USA work is in progress to
use human stem cells for transplantation purposes.
Stanford University announced in December the
establishment of a stem cell research
institute.
Sources:
China approves stem cell bank, BBC News, 11
December, 2002:
http://news.bbc.co.uk/1/hi/sci/tech/2567757.stm
New Institute Targets Stem Cells, Washington
Post, December 11, 2002:
http://www.washingtonpost.com/wp-dyn/articles/A37453-2002Dec10.html
Research
News
Human
therapeutic proteins from silkworms
Recombinant protein
production remains a bottleneck in the
biotechnology industry. Significant progress has
been made with all available expression
technologies, but production yields are still
insufficient for a large number of proteins. For
example, 1,2 tons of human serum albumin are needed
annually in a country as small as Switzerland.
Other proteins needed in large quantities include
collagen, thrombin and antibodies or antibody-like
molecules. But a novel production system might be
in the pipeline. In January 2003, Japanese
researchers (Tomita et al) showed for the first
time that stable, long-term expression of a human
recombinant protein (procollagen) is possible in
the silk glands of the Bombyx mori larvae (the
ordinary silkworm).
It is obvious that the protein production capacity
of silkworms exceeds that of any other industrial
system in use today. In addition, the glands of
these animals produce an almost pure product.
Purification of recombinant protein from cocoons
seems to be a rather simple process despite
silk-fibroin synthesis being maintained in the
insect. The authors indicated that even with 'low'
yields being reported, 5 kg of pure collagen was
produced on a surface area of 300 m2 with five
workers caring for 1.5 million silkworms. The only
remaining issue is protein quality, but recent
papers have shown that expression of mammalian
glycosyltransferase genes in insect cells can
broaden their capacity for glycosylation.
Source:
Nature Biotechnology Jan 2003, vol 21, pp 34-35,
52-56
Glycosylation
in E.coli
Researchers in Switzerland
and the UK recently reported a way of engineering
E.coli to carry out oligosaccharide modifications
similar to mammalian cells, providing a system that
is not only applicable to mammalian protein
expression, but also robust and relatively low
cost. The authors introduced a Campylobacter jejuni
gene (pgIB) with high sequence homology to a
protein essential in the process of N-linked
glycosylation into E.coli. That resulted in a
mutant able to glycosylate proteins in a way
similar to eukaryotic cells. However, at present
the protein-linked oligosaccharide structure in
E.coli differs significantly from the eukaryotic
modifications, but there is good hope that it will
be possible in the future to generate E.coli
strains that attach the specific desired glycan to
proteins.
Source:
Science 2002, vol
298, pp 1790
Business
News
Rapid HIV
test obtains FDA approval
OraSure Technologies (USA)
has received FDA approval to manufacture and
markets its OraQuick Rapid HIV-1 antibody test.
This is a point-of-care dipstick test to detect HIV
antibodies in whole blood samples within 20
minutes. The test has a sensiticity of 99.6% and
specificity of 100% on clinical studies performed
with blood specimens.
Source:
IVD Technology
Jan/February 2003
Rapid test
for West Nile Virus
Manufacturers are scrambling
to develop rapid and effective nucleic acid tests
to screen donated blood for West Nile Vitrus (WNV)
before the onset of the modsquito season this
summer. In 2003, the FDA will require WNV screening
of the entire blood supply. In 2002, the US
WNV-epidemic escalated to a total count of 3873
confirmed cases and 246 deaths. 80% of infected
people are asymptomatic. The WNV test development
process will serve as the example for rapid
response in the future. It is a test of flexibility
and agility for the blood industry, for the
diagnostics industry and for the FDA.
See also: www.devicelink.com/ivdt
Source:
IVD Technology
Jan/February 2003
Japanese
and British databases for genetic
research
This year the Japanese government will establish a
database with the DNA and lifestyle data of 300,000
Japanese citizens. The objective is to link
diseases that will be found in the coming years in
this group to genetic data.
In other countries similar projects are being
contemplated. Also this year, the British medical
Research Council will start a large-scale
investigatuion into the genetic cause of disease.
Medical and genetic data of 500,000 British
citizens between 45 and 69 years old will be
collected and studied over a period of 10-20 years.
This study, dubbed the UK Biobank, is the largest
of its kind sofar.
Sources:
Asahi Shimbun,
01-01-03: http://www.asahi.com/english/national/K2003010100139.html
Biobank UK: http://www.biobank.ac.uk/Welcome.htm
Swedish
Biotechnology Industry Organization
The first Swedish Biotech
Industry Organization has been launched under the
name SwedenBIO. It aims to campaign for a national
investment programme as well as for more foreign
investment in the sector. Chairman is Bjorn
Nilsson, president of Karo Bio.
Dolly is
dead
On February 14, 2003, the
Roslin Institute announced the death of Dolly, the
world's first cloned sheep made from a mamma cell
from an adult animal. While Dolly seemed healthy in
the first few years of her life (she gave birth to
6 lambs), she became ill when only 5 years old. It
started with arthritis, and last year a viral
infection that resulted in a lung tumour. Both
diseases are ageing diseases. A normal sheep lives
10-12 years. Also other cloned animals (goats,
cows, pigs, mice, rabbits, cats) show a variety of
diseases, such as defect of the immune system,
miscarriages, obesity, pulmonary and circulatory
problems, kidney and brain disorders, diabetes,
malformations, early death due to lungproblems,
cancer and liver diseases.
Source:
Bionieuws February
28, 2003
The
promise of pharmacogenomics and
pharmacogenetics
Pharmacogenomics as applied
to medical practice offers the promise of reduction
in adverse drug events (ADEs), enhanced drug
efficacy and selection of patients able to respond
to specific agents. The estimated annual cost of
drug-induced illness in the US is 136 billion USD,
and ADEs were estimated to be the 4th to 6th
leading cause of death in the US. Pharmacogenomics
offers the promise of improving medical care
through selection of patients who will respond more
effectively to drug therapy, optimizing efficacy
and decreasing the frequency of ADEs. Many ADEs
have underlying identifiable genetic components.
Pharmacogenetics is now poised to move into the
clinic from a strong base of support built upon
research studies on polymorphic drug metabolism. To
successfully reduce the frequency of ADEs,
pharmacogenetics and pharmacogenomics must broaden
its focus to include not just a consideration of
polymorphic drug metabolizing enzymes, but also
additional pathways that contribute to polymorphic
drug disposition such as drug-transporter and
receptor polymorphisms and drug-drug interactions.
A new level of complexity involving management of
many bits of information is essential to move the
prediction of phenotype from genotypic analyses
into patient care.
Source:
Pharmacogenomics
(2003) 4(1), 1-4
On
the web
Free
medical publications
Thousands of medical publications, free on-line
at:
http://www.ncbi.nlm.nih.gov/PubMed/
Biotech
abbreviations
The Pharma Lexicon search box gives free access to
theÝworld's largest online database of
medical, pharmaceutical and biotech abbreviations.
&endash; more than 70,000
Visit: http://www.pharma-lexicon.com
Weekly
summary R&D and innovation
The European Commssion has
launched a new electronic information service
termed CORDIS Express digest. Every Friday the
weekly electronic bulletin summarizes the latest
European research and innovation developments.
Visit: http://www.cordis.lu/express"
Overview
Italian Biotech
A new public database now
offers a complete overview of Italy's biotechnology
industry sector. It provides instant access to over
150 companies and research organizations.
Visit: http://www.biotechwithitaly.com/companies.asp
Nanotechnology
Are you interested in
micro/nanotechnologies, information technology and
neuro/biotechnologies? You then might want to check
out the APTE Association, a knowledge and
co-operation network particularly active in Europe.
Please visit: http://apte.net"
http://apte.net
Human
tissue and cell products &
transplants
If you are interested in
position papers on human tissue and cell products
& transplants, you might want to check out the
following documents and position papers:
Proposal for a Directive on setting clear safety
and quality standards on donation, testing and
procurement for human tissues and cells regardless
of final use, including transplantation and related
medical applications. http://europa.eu.int/comm/health/ph/others/human_tissues/index_en.htm
3/12/02 &endash; EuropaBio's
Human Cell and Tissue Working Group publishes
position paper on DG Sanco proposed directive. The
final version of EuropaBio position paper was
addressed to Commission (DG Sanco, DG Entreprise)
and MEP, Dr P Liese http://www.europabio.org/xtranet/wo_contents.asp?do_id=482
3/12/02 &endash; EuropaBio
explanatory document re: proposals and queries on
the Tissue Banks and Clinical Trials sections of DG
Sanco Directive; The paper was sent to P Liese and
D Bouis (DG Enterprise) http://www.europabio.org/xtranet/wo_contents.asp?do_id=500
Review of
pharmaceutical legislation
The Commission modified
proposal on the Review of Pharmaceutical
legislation is available at the following website:
http://dg3.eudra.org/F2/pharmacos/docs.htm
Publications
New
magazine: European Biotechnology Science &
Industry News
This new magazine will offer
a multinational forum for opportunities and
developments throughout Europe focused on the
biotechnology sector. It features a new forum for
current economic affairs, qualified political
background information from Brussels and the latest
highlights from science and technology. The
magazine is published by BIOCOM AG (Berlin) in
association with the European Federation of
Biotechnology.
G10
medicines group report
This group was established in
March 2001 to look at ways of encouraging
innovation and competitiveness in the EUs
pharmaceutical industry. The group presented its
final report in April 2002. Conclusions:
- firms offereing
innovative products should be given greater
opportunity to make profit than those whose
products are more traditional;
- call for the creation of
virtual networks of health institues amnd
improvements to peocedures for introducing
innovative medicines to the
mnarketr.
- member states and the
Comjission shoulkd coordinate Europe wide
clinical trials and establish a database of
trials and clinical research results
Downloadable from:
http://pharmacos.eudra.org/F3/910/g10home.htm
Apoptosis and programmed cell
death: molecular mechanisms and applications in
biotechnology and agriculture &endash;project
report
EUR-OP (Office for Official Publications of the
European Communities). See also http://europa.eu.int/comm/research/pub_rtd.html
Stem cells: therapies for the future? &endash;
Conference Report
mailto:Quality-of-life
@cec.eu.int
Training
courses
How to
use the European Pharmacopoeia, New approaches and
media
26-27 June 2003
Training
III: Herbals (herbal
drugs , extracts , essential oils etc.)
4-5 December 2003
Training
IV: General (chemical
products )
Information: Caroline Larsen Le Tarnec, Public
Relationss , EDQM ,
Fax: +33 (0)3 8841 2771 - Tel: +33 (0)3 8841
2815/2824
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.
China-EU
Colloquium on Functional Genomics and Technology
Transfer
April 7, 2003, Lyon, France
More information: http://www.efbweb.org/activities/efbicintro.htm
BioVision
2003
April 8-11, 2003, Lyon France
Organisation: http://www.biovision.org"
www.biovision.org
The
commercialization of tissue engineering and
regenerative medicine
9-10 April 2003, London UK
Information: Marcus Evans Life Sciences; mailto:
OlaS@marcusevansuk.com
ACTIP meeting
on biomanufacturing variations and stem
cells
April 24-25, 2003
Information mailto:actip@wirehub.nl:
ACTIP Secretariat
Linking
phenotype to genotype
April 24-25, 2003, Munich, Germany
Information: http://healthtech.com/conference-info
Clinical
Quality Assurance & GCP
Compliance;
April 28-29, 2003, UK
Information: Marcus Evans Life Sciences; mailto:
OlaS@marcusevansuk.com
ESACT
meeting: animal cell technology meets
genomics
May 11-15, 2003, Granada
Organisation: ESACT, http://www.esact.org
or + 34 932 388 777
Recombinant
antibodies
May 14-15, 2003, Cambridge, Massachusetts
Information: http://healthtech.com/conference-info
Macroresults
for microarrays
May 13-14, 2003, World Trade Center, Boston,
Massachusetts
Information: http://healthtech.com/conference-info
Genomic and
proteomic sample preparation
May 15-16, 2003, World Trade Center, Boston,
Massachusetts
Information: http://healthtech.com/conference-info
European
Science Foundation:
Functional Genomics and Disease
2003
May 14-17, Prague, Czech Republic
Information: www.functionalgenomics.org.uk/sections/news/programme.htm
Genetics.
Genomes, the linkage to life
July 6-12, 2003, Melbourne Australia
Organization: www.geneticscongress2003.com
11th European
Congress on Biotechnology, 25th anniversary of
EFB:
Building bridges between biosciences and
bioengineering
24-29 August, 2003, Basel, Switzerland
Organisation: ECB11, Tel + 41 61 686 28 28; fax:
+41 61 686 21 85; email: mailto:info@ecb11.ch
; web: www.ecb11.ch"
http://www.ecb11.ch
6th
Conference on
Protein Expression in Animal
Cells
September 7-11, 2003, Montreal, Canada
Information: Amine Kamen, Biotechnology Research
Institute, tel + 514 496 0915, fax + 514 496
6785
Email: mailto:6thPEACe@nrc.ca;
www.bri.nrc.ca/6thPEACe
CORDIA-EuropaBio
Convention 2003
Dec 2-4, 2003, Vienna, Austria
Information: mailto: clare.king@reedexpo.co.uk
http://www.cordiaconvention.com
ACTIP bulletin no. 33,
March 2003
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