Environmental enrichment in the
standardised cages of laboratory animals has a beneficial
effect on animal welfare by creating opportunities for the
animals to perform a more species-specific behavioural
repertoire. However, it has been argued that enrichment may
increase the intra-group variability in experimental
results, and thus increase the number of animals necessary
to produce statistically significant data. To date,
contradictory results have been reported, some showing an
increase, other a decrease, and still others unchanged
within-group variability in animals living in enriched
environments.
A project headed by prof Vera Baumans of the Karolinska
Institute in Stockholm, with participants in Uppsala,
Newcastle, and Utrecht, was designed to provide solid
experimental evidence to help settle this controversy. The
aim was to discover the effects of environmental enrichment
on experimental results and on the variability of behaviour
of mice given the same dose of benzodiapezam in the
Light/Dark paradigm. Two commonly used strains of laboratory
mice were used; groups of four mice were housed in either
non-enriched, enriched or super-enriched cages. The results
showed that the mouse strain used appeared to be the factor
responsible for the greatest difference in experimental
results (i.e. latency to enter a lit compartment). Enriching
the environment produced no significant difference in either
the mean or the intra-group variation.
The results of this study show that there is no scientific basis for not adding enrichment factors to cages of rodents in this kind of study. Indeed, the beneficial influence of enrichment factors on animal welfare has been well established, and it is hoped that this practice will become standard in the near future.
Source:3R Info Bulletin no 22, January 2003; published by the 3R Research Foundation Switzerland.
See also
www.
Forschung3r.ch
In the Netherlands, the number of
animal tests has been steadily declining since 1977 from 1,5
million/year to 700,000 in 1999. However, since the year
2000 this decrease stopped and the number of animal tests
started to increase again, mainly due to an increased use of
transgenic animals. However, the year 2001 again saw a
decrease, albeit a small one. This relative decrease is
attributable to the use of fewer transgenic animals than
expected (37,000 in 2000 versus 26,000 in the year 2001). In
countries like Germany and the UK the trend towards an
increase in the use of transgenic animals is continuing.
Of all animal tests, 46% was used in research into cause and
treatment of diseases like cancer and cardiovascular
diseases; 40% was used in research, development and
production of medicines; the remaining 14% was used in
investigations into dangerous compounds, diagnostics,
teaching & training and defence.
Source: Bionieuws Dec 7, 2002
On Jan 15 last, the European
Parliament passed the 7th amendment, in effect banning the
sale and production of cosmetic products tested on animals,
regardless of whether they have been produced in the EU. On
Feb 27 the Council approved the amendment, and it was issued
on March 11 in the Official Journal of the European Union,
which can be downloaded under:
http://europa.eu.int/eur-lex/en/dat/2003/l_066/l_06620030311en00260035.pdf
The table of contents for Volume L66 of the Official Journal is available at: http://europa.eu.int/eur-lex/en/oj/2003/l_06620030311en.html and a chronological listing of the 2003 journals and previous years archives can be viewed at: http://europa.eu.int/eur-lex/en/oj/index-list.html
Starting in 2009, the majority of
the tests conducted on animals to ensure the safety of
cosmetic products will be outlawed, with companies forced to
use alternative methods. For those remaining tests where no
alternative has been developed yet, companies will be given
a grace period until 2013. The new directive also bans
substances classified as carcinogenic, mutagenic or toxic in
the production of cosmetic and forces cosmetics firms to
label products more comprehensively Parliament passed the
law despite fears the move would put trade at risk between
the EU and countries that continue to produce cosmetic
products still tested on animals. However, EU Commissioner
Erikki Liikanen assured the parliament the new law would not
pose a problem.
Animal rights campaigners were pleased by the news, although
they remained critical about the delay before the new law
can come fully into force.
"It's a small step in the right direction, although the
phase out (of testing on animals) till 2009 is ridiculously
long, given all the effective alternative that exist right
now," said Sean Gifford, Director of Campaigns for the
European chapter
of People for the Ethical Treatment of Animals.
Well-known EU Scientific Officers Line Matthiessen, Beatrice Lucaroni and Elena Sanchez recently published a Viewpoint paper in the ëEMBO reportsí addressing the ethical dimension of animal experimentation and implementing the 3Rs principle in biomedical research, as well as the Commission's commitment to these principles in the coming years. In the paper, they explain the rationale behind the EC's policy on the use of animals in research and its proposed actions to decrease the number of animals involved. Here we summarize the main points of this highly readable and well-referenced article. A copy of the full article is available on request from Beatrice.Lucaroni@cec.eu.int Dr. Beatrice Lucaroni or from the IVTIP@wirehub.nl IVTIP Secretariat.
The main goal of EU legislation
is:
to accomplish a uniformly high standard for the use and care
of animals in experimental research;
to replace the use of animals with other methods and when
this is not possible, to make sure that such experiments are
undertaken only with the greatest attention to animal
welfare.
The principal instrument is the
Council Directive from 1986 (86/609/EEC) regarding the
protection of animals, with an emphasis of article 7 of this
directive, which expresses support for and outlines the
practical application of the 3Rs (reduction, replacement and
refinement in animal testing). It specifies that
'experiments may not be performed if another scientifically
satisfactory method of obtaining the result sought, not
entailing the use of an animal, is reasonably and
practically available'.
Another directive that now features animal welfare can be
found in the EC legislation concerning the legal protection
of biotechnological inventions (98/84/EEC), which states
that 'processes for modifying the genetic identity if
animals, which are likely to cause them suffering without
any substantial medical benefit to man or animal, and also
animals resulting from such processes, are not
patentable'.
Even more important is the Treaty of Amsterdam that came
into force in May 1999. The treatyís protocol on
animal welfare introduces for the first time legal
stipulations in favour of animal welfare in both law and
politics. As a consequence, European institutions and member
states now have to pay full regard to the welfare of animals
when drawing up new agriculture, transport, research and
single-market policies.
Based on these regulations and on the opinions of the European Group on Ethics, the Council and the European Parliament have laid down restrictive provisions for animal experimentation and tests performed on animals in all EC funded research projects. They specify that ëanimal experiments and tests on animals should, whenever possible, be replaced by in vitro or other alternative methodsí and that 'the modification of the genetic heritage of animals and animal cloning can only be envisaged for objectives which are justified on ethical grounds ..... with respect for the well-being of animals and the principles of genetic diversity'.
Under the Quality of Life
Programme of Framework Programme (FP) 5, several actions
have been taken to ensure that these provisions are
implemented for EC funded research:
applicants are obliged to describe the potential ethical
implications of their research proposal; the application
should justify the research design and in particular
describe the procedures used to respect the 3Rs principle
and to protect the welfare of animals; also, the applicants
need to explain how ethical requirements will be
fulfilled;
there is an assessment of the level of awareness among
applicants about the ethical implications of their research,
including ethical aspects of animal experimentation, and of
their responsibility to address these issues; when there is
reason for, the proposals are examined by a panel of
independent ethical experts, appointed by the EC. Between
October 1999 and January 2001 the panel examined 121
proposals (13% of the total number remaining eligible for
funding in the QoL programme). 33 proposals dealt with
non-human primates, dogs, cats or transgenic animals. The
funding of any project was suspended until the applicants
had satisfactorily answered all questions regarding ethical
implications.
there is EC support for research in bioethics
http://biosociety.cordis.lu/Home_Bioethics.cfm
. Currently, 22 bioethics
research projects are funded under the QoL programm,
including one aiming to come up with an updated concept of
alternative methods and of the 3Rs concept as applied to
research.
there is financial support for research into the development
of alternatives to animal experimentation to reduce the use
of animals in research and in toxicity testing. Such support
rose from 2 mEURO under the Biotechnology Action Programme
(1984-1988) to its current 65 mEURO support for more than 43
projects to develop in vitro or in silico alternatives. The
development of alternative methods is specifically supported
under the Key Actions 1 (Food and Health), Key Action 3
(Cell Factory) and Key Action 4 (Environment and Health) of
FP5. In addition, relevant research projects, workshops,
conferences, training programmes and activities to stimulate
awareness in small and medium sized enterprises are funded
as well.
In 1991, the EC created the European Centre for Validation
of Alternative Methods (ECVAM), which is a unit of the
Institute for Health and Consumer Protection with the EC's
Joint Research centre in Ispra, Italy. ECVAM coordinates the
validation of alternative tests at the EU level and manages
databases on these procedures. In addition, the centre acts
as a focal point for the exchange of information on the
development of alternative test methods while promoting
dialogue between legislators, industries, biomedical
scientists, consumer and patient organizations and animal
welfare groups.
research on animal welfare, in particular in the context of
farming, has so far received 11,5 million EURO funding.
Examples of funded projects are long distance cattle
transport, animal welfare in organic farming, poultry
genetics and feather picking in chickens, and a study on
public attitudes to welfare issues http://europa.eu.int/comm/research/quality-of-life/animal-welfare/seminars/index_en.html
The EC is committed to continue these activities in the future. Under FP6 (http://www.cordis.lu/rtd2002/ ) it will take further responsibility for promoting the ethical debate, addressing animal welfare issues and ensuring that the principle of the 3Rs becomes an integral part of all research projects that are funded. The development of new in vitro tests will be continued with funding from the 'Life Sciences, genomics and biotechnology for health' priority created in FP 6. These projects will focus on the medium and long-term perspective. The short-term perspective will be dealt with under the policy-oriented research in the FP6 action line on 'Supporting policies and anticipating science and technological needs'. This will be particularly helpful to cope with EU specific requirements to use, wherever possible, alternative methods such as those included in the White Paper on the Strategy for a Future Chemicals Policy (the plans for retesting of chemicals under the REACH programme) and in the 7th amendment to the Cosmetics Directive (Directive 76/768/EEC).
The need for commitment from all
the different parties involved has been highlighted in the
EC's Communication (COM 2002) on 'Life Sciences and
biotechnology a strategy for Europe' (
http://europa.eu.int/comm/biotechnology),
published in January 2002. The plan stresses the need to
identify ethical issues at an early stage of research and
the importance of public participation early in the process
of developing applications of biotechnology.
The need for coordination is also stressed in the
ECís Action Plan on Science and Society
(http://www.cordis.lu/science-society).
It proposes, among others, to establish a network of animal
welfare committees in order to exchange information and
develop best practice for the ethical review of animal
experiments.
Source: Viewpoint in EMBO reports vol 4, no 2, 2003, 104-107
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:
The full report (2002 European
Innovation Scoreboard SEC 2002 1349 of Dec 9 2002) can be
requested from mailto: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 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 'lack 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
Information about funding
opportunities for research that may lead to the
reduction, replacement, and/or refinement of animal use in
research,
testing, and education is provided in the link
below:
http://nextwave.sciencemag.org/cgi/content/full/2003/02/28/5
Posters on the ICCVAM In Vitro
Endocrine Disruptor and In Vitro Cytotoxicity
Assays have been placed on the ICCVAM web site.
These posters have also been
presented at the 42nd Annual Meeting of the Society of
Toxicology, which was held March 9-13, 2003, in Salt Lake
City, UT. The five (5) posters and the abstracts are
available on the ICCVAM web site at iccvam.niehs.nih.gov/meetings/SOT03/sotablst.htm
as well as linked from the ICCVAM home page
(iccvam.niehs.nih.gov)
and the ICCVAM meetings page (iccvam.niehs.nih.gov/meetings/schedule.htm"
) under "Upcoming Related and Sponsored
Meetings."
The Institute for In Vitro
Sciences (www.iivs.org/),
together with ICCVAM, support the workshop "Practical
Methods in In Vitro Toxicology,".
This 3-day workshop will be held June 10 - 12, 2003.
A copy of the brochure can be viewed at the following
link:
iccvam.niehs.nih.gov/meetings/iivs03wkshp/iivs03flyer.pdf.
More information from Ms. Amanda Lawrence, +1 301-947-5578, email alawrence@iivs.org
Reactions on REACH (the planned
system to retest 30,000 chemicals in Europe) are still
abounding.
The United States Government denounced the planned system in
a two-page report as 'costly, burdensome and complex',
adding that it 'might prove unworkable in its
implementation'. In this paper it says that it is estimated
that it could cost companies around 250,000 EURO to test
each chemical, might require 13 million additional animal
tests and make Europe the 'most expensive place to bring a
chemical to market'. However, a HESA (Health and
Environmental Safety Alliance) calculation arrives at an
amount of 110,000 USD per chemical.
Whether that really would be the case is the subject of a
French study, initiated by the association of the French
Chemical Industry (UIC) to assess the impact of the new
regulations on the French economy. The study is being
carried out with the participation of various ministries
(environment and industry), and industry federations. The
French results will complement similar studies that have is
underway by the European Commission. The results
expected April 2003 will help assess the economic
and social consequences of the White Paper and its
environmental and health impact.
One initiative to streamline the
foreseen REACH process would be to focus initially on the
1,500-2,000 really dangerous substances, and the rest to be
tested later in a staggered process.
Another initiative might be the establishment of a new EU
chemicals agency, similar to the highly successful, central,
self-financing European Agency for the Evaluation of
Medicinal Products (EMEA).
Yet another way to keep costs as
low as possible is a step-by-step approach as advocated by
HESA:
Get the most out of existing information;
Use validated chemical property estimation techniques
Donít underestimate the value of decades of
experience
Spend dollars wisely, by doing only what is truly necessary
and by taking a tiered approach to testing
Group chemicals into categories
Make the dossier a multipurpose safety dossier
Consider limiting the uses of chemicals
The REACH programme provides the chemical industry with a
strong incentive to create a single database (REACH-IT) that
will contain safety-related information on chemical
substances. At HESA a concept has been developed for a
global toxicological database for chemicals. Such a database
would take full advantage of existing databases (IUCLID and
others) and be fully web-enabled, featuring public and
restricted areas. It would hold toxicological data as well
as risk assessments. This concept is now being presented to
stakeholders in industry, industry associations ands
regulatory agencies. Suggestions and comments are invited at
hesa@hesaonline.com
Sources:
European Voice, January
15, 2003
CEFIC e-spotlight, issue 11, April 2003
HESA Newsletter February 2003, see also www.hesaonline.com
By now the list is growing of
possible uses for stem cells. Let's take a look:
* Nerve cells: stroke, Parkinson's disease, spinal cord
injury, multiple sclerosis
* Heart muscle cells heart attacks, congestive
heart failure
* Insulin-producing cells diabetes
* Cartilage cells osteoarthritis
* Blood cells cancer, immunodeficiency, inherited
blood diseases, leukaemia
* Liver cells hepatitis, cirrhosis
* Skin cells burns, wound healing
* Bone cells osteoporosis
* Eye cells macular degeneration
* Skeletal muscle cells muscular dystrophy
Source: Burrell & Company, from European Biopharmaceutical Review, Autumn 2002
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 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
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.
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:
www.washingtonpost.com/wp-dyn/articles/A37453-2002Dec10.html
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
For the application of gene
expression microarrays in high-volume toxicological studies,
experimental as well as data analysis procedures have to be
highly standardised. Standardisation of data analysis
applies to the assessment of data quality;
the generation of a database collection of mRNA signatures
of known compounds together with other related information
on these compounds;
sophisticated data analysis methods to rapidly and
unequivocally categorise novel compounds, determine their
mechanism of action and predict potential severe side
effects at an early stage.
The basic steps in generating a toxicogenomics knowledge
base for the evaluation of novel compounds includes the
establishment of high quality mRNA expression data;
the construction of a reference database comprising a number
of well-known and well-characterized compounds;
the selection of toxicological marker genes based on
statistical methods.
After validating and refining the reference compendium the system can be used to classify novel, uncharacterised compounds. With the inclusion of other related functional genomics data, the compoundís mechanism of action can be determined.
Experts are of the opinion that we
are at the beginning of a toxicogenomics era that will
provide more detail on the compoundís effects at the
molecular level. This will enable us to answer detailed
questions about drug effects at a very early stage in drug
development. Computational research can help in the process
by providing solid mathematical foundations for data quality
assessment, reference compendium construction and knowledge
base creation.
Source:
Hans Gmuender and
Andreas Hohn, GeneData AG, European Biopharmaceutical
Review, Autumn 2002, pp 90
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 investigation 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 so far.
Sources:
Asahi Shimbun,
01-01-03: www.asahi.com/english/national/K2003010100139.html
Biobank UK: http://www.biobank.ac.uk/Welcome.htm
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.
On February 14, 2003, the Roslin Institute announced the death of Dolly, the worldís 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
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
The European Commission 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:
www.cordis.lu/express
A new public database now offers a
complete overview of Italyís biotechnology industry
sector. It provides instant access to over 150 companies and
research organizations.
Visit:http://www.biotechwithitaly.com/companies.asp"
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
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 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 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
The Commission modified proposal on the Review of Pharmaceutical legislation is available at the following website: http://dg3.eudra.org/F2/pharmacos/docs.htm
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.
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 offering 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
institutes and improvements to procedures for introducing
innovative medicines to the market.
member states and the Commission should coordinate Europe
wide clinical trials and establish a database of trials and
clinical research results
Downloadable from:
pharmacos.eudra.org/F3/910/g10home.htm
Apoptosis and programmed cell
death: molecular mechanisms and applications in
biotechnology and agriculture 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? Conference
Report
Quality-of-life@cec.eu.int
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 IVTIP secretariat.
Organisation: www.biovision.org
Organization: Mr. Stephen Meulebroeck
pdk@las.vet.uu.nl
Information: www.esact.org
Information: healthtech.com/conference-info
Information: /www.functionalgenomics.org.uk/sections/news/programme.htm
Information: http://www.sivb.org
Information: http://iccvam.niehs.nih.gov/meetings/iivs03wkshp/iivs03flyer.pdf"
Info: http://www.ina-9.org/
Organization: http://www.geneticscongress2003.com
Information: http://www.fmv.utl.pt/eavpt2003/congress.htm
Organisation: ECB11, Tel + 41 61 686 28 28; fax: +41 61 686 21 85;
email: info@ecb11.ch;
web: www.ecb11.ch
Information:http://www.wessex.ac.uk/conferences/2003/healthrisk03/index.html
Organization: fab2003@biomath.rug.ac.be
Information: http://www.eurotox2003.org/
Organization: blhata@uta.fi or www.uta.fi/fst