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ACTIP Bulletin 23 December 2000 |
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In this issue: ESACT prepares
for Medical Biotechnology Section
ESACT
prepares for section Medical Biotechnology The European Federation of Biotechnology
(www.efbweb.org) is creating larger sections than the earlier
working parties, pushing for improved links to industry and academia
and devising ways of interlinking with cross national societies
like ESACT. As a result of the closer rapprochement of late,
ESACT has been preparing the ground for a Medical Biotechnology
Section, whose main aim is to foster faster moves in Europe to
push products and processes from biotechnology to clinical utilisation;
a key component of such a section is, of course, to have members
which are clinician practitioners. Working together with EFB
and ESGT, a Steering Committee which met in Frankfurt last February,
proposed a workshop entitled “From Medical Development
to Clinical Practices” conducted under the aegis of the
European Commission External Advisory Group “Cell Factory”
which took place in Brussels last June; the report conclusions
and summary can be consulted in (http://forum.europa.eu.int). This allowed ESACT to invite
some of the clinical participants to become members of the Medical
Biotechnology Section. So, now, the Section seems ready to take
off. ACTIP and ESACT members are invited to contact the ESACT
Secretariat should they wish to become a member.
On November 15 last, the European
Commision has launched an initiative to reinforce European activities
in genome research related to human health. Genome research is
strategically important for Europe as it is expected to unlock
considerable economic, medical and social benefits. The development
of new genome-based technologies, as well as new bioinformatics
tools, is of primary importance for competitive genome research
and for the development of new diagnostics and new therapeutic
approaches. It is also important to create and maintain in Europe
infrastructures to support genome research (for example, databases
and animal model resources). On 8 November, the Commission
services and Member States experts agreed:
A European Genome Area The Commission initiative on
Genome Research for Human Health has two main features: (1) to create a new type of project,
the integrated project; and Other features of the initiative
include a reinforcement of research into the ethical implications
and societal impact of genome information. It is expected that
in 2001 over EURO 100 million in total will be available for
this initiative.
Integrated Projects Integrated projects are designed
to stimulate progress in functional genomics Integrated projects will be selected
by a novel procedure that involves a preliminary call for expressions
of interest for topics that may be suitable for such support
(deadline 9 February 2001). From these, a limited number of topics
of strategic importance will be selected and these will be invited
to submit under a dedicated call for proposals from which the
integrated projects will be selected. This Source: Press Release European
Commission, 15-11; www.cordis.lu/life Manuel Hallen, Quality of
Life programme, Research DG. Tel : +32.2.295.74.07, E-mail manuel.hallen@cec.eu.int
Genome mouse
finished
Mid October, Celera Genomics
announced that 95% of the DNA of the mouse has been sequenced.
Again, Celera beats a public-private consortium (the Mouse Sequencing
Consortium) to the finish.
On the web
The most up to date genome information,
freely available from: An incredible amount of information
and useful links can be found on the site of the Craig Venter
created TIGR, the not for profit sequencing center: http://igweb.integratedgenomics.com/GOLD And for something completely
different, namely art in the genetic age, visit:
On November 15, 2000, the new
FP5 Work Programme 2001, covering the Quality of Life Pogramme,
was published. The programme has been adopted on several places
to new developments in technology. Most notable is the emphasis
given to genome research. Furthermore, there is
Emphasis on Genome Research As part of the Commisson initiative
on the European Genome Area (see above), genome research will
be a research priority in Key Actions, generic RTD programmes
and infrastructures. Integrated project on genomics and human
health, will be accommodated under a new key action iten, Key
Action 8.5. The call for an expression of interest has recently
been issued.
Reinforcement demonstration
projects The Commission would like to
see a strengthening of demonstration projects. Demonstration
projects will be open in all Key Actions, but note: there will not be any RTD projects
but only demonstration projects in areas:
Calls for proposals As already mentioned, a separate
call for expression of interest in genome research has recently
been issued. There will also be a separate joint call of the
Quality of Life and Environment programmes on endocrine disruptors. Last date for FP5: October
2001 As for the 'regular' call for
proposals, the deadlines of October 10, 2001 and March 2002 will
be fused, since projects starting late in 2002 would hardly have
2 years to run. Thus, please note that October 10, 2001 will
be the ultimate date that projects can be submitted for FP5 under
dedicated calls for proposals.
Deadlines (last chances!) The following deadlines have
been set for Key Actions that might be of interest to the membership: KA 1. Food, nutrition and
health: KA 2. Infectious diseases: KA 3. Cell Factory KA 4. Environment and health KA 6. Ageing population Generic research Fellowships: Accompanying measures:
Industry
trends in biotechnology
The Nature Biotechnology Volume
18 supplement October 2000 is entirely devoted to Industry Trends
in Biotechnology. It containes snapshots of industry's fastest
moving fields. The selection of topics includes some of the hottest
areas and issues in biotechnology. The content focuses mainly
on technology platforms and disease areas, and each article refers
to companies active in the fields mentioned. In the area of diseases, some
of the biggest killers and debilitators have been included. According
to estimates of the editor, the total disease burden, both in
direct and indirect costs, of the eight diseases covered amounts
to a staggering $ 500 billion. Nevertheless, all of these diseases
are manageble today. Several articles cover many of the technology
platforms offered by biotechnology companies. Feeding these technology
platforms are fields of biology where research is rapidly advancing.
In addition, two articles are entirely devoted to business issues. To give you a taste of the articles,
I have summarized here the topics to be discussed and some of
the most salient statements to be found in the articles.
Business
Business models in biotech * companies with technology platforms
that address only a tiny part of the drug discovery process risk
becoming optional or redundant accessories; Competitive business intelligence
gathering and analysis * intelligence systems are providing
an answer to the avalanche of information in science and business
Diseases
Autoimmune diseases * rapid progress in our understanding
of immune function promises more effective treatments for autoimmune
disorders;
Asthma * with asthma cases on the rise,
a better understanding of the disease on the molecular and systems
levels promises more efficacious treatments;
Arthritis * the ageing populations of developed
countries are likely to present a growing market for arthritis
therapies;
Cardiovascular disease * prognostic/diagnostic testing
and a raft of new drug targets from genomics promise to transform
cardiovascular medicine;
Cancer multidrug resistance * progress in understanding the
molecular basis of drug resistance in cancer promises more effective
treatments;
Malaria * together with major international
initiatives, companies are launching an offense against the world's
most deadly parasitic diease;
Antibacterial and antifungal
drug discovery Companies are racing to keep
pace with the emergence of drug-resistant micro-organisms;
HIV * the need for new treatments
for AIDS is more urgent than ever;
Technologies
Bioinformatics * companies are selling research
software to a small number of rich clients or offering services
to researchers over the Internet;
Data mining * software and services are developed
to analyze complex biological and chemical data in an intuitive
and efficient manner
Signal transduction * mapping the key signaling molecules
in biochemical pathways will be central to future drug discovery
efforts;
Pharmacogenomics * information on human genetic
variance is only just beginning to be used in drug development;
Biochips * with products already on the
market, biochips are likely to have an increasing impact on genetic
diagnostics, drug discovery, and basic research applications
Proteomics * by globally catalogueing cellular
protein content and state, proteomics promises to complement
genomics in drug discovery and basic research
Lead validation platforms * a battery of screening systems
are under development to validate compounds for further development;
Combinatorial chemistry * to avoid becoming a commodities
industry, combinatorial chemistry companies are broadening their
technology base;
Xenotransplantation * work to combat immune rejection
is progressing, concerns remain as to the risks of disease transmission;
Tissue engineering * despite technical and regulatory
challenges, the prospects for tissue engineering are good;
And some more
predictions: The golden age
of pharmaceutical industry
Randy Scott, president of Incyte
Genomics, predicts that in 2010 the molecular basis for most
major diseases will be understood, resulting in numerous new
targets for the pharmaceutical industry. His predictions include: * 2000: every gene sequenced; An interesting article, available
from the ACTIP Secretariat
The
Future of Genomics in Europe
In the beginning of November,
a 2-day conference, organized by the Life Sciences High Level
Group of Experts (advicers to Commissoner Busquin), was held
in Brussels. There were sessions on Human Health, Food Integrity
& Supply, Valuing Biodiversity and Responsible Use of Genomics.
Below you will find my own (Helma Hermans') interpretation of
key points mentioned during the two day conference. Please note
that I do not refer to one single speaker, but have mixed my
notes from different presentations.
The challenges Three challenges of genome technologies
could be identified: scientific, economic and cultural (1) scientific: (2) economic:
* with genomics we come on the
slippery slope of genetic screening, gender choice, embryo selection,
genetic manipulation, cloning; * genetic testing will take the
form of diagnostics (disorders), presymptomatic screening (family
history), screening of healthy carriers (reproductive, preventive)
and predictive (about increased or reduced chances to get a disease);
Supporting the use of
embryonic cells Dutch government has drafted
a proposal for an act in which human embryonic cells should be
allowed for medical and biological research. However, embryos
should not be grown specifically for that purpose; only ova and
embryos left over from in vitro fertilization attempts can be
used. The proposal still needs to be debated. Therapeutic cloning
will not be possible.
Workshop on certification
of suitability for TSE risk products The EDQM is pleased to invite
all interested parties to a workshop so that you may become more
familiar with the contribution of the TSE certification procedure.
This certification procedure is intended to demonstrate compliance
to the amended EU Directives 75/318/EEC for human products and
81/852 EEC for veterinary products, and with the status of the
procedure. The content and preparation of the dossiers will be
dealt with, as well as some specific cases (gelatin, tallow derivatives
etc.)
Pestivirus contaminations
of bovine sera and other bovine viruses contaminations The EDQM also organizes a two-day
meeting to clarify the technical and regulatory questions surrounding
sourcing, production, testing and use of bovine sera. In addition
to scientific and technical presentations and discussions, the
last part will focus mainly on the detection and inactivation
of methods in order to propose recommendations in this field.
In-utero immunization
technique Reseachers of the Veterinary
Infectious Disease Organization at the University of Saskatchewan
have developed a method for inoculating livestock in utero. The
same method could also be used to vaccinate human babies against
viral diseases such as herpes simplex, hepatitis B, human cytomegalovirus,
and group B streptococcus, all of which are most frequently contracted
from the mother during or shortly after birth. The researchers
injected fetal lambs with a DNA vaccine for bovine herpesvirus-1.
The vaccine caused the lambs to produce mucosal antibodies to
the virus, but otherwise they developed normally during gestation
and after birth.
Alpha-glucosidase keeps
babies alive A recent publication in The Lancet
demonstrates how treatment with alpha-glucosidase has kept 4
babies with Pompe's disease already alive for more than one yera.
Their muscles have become stronger and the heart muscle functions
better. The children will have to use the product for the rest
of their lives. Depending on clinical tests, Pharming hopes to
register the drug at the end of 2001.
Gene technology with
laser pulse Researchers at the US Beckman
Laser Institute have developed an innovative method to knock
out genes. They used a two-photon laser microscope to direct
a very narrow, high energetic laser pulse on a previously selected
part of a chromosome. The chromosome was coloured with a fluorescent
dye, making it sensitive to the laser light. With this technique
they succeeded in knocking out a number of ribosomal genes in
Potorous tridactylis, a marsupial with extremely flat cells in
cell culture. Source: PNAS 97 (17): 9504.
Support for EU plant
research in europe plummets downward Support for plant science research
by the European Union has been dropping sharply. In FP5 there
has been a two-thirds reduction in the number of successful plant
research proposals funded by the EU. Dutch authorities are in
the midst of implementing a 30% cut of plant research funding
over 5 years and have ended funding for all collaborative projects.
All Danish programs in plant biotechnology will expire by 2002,
and no new initiatives are planned. According to Nature Biotechnology
(18, pg.919) Italy's Green minister for agriculture and forestry,
Alfonso Pecoraro Scanio, is pushing Italian agbiotech research
to the point of collapse. There has been a 75% cut of financial
resources for research inside the agriculture ministry in the
last two years. In addition GM field trials have fallen from
about 40 in 1999 to 26 this year. "The precautionary principle
is turning out to be a 'no experimentation principle',"
says Roberto Defez. In practice, this means a halt to research,
whether in applied sectors or in biosafety.
GM tomato rsv antigen
vaccine University of Illinois scientists
report in the Eur. J. Transgenic Research on a tomato derived
edible vaccine and tests. The scientists used the expressed major
protein on the outside envelope of the respiratory syncytial
virus. Increased antibody production in the mucosal and serum
immune systems of mice was observed when fed five times with
GM tomatoes. Source: 2/8/2000 ; ref: AN2042
Delays in implementing
biotechnology patenting directive By June 2000, the EU biotechnology
patenting directive should have been implemented in the EU member
states. As per September 2000, it was only implemented in Denmark,
Finland, Ireland, and the UK. The directive is under discussion
or in the form of a draft proposal in Austria, Belgium, France,
Germany, Greece, Italy, Spain, Sweden, and The Netherlands. Source: CEFIC/FEBC, personal
communication
Patent application human/animal
embryos withdrawn Under pressure of Greenpeace,
companies Australian Stem Cell Sciences and US BioTransplant
have withdrawn their patent application covering technologies
to create human embryos using animal cells. The patent application
covered the transfer of the nucleus of one species to the cell
of another, creating i.e. a human nucleus into an enucleated
pig ovum. A 32-cell embryo was the result. Nuclear transfer is
potentially of interest in the cultivation of tissues and organs
for xenotransplantation.
.... and a new Xenotransplant
company Biotechnology companies Novartis
and BioTransplant have announced the establishment of a joint
company, to be based in Boston, for the development of xenotransplantation.
BioTransplant is active in the development of systems reducing
immune rejection and works on both allo- and xenotransplants.
Novartis will contribute Cambridge-based subsidiary Imutran.
High cell density bioreactor
with ultrafast on-line dsp Computer Cell Culture Center
was set up in 1989 by our good friend, prof. Alain Miller. In
March 1999, the company raised 150 million Bfrs in a private
placement. |
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