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ACTIP Bulletin 22 October 2000 |
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In this issue:
Complaints about Brussels bureaucracy Nature special on Functional Genomics Keynote speakers at ESACT 2001 meeting Document on Biological Weapons
Complaints
about Brussels bureaucracy For years, scientists from academia
and industry have been complaining about the bureaucracy and
delays involved in the funding of projects by the European Commission.
An independent advisory panel has reviewed the situation and
endorsed these complaints, saying that improvements are essential
if the Commission is to achieve its goals. The programme's inefficiency
is mainly due to cumbersome administrative procedures. The Commission sets up the panel
every 5 years to evaluate its Framework Programmes. Academics
and industrialists from 11 countries carried out the 1995-1999
assessment, chaired by Joan Majó, former industry minister
of Spain. A survey of 2,275 respondents
carried out for the advisory panel showed that: The panel also said that the
Framework Programme is unable to meet the coordinated science
policy goals, intended to make Europe the world's most dynamic
and competitive knowledge-based economy. The panel made several recommendations,
with as main one Commision officials are already
exploring improvements to the application and evaluation procedure;
some of these will be tested in a pilot call for proposals in
bioethics and the socioeconomic aspects of biological research.
The Commission is also considering changing the rule that FP5
grant proposals should be anonymous during the 1st stage of evaluation. Source: Nature, Vol 406, July
27, 2000 The August issue of Nature Biotechnology
(vol 18, 2000) contains a very extensive review with all biopharmaceuticals
now in general medical use. By now, 84 have been approved in
the US or EU, and some 60 million patients worldwide have thus
far benefited from these drugs. The industry's global market
value currently stands in excess of $ 12 billion. The article is accompanied by
extensive tables, listing the products, the host organism in
which it is produced, the company, the therapeutic indication
and the year of approval. One of the tables shows that 18 of
the 84 products are produced in animal cells, not counting 18
monoclonal antibody products. Approvals are as of May 2000. Approvals to date suggest that
the decade of replacement proteins may be coming to an end and
that companies are increasingly exploring new types of biologics
for new indications and new markets. The article is highly recommended! Source: Nature Biotechnology
Vol 18, August 2000, pp 831-833, with separate fold-out tables. For a reprint of the tables,
call Layonne Holmes (+1 212 726 9278). Alternatively, you may
request the ACTIP secretariat for a copy of the article and tables.
We do recommend however that you obtain an original copy of the
tables. Nature
special on Functional Genomics Another highly recommended read
is the special issue 'Nature Insight-Functional Genomics', accompanying
Nature, Vol 405, no 6788, June 15, 2000. The special contains articles
on: The sequence for the published
genomes and human chromosomes can be accessed online on: http://www.nature.com/genomics A copy of the article can be
requested from the ACTIP Secretariat. However, if you don't want
to miss all the good full colour illustrations, you are advised
to order a copy directly from Nature. Source: Nature Insight - functional
genomics. Nature, vol 405, no 6788, June 15, 2000, pp 819-865 Keynote
speakers at ESACT 2001 meeting The 17th meeting of ESACT, called
'From target to market', will take place in Tylosand, Sweden,
from 10-14 June, 2001.
In May 1999, the UK Royal Society
hosted a meeting to discuss aspects of the control of biological
weapons with the National Academy of Sciences (USA) and the French
Academie des Sciences. Following that meeting, the Royal Society
decided to prepare a document that would examine this topic from
a UK perspective, and whci would inform policy-makers and the
public about the measures required to counter the threat posed
by biological weapons to civilian populations. The document has now been published
and is available at a cost of BP £ 10. A very readable
document for anyone interested in the topic. For more information: Also available from the ACTIP
Secretariat.
Fascinating chemistry
In November 1997, a consortium
of 16 major European Science Centers and technology museums started
an ambitious project called 'Chemistry for Life'. The project
was designed to stimulate interest and scientific awareness among
the tens of millions of visitors to museums and science centres
across Europe. The project involved the development of some 30
prototype exhibits, including hands-on interactive exhibits,
spectacular shows, multimedia and laboratory workshops etc. All
this gives the public, in particular younger people, a better
understanding and appreciation of the importance of chemistry
in every day life. All the new exhibits, workshops,
films and shows from the Chemistry for Life project are now collected
in a new website, the 'Chemistry for Life Virtual Gallery - to
learn more about the fascinating world of chemistry'. i tried
it and it is very, very good! Visit: Further information, i.e. visits
etc, from:
News about the EU
EUR-OP News has only been published
on paper twice this year. However, they promise to keep us constantly
up to date on current EU topics and new publications via: http://eur-op.eu.int/
(updated daily) and
Orphan drugs regulation entered into force
The European Orphan Medicinal
Products Regulation entered into force on April 27th, 2000, after
the European Commission adopted the implementing regulations,
including definitions for 'similar product' and 'clinical superiority'.
Bright future for medicinal glycoscience
The August issue of Nature Biotechnology
contains an extensive review of emerging themes in medicinal
glycoscience. The authors, Koeller and Wong, recognize that numerous
medicinally relevant physiological events rely on glycoconjugates
for their viability. Events include: This growing list assures that
this field will be at the forefront of research for years to
come. In this respect, we are looking forward to the presentation
of Prof. Matthijs on the Euroglycan project at ACTIP's coming
Paris meeting. A copy of the article may be requested from the
ACTIP Secretariat. Source: Nature Biotechnology
Vol 18, Aug 2000, pp 835-841
Pathway to apoptosis
The search for the biochemical
mechanism of apoptosis has now led to the identification of an
elaborate pathway that triggers cell death by activating a group
of intracellular proteases known as caspases, leading to the
so-called caspase cascade. Fussenegger, Bailey and Varner recently
presented the first mathematical description of caspase activation.
It shows that apoptosis can be induced by both intracellular
stress and receptor-mediated signals following an extracellular
stimulus. Their effort may represent an important first step
toward rational identification of best strategies to regulate
apoptosis for clinical applications. Source: Nature Biotechnology
Vol 18, July 2000, pp 768-774
From skin to bone
Researchers at the University
of Michigan have engineered human gingival and rat dermal fibroblasts
that form bone capable of supporting hematopoietic tissue in
vivo. An adenovirus engineered to express bone morphogenetic
protein-7 was used to transduce both type of fibroblasts ex vivo.
The authors used immunocompromised mice and rats. The transplanted
cells did not migrate from the surgical site, nor was there any
sign of inflammation or dysplasia. Source: Human Gene Ther. 11,
1201-1210, 2000
Artificial thymus for T-cell production
Methods for generating T cells
in vitro from human CD 34+ typically have been cumbersome and
yielded few mature T-cells. A new method has been developed by
Poznansky et al, using a biocompatible three-dimensional carbon
matrix to engineer an artificial thymus. The matrices were seeded
with thymic tissue from mice; in a next step human bone-marow
derived progenitor cells were added. In this environment the
progenitor cells produced large amounts of functional T-cells.
They found that the three-dimensional matrix was a key element
in the production, confirming the importance of three-dimensional
cell-cell interactions for successful tissue engineering. Source: Nature Biotechnology
vol 18, July 2000, pp 729-734
Lentivirus for stable gene therapy
American researchers have used
a lentiviral vector to introduce functional beta-globin genes
into haematopoietic stem cells in a beta-thalassemia mouse model.
The work demonstrates that the vector can introduce and regulate
corrected genes during stem cell development. Source: Nature 406, 82-86,
2000
Targeted spinal cord gene therapy
A group of American researchers
have succeeded in delivering therapeutic proteins (TNF-alpha)
to the spinal cord of mice expressing the human poliovirus receptor.
They succeeded by taking advantage of the strong natural tropism
of poliovirus for motor neurons. The researchers engineered poliovirus
replicons to express foreign genes in place of capsid proteins,
which rendered them non-infectious. The mice were injected intraspinally.
Targeted gene therapy for the CNS could potentially be used to
treat spinal cord trauma and neurological disease. Source: Nature Biotechnology
Vol 18, September 2000, pp 964-969
Generating mast cells
A team of researchers recently
generated mast cells from genetically manipulated embryonic stem
cells. According to researcher Galli, the new approach has broad
potential, because mast cells are thought to participate importantly
in many biological responses, such as angiogenesis, wound healing
and tissue modelling, responses to neoplasms and non-immunological
forms of chronic inflammation. Source: PNAS, vol 97, 2000,
pp 9186-9190
Potato vaccin triggers human immune response
Scientists from the Boyce Thompson
Institute (BTI) at Cornell University and the University of Maryland
reported on the success of the first human trials of a potato
vaccine in the July 2000 issue of The Journal of Infectious Diseases.The
BTI team had previously triggered human immune response to E.
coli through a transgenic potato. For more information, see: http://unisci.com/stories/20003/0706003.htm
Peptide vaccine on display
Italian and British researchers
show that bacteriophages can be used to display peptide epitopes
capable of inducing both cytotoxic T-cell and T-helper cell responses.
Thousands of copies of a peptide derived from HIV-1 reverse transcriptase
were displayed on the surface of the bacteriophage fd. The ability
to stimulate both arms of the immune system suggests the technique
may be useful in vaccination strategies. Source: Nature Biotechnology
Vol 18, August 2000, pp 873-876
In vivo diagnosis Alzheimer's disease
Currently, Alzheimer's Disease
(AD) can only be diagnosed conclusively after death. American
researchers report a promising new in vivo technique to detect
the accumulation of beta-amyloid in the brain. The method involves
labelling of beta-amyloid with I-125 and injecting it. It crosses
the blood-brain barrier and labels beta-amyloid deposits in the
brain (in a living mouse model and in human AD brain sections).
By linking the radiolabeled compound to the polyamine putrescine,
they enhanced the compound's ability to cross the blood brain
barrier. Source: Nature Biotechnology
Vol 18, August 2000, pp 825-826 and 868-872
Therapeutic proteins from corn
Integrated Protein Technologies,
a Unit of the Monsanto Company, claims that their proprietary
transgenic corn-based system can produce large quantities of
pharmaceutical grade proteins that are as efficacious as mammalian-derived
biologics. They invite you to call them to set-up a comprehensive
in-house seminar to learn more about this process.
Approval for therapeutic cloning
The British government wants
to extend the possibilities for experiments with embryo's, including
the use of cloned embryo's for stem cell research for medical
purposes. The latter part is the most controversial in the British
proposal, since (1) it will bring reproductive cloning a step
closer and (2) involves the specific creation of a human embryo,
to be sacrificed two weeks later. Opponents think this should
not be allowed, although the use of superfluous rest-embryo's
is allowable. Use of embryo's for research purposes has taken
place in the UK for some time now: between 1991 and 1998, 48,000
rest embryo's have been used for 5 regulated purposes, including
research into unfertility and congenital diseases. Until now,
research on embryonic stem cells for cell therapy was not allowed. Source: BioNieuws 26/8/2000; For companies involved in stem
cell research, see ACTIP Bulletin 21
CD-18 trials disappoint again
Genentech has announced disappointing
phase II trial results of its anti-CD18 monoclonal antibodies
in treating heart attacks. The antibody failed to meet its primary
objective of improved coronary blood flow 90 minutes after treatment. Source: Nature Biotechnology
Vol 18, August 2000, pp 817-818
Introgene fused into Crucell
Well-known gene therapy company
Introgene will cease to exist as an independent company. It has
recently fused with biotechnology start-up company U-BiSys (Utrecht
Biotechnology Systems) to form Crucell, a company aimed at the
development of gene therapy, genomics, production of vaccines
and production of human proteins. Introgene-founder Dinko Valerio
will be the new general director. Crucell will be based in Leiden,
the Netherlands. The move will complement IntroGene's portfolio.
Centrally in Crucell's strategy will be a human cell line, PER.C6,
capable of producing adenoviruses with therapeutic genes. The
cell line will also be used to investigate gene function. Galapagos,
a collaboration between Introgene and Belgium company Tibotec,
has already started suvch investigations. The PER.C6 cell line
will also be used for the production of human vaccines and proteins,
including monoclonal antibodies. Source: BioNieuws, August
26, 2000
Gene therapy buy
Gene therapy specialist, Targeted
Genetics, USA, is to buy another gene therapy company, Genovo,
in a stock swap. Genovo is strong in liver- and lung related
genetic therapies. New Zealand effectively bans GMOs
The environmental agency in New
Zealand is imposing draconian strictures on researchers undertaking
the most basic manipulations of genetic material. No distinctions
are made between experiments performed for release and those
conducted in contained laboratories. Costly procedures are required,
and the use of biological materials from international collections
is effectively banned, since researchers must pay $ 1,400 per
application to import GM organisms. Source: Nature Biotechnology,
Vol 18, August 2000, pp 810
........and France refuses to implement biotech patenting directive
On July 30, 2000, all EU member
states were to have altered their national laws in line with
directive EU 98/44 on the legal protection of biotechnological
inventions. Even though France originally ratified the directive,
it is now refusing to comply. Opponents in the French government
claim that some of the wording of the directive could be misinterpreted
to allow patenting of raw DNA without knowledge of its utility.
Industry representatives fear the controversy could damage an
already weak biotech industry. The European Commision is threatening
France with legal action, including fining France 631,771 EURO
for each day the directive is not implemented. Source: Nature Biotechnology
Vol 18, August 2000, pp 820
Changes in US patent law
As of November 29, 2000, any
patent application filed or pending in the USA will be subject
to publication within 18 months of filing date. Although nothing
new to those filing patents in Europe, Canada or Japan, the rule
is new to the USA. In addition, the act also provides that the
Director of the US Patent and Trademark Office (PTO) may permit
the public access to file wrappers of published patent applications.
In addition, the new act also establishes the effective prior
art dates of US applications and international applications. Source: Nature Biotechnology
Vol 18, August 2000, pp 795-796
National Biotech reports
The Commision has recently published
3 (voluminous) reports: the three volumes of 'Inventory of public
biotechnology R&D programmes in Europe: Volume 1, the analytical
report; Volume 2 and volume 3: National reports'. One may request the European
Commision or the ACTIP secretariat for a copy of the reports.
Alternatively, one may request the ACTIP Secretariat for a copy
of the 6 pages of Conclusions, dealing with issues such as biotech
policy systems in Europe, the role of the private sector, national
characteristics of public biotech R&D, national biotech funding
systems, biotech transfer instruments, public-private networks,
specialisation in funding, and future trends. References: Office for Official
Publications of the European Communities, 1999 Office for Official Publications
of the European Communities
Women in science not at the top
Extraordinarily few women in
Europe have an equal opportunity to make a contribution to science
and enjoy the benefits of a scientific career. Despite the increased
participation of women in higher education (50% of first degree
students in many countries), and despite the increase in women
taking science subjects and moving into doctoral and post-doctoral
studies, there remain remarkable few women in top jobs in any
of the EU member states: in many states, women represent less
than 5% of the members of learned academies. In addition, the
percentage of female directors in small and medium-sized enterprises
throughout Europe is around 6%. The EU has published several
documents on the issue of gender (in)equality. Check out: Science policies in the EU: promoting
excellence through mainstreaming gender equality; a review of
the position of women in science and technology. Free in English,
Nicole Dewandre, fax + 32 2 29 93 746, email improving@cec.eu.int Equal opportunities for women
and men in the EU-annual report 1999. Free in English. Fax: +
32 2 29 623 93 Quality between women and men
in the EU: http://europa.eu.int/comm/employment_social/equ_opp/index_en.htm
Improving the Quality of Life
The Commisson is publishing a
series of brochures on the thematic programmes of FP 5. The most
recent one is explaining the Quality of Life programme. Nothing
new, but a nice lay-out makes the information much more accessible
than the official 'work programmes'. Ref: ISBN 92-828-5549-X For more information or orders:
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