The French Agency on Safety of Health Products (Afssaps) has been actively involved in the development of alternative methods to animal testing. Based on earlier work, the Afssaps has set up an array of four alternative methods for the ocular irritancy evaluation of topic products and proposes a step by step strategy based on these alternative methods for the evaluation of surfactant-based formulations such as shampoos.
The alternative methods were: HET-CAM test, Agarose overlay method, neutral red release assay (all 3 as regular methods) and a previously published protocol using a reconstructed cornea model (non regular method).
The strategy proposed when testing 33 shampoos involves a first evaluation using the three regular methods (if a product classifies as irritant, no further animal testing); if the product classifies as 'non-irritant, continue with the reconstructed cornea model test. If then tested as irritant, no further animal testing; in a third step, the products classified as 'non-irritant' according to the reconstructed cornea model are evaluated according to the Draize eye test.
This procedure leads to a satisfactory safety control strategy and allows 84,5% reduction of animal use.
A copy of the abstract presented is available upon request from the IVTIP Secretariat.
Between May 15 and June 15, 2001, 16,029 Europeans were interviewed, making an average of about 1,000 in each country, on the basis of a representative sample of the population. The respondents were asked for their attitudes to science (in general, as opposed to biotechnology surveys). It was almost 10 years since the last Eurobarometer of this kind.
The results show that the much discussed divide between science and society has not closed much. Science is starting to be perceived as a sort of Pandoraís box out of which rather dubious inventions sometimes spring. This feeling has increased the past 10 years.
Some salient findings:
Source: RTD Info special edition: Europeans, Science and Technology, March 2002
The full report is available at:
http://europa.eu.int/comm/research
Alternatively, approach the ACTIP@ACTIP.org IVTIP secretariat for a brochure with the most important results.
Following discussion in the Council and the Parliament, the Commission adopted an amended proposal for Framework program 6 (FP6) on November 22, 2001. The Council adopted a Common Position on January 28, 2002. The next step is that the European Parliament will give the program a second reading. Mid 2002 the Council and parliament should adopt a final text including a budget. At the end of 2002, the Council is to decide on specific instruments for implementation.
The November 2001 document is to be downloaded from the secure page of the IVTIP website ( www.ivtip.org/secure ) or from the European Commissionís sites.
In the meantime, on March 15-16 2002, the European Council in Barcelona called upon the EU member states to increase their spending on R&D and innovation to 3% of GDP. Only Finland (3.3% of GDP) and Sweden (3.5-4.0%) come above the mark.
Prior to the formal adoption of FP6 and the first calls for proposals, the European Commission now consults the Research Community and is inviting submissions for 'Expression of Interest' to participate in research actions for topics throughout the 7 thematic priorities that could be subjects for the two new FP6 instruments ëintegrated projectsí and 'networks of excellence'. This initiative will assist the EC in preparing working programmes and in defining the scope of the first calls for proposals for FP6 envisaged later this year. The submission of an Expression of Interest is by no means obligatory. It may optimise the chances of a particular topic included in an early call. But the review of the EoL by the EC is neither a pre-assessment of the scientific and technical quality of any subsequent proposal nor a pre-selection process for any consortium.
Deadline for an Expression of Interest: June 7, 2002-04-15 For more information, see:
http://www.cordis.lu/fp6/eoi-instruments/tp.htm
In the meantime, a Commission working document is available how officials see the new instruments working. For example:
Each integrated project must contain a research component and may contain technological development, demonstration and training components. A minimum of 3 participants from different countries, but new participants may be taken into the project as it evolves. Projects are expected to run between 3-5 years.
A key innovation in the evaluation process is allowing applicants to present their proposal in person to the panel assessing it.For details of the integrated projects document, see: http://europa.eu.int/comm/research/nfp.html
FP6 seeks to fully integrate research that is being carried out at the European, national and regional levels. To help achieve this, new instruments have been developed in which SMEs will play a key role. These are:
networks of excellence to reinforce Europeís scientific and technological skills;
integrated projects to draw in resources around key objectives.
SMEs will mainly participate in the next FP through the new instruments in the 7 priority themes, chosen for their particular importance to Europe's industrial competitiveness. This includes the themes genomics and biotechnology for health. 15% of the financial amount available for the thematic priorities is intended for SMEs.
Two specific additional activities are proposed especially for SMEs with lower-level research capabilities: co-operative research activities (by SMEs. Research centres and universities) will be extended, and new are collective research activities, carried out by research centres for industrial associations and groupings for the benefit of entire SME communities.
For more formation: http://sme.cordis.lu/home/index.cfm
or http://www.europa.eu.int/comm/research/nfp.html
FP6 launch event: Nov 11-13, Brussels
http://www.europa.eu.int/comm/research/conferences/2002/index_en.html
FP6 instruments:
http://europa.eu.int/comm/research/nfp/networks-ip.html
FP6 PowerPoint presentation:
http://www.europa.eu.int/comm/research/nfp/pdf/fp6-presentation.pdf
Help and Information desks for the different thematic priorities:
Genomics and biotechnology for health: rtd-genomics@cec.eu.int
Naotechnologies and nanosciences: mailto:rtd-nanotech@cec.eu.int
The Commission's Joint Research Center is inviting expressions of interest from contractors wishing to be included on a list of potential service providers to carry out analyses for stability monitoring of certain reference materials: veterinary drug residues and related substances. As the need arises, service providers may be invited to submit formal quotations for one or several analyses. OJ S25 (5/2/02) pp 54. Contact: B. Gawlik, JRC, Geel, Belgium, tel + 32 14 57 19 56. Deadline: February 8, 2004.
The World Health's Organisations Pathogenesis and Applied Genomics Committee invites proposals for research on the pathogenesis of African trypanosomiasis, Chagas disease, dengue fever, lymphatic filariasis, leishmaniasis, leprosy, malaria, oncocerciasis, schistosomiasis and tuberculosis.
Grants are for 40,000 USD maximum per year for 2 years. Support will also be given for multicentre projects representing collaborationbs between investigators in endemic countries or with resourceful laboratories in non-endemic countries.
Contact: Ayoade Oduola, WHO, Geneva, tel + 41 22 791 32 12, email: oduolaa@who.int
EMBO is inviting applications for its re-start fellowships for research in the life sciences. The fellowships are designed to help researchers in the life sciences who want to return to research after they have taken a break in their careers for child care.
Contact: EMBO, email: mailto:women@embo.org
Web: www.embo.org/projects/women
Deadline: August 15, 2002
On 18 March the Industry, External Trade, Research and Energy held an exchange of views on the second reading recommendations on the 6th R&D Framework Programme.
The rapporteur, Mr Caudron (PES, F), re-tabled 43 first reading amendments, which he felt were not sufficiently taken into account in the Council Common Position.
Amendments tabled by the rapporteur:
extend the scope of the first health-related priority to non-genomic research on major diseases such as cancer, cardiovascular diseases, diabetes, neurological diseases (CJD, Alzheimer's, Parkinson's) and rare diseases
list a number of actions, inter alia clinical trials on new medicines, combating resistance to medicines and research on alternative non-conventional medicines.
Mr Liese (EPP, D) would table again amendments relating to paediatric medicines and palliative care and the one on ethics
The Industry Committee intends to vote on 22-23 April. The plenary debate and vote would then take place in May.
Human protein research remains very difficult, because human cells contain millions of different protein variants, thanks to post-translational modifications. The protein chip potentially offers a solution to protein variant identification, with claims of a speedy and high-throughput means to profile disease-related proteins or study protein-protein or protein-drug interactions. However, despite early promises, the field develops slowly.
In an easy-to-read feature article, Peter Miller, a science writer, has listed all the hurdles and potential solutions facing the protein chip. The article is organized around the three basic elements of a protein chip platform:
Surface chemistry (i.e. slides coated with polylysine, aldehyde, or proprietary surface chemistries)
Protein capture agents: antibodies (not very specific but several large libraries are available), aptamers (nucleic acids that bind to proteins), fibronectins (used to generate antibody mimics) or phage display peptides (binding to proteins)
Detection methods: chemoluminiscence (sensitive but requires enzymatic reaction), fluorescence (sensitive but requires labelling of the protein), mass spectroscopy (low throughput but no labeling required) and surface plasmon resonance (low throughput but no labeling required).
Many of the options mentioned here are still in an experimental stage.
Exotic variants are being developed as well. For example, David Sabatini of the Massachusetts Institute of technology made ëliving arraysí by spotting cDNA onto glass slides and co-culturing human embryonic kidney cells on the surface. The kidney cells take up the cDNA and express the corresponding proteins. These living arrays might in particular be useful for expression monitoring, e.g. to identify proteins that induce apoptosis.
According to the author, it is very likely that the technical problems now surrounding the field can be overcome, but that the real challenge will be how to make it commercially attractive.
Source: Peter Mitchell, Nature Biotechnology March 2002, Vol 20, pp 225-229. Alternatively, a copy of the article may be requested from the IVTIP Secretariat.
Founder of Dutch start-up company Pamgene, Henk van Damme, recently received a prize for industrial application of research, awarded by NIABA, the Netherlands Biotechnology Association and the Dutch Biotechnology Society. The founder developed at Organon Teknika a microarray featuring a porous carrier. This allows samples to be pumped through the chip, instead of applied on top of the glass slide. This flow-through array already demonstrates results after 10-15 minutes, while a normal 2D-array needs 16 hour incubation time. In 2001, the company was already awarded 'most promising Dutch biotech company'.
Source: BioNieuws, March 16, 2002
The Bush administrationís budget proposal for the year 2003 substantially boosts research to combat bioterrorism, is vague about programs to support biotechnology research, and addresses regulatory oversight issues.
In particular, the budget proposes:
Source: Nature Biotechnology March 2002, Vol 20, pp 209
The US Biotechnology organization BIO has sent president Bush a biotech policy wish list for the year 2002:
appointment of an FDA Commissioner
maintenance of adequate funding for the US Patent and Trademark Office to avoid undermining IP protections
review of licensing practices of the NIH to ensure that dissemination of important technology is not stifled;
changes in tax credits and other measures to maintain a favorable biotech investment climate.
Source: Wang et al, Nature Biotechnology March 2002, Vol 20, pp 275-281
Scientists from the Dutch Institute for Brain Research have managed to keep brain cells from deceased human beings alive for up to 78 days. The brain cells (neurons in tissue slices) were taken within 2-8 hours following death from patients with neurodegenerative disorders. The tissue slices thus obtained were then transfected, using adenoviruses, with the reporter gene LacZ. The cells also reacted to administration of pyruvate or growth factors. The cells remained active for at least 3 weeks.
These results suggest that it is possible to investigate the regenerative capacity of human neurons, an area lacking in adequate animal models.
On March 21, it was reported that a team of US researchers, led by Nobel Prize winner Stanley Prusiner, discovered prions in the hind legs of mice, indicating that BSE prions could infect the muscle of cattle. Up to now, measures against BSE were based on the assumption that prions are transmitted only through the nervous systems or lymphatic system of cattle.
The European Commission welcomed the study, but commented that so far no other study on BSE had been able to prove the presence of prions in muscular tissues and underlined that the structure of mice and humans are very different.
Carbohydrates in the form of glycoproteins, glycolipids, glycosaminoglycans and proteoglycans are extremely common on the surface of mammalian cells. The ability to profile the type of cell-surface glycoconjugates, so-called glycomers, is the focus of a nascent field termed glycomics. Recently, Wang et al. successfully produced a carbohydrate microarray, allowing the profiling of many glycomers in one experiment. Using the host-pathogen interaction between mammalian cells and a micro-organism as a model, the authors report the production of a surface-modified glass slide microarray containing microbial polysaccharides as probes. Potentially, the system will allow the spotting of 20,000 glycoconjugates, permitting testing of glycan signatures of most common pathogens.
Source: Nature Biotechnology March 2002, Vol 20, pp 211
All official journals are available on the following website:
http://europa.eu.int/eur-lex/en/oj/index.html
C71 - 20.03.2002
Invitation to submit expressions of interest - An opportunity for Europe's research community to help prepare for the first calls of FP6
C75E - 26.03.2002
- Modified Commission proposal for 6th R&D Framework Programme (COM(2001)709)
- Proposal for a Regulation on authorisation and supervision of medicinal products and establishing EMEA (COM(2001)404)
- Proposal for a Directive amendment Directive 2001/83/EC on the Community code relating to medicinal products for human use (COM(2001)404)
C77 - 28.03.02002
Summary of Community Decisions on marketing authorisations in respect of medicinal products form 15.02 to 15.03.2002
Assistence to SMEs to find matching project partners in FP6:
www.bba-bio.be/smes/index2.asp
Partners for Life: gateway to EU research and technology funding for SMEs in the Life Sciences:
www.bit.ac.at/partners_for_life.htm
Biobiz workshop series to help researchers to acquire the skills needed to start a biotech business:
europa.eu.int/comm/research/biotech/biocourt1.html
Organisation: IIR Ltd, fax + 44 20 7915 5056, www.iir-conferences.com/patent
Registration: tel + 1 508 616 5550 fax + 1 508 616 5522
Organisation: Cambridge Healthtech Institute (CHI)
www.chi-intelligentdrug.com
Organization: Ernst & Young Association Management, Tel: +32 2774 9610,
Fax: +32 2 774 9690 Email: euro.conference@eyam.be
or visit the website www.ey.be/euroconference
Organisation: Cambridge Healthtech Institute Conferences
www.healthtech.com/
Organisations: EFB Office and Congress Service, DECHEMA;
Tel.: ++49-69-7564-221
Fax: ++49-69-7564-169
email: efb@dechema.de;
web: www.efbweb.org
Organisation: Mr. Stephen Meulebroeck, email: pdk@las.vet.uu.nl
Organization: BBA and the Danish Chamber of Commerce, Denmark, the Danish Export Council and the Danish Embassy.
Registration at www.bba-bio.be/pages/danish_forum_290502.asp
Organisation/registration: www.LifeSciencesInfo.com/chemgen
Organization: Biotechnology Industry Organization, 1225 Eye Street, NW;
Suite 400, Washington, DC 20005-5958
Organization: EFB Task Group on Public Perceptions of Biotechnology
efb.cbc@tnw.tudelft.nl
web: http://www.kluyver.stm.tudelft.nl/efb/TGPPB/oxford.htm
Organization: ACTIP@ACTIP.org
ACTIP Secretariat : ACTIP@ACTIP.org
Organization: National Institute of Environmental Health Sciences
MD EC-17; P.O.Box 12233
Research Triangle Park, NC 27709
tel. 919-541-7997; fax 919-5410947
stokes@niehs.nih.gov
http://iccvam.niehs.nih.gov
Organisation: COLIPa@Colipa.be
Organisation: American Society for Pharmacology and Experimental Therapy,
tel + 1 301 530 7060
Organization: IBC. See:
www.drugdisc.com
Organisation: The Alternatives Congress Trust. Tel + 1 301 548 7771/7726;
email: worldcongress@bring.com
or fourthworldcongress@starpower.net
Organisation: betatechnology.co.uk Tel: + 44 1302 322 633
Organisation: Ms Alicia Druga, tel + 36 1 169 14 25; fax: + 36 1 169 3229
Organization: Congrex Sweden, Tel: + 46 84 59 6600; fax: + 46 86 61 9125;
email: esgt@congrex.se
Organization: ESTIV, email: floestiv@tiscalinet.it
or invitox@iss.it
Organization: DG Research, tel + 32 295 99 71; fax: + 32 2 295 82 20;
email: rtd-conference2002@cec.eu.int;
web: http://europa.eu.int/comm/research/conferences/2002
Organisation: JAACT. Web: www.tuat.jp/~jaact02/
Organization: Finish Bioindustries/Sitra/Tekes. Tel: + 358 917 28 43 14
Web: www.biotechhelsinki.com
Organization: ESACT, www.esact.org or
+ 34 932 388 777
Organization: ECB11, Tel + 41 61 686 28 28; fax: + 41 61 686 21 85;
email: info@ecb11.ch;
web: www.ecb11.ch
Organisation: University of Tampere, Ms Hanna Tahti, tel + 358 3215 6672; fax: + 358 3215 6170;
email: blha-ta@uta.fi;
web: www.uta.fi/fst