As you know, IVTIP sent a letter to Commissioner Wallstrom with our comments on the White Paper on a strategy for a future chemicals policy and its relation to the proposed FP6. We pointed out that one of the White Paperís objectives is promotion of the development and validation of non-animal test methods, while in the proposal for the 6th Framework Programme there is no explicit mention of non-animal test methods.
On August 28, 2001, the Director General of the Environment Directorate sent us a reply on behalf of Commissioner Wallstrom. She states that in such a high level document as the proposal for FP6, it is not possible to mention every activity (we of course agree to that). She goes on to say that ìthis does not mean that the programme will neglect this important issue. Ö.In cooperation with our colleagues in DG Research, we will work to address the need for development of non-animal test methods in the Specific Work ProgrammeÖ..The work on validation of non-animal test methods is the primary task of the Joint Research centreís European Centre for Validation of Alternative Methods. This important work will be continued so ensuring that test methods developed with the support of FP6 can be validated.
Focus on Alternatives, an umbrella group of organisations working to advance the replacement of animal experiments, have produced posters showing the decision-making strategy for considering alternative approaches. The aim is to help scientists meet their obligation to ensure that the Three Rs have been implemented wherever possible, when devising project proposals that may involve the use of animals.
Copies of the posters are available at the FRAME Web-site
The exact sites of the posters are:
http://www.frame.org.uk/Images/EarlyPlanningPosterCompressed.pdf
http://www.frame.org.uk/Images/InvestigationPosterCompressed.pdf
From Dr. Beatrice Lucaroni of DG Research we received the final reports, with a comprehensive listing of all achievements, from the following FP-4 EU-funded projects:
Several of these projects are also described in a good article, which appeared in RTD Nr. 30 of June 2001. Available from the IVTIP Secretariat.
This is a reminder that the 4th World Congress on Alternatives and Animal Use in the Life Sciences will be held at the Hyatt Regency New Orleans, New Orleans, Louisiana / USA, on: August 11 - 15, 2002
Remaining deadlines for abstracts are Second call 12/31/01 and Final call 1/30/02
For more detailed information on the venue, registration or abstract submission, please visit the web site at
http://www.worldcongress.net.
Read the submission guidelines for abstracts at
http://www.worldcongress.net/program/submission.html.
Any other questions regarding this meeting should be sent to
From IBC we learned that the following keynote lectures, held during their Drug Discovery World Congress, will be available at their website through December 31, 2001. The lectures all deal with a perspective on the practical applications of the Human Genome.
To view, visit http://www.drugdisc.com/us/?source=us-309.
Mark J. Levin, Chairman and Chief Executive Officer, Millennium Pharmaceuticals, Inc.
George M. Milne, Jr., Ph.D., Executive Vice President, Pfizer Global Research and Development
Eric S. Lander, Ph.D., Director, Whitehead Institute/MIT Center for Genome Research
Available: Guidance Document on the recognition, assessment, and use of clinical signs as humane endpoints for experimental animals used in safety evaluation.
At the end of June this year, the OECD published its Guidance document no. 19 on humane endpoints. All members of IVTIP are encouraged to assist in the introduction and application of the guidance provided in this document in animal laboratories within your company/country, as appropriate. In this respect we are all requested to raise awareness and distribute this document to experts and managers who are responsible for the conduct of animal experiments.
Electronic copies of this document are available free of charge on the OECD webpages of the test Guidelines Programmes ( http://www.oecd.org/ehs/test).
Available for review: Draft Guidance Document on the Development, Validation, and Regulatory Acceptance of New and Updated Internationally Acceptable Test Methods in Hazard Assessment.
The IVTIP Secretariat received from the OECD (Dr. Herman Koeter) the long awaited draft guidance document on validation approaches. This document builds on the 1996 Solna Workshop Report [ENV/MC/CHEM/TG(96)9].
The draft Guidance Document will be prominently on the Agenda of a Solna follow up meeting, which is scheduled to take place early spring next year in Stockholm, Sweden.
National Experts and other interested scientists are now requested to submit their comments and suggestions to their National Co-ordinator not later than 30th November 2001. Member countries' National Co-ordinators and Co-ordinators of other stakeholders are requested to submit their national/stakeholders positions to the OECD Secretariat not later than 14th January 2002.
The document (in both Word and PDF-format) is available as monograph 34 upon request from the IVTIP Secretariat and on the secure part of the IVTIP website.
NICEATM announces the availability of a background review document entitled "EPISKINTM, EpiDermTM, and Rat Skin Transcutaneous Electrical Resistance (TER) Methods: In Vitro Test Methods for Assessing the Dermal Corrosivity Potential of Chemicals'' . Also available are proposed test method recommendations from the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) on the use of these methods. This document is available on the ICCVAM web site at http://iccvam.niehs.nih.gov/methods/epiddocs/epis_brd.pdf
The NICEATM invites public comment on the background document and ICCVAM Recommendations, preferably by email, to
niceatm@niehs.nih.gov .
Deadline for comment submission is November 13, 2001.10.1
For more information on Dermal Corrosivity, please visit the following page:
http://iccvam.niehs.nih.gov/methods/epiderm.htm
Source: Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the NTP Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM)
http://iccvam.niehs.nih.gov
The NTP Advisory Committee on Alternative Toxicological Methods (ACATM), which was scheduled for September 25, 2001 at the National Institute of Environmental Health Sciences (NIEHS), has been cancelled as a result of the September 11 events in the USA.
The next ACATM Meeting is tentatively scheduled for February 27, 2002. Please note this on your calendar:
For further information visit the NTP web site at:
http://ntp-server.niehs.nih.gov/htdocs/liason/ACATM_cancel.html
The following documents have been published in the Federal Register and are available:
You can also access these documents from the ICCVAM home page at http://iccvam.niehs.nih.gov by visiting the links in the Announcements box. For more information, please visit the In Vitro page at http://iccvam.niehs.nih.gov/methods/invitro.htm.
The NTP Report of the Endocrine Disruptors Low-Dose Peer Review, held October 10-12, 2000, in Research Triangle Park, NC, is available and comments are being solicited.
To view the report and for additional information please visit the NTP web site at
http://ntp-server.niehs.nih.gov under "What's New"
The National Advisory Council for Environmental Policy and Technology
(NACEPT) will host the proposed Endocrine Disruptor Methods Validation Subcommittee (EDMVS). NACEPT is a chartered federal advisory committee subject to the provisions of the Federal Advisory Committee Act.
Through NACEPT, the EDMVS will provide technical advice and recommendations to EPA regarding validation of the Tier 1 Screening and Tier 2 Testing methods for its Endocrine Disruptor Screening Program (EDSP).
Further information can be found on EPA's Endocrine Disruptor Methods Validation Subcommittee page at
http://www.epa.gov/oscpmont/oscpendo/edmvs.htm.
The Endocrine Disruptor Screening Program Web Site is located at http://www.epa.gov/oscpmont/oscpendo/index.htm.
The Biotechnology Thematic Group in the Innovation Relay Centre network organizes on October 9th a 1-day event, called CellExploit, during the Biotechnica Fair in Hannover, Germany. The CellExploit event is an accompanying measure in the Cell Factory area and features both technology offers as well as technology requests. A website will continuously update offers and request and can be accessed at:
http://www.cellexploit.net
Plenary events organized during the day will focus on European research results.
On August 31, 2001, the current IPR-Helpdesk pilot project has ended. All services will be suspended. The website www.ipr-helpdesk.org is likely to go off the air for a short period, but is expected to be back online thereafter.
All other services, including the Legal Helpline ( info@ipr-helpdesk.org ) and newsletter services (IP-News & IP-Wire), will be suspended for a few months due to contractual negotiations which are currently underway for the continuation of the IPR-Helpdesk service.
For further information please contact Alexander.Weir@ipr-helpdesk.org before Friday, 31st of August 2001.
Thank you for your patience and continued support.
"From Genomes to Cures", is a multidisciplinary Science & Societyconference jointly organized by the European Molecular Biology Organization (EMBO) and the European Molecular Biology Laboratory (EMBL).
It examines in scientific and societal terms the impact of genomics research on the treatment and cure of human diseases, and represents a platform for dialogue and discussion between the stakeholders involved.
For registration and a continually updated version of the programme, please visit:
http://www.embo.org/SS_2001.html
Speaking at an international congress on global health equity: medical progress and quality of life in the 21st century, President of the European Parliament Nicole Fontaine called for an ethical dimension to biotechnology. Ms Fontaine conceded that the prohibition of certain types of research, particularly in genetics, could delay the discovery of certain more effective treatments and create a technological and economic divide between Europe and other developed regions, which may impose less stringent conditions.
'However, we [the European Parliament] believe that universal prudence is essential because what is at stake is the future of humankind in this new century,' she added. 'The international scientific community, whatever the ethical view to which the majority of its members subscribe, cannot be answerable for the deviations of 'sorcerer's apprentices', which we are now seeing on a worrying scale.'
The Parliament President expressed her hope that, 'beyond the European Union, the international scientific community will bring its full weight to bear to ensure that this moral conscience extends throughout the world.'
Ms Fontaine also criticised European research for its fragmentation, and called for more co-operation. 'Research and development are less effective than they might be, particularly in areas where Europe, because of its level of development and facilities, could play a more pioneering role in leading edge sectors: genomics, artificial organs, bioinformatics, tissue organ repair using stem cells, immunotherapy, telemedicine, gene therapy and so on,' said Ms Fontaine.
EU research is less effective than it could be as it is 'still over compartmentalised because the idea of national frontiers is still rooted in attitudes and behaviour,' Ms Fontaine said.
Source: European Parliament. Based on a speech by Nicole Fontaine, 2001-07-17
Nature Biotechnology of August 2001, Vol 19, features an interesting article on ADMET - which is the well-established journey of a drug through the body measured in dimensions of absorption, distribution, metabolism and elimination. Increasingly, the T of toxicology is added and this creates ADMET, or the drug's journey coupled to the art of making sure that the molecule causes no harm, regardless of what good is does.
The article lists companies predominantly in the US) that are working directly or indirectly in the ADMET arena, and concludes as follows:
ADMET technologies are radically reshaping the pharmaceutical development process. Improvements in in vitro molecular and cellular assays enable a compounds' ADMET characteristics to be approximated well before the pre-clinical phase. The application of high throughput approaches to these assays, and to the determination of chemical properties, not only reduces the dependence on animal models and the use of primary animal tissues, but also generates databases of huge amounts of ADMET-relevant data. The simulations specialists both inside large drug companies and outside are now mining this data in search of the ërulesí that connect chemical structure to ADMET properties. The iterative process of designing, making and testing libraries of new molecules is no longer pegged to the schedules of combinatorial library synthesis and ëwetí testing. Instead, compounds can be designed in silico (virtually synthesized) and tested in silico at speed determined by micro-arrays. Many will be thought of, but few will be chosen.
However, we are still far from virtual drug discovery. Refined in vitro and in vivo assays are still needed to keep the modeling approaches valid in their predictions of the likely absorption pattern of a would-be drug. The uncertainties that continue to surround both the metabolic and toxicological fate of chemicals in the body mean that these will be needed to be determined biologically in most instances.
ìIt is still too early to tell whether shifting ADMET determinations back from ethical and pre-clinical phase to the discovery phases will improve the prospects for compounds in trials or on the market.
Source: Nature Biotechnology Vol 19, no 8, August 2001, pp 722-726.
On August 8 2001, President George W Bush has made public his decision on the federal funding of embryo stem cell research. Bush said that he would not allow federal funds for deriving stem cells from embryos or for using embryo stem cells newly derived in the private sector. But, he said, he would allow research on a number of stem cell lines that are already in existence. 60 stem cells lines are currently in existence, although this figure is doubted by some stem cell researchers.
For Bush, research on these cell lines is permissible because 'the life-and-death decision has already been made'. He was keen to avoid 'crossing a fundamental more line by providing taxpayer funding that would sanction or encourage further destruction of human embryos'.
The president also announced that he intends to set up a council, chaired by conservative bio-ethicist Leon Kass, designed to monitor stem cell research and recommend appropriate guidelines. In the meantime, the National Institutes of Health has already started a registry which will eventually list the existing stem cell lines that federally funded researchers will be allowed to use.
Source: The New York Times 10/8/2001 'Text: Bush's address on stem cell research'
http://www.nytimes.com/2001/08/10/politics/10BTEX.html
Sixty-four embryonic stem cell lines have been identified by the US National Institutes of Health (NIH) as eligible for use in federally funded projects.
Ten research centres and companies around the world hold these stem cell lines. Only four of these groups are in the US, with others in Australia, Sweden, Israel and India.
President Bush recently limited federally-funded stem cell research in the US to cell lines that are already in existence. He claimed that more than 60 such lines were in existence, a figure that many scientists challenged. The NIH has assured scientists that the 64 stem cell lines are 'genetically diverse', therefore providing enough variety for research.
Scientists in the US are also worried about access to the stem cell lines, including being able to use those covered by patents. The NIH said that it has been dealing with this issue and is 'working to help researchers gain access to the cells'. The NIH is establishing a registry to keep information about the cell lines, including their location and details about their derivation and growth progress. A spokesman said the agency is taking applications for funding and hopes to award the first grants early next year.
Source: National Institutes of Health 27/8/2001 'Update on existing human embryonic stem cells'
http://www.nih.gov/news/stemcell/082701list.htm
American newspapers have reported a fall in biotech share prices, following President Bush's decision to limit embryo stem cell research to existing cell lines. Despite reassurances from stem cell company executives that the field has a promising future, investors were unable to share the optimism.
Source: LA Times 11/8/2001 'Biotechs fall on stem cell news' http://www.latimes.com/business/la-000065085aug11.story
Scientists from the Eastern Virginia Medical School in the US have reported that they have been creating embryos from donated eggs and sperm for the sole purpose of obtaining stem cells. The research, which was privately funded, began in 1997 and ended last July. Embryonic stem cells had previously only been derived from embryos 'left over' from fertility treatments. In this case, men and women were asked to donate sperm and eggs purely for stem cell research. 162 eggs were extracted from 12 women and fertilized with donor sperm from two men. Fifty developed into embryos, and stem cells were extracted from 40 of these. Three stem cell lines have been isolated and maintained in culture.
The donors were asked to sign detailed documents signaling their informed consent, and before the study was started the procedure was checked with ethicists, the church, and lawyers. Sean Tipton, a spokesman for the ASRM said that they were impressed with the high consideration paid to the ethics of the research. He said 'at one level, it's cleaner (ethically) than using leftover embryos, there's no question as to what you're going to do with these embryos. You're going to the individuals up-front.' But the scientists have been criticized by those who believe creating embryos for destructive research is wrong.
Meanwhile, it has been announced by US company Advanced Cell Technology Inc. that they are attempting to use cloned embryos to obtain stem cells, a technique currently under legal consideration by the Bush administration.
Source: The New York Times 11/7/2001 'Scientists create scores of embryos to harvest stem cells'
http://www.nytimes.com/2001/07/11/health/genetics/11CELL.html
Scientists from Canada's McGill University in Montreal have reported that it may become possible for human skin cells to transform into other types of tissue cells, such as muscle, nerve or fat. The researchers think that stem cells isolated from the lowest levels of skin may eventually be harvested in enough quantities to allow a patient to be treated with his or her own cells.
The Canadian team has managed to isolate stem cells from the skin of adult mice and to proliferate them in a laboratory. The stem cells were then developed into neural cells of the type that could potentially be used to treat spinal cord injury or diseases like Parkinson's. Studies on humans have indicated that similar types of cell can be found in human skin.
Source: Science Daily 14/8/2001 'Study identifies new source of stem cells' http://www.sciencedaily.com/print/2001/08/010814063557.htm
Scientists from the University of North Carolina, US, have discovered a gene that is linked to whether female embryos survive or not. The gene, called eed, is thought to keep the X chromosome that is inherited from the father (females have two X chromosomes) inactive during early embryo development. The gene also keeps many of the other genes on this chromosome switched off during the first stages of development of the placenta.
The scientists, who carried out the research on mouse embryos, have found that female embryos that do not have a working eed gene do not survive because the placenta does not develop properly. Theyalso believe that a functioning eed gene causes cells in the embryo to organise themselves correctly, and that if the gene does not function properly, many problems, such as the development of leukaemia, skeletal abnormalities or other birth defects, can occur.
Source: BBC News Online 22/7/2001 'Clues to embryo development'
http://news.bbc.co.uk/hi/english/health/newsid_1447000/1447429.stm
A report commissioned by the UK's largest medical research charity, the Wellcome Trust, says that science teaching in schools and colleges is failing children as it contains no ethical or moral content. The report says that issues raised by contemporary science need more and more to be considered to equip children with the skills needed. Scientific advances such as the sequencing of the human genome, cloning and stem cell research raise many ethical issues, and cannot be taught in a vacuum, the report says.
The Institute of Education, which compiled the report, surveyed teachers from 305 institutions across England and Wales. Sixty per cent of the teachers in those schools or colleges felt that too little attention was paid to ethical or moral issues in science.
Dr Mike Dexter, Director of the Wellcome Trust, said 'today's young people will be the first to benefit from developments such as the Human Genome Project, but they will also be the first to face the challenging social and ethical questions arising from these advances'. Because of this, he said, the way science is taught in schools should be 'shaken up'.
Source: BBC News Online 16/7/
http://news.bbc.co.uk/hi/english/education/newsid_1440000/1440993.stm
Wellcome Trust news 16/7/2001:
http://wwwwellcome.ac.uk/en/1/awtprerel0701n234.html
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.
October 17-19, 2001, Paris France
Organization: Institut Pasteur Euroconferences. Fax: + 33 1 40 61 34 05. www.pasteur.fr/applications/euroconf
Organization: IVTIP Secretariat and Novartis Pharma. IVTIP@IVTIP.org
Organization: Dr. Mohammed Al-Rubai, Dr. David lLoyd: email: D.R.Lloyd@bham.ac.uk;
http://www.bham.ac.uk/ChemEng/actg/ewce2.htm
Organization: MNBWS Office. http://www.med.miami.edu/mnbws
Organization: Institut Pasteur Euroconferences. Fax: + 33 1 40 61 34 05. www.pasteur.fr/applications/euroconf
Organization: IBC. See: http://www.drugdisc.com
Organization: HSUS, ZEBET. Contact: email dpease@hsus.org