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ACTIP Bulletin 37

February 2004

 

 

 

Next ACTIP meeting

 

The next ACTIP meeting will be held in Marburg, Germany

June 3-4, 2004

Please already reserve the date. Details will follow soon.

 

Members: did you submit your company profile?

At the Montreux meeting it was decided to extend the membership listing on the ACTIP website with a short company profile. You are all kindly asked to write such a short profile about your company. The profile will be available when someone clicks on your company name. From there on the reader will be referred to your company's website.

Please be so kind to make such a profile if you have not already done so and send it to the ACTIP Secretariat as soon as possible!

 

 

In this issue

 

Zoonoses set to increase

The killer diseases

Biotechnology and Development Programmes

News from the Commission

Research News

Business news

News from other organizations:

On the web

Most successful Y-chromosomes

Agenda

 

Zoonoses set to increase

With global trade and the worldwide ecological crisis, the danger from zoonoses (animal diseases which can spread to human beings) is set to increase in the decades to come. The recent outbreak of avian flue in Asia is an example, as was the SARS outbreak last year. Many specialists believe that zoonoses will represent a major threat to public health in the coming century. Certain diseases return at regular intervals, others strike like bolts out of the blue, others never disappear.

Below we give some examples:

  • influenza: comes back yearly, from farm animals to human beings. Can be deadly, i.e. Spanish flue, 1918, worldwide 20-40 million deaths.
  • Marburg fever: 1967, 7 deaths, violent hemorrhagic fever, green monkeys brought to German laboratory
  • Malaria, hematozoan transmitted by anopheles
  • Brucellosis, leishmaniosis: endemic in Mediterranean populations
  • AIDS (HIV virus most likely passed from monkeys to people through hunting and eating bushmeat)
  • Hendra (1994) and Nipah (1999) viruses, originated in fruit-eating bats from south-east Asian forests
  • SARS, coronavirus
  • Hanta viruses, passed by rodents (forestry workers, farmers (in the Balkans, deadly in 12% of cases).
  • New variant CJD (spread of TSEs from bovines to humans)
  • Brucellosis (undulant fever), sheep, Mediterranean shepherds

 

Some say that the fear for zoonoses is overdramatic: have human not always lived in contact with animals? Has our immune system over millions of years not learned to combat these pathogens? Does the species barrier not provide protection? The answer is no, as the examples above demonstrate. Also, some 200 zoonoses are known today.

Zoonoses are expected to increase since the opportunities for pathogens to jump across the species barrier have multiplied in recent decades. The reasons are: rapid urbanization, population movements, the clearing of new agricultural land, the growing trade in meat, milk and other animal products, the increasing speed and number of vehicles, increased tourism. Other factors are global warming, which allows certain species, in particular insects, to colonize new regions where they propagate new pathogens. Also, tropical deforestation is bringing humans into contact with animals they have not encountered before. Acceleration of international trade and travel put all world inhabitants at risk.

 

In the EU it has been proposed to set up a European Diseases Prevention and Control Centre. Its primary missions will be epidemiological surveillance, including a network of pathologists who can be called upon 24 hours a day to formulate scientific opinions on policies and to provide technical assistance. This independent agency should come into being in 2005.

Several EU-funded projects are targeting zoonoses. Here are some of their titles and contact details:

  • EU contact: Isabel.minguez-tudela@cec.eu.int; anna.lonnroth@cec.eu.int
  • Bivalent hanta-virus vaccine for Europe: detlev.kruger@charite.de
  • Diagnostics and control of rodent-borne viral zoonoses in Europe: antti.valeri@helsinki.fi
  • Pathogenesis, diagnosis and control of avian influenza infections: j.banks@vla.defra.gsi.gov.uk
  • European surveillance network for influenza in pigs: G.Koch@id.dlo.nl
  • Preparing for an influenza pandemic: new vaccination strategies: jwood@nibsc.ac.uk
  • Tick-borne diseases: philippe.brouqui@medicine.univ-mrs.fr
  • RA and prevention alveolar echinococcis: peter.kern@medizin.uni-ulm.de
  • All EU funded research into TSEs: europa.eu.int/comm./research/quality-of-life/tse/index_en.html
  • Brucellosis vaccines: guillote@tours.inra.fr; imoriyon@unav.es; liautard@univ-montp2.fr; COST network with 400 researchers: www.brucella.org

 

Source: RTD Info, November 2003

The killer diseases

On the topic of infectious diseases: throughout history they have had a devastating effects on humanity as well as society &endash; depleting the workforce, burdening the health care system, weakening the economy. Below a table of the WHO, identifying the big killers of today, yesterday and yesteryear

 

Outbreaks in 2003:

SARS; 7919 cases, 662 deaths

Meningococcal disease, 7146 cases, 1058 deaths

Ebola, 143 cases, 128 deaths

 

Big killers of today:

Malaria, 300-500 million cases/year; 1.5-2 million deaths/year

Tuberculosis: 8 million cases/year; 2 million deaths/year

AIDS: 6 million cases/year; 3 million deaths/year

 

Big killers of yesteryear:

6th Century, Plague: 142 million cases, 100 million deaths

Bubonic plague, 30 million cases, 12 million deaths

Spanish flue (1918), 1 billion cases, 21 million deaths

 

Source: WHO, represented in EBR, winter 2003

 

 

Biotechnology and Development Programmes

All 1889 United Nations member states have committed to achieving the Millennium Development Goals by 2015. These goals are aimed at poverty alleviation, improved education and health, environmental sustainability and other development indicators. At first glance it appears that science and technology have no role to play in meeting these targets. However, in a recent report it was shown that there is a very close match indeed. The authors mapped a list of 'top 10 biotechnologies to improve health in developing countries' onto the Millennium Development Goals. This study challenges the common assumption that high tech solutions are unsuitable for development goals. Below we reprint the match between technologies and development goals:

 

Combat infectious diseases; reduce child mortality; improve maternal health:

Molecular diagnostics (i.e. dipstick assays)

Recombinant vaccines (reduced risk vaccines, rational vaccine design)

Improved vaccine delivery systems (needle free technologies, temperature stable controlled release systems)

Sequencing pathogen genomes (understanding disease mechanisms; boosts search for novel drugs and vaccines)

Recombinant proteins (cheaper synthesis drugs in i.e. E. coli)

Combinatorial chemistry (rapid generation compounds (i.e anti leishmaniosis drugs)

Improving children's nutrition:

Nutritionally enhanced GM crops (golden rice with beta-carotene)

Ensuring environmental sustainability (bioremediation, clear contaminated sites, degrade pollutants)

Promoting gender equality (female controlled protection against sexually transmitted infections (i.e. novel mandelic acid condensation polymer blocks)

 

Source: Nature Biotechnology, Vol 21, nr 12, Dec 2003, pp 1434-1436

 

News from the Commission

 

More funding to combat HIV/AIDS, malaria and tuberculosis

The EU has stepped up its AIDS research funding in the developing world. While the EU has agreed to contribute some 60 million _ towards the 4 billion _ Global Health Fund, this does not fund R&D activities. To fill the gap, a separate EU initiative called the Europe Developing Countries Clinical Trial Partnership (EDCTP) allocates 600 million _ during a 5-year period until 2007 to create new medicines and vaccines against AIDS, malaria and tuberculosis. EDCTP will initially focus exclusively on Africa. EDCTOP will get 200 million _ in EU funds, 200 million _ from EU member states and 200 million _ from industry, charities and private research organizations. Moreover, an additional 200 million _ will be donated via the Commission's FP6 programmes for 'normal calls for proposals' which target HIV/AIDS. In fact, 6 projects due to be funded under FP6 will start in 2004. According to the Commission, 19,000 lives are lost each day to HIV/AIDS, malaria and tuberculosis.

 

Prodi: research has to be key priority

In a recent speech, knowledge and innovation were highlighted by Commission President Romano Prodi as the Union's 'key priorities'. Mr Prodi called for a more proactive approach to the issue by Member State governments, saying that "The Commission will make its proposals and the Council will take its decisions. However, nothing will actually happen until these decisions become policies at national level."

Mr Prodi deplored the fact that there are 400,000 'top EU researchers' currently working in the US, and stressed that Europe must create research centres of excellence that are the best in the world. "They must become the vital symbol of our belief in the future, and that here in Europe we are capable of planning for the future and making it happen," he said. Echoing previous calls for a 'new European Renaissance', the president called for Europe to "become what it was for centuries: the point of reference for young researchers throughout the world."

Emphasizing the urgency of the situation, he claimed that investment in education and research is not an "abstract problem", but an issue to be addressed now, as international competitors are already overtaking Europe. He concluded his address with a few words about Europe's researchers of the future, and their significance for European competitiveness. "Our young people must be able to find in Europe the opportunities to study, work and be successful that are their right. I must stress that I am not speaking only in their interests; this is the key to our very survival," he said.

Source: CORDIS News, Jan 19, 2004

 

EU to be more active in 'war without guns'

There is a war without guns between North America, the Far East (China and Japan) and the EU. According to E. Vizi, president of the Hungarian Academy of Sciences, this War refers to the war in science, and he thinks the EU should do more to promote advances in crucial areas of research such as genetic engineering and nanotechnology. He also thinks that the 'EU should create a knowledge based society and a knowledge-based economy' if it wants to keep up. While the EU has made these pledges before, the transatlantic brain drain is still continuing. Vizi said EU governments were finally beginning to take science as seriously as they should, given that intellectual property rights account for 80% of an average product's value, while only 100 years ago it was the other way around, with labor costs and material costs taking up the lion's share. Goverdhan Mehta, president elect of the International Council of Science, said that the 'growth of knowledge' had doubled from the years AD1 to 1750, between 1750 and 1900 and again between 1900 and 1950. Today, however, knowledge is doubling every 3-4 years. Or: more information has been generated in the last 30 years than in the previous 5000. All these wise quotes were heard during the World Science Forum, hosted by Hungary on November 8-10 last year.

Source: European Voice, Nov 13, 2003

 

Commission: wake-up call for basic research in Europe

With the aim of sparking off a debate on how to promote basic research in Europe, the Commission on 15 January 2004 published a Communication on "Europe and fundamental research". Commissioner Busquin said that the paper was designed to act as a "wake-up call" for Europe to realize that it is quickly losing ground in the area compared to the US and Japan. Fundamental research, he said, is key to growth, competitiveness and better quality of life, and must not be neglected.

'Basic research' is driven by a researcher's interest in a scientific question with no immediate or obvious commercial value. Nonetheless, results of basic research have often led to ground-breaking scientific discoveries such as the DNA and X-rays and inventions like the Internet. Basic research also plays a crucial rule in the training of scientists.

High marks on publications, lower on citations. In terms of publications, Europe is in the lead with 41.3% of the world total compared with 31.4% for the USA. In terms of number of references, regarded as the best indicator of the quality of research, Europe is behind in most disciplines: US researchers account for about one-third more references. Europe achieved very good results during the early 20th century Nobel awards, but performances have been falling ever since.

The fragmentation of Europe's research systems due to structural differences within Member States of the European Union has had an impact on several aspects: lack of co-operation and co-ordination, lack of critical mass, but also more importantly, lack of competition at the European level.

While the EU held a leading position in basic research in the early 20th century, this has been overshadowed by other fields which are seen to be more profitable, such as applied, market-orientated research.

The Commission's initiative comes at the time when public research organizations have showed their dismay at governments' failures to increase research budgets despite their pledge to achieve the three percent target as set out by the 2002 Barcelona Council. In France, more than 5,500 leading researchers have signed an internet petition threatening to resign from their positions if their demands for boosting national research

Source: CORDIS News, January 16, 2004

See also: http://europa.eu.int/comm/research/press.cfm

 

More on the ERC

Discussions on the European Research Council at various meetings have been summarized in:

European Research Council &endash; the life scientists' view'

www.elsf.org/elsfbrochures/elsferc03.pdf

 

EU scientists against clinical trials directive

Thousands of EU scientists have signed a petition against the EU clinical trials directive, saying new red tape could smother independent medical research. Cancer specialists said the directive, which imposes strict controls on monitoring and reporting drug trials, would mean only big companies could afford to carry out clinical research.

Source: European Voice, Jan 22, 2004

 

…. While Busquin calls on medical researchers to create a forum

EU Research Commissioner Philippe Busquin has invited the opinions of the research community on the contributions that a forum on academic medical research could make to European research in this field. Speaking to the French national institute for health and medical research (INSERM) on 15 December, Mr Busquin acknowledged that while the directive on good clinical practice, adopted in 2001 and to have been implemented in 2003, is necessary, it is, to an extent, problematic for public sector researchers wishing to carry out clinical trials.

While ensuring an appropriate research climate is essential for the continuation of publicly funded clinical trials, it is no less so encouraging private companies to carry out research in Europe. According to Mr Busquin, 73 per cent of investment by European pharmaceutical companies was channeled into Europe in 1990, while this figure had fallen to below 60 per cent in 2000. The answer to the drop in medical research in Europe is to carry out more research on a pan-European scale in order to create a genuine critical mass of resources, and to disseminate knowledge gained throughout the whole of Europe, concluded Mr Busquin.

Source: CORDIS News

 

'Europass' brings together CV, diplomas and training certificates

The Commission has recently adopted a proposal on the creation of a 'Europass', designed to improve the transparency and EU-wide recognition of EU citizens' skills and qualifications as part of the Union's commitment to lifelong learning. This booklet (which will be available online) brings together five existing documents covering the following skills and qualifications:

  • the European CV;
  • a list of language skills (the European Language Portfolio);
  • experience of transnational mobility (the MobiliPass, which will replace the current Europass-Training);
  • higher education diplomas (the Diploma Supplement) and
  • vocational qualifications (the Certificate Supplement).

The Commission does not rule out adding further documents to the 'Europass' in the future in order to address specific sectors or skills in more detail.

The draft decision is expected to be adopted by the Parliament and Council by the end of 2004. The official launch of the new Europass should take place during a conference on vocational education and training to be held in Maastricht in December 2004.

Source: Commission: Europass : a new instrument for better recognition of qualifications and skills in the enlarged Europe [FR] [DE]

 

Focus on human tissue engineering potential

The European Commission recently published a report on prospects for commercial and research activities in the field of human tissue engineering (regeneration of tissues). The European Commission is currently seeking to prepare legislation which will harmonizes the authorization procedures for marketing products/processes from human tissue engineering.

The Commission report, elaborated by its Institute for Prospective Technological Studies at the EU Joint Research Centre (JRC) in Seville, represents the first comprehensive map of the emerging industry of human tissue engineering in Europe. The paper makes clear that the lack of an EU-wide authorization process is hampering the growth of a nascent knowledge-based industry.

The European tissue-engineering sector is characterized by young, small, research-based and technology-oriented companies. A total of 113 European companies are now active in tissue engineering in Europe (EU25), with 54 companies engaging in in vitro production of tissues. The European structure is similar to that of the USA, regarding the number and size of companies.

The size of the tissue engineering market development and the commercial range of applications is still in its infant phase. Many of the tissue-engineered products are still in early stages of development. The small biotech companies involved do not have the resources for large, long-term clinical trials to provide information on the cost-effectiveness of the treatment compared to conventional alternatives. Lack of cost-effectiveness data is the main reason for which insurance companies are reluctant to reimburse treatment with tissue-engineered products.

The present regulatory framework applied differs from Member State to Member State, which presents an obstacle to free movement of tissue-engineered products and hampers market growth in the EU. Some measures at European level are already on the way. A Directive on standards for quality and safety of human tissues and cells is now being examined by European institutions. Measures on marketing of products and consumer safety are currently under preparation. This new legislation should cover the marketing of tissue-engineered products to safeguard consumer and user protection and enable an effective common market for these products.

The JRC report "Human tissue-engineered products. Today's markets and future prospects" may be downloaded at:

www.jrc.es/home/toolbar/whats_new.html

 

Source: CORDIS News, January 22 2004

 

MEPs approve cell and tissue directive

On Dec 16, 2003, MEPs adopted the human cells and tissues directive (503 for, 42 against). The directive sets minimum standards for the donation, procurement, storage and processing of human tissues and cells. The directive holds that donors can be paid for cells and tissues &endash; but only for loss of earning or expenses. This compromise was reached to avoid fears that payment would encourage a trade in body parts. However, within the directive, human embryos for stem cell research are not covered, leaving controversial ethical questions surrounding EU funding for this type of research in a grey zone of legal uncertainty. Approval procedures for the least controversial projects will be started on a case by case basis after January 1.

Source: European Voice, Dec 18, 2003

 

Research News

 

First human HIV vaccine trial in South Africa

In a US backed study, South Africa's first human trial of a HIV vaccine started early November 2003. The new vaccine is being tested for safety and its effects on the human immune system in 48 volunteers in South Africa and the US. The vaccine is the first to specifically target the strain of HIV that is devastating South Africa, as well as India and other countries. South Africa has a greater number of AIDS cases than any other nation; the predominant cause is HIV-1 subtype C. The predominant subtype affecting the Western world is subtype B, for which there are a number of vaccine trials under way.

Source: European Voice, November 27, 2003

 

Good results gene therapy trial

Schering's AGT-MI is one of the first projects in the field of gene therapy, which has entered advanced clinical trials. Schering is one of the pharmaceutical companies active in the field of regenerative medicine.

Recently the company announced that the results of the AGENT-2 study, part of the clinical development program for the AGT-MI project, were published in the Journal of the American College of Cardiology. The study examined the efficacy and safety of Schering's product in improving blood flow in the hearts of patients with ischemic heart disease. The study showed positive outcomes of its therapeutic angiogenic product Ad5FGF-4 in the treatment of patients with chronic stable angina.

The substance of AGT-MI, Ad5FGF-4, is an adenoviral vector that has been designed to transport the gene that encodes for the growth factor FGF-4 into cells of the heart, leading to the formation of new small blood vessels (angiogenesis). This procedure is sometimes referred to as a "microcirculatory bypass". The product (1010 viral particles [vp)]) or a placebo was delivered through a subselective catheter into the coronary vessels of the hearts of 52 patients with coronary blood flow (perfusion) defects during a minor surgical procedure. Four and eight weeks later, perfusion of the heart muscle was measured in these patients with single photon emission tomography (SPECT) imaging.

Angiogenesis with Ad5FGF-4 is designed to stimulate new blood vessel growth which may provide alternate routes for blood to flow into oxygen-deprived ischemic areas of the heart due to blocked or narrowed arteries. Envisioned as a procedure that could be administered by interventional cardiologists, Ad5FGF-4 involves a one-time administration of an adenoviral gene therapy vector containing the human Fibroblast Growth Factor 4 (FGF4) angiogenic gene delivered into the coronary arteries through a standard catheter.

Source: Schering AG, Berlin

For more information, call 973/487-2095, or visit www.schering.de/eng.

 

Heart stem cells found

Researchers have identified heart cells that meet most of the criteria for stem cells: rat cardiac cells that are self renewing and multipotent, with the ability to differentiate in vivo into myocytes, smooth muscle cells and endothelial cells.

Source: Cell 114, 763-776, 2003

 

Wider applicability for EPO

Recently, German researchers concluded that EPO has a wider applicability then treating severe anemia or boosting an athlete's performance. It has been demonstrated to be a good candidate for the treatment of schizophrenia. The hormone does not work by affecting the symptoms (paranoia and delusions), but acts by decreasing the progression of neurodegeneration. EPO appears to influence various processes, such as apoptosis and a neuron's metabolism. In addition, EPO has been shown to improve cognitive functions in the mouse model. Furthermore, EPO seems to have favorable effects following brain seizures. Eight German centers are involved in experimental treatments of schizophrenia.

Source: Bionieuws, Dec 19, 2003

Business news

 

100 million _ for R&D of Eastern SMEs

The European Investment Bank (EIB) has pledged 100 million _ in support of entrepreneurs in Hungary, Slovenia and Romania. The funds will be allocated to small and medium-sized enterprises (SMEs), along with public and private agencies active in the diffusion of innovation, research and development, and information and communications networks.

Funds will also be made available to other sectors, including health and education, social housing, energy, environmental protection and general infrastructure. Philippe Maystadt, President of the European Investment Bank, spoke of the importance of developing small and medium-sized enterprises "in countries where the SME sector is not yet a deeply-rooted part of the economic scene."

"Global loan facility will provide an advantageous source of finance for the development of this sector that encourages entrepreneurship and represents an important source of job creation," Mr Maystadt added. Additional information about the European Investment Bank can be found at www.eib.org.

 

FDA guidance on pharmacogenomics data

Recently, the FDA issued the 'Draft guidance for industry: pharmacogenomics data submission. This document encourages drug and biologics developers to perform pharmacogenomics testing during drug development and clarifies how the FDA will evaluate the resulting data. The guidance also provides specific criteria and recommendations on submitting pharmacogenomics data for investigational new drug applications (INDs), new drug applications (NDAs) and biological license application (BLAs). This includes information on what data are needed and how FDA will use or not use such data in regulatory decisions. The draft guidance is available at: www.fda.gov/cder/guidance/5900dft.pdf

Source: IVD technology, February 2004

 

EU should invest in 'white biotechnology'

The EU must invest heavily in industrial biotechnology to boost both environmental and economic growth, say Belgian scientists in a report for the Royal Belgian Academy Council of Applied Sciences. The authors want an EU action plan on environmental technologies due later this month to provide a boost for industrial biotechnology. This sector is called 'white biotechnology' to distinguish it from 'green' (environmental) and 'red' (medical) biotechnology. The Ghent University researchers say the EU is already lagging behind the US in the development of energy saving technologies, including renewable sources using sugars or vegetable oils. In America, where the promise of a new bio-based economy has spurred a long term strategy and technology road-map to the year 2020, companies already produce biomaterials for soft drink cups, bedding and clothing. The white biotechnology sector already accounts for around 5% of the EUs chemical production and this proportion is expected to rise to 20%, saving 11-22 billion _ through lower production costs. For example, producing vitamin B2 using enzymes instead of a chemical process cuts costs by 40%.

Source: European Voice, Jan 22, 2004

 

Germany not innovative on biotech medicines

Peter Heinrich, president of Emerging Biopharmaceutical Enterprises (EBE) (representing sSMEs within EFPIA), applauded EU leaders for pledging to increase research funding for medical biotechnology. However, he said, it is like trying to run a bath with the plug out. You cannot on the one hand commit to increasing innovation if, with the other hand, you are not supporting the fruits of that innovation. With the last remark he refers to Germany's biopharmaceutical policy (notably health care reform plans, reference pricing and mandatory 16% rebates), which have already prompted several firm to shut down or move their R&D activities elsewhere.

Source: European Voice, December 17, 2003

 

…. but new funds for German biotech

The German government has published three measures to boost its biotechnology industry. The centerpiece is 500 m_ for Germany's venture capital sector to spend over 5 years to support the formation of funds that invest in early, developmental and mid-stage technology companies. This measure is expected to leverage another 1.2 billion _ in private sector finance.

The second measure is competitive programs to encourage collaboration between academia and industry. Two schemes have been announced: BioChancePLUS (to fund collaborative research projects between academic groups, biotechnology firms and medium-size pharmaceutical companies; budget 100 m_ over 5 years) and BioFuture (1.5 million _ in total funding to 7 academic groups engaged in basic biotechnological research.

Essential is that in the past projects were focused on bringing back researchers to Germany; the new approach focuses on funding of teams that are defining new strategic research directions.

Despite all these measures, analysts say a serious flaw still exists: no tax incentives for R&D intensive young firms, and no exit routes for investors.

Source: Nature Biotechnology, Vol 21, nr 12, Dec 2003, pp 1414

 

Positive CPMP opinion for radioimmunotherapy Zevalin in Europe

Schering has received a positive opinion from the Committee of Proprietary Medicinal Products (CPMP) for its radioimmunotherapy product Zevalin®. Zevalin is used in the treatment of adult patients with a particular form of non-Hodgkin's Lymphoma (NHL), namely those with rituximab relapsed or refractory CD20+ follicular B-cell NHL . Schering expects the European Commission's marketing approval for Zevalin within the next months and is ready to launch the product shortly after approval in the EU countries.

Zevalin is the first commercially available radioimmunotherapy for low grade B-cell NHL.

Zevalin has proven to be effective in heavily pretreated patients who are refractory to prior antibody. Zevalin has also shown high efficacy in a comparative clinical trial with overall response rates significantly superior to antibody treatment alone.

Source: CORDIS News nov 6, 2003

 

Genzyme to establish research facility in Europe

Genzyme Corporation has announced that it will open a research facility in Cambridge, UK. The new facility will bring Genzyme into proximity with renowned academic institutions, a cluster of nearly 200 biotechnology companies, and a large pool of world-class scientific talent. The facility is scheduled to open early in 2004 and to focus initially on antibody technology and its applications in oncology, renal disease and immune-mediated diseases. Genzyme's research activities in Cambridge will be led by Bruce Roberts, general manager of Genzyme Science Europe.

In a recent survey commissioned by the journal Science and the American Association for the Advancement of Science, Genzyme was ranked among the top ten most highly regarded employers for scientists in the biotechnology and pharmaceutical industries.

Source: Pressi, Jan 19, 2004

 

European Association of Pharma Biotechnology (EAPB) initiative on Regulatory Affairs

Regulatory Affairs is one of the most important disciplines accompanying drug development from tube to market. Regulations governing research, development and marketing of medicinal products are nowadays developed in close co-operation between authorities and pharmaceutical industry. Methods and technology in pharmaceutical biotechnology are advancing much faster than the respective regulations. In the EU as well as elsewhere - and also at ICH (International Conference on Harmonisation of the technical requirements for drug registrations) - we must take into account, that the development of guidances, directives and regulations takes a long time before they come into force.

In the meantime, biotechnology based companies which develop their new drugs with new technologies, have a regulatory "black box" concerning the design of their development program.

Therefore, the European Association of Pharma Biotechnology (EAPB) has plans to establish a highly competent and efficient Special Interest Group of Reg. Aff. Professionals. The group should

* become knowledgeable concerning existing biotech related legislation

* analyse week points in existing legislation and

* bring case studies and subjects for discussion

* start co-operating contacts to EC DG Enterprise, EMEA as the major

European authorities re Biotechnology as well as to ICH

* represent EAPB and biotech Reg. Aff. in the public in presentations and publications

Source: EFB Newsletter November 2003

News from other organizations:

 

News from EFB

Currently, the European Federation of Biotechnology (EFB) has 3,800 personal and 190 institutional members. In 2003, 11 EFB regional branch offices have been established all over Europe (for details please visit www.efbweb.org/rbo/rboview.htm. In addition, 2 new EFB Sections on Medicines Development and NanoBiotechnology have been established. Please visit www.nsmf.org and www.efbweb.org/sections/nanobio.htm for more info or to register as member. These two new Sections are significant extensions of the topics covered by EFB thus including activities related to drug development, medicine and applied biophysics. The Section on Medicines Development also represents a platform for a new visionary European initiative called New Safe Medicines Faster (www.nsmf.org) while Section NanoBiotechnology represents the Nano2Life Consortium.

 

Young European Biotech Network (YEBN)

Since September 2003 the EFB has been re-enforced by a new associated section, the Young European Biotech Network (YEBN). YEBN is a non-profit organization with the aim to strengthen the co-operation of students and young Life Scientists throughout Europe. YEBN is comprised of presently five national associations with different focus from education-improvement or university-industry linkage to entrepreneurship. YEBN is organized as a project platform with 'Project0' as a core group. The flexible structure allows launching independent projects.

More info on the YEBN: www.yebn.de/portal/

  

Cytotechnology: Special issue on Metabolic Engineering

ESACT members are planning to produce a special issue of Cytotechnology on metabolic engineering: current status of cellular modification approaches towards maximization of yield from animal cells. The editors, Otto Merten and Mohamed Al-Rubeai are keen to see a special issue of original work right across the field of metabolic engineering application in cell culture such as the modification of apoptosis, proliferation, glycosylation and other cellular properties. They are therefore inviting researchers in animal cell culture to submit their works to this special issue. The editor and publisher are aiming for a publication in October 2004. If you are interested in making a contribution, please contact them immediately with a title.

This special issue is aimed at all those involved in, and those entering or interfacing with metabolic or cell engineering of animal cells, whether graduate student or experienced research worker.

Please, contact one of the editors at their email addresses:
Mohamed Al-Rubeai:
m.al-rubeai@bham.ac.uk
Otto-Wilhelm Merten: omerten@genethon.fr

 

On the web

 

RNA interference

RNA interference (RNAi) is being harnessed for target identification and validation and developed as a powerful new therapeutic class. A lengthy but complete review of the technology and the key players is given in the December issue of Nature Biotechnology. It also lists the following useful websites offering RNAi selection tools:

Ambion's siRNA Target Finder: www.ambion.com/techlib/misc/siRNA_design.html

Cold Spring Harbor's RNAi OligoRetrivere: http://katahdin.cshl.org:9331/RNAi/

Dharmacon's siDesign Center www.dharmacon.com

Qiagen's siRNA Target Sequence Design: www.qiagen.com/jp/siRNA/sirna_design.asp

Sirna's Emboss: www.biobase.de/embossdocs/sirna.html

Tuschl Laboratory siRNA User Guide: www.rockefeller.edu/labheads/tuschl/sirna.html

The Whitehead RNAi Selection program: http://jura.wi.mit/edu/pubint

Source: Nature Biotechnology, vol 21, nr 12, December 2003, pp 1441-1446

Most successful Y-chromosomes

The male Y-chromosome is doomed to disappear: per million years, 3-6 genes disappear from the Y-chromosome. It has been sequenced (Nature, June 2003) and currently contains not more than 78 active genes, sufficient to produce 27 proteins. The reasons of this doom and gloom are a lack of recombination and surprisingly few variations: some Y-chromosomes occur frequently, others are rare. In a nicely written article, two examples of the world's most successful Y-chromosomes are given.

Probably the world's most successful Y-chromosome is the one allegedly from the Mongolian leader Genghis Kahn, ruler of an area encompassing Asia from the Pacific Ocean until the Caspian Sea. Exactly along the borders a particular Y-chromosome is found frequently: it is most likely of Genghis Kahn and his four sons and one grandson. The reason: all men were killed and cities destroyed. Each warrior was free to do as he pleased with one exception: all pretty women were sent to Genghis Kahn. Currently, there are 16 million people with the alleged Kahn Y-chromosome. This particular Y-chromosome is not found outside the old Mongolian borders. Thus, this Y-chromosome succeeded to multiply from one copy to 16 million in only 30 generations!

An example closer to home is that of the Scottish leader Somerled of Argyll (1100), who is at the root of three Scottish clans, the MacDonalds, the MacDougallls and the MacAllisters. At present, there are close to half a million copies of Somerled's Y-chromosome; after all, he was rich, powerful, had a lot of land and attractive sons who later became the founding fathers of the three clans.

Source: Bionieuws Jan 16, 2004, and Nature, June 19, 2003

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