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US and EU Experts Discuss Collaboration on New Toxicology Tools

FDA says joint work is essential to define the path forward and catalyse change

11-Oct-2012

The US Food and Drug Administration (FDA) wants to collaborate with
European researchers in developing new toxicology tools that advance non-animal
based safety science and health research. Speaking at a European
Parliament workshop in Brussels Donald Prater of the FDA’s Europe office said
that “collaboration is essential to define needed pathways and catalyse
change.”

He said the FDA and the National Institute of Health in the US have launched
a new regulatory science programme including support for novel approaches
for transforming toxicology. Dr Prater echoed the general consensus amongst
experts at the meeting that 21st century toxicology is moving away from
animal-based techniques.

“It is clear that in vivo animal studies may not be the gold standard that new
toxicology methods are compared against,” he said. “There is a need to
determine the relevance of in vitro results to what occurs in humans rather
than what occurs in rodents and other test animals.”

Troy Seidle, of both Humane Society International and AXLR8, an EU
coordination project that is working to accelerate development and integration
of advanced tools into health research and safety testing, said “investment in
innovative, human-relevant tools and technologies for research and safety
testing is key to unlocking the major human health questions that animal
models have failed to address.”

The new EU research and innovation framework programme Horizon 2020,
that is currently before various EU Parliamentary committees, provides “a
historic opportunity for Europe to take the lead in this global paradigm shift,”
he said.

The AXLR8 project suggests that an investment from the EU and industry of at
least €325m should be committed to research for advancing and implementing
a 21st century safety testing programme. Key AXLR8 recommendations are a
public-public partnership between the EU and US and a public-private
partnership with industry.

European and US collaboration was also highlighted by Julia Fentem, head of
Unilever’s Safety and Environmental Assurance Center in the UK. “Horizon
2020 is an opportunity for EU-US transatlantic research collaboration and
substantial EU research investment in safety science,” she said. “The EU needs
to start to increase its investment in this space... we have the opportunity to
bring the EU and US work in this area under one umbrella.”

“Research outputs will enable the EU to have a strong scientific and policy voice
on chemical and product safety at the OECD and in other international fora,”
continued Dr Fentem.

Maurice Whelan, head of the Systems Toxicology Unit and the European
Union Reference Laboratory for Alternatives to Animal Testing (Eurl Ecvam),
at the European Commission Joint Research Centre (JRC), commented on the
level of consensus among workshop speakers: “I’ve been curious to see how
different people are presenting the same ideas in different ways.”

In his opinion Horizon 2020 should be supporting a safety assessment
paradigm that is knowledge-driven rather than observation-driven. It must
rely on “understanding toxicity rather than simply observing its effects.”

It is critical that there is continuity and that all knowledge be shared from a
central place, he said. “It sounds simple but we’ve been dreadful at it. With an
extensive research programme of its own and its heavy involvement in key
international collaborations, the JRC/Ecvam is ideally placed to provide an
organisational hub and an overall reference point for pan-European efforts.”

Other speakers included Lisbeth Knudsen of the University of Copenhagen
who said “the time is here to join and shape modern toxicology for a human related
assessment” and Marcel Leist, director of the Center for Alternatives to
Animal Testing in Europe and of the University of Konstanz, who said that we
“now have a comprehensive toxicological toolbox for faster testing and better
consumer protection.”

The final speaker, Gill Langley of HSI, publicly-launched a new HSI report on
advancing safety science and health research with innovative non-animal tools.
She said the report was a “key resource for Horizon 2020 proposals.”

The workshop was hosted by MEP Mario Pirillo of the progressive alliance of
socialists and democrats. He said that “we have to explore means of research
other than animal testing” and that Horizon 2020 should “boost modern and
effective tools for human health and safety.”

Iva Pocock

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Used with permission.

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