content - europa · pdf...
TRANSCRIPT
EPAA l The European Partnership for Alternative Approaches to Animal TestingSecretariat: 45 Avenue d’Auderghem l 1040 Brussels l Tel: +32 2 295 66 00 l e-mail: [email protected]
ANNUAL REPORT2010
Foreword . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Overview.of.the.EPAA.activities.in.2010. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Workshop.on.2Rs.-.Reduction.and.Refinement,.combining.excellence.in.science..and.animal.welfare . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Computational.Chemistry.&.Systems.Biology.-.Workshop.on.“Harnessing.the.Chemistry.of.Life”. . . . . . . . . . . . . . .5
Workshop.on.acute.toxicity.testing.-.reviewing.the.drivers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Workshop.on.vaccines.-.the.consistency.approach. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Thematic.review.on.Reproductive.Toxicity.supported.by.the.EPAA. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
The.extended.one-generation.study. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
The.EPAA.awards .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. ..8
The.next.the.EPAA.Action.Programme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
A.look.back.over.the.first.five.years.(2006-2010). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
The.EPAA.partners. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10
The.EPAA.projects.underway. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Governance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
CONTENT
Annual Report 2010
3
“The mission of the EPAA is fully consistent with the objective of the EU to secure more competitiveness through innovative research, which would deliver better and safer products to EU in-dustries, consumers and patients… We need to explore the full potential of the virtuous circle of innovation resulting in better animal welfare, and animal welfare resulting in better science”.
Antonio Tajani, European.Commissioner.for.Enterprise.and.Industry
FOREwORdThe.EPAA’s.aim.is.to.accelerate.the.development,.validation.and.acceptance.and.use.of.alternative.approaches.to.animal.testing ..For.five.years.now,.the.EPAA.has.initiated.and.recommended.many.actions.regarding.3Rs.methods.and.strategies ..The.EPAA.work.adapts.to.evolving.scientific.progress.and.policy.changes .
Crucial. legislative.initiatives.with.implications.for.the.concept.of.3Rs.have.been.taken.on.over.the.past.two.years ..This.has.led.to.some.major.changes,.which.are.now.being.implemented,.including.a.definition.of.3Rs.methods.under.the.new.rules.on.the.protection.of.animals.used.for.scientific.purposes,.and.the.mandatory.provisions.on.3Rs.for.regulatory.tests,.notably.under.REACH ..These.offer.possibilities.for.constructive.dialogue.on.how.best.to.move.from.principle.to.practice ..The.EPAA.is.determined.to.play.its.role,.through.its.unique.pooling.of.expertise.and.its.ambition.to.see.the.widest.applica-tion.of.the.3Rs .
Georgette Lalis Gerd Ries. European.Commission. Johnson.&.Johnson. Commission.Co-chair.Steering.Committee. Industry.Co-chair.Steering.Committee
whAT is ThE EPAA?The.European.Partnership.for.Alternative.Approaches.to.Animal.Testing.(EPAA).is.an.unprecedented.collaboration.between.the. European. Commission. and. major. companies. from. seven. industry. sectors .. It. is. a. partnership. in. which. knowledge,.research.and.resources.are.pooled.to.accelerate.the.development,.validation.and.acceptance.of.modern.alternative.ap-proaches.for.regulatory.use,.and.in.which.best.practice.is.shared.to.promote.the.use.of.3Rs.methods .
© B
elpr
ess/
Belg
a
Annu
al R
epor
t 20
10
4
OVERViEw OF ThE EPAA ACTiViTiEs iN 2010
wORkshOP ON 2Rs - REdUCTiON ANd REFiNEmENT, COmBiNiNg ExCELLENCE iN sCiENCE ANd ANimAL wELFARE
Opening.a.specifically.dedicated.workshop.on.the.2Rs,.on.4.-.5.October.2010,.Gustaaf.Borchardt,.Director.for.Water,.Chemi-cals.and.Biotechnology.in.the.European.Commission’s.DG.Environment,.said.that.“whilst.emphasis.should.not.be.diverted.from.the.importance.of.replacement.methods,.oftentimes.considerable.and.more.immediate.animal.welfare.benefits.can.be.achieved.through.the.application.of.reduction.and.refinement.methods” ..He.welcomed.the.EPAA.spotlight.on.the.“hith-erto.veiled.potential.of.the.2Rs” ..A.structured.discussion.among.the.participating.test.method.developers,.test.method.users,.regulators.and.policy.makers.then.made.it.possible.to.reach.concrete.views.on.the.next.steps.to.be.taken.towards.the.use.of.“non-replacement”.methods.and.strategies ..These.recommendations.on.implementing.“reduction”.and.“refine-ment”.methods.and.strategies. focused.on.how.to. include.opportunities. for. research. in.the.area.of. refinement.and.re-duction,.as.well.as.on.coordination.actions.-.through.consortia.-.that.could.be.supported.through.public.and/or.private.financing.schemes .
The. conclusions. recommended. promoting. reduction. and. refinement. whilst. keeping. replacement. as. the. ultimate. goal ..They.also.urged.the.use.of.existing.data.to.validate.the.2Rs,.replacing.prescriptive.regulatory.standards.with.perform-ance.standards,.and.improving.perception.and.raising.awareness.of.their.value ..This,.the.conclusions.noted,.will.increase.understanding.of.refinement,.bring.greater.coherence.and.specific.objectives.to.research.funding.relating.to.reduction.and.refinement,.and.facilitate.consultation.with.regulators.and. legal. risk.assessors.on.requirements.for. reduction.and.refinement.to.be.validated.and.accepted .
Examples.of.2R.approaches.submitted.by.industry,.regulators,.academia.and.animal.protection.organisations.were.selected.for.presentation.based.on.their.potential.to.improve.the.quality.of.science.and.animal.welfare,.interest.for.further.dissemination.and.wider.use.both.within.and.across.industry.sectors ..Some.of.these.approaches.-.including.good.practice.-.could.be.used.across.the.range.of.safety.testing,.from.screening.to.methods.accepted.by.regulators ..The.submissions.received.were.presented.in.the.poster.session.and.competition.at.the.EPAA.2010.annual.confer-ence.on.30.November.and.will.appear.in.an.EPAA.on-line.publication.soon.after ..The.flash.report.of.the.2RS.workshop.is.available.on.the.EPAA.website .
The.EPAA.chose.this.theme.for.2010.because,.while.significant.efforts.are.being.made.in.developing.and.validating.new.alterna-tive.methods.that.can.completely.replace.the.use.of.animals,.im-portant.progress.has.also.been.made.in.the.other.two.Rs ..As.said.Commission’s.Vice.President.Antonio.Tajani,.“Science progresses at a much slower pace than policy makers would sometimes wish”,.and.“the choice of reduction and refinement as the EPAA lead theme for 2010 will make it possible not only to qualify but also to quantify certain achievements” ..Conditions.are.being.im-proved.for.animals.still.used.in.procedures,.and.their.numbers.are.being.reduced.at.the.same.time.as.the.scientific.validity.of.animal. models. still. required. in. risk. assessment. is. constantly.being.improved ..Reduction.and.refinement.methods.are.capable.of.producing.immediate,.tangible.and.significant.results.in.terms.of.numbers.of.animals.saved,.scientific.output.and.animal.wel-fare ..They.are.easily.disseminated.among.scientists,.and.merit.recognition.and.encouragement ..Drawing.the.attention.of.policy.makers. to. the. enormous. potential. of. these. approaches. and.building. trust. in. these. methods. with. regulators. are. tasks. that.the.EPAA.has.taken.on .
Replacement remains the final objective of the EPAA, but this year the EPAA decided to highlight the significant opportunities that Reduction and Refinement offer, for both animal welfare and science. so as its lead theme for 2010, EPAA selected “harnessing the untapped Reduction and Refinement potential (2Rs) in the regulatory context”, to highlight its work on reduction and refinement strategies.
The workshop recommendations:
1 ...Promote.reduction.and.refinement.whilst.keeping.replacement.as.the.ultimate.goal
2 ..Use.existing.data.to.validate.reduction.and.refinement
3 ...Replace.prescriptive.regulatory.standards.with.performance.standards
4 ...Improve.perception.and.raise.awareness.of.the.value.of.reduc-tion.and.refinement
5 ..Increase.understanding.of.refinement
6 ...Bring.coherence.and.specific.objectives.to.research.funding.relating.to.reduction.and.refinement
7 ...Consult.with.regulators.and.legal.risk.assessors.on.requirements.for.reduction.and.refinement.to.be.validated.and.accepted .
8 ...The.EPAA.to.maintain.a.focus.on.reduction.and.increase.refine-ment.in.its.second.five.year.programme
More.information:.Flash.report.available.on.the.EPAA.website .
Annual Report 2010
5
COmPUTATiONAL ChEmisTRy & sysTEms BiOLOgy - wORkshOP ON “hARNEssiNg ThE ChEmisTRy OF LiFE”In.2010.the.EPAA.followed.up.on.the.recommendations.of.the.2008.High.Level.Workshop.on.“New.Perspectives.on.Safety”.-.an.initiative.to.articulate.clearly.the.challenges.that.toxicologists.face.in.developing.approaches.for.safety.assessment.of.chemicals.and.medicines.without.the.use.of.animals ..Computational.chemistry.and.systems.biology.were.amongst.the.scientific.areas.that.were.suggested.for.further.investigation .
On.5-7.July.an.expert.workshop.brought.together.about.20.experts.from.different.disciplines.to.assess.recent.advances.in.compu-tational.chemistry.which,.taken.together.with.state-of-the-art.expertise.in.systems.and.synthetic.biology.and.in.biological.modelling,.could.lead.to.the.development.of.truly.novel.approaches.to.toxicity.testing.that.will.obviate.the.need.for.testing.on.animals .
The. EPAA. aimed. to. identify. the. needs. for. delivering. against. this. chal-lenge,. including. the. requirement. for. engagement. with. other. scientific.disciplines,.and.to.agree.on.a.strategic.plan.and.a.roadmap.for.progress .
The. EPAA. addressed. the. questions. of. whether. recent. advances. in.chemistry.and.effects.on.biological.systems.can.be.exploited.to.pre-dict.that.a.chemical.will.cause.damage.to.the.human.liver,.and.under.which.circumstances ..Requirements.to.drive.this.investigation.forward.were.studied,.as.well.as.which.information,.skills.and.disciplines.would.be.needed ..The.EPAA.considered.intrinsic.chemical.reactivity.(towards.proteins,. DNA. etc);. biologically-specific. chemical. interactions. (e .g ..receptor. and. enzyme. reactivity. and. mediation);. integration. of. these.chemical. interactions. with. initial. biological. consequences. (metabo-lism,.response.to. interference.with.macromolecules,.disturbed.cellu-lar. metabolism. etc);. integrative. bioinformatics. and. systems. effects;.quantitative.aspects.of.these.variables.(dose.responses,.kinetics.etc);.and.systems.and.synthetic.biology ..The.liver.was.used.as.a.case.study.for. this. workshop,. with. the. approach. extended. to. other. organs. if. it.proved.useful .
wORkshOP ON ACUTE TOxiCiTy TEsTiNg - REViEwiNg ThE dRiVERsIn.2010.the.EPAA.followed.up.a.project.-.initiated.in.2008.-.to.review.the.scientific.and.regulatory.drivers.for.acute.toxicity.test-ing.and.to.promote.the.use.of.3Rs.approaches.in.this.area ..This.year.it.published.a.paper.and.held.a.workshop.on.the.subject .
The.project.originated.from.the.recognition.in.the.pharmaceutical.sector.that.regulatory.testing.requirements.on.acute.toxicity.were.no.longer.relevant ..In.light.of.this.conclusion,.the.International.Conference.on.Harmonisation,.which.assures.cooperation.between.pharmaceutical.regulators.in.the.US,.Europe.and.Japan,.modified.the.testing.requirements.for.pharmaceuticals.accordingly .
Because.the.EPAA.brings.together.a.wide.range.of.industry.sectors,.it.can.offer.a.unique.overview.of.the.regulatory.and.scientific.issues.in.this.field,.and.can.recommend.approaches.that.could.be.adopted.widely.across.different.sectors .
Together.with.representatives.of.the.International.Humane.Society,.and.in.association.with.the.UK.NC3Rs,.the.EPAA.ana-lysed.these.testing.requirements.in.other.industrial.sectors ..Data.from.17.companies,.obtained.through.an.EPAA.survey,.led.to.the.conclusion.that.scope.existed.for.reviewing.requirements,.as.a.contribution.to.better.testing.and.better.animal.protection ..The.survey.revealed.that.the.key.driver.is.classification.and.labelling,.and.showed.that.certain.stated.reasons.for.testing.are.not.necessarily.supported.by.the.information.generated.from.the.studies ..Most.companies.also.confirmed.that.they.would.be.ready.to.skip.the.dermal.testing.route.if.a.robust.set.of.data.supported.the.possibility ..The.findings.were.published.in.the.paper.“Cross-Sector.Review.of.Drivers.and.Available.3Rs.Approaches.for.Acute.Systemic.Toxicity.Testing”,.T ..Seidle.et.al,.in.Toxicological.Sciences ..(Full.paper.available.at.http://toxsci .oxfordjournals .org/cgi/content/full/116/2/382)
An.EPAA.workshop.involving.regulators,.academics,.poison.centre.staff.and.industry.representatives.held.in.Brussels.on.16.September.2010.focussed.on.two.areas.stemming.from.the.review ..These.were.assessing.whether.there.are.scientific.drivers.for.acute.toxicity.testing.and.whether.the.available.concordance.data.set.is.adequate.to.support.the.deletion.of.the.requirement.for.dermal.testing.from.relevant.legislation .
Specific. proposals. were. made. for. waivers. that. would. deliver. direct. 3Rs. benefits .. The. outcome. of. the. workshop. will. be.communicated.in.the.workshop.report.which.will.be.made.available.on.the.EPAA.website ..Follow.up.steps.will.include.a.wider.consultation.of.the.key.recommendations.with.regulatory.stakeholders.and.considerations.of.how.the.removal.of.the.dermal.route.as.part.of.default.testing.can.be.implemented .
The workshop concluded that integrated research should be undertaken which would:1 ...Consider.modelling.transport.and.interactions.from.molecular.to.cel-
lular/organelle.levels.(mitochondria.specifically)
2 ...Tightly.integrate.with.in.vitro.stem.cell.experimentation.designed.specifically.to.inform.this.modelling.activity
3 ..Couple.directly.to.systems.modelling.from.cellular.to.organ.level
4 ...Take.account.of.mechanistic.understandings.of.toxic.responses.in.the.liver
5 ...Establish.an.appropriate.infrastructure.for.computation.data.basing.and.sharing .
A.dedicated.team.drawn.from.workshop.members.works.on.the.key.strategic.principles.to.define.a.workable.action.plan .
Annu
al R
epor
t 20
10
6
wORkshOP ON VACCiNEsThe.EPAA.organised.in.Brussels.a.workshop.on.11-12.January.2010,.together.with.ECVAM,.to.discuss.the.consistency.ap-proach.for.quality.control.of.vaccines ..The.workshop.was.attended.by.about.60.participants.from.industry,.academia.and.regulatory.agencies .
The.consistency.approach.is.based.upon.the.principle.that.the.quality.of.a.vaccine.is.the.consequence.of.the.strict.appli-cation.of.a.quality.system.and.of.a.consistent.production.of.batches ..Through.the.application.of.this.principle,.which.has.been.implemented.for.some.novel.human.vaccines,.agreed.product.characteristics.can.be.tested.in.vitro.during.the.manu-facturing.process.of.a.batch.and.shown.to.be.similar.to.those.of.batches.demonstrated.to.be.safe.and.effective.in.clinical.trials ..The.concept.of.consistency.may.therefore.be.applied.to.conventional.vaccine.production.in.order.to.replace.in.vivo.tests.with.in.vitro.tests.indicative.of.the.quality.of.the.product.whilst.maintaining.the.highest.quality.and.safety.standards .
The. central. recommendation. was. to. include. in. the. European. Pharmacopoeia. monographs. an. explicit. request. from. the.European.Directorate.for. the.Quality.of.Medicines.&.Healthcare.of. the.Council.of.Europe.to.allow.the.application.of. the.consistency.approach ..A.further.result.was.a.plan.for.industry.to.advance.technical.reflection.on.how.this.might.be.applied.to.all.vaccines,.under.the.EPAA.umbrella,.and.with.involvement.of.regulatory.agencies ..The.EPAA.agreed.to.support.the.implementation.of.the.workshop.recommendations.through.a.human.and.a.veterinary.vaccines.platform .
According.to.participants,.the.opportunity.exists.to.introduce.the.approach.into.established.vaccine.production,.with.the.potential.to.replace.in.vivo.tests.with.non-animal.tests.designed.to.demonstrate.batch.quality.and.antigen.quantity ..In.this.way,.the.highest.quality,.safety.and.efficacy.standards.could.be.maintained.while.allowing.for.a.significant.reduction.in.animal.use ..The.report.indicates.how.this.approach.may.be.further.developed.for.application.to.established.human.and.veterinary.vaccines.and.emphasizes.the.continuing.need.for.co-ordination.and.harmonization ..It.also.gives.recommenda-tions.for.work.to.be.undertaken.in.order.to.encourage.acceptance.and.implementation.of.the.consistency.approach .
The.full.report.should.be.submitted.for.publication.in.a.peer.reviewed.journal.by.the.end.of.2010 .
in the meantime, the EPAA steering Committee agreed on follow-up actions:1 ...Organise.a.workshop.to.secure.the.agreement.of.the.appropriate.members.including.regulatory.authorities,.for.identifying.current.
alternative.initiatives.amongst.stakeholders,.for.prioritising.the.tests.to.be.replaced.according.to.specific.criteria,.and.for.recommend-ing.minimum.validity.criteria.for.acceptance.of.alternatives.to.in.vivo.testing.methods .
2 ...Facilitate. the. exchange. of. technical. information. on.test.methods.and,.if.relevant,.reagents.and.materials .
3 ...Create.working.groups.focussing.on.specific.meth-ods. with. the. support. of. experts. from. Academia,.EDQM,.OMCLs,.ECVAM,.EVM.and.IFAH,.regulatory.au-thorities.and.experts.from.FDA.and.WHO…
4 ...Establish. proof. of. concept. for. specific. tests. identi-fied.through.workshops.before.validating.the.meth-od.and.before.proposing.the.alternative.method(s).to. standardisation. bodies. such. as. EDQM. with. the.support.of.stakeholders .
5 ...Support. dissemination. through. publications. in. sci-entific.journals
OVERViEw OF EPAA ACTiViTiEs iN 2010
Annual Report 2010
7
ThEmATiC REViEw ON REPROdUCTiVE TOxiCiTy sUPPORTEd By ThE EPAATo.implement.one.of.the.three.main.objectives.agreed.on.during.2009,.the.EPAA.decided.in.2010.to.promote.a.mechanism.by.which.regulators,.industry.and.other.parties.are.provided.with.concise,.comprehensive.and.peer-reviewed.information.regarding.existing.Replacement,.Reduction.or.Refinement.methods.(3Rs).for.regulatory.safety.testing .
The.first.in.this.series.is.the.provision.of.an.up-to-date.picture.of.alternative.methods,.from.development.to.regulatory.ac-ceptance,.in.use.for.reproductive.toxicity.testing.of.chemicals.and/or.formulations ..(This.review.does.not.cover.methods.to.detect.developmental.neurotoxicity.and.endocrine.disruptors,.which.could.be.part.of.a.separate.review) .
The.review.is.carried.out.by.a.scientific.consultant.under.the.overall.coordination.of.ECVAM.and.it.is.financially.supported.by.the.EPAA.industry.partners ..Companies.were.invited.to.provide.input.on.the.in.vitro.methods.used.by.industry.by.com-pleting.a.questionnaire.that.was.made.available.on.the.EPAA.website ..Another.questionnaire.addressing.in.vivo.Reduc-tion.and.refinement.methods.or.Integrated.Testing.Strategies.(ITS).is.under.preparation.and.shall.complement.this.first.project .
The.outcome.of.the.review.will.be.disseminated.via.the.ECVAM.DataBase.service.on.ALternative.Methods.to.animal.experi-mentation.(DB-ALM).http://ecvam-dbalm .jrc .ec .europa .eu .
DB-ALM.ensures.a.wide.and.targeted.distribution.of.the.results.reached.having.the.DB-ALM.over.2000.subscribed.users.from.75.countries.covering.all.relevant.user.profiles.in.the.topic.area.of.animal.alternatives .
ThE ExTENdEd ONE-gENERATiON sTUdyThis.was.an.EPAA.initiative,.which.has.been.worked.on.for.a.long.time,.and.has.been.reported.on.in.previous.years ..EPAA.industry.partners.have.made.available.data.and.prepared.a.protocol.to.promote.an.extended.one-generation.study.origi-nally.developed.for.plant-protection.products,.for.wider.use.in.the.chemical.sector ..Final.acceptance,.however,.is.the.com-petence.of.the.OECD .
In.accordance.with.principles.of.consistency.as.set.out.at.the.2009.the.EPAA.Conference,.it.makes.sense.that.where.the.EPAA.starts.an.action.that.proves.to.have.value.and.potential,.the.European.Commission.and/or.industry.pursue.that.ac-tion.in.their.particular.fields.of.activity.and.competence . .
In.2010,.a.number.of.expert.discussions.were.held.by.the.OECD.to.advance.the.project ..It.is.expected.that.the.Extended.One-Generation.study.test.guideline.will.be.put.forward.for.a.formal.adoption.at.OECD.and.then.at.the.Council.level.in.spring.2011 ..The.exact.use.of.the.guideline.within.the.different.EU.regulatory.frameworks.will.still.need.to.be.determined .
The objectives of the Reproductive Toxicity review are to provide: an up-to-date overall picture of the state-of-the-art of alternative methods in use for assessing (aspects of ) reproductive toxicity at any stage of development: from development, through (formal) validation, to regulatory acceptance. Ready-to-use information will be presented for each method with their potential and limitations as peer-reviewed data sheets with predetermined criteria for data content as developed by ECVAm, that ensures the data quality. The review will be made available within dB-ALm benefitting from its data retrieval facilities and the large scientific and regulatory community who subscribed to this service ensuring a wide and targeted distribution of the project outcome. The project started in may 2010 and is expected to deliver a good overview before the end of the year.
Annu
al R
epor
t 20
10
8
ThE EPAA AwARdsTo.increase.awareness.of.alternatives.and.promote.them.to.young.scientists,.the.EPAA.launched.two.awards.in.2010.-.one.dedicated.to.scientists,.and.one.to.communication .
With.the.science.award,.the.EPAA.is.offering.support.of.up.to.€100,000.for.the.development.and.regulatory.acceptance.of.3Rs.alternative.methods ..The.focus.is.on.practical.steps.to.improve.the.acceptance.and.implementation.of.the.3Rs.in.the.regulatory.context ..Finance.will.be.provided.to.the.institution.of.the.successful.candidate.to.allow.a.one-year.extension.of.an.existing.postdoctoral.contract,.to.promote.the.transition.from.innovative.and.experimental.alternative.approaches.to-wards.industrial.application.and.regulatory.acceptance ..The.call.was.launched.in.June.2010,.and.received.13.submissions
With.its.communication.prize,.the.EPAA.is.offering.€3,000.for.an.essay.or.article.that.broadens.awareness.of.the.role.of.safety.assessment.and.regulatory.compliance.in.product.development.and.that.promotes.replacement,.reduction.and.re-finement.(3Rs) ..The.key.criterion.for.the.winning.essay.is.that.it.will.help.inform.the.wider.policy.community.and.decision-makers.about.the.opportunities.and.challenges,.including.limitations,.offered.by.scientific.and.technological.progress ..The.call.was.launched.in.June.2010.and.7.entries.were.received .
As.part.of.its.policy.to.widen.understanding.and.acceptance.of.the.3Rs.approach,.the.EPAA.also.provides.support.for.other.organizations’.events ..The.EPAA.website.carries.details.of.criteria.for.applications.for.sponsorship,.the.selection.process,.and.the.conditions.for.validating.sponsorship .
The.EPAA.continued.to.implement.an.active.communication.policy.especially.through.its.website,.newsletters.and.contri-butions.in.several.3Rs-related.scientific.conferences .
ThE NExT EPAA ACTiON PROgRAmmEReaching.the.end.of.the.original.first.programme,.the.EPAA.needed.a.new.plan,.to.develop.actions.reflecting.its.partners’.continued.commitment.to.3Rs .
The.new.Action.Programme,.for.2011-2015,.is.based.on.a.critical.assessment.of.the.first.programme,.in.2006-2010,.and.on.likely.upcoming.scientific,.policy.and.legislative.challenges ..It.also.reflects.structural.changes.the.EPAA.implemented.in.2009.to.increase.its.efficiency.and.make.the.best.use.of.resources .
It.is.more.selective.than.its.precursor,.with.activities.prioritised.on.the.basis.of.their.relevance.to.EU.sectoral.legislation,.animal.welfare.legislation.and.policies,.to.unmet.scientific.challenges,.to.tangible.impact.on.numbers.and.welfare.of.labo-ratory.animals,.and.to.the.EPAA.partners’.competence.and.resources ..It.also.provides.for.flexibility.in.planning.activities.and.for.regular.review.to.adapt.them.to.circumstances .
It.has.three.main.objectives:.increase.international.coordination.on.scientific.and.regulatory.matters;.improve.the.quality.of.the.links.with.national.regulators.in.the.EU;.and.profile.more.the.EPAA.when.it.is.about.the.merits.of.all.3Rs.methods
The. Platform. on. Science. will. aim. to. identify. knowledge/scientific. gaps. in. the. fields. of. computational. chemistry. and.systems.biology.and.will.recommend.areas.for.further.research.in.these.fields:.(i).identify.and.address.research.needs.for.developing.or.optimising.alternative.methods.through.relevant.programmes.and.calls.for.proposals.of.the.European.Commission. and. other. research. funding. institutions;. (ii). seek. involvement. of. young. scientists. and. scientists. from.areas.not.directly.related.to.biosciences.to. increase.knowledge.and. leverage.understanding.of.3Rs.within.scientific.community;.and.(iii).assess.the.feasibility.of.technology.transfer.across.sectors.(e .g ..optimization.of.study.design.in.toxicological.testing) .
The.Platform.on.3Rs.in.Regulation.aims.at.(i).identifying.areas.where.implementation.of.regulatory.requirements.could.be.optimized/rationalized.in.line.with.the.3Rs.principles;.(ii).fostering.regulatory.acceptance.of.rationalised.acute.toxicology.testing.methodologies.(including.waiver.of.one.of.the.administration.routes);.(iii).supporting.further.development.of.the.scientific.data.to.promote.the.vaccines.consistency.approach;.(iv).promoting.acceptance.of.the.extended.one-generation.study. by. regulatory. authorities;. and. (v). understanding. regulators’. requirements. for. levels. of. confidence. in. integrated.testing.strategies .
The.Platform.on.Dissemination.&.Communication.aims.at.(i).reviewing.key.3Rs.topics,.so.as.to.present.the.options.avail-able.today.to.regulators.and.users.in.a.form.of.thematic.reviews;.(ii).developing.communication.tools.that.improve.un-derstanding.of.the.results.3Rs.approaches.can.deliver.in.different.sectors;.(iii).defining.mechanisms.to.provide.greater.access.to.information.and.opportunities.to.connect.those.who.have.and.those.who.need.information;.and.(iv).promoting.the.potential.of.alternative.approaches.with.young.scientists .
A.mid-term.revision.of.the.programme.is.foreseen.in.2013 .
OVERViEw OF EPAA ACTiViTiEs iN 2010
Annual Report 2010
9
“I hope and expect that we will witness much activity in the area of 3R development during the coming years. Promotion of alternatives is an ongoing task of highest importance. Each time we propose new legislation, or revise existing legislation that involves the use of animals, the EU legislator will assess how on the basis of experience acquired, we can improve the promotion of the 3Rs. Against this background, work on the 3Rs, that is not only Replacement but equally Reduction and Refinement, and the work pursued by the EPAA remain key in the Commission’s strategy on alternative approaches.”.Gustaaf.Borchardt,.Director.for.Water,.Chemicals.and.Biotechnology.in.the.European.Commission’s.DG.Environment
A LOOk BACk OVER ThE FiRsT FiVE yEARs (2006-2010)With.the.platform.on.science,.the.EPAA.started.in.2006.to.evaluate.opportunities.for.wider.application.of.testing.strategies.being.developed.as.the.Agricultural.Chemical.Safety.Assessment.(ACSA).approach.for.reproductive.toxicity,.e .g .,.for.regula-tory.testing.under.REACH ..This.led.to.the.establishment.of.an.OECD.task.force.in.2007,.and.feasibility.studies.conducted.by.four.EPAA.member.companies.that.are.close.to.completion.at.the.end.of.2010 ..The.approach.promises.to.deliver.real.animal.welfare.benefits:.refinement,.and.a.reduction.in.the.number.of.animals.used.(more.than.40%.compared.to.the.two-generation.study) ..It.is.now.up.to.OECD.to.make.a.final.decision.on.whether.and.how.to.implement.this.important.reduction.approach .
With.the.help.of.scientists.from.various.fields,.including.outside.the.life.sciences.field,.the.EPAA.explored.“New.perspectives.on.safety.testing” ..This.reflection.addressed.forward-looking.issues,.including.future.hazard.iden-tification.with.regards.to.chronic.repeat.dose.systemic.toxicity.without.the.use.of.animal.test-ing,.and.novel.approaches.for.the.characterization.of.the.potential.hazards.of.chemicals.and.drugs ..The.EPAA.explored.which.areas.of.science.and.technology.could.create.new.approaches.to.safety.assessment ..As.a.follow.up,.scientific.workshops.were.organised.to.discuss.the.po-tential.of.computational.chemistry.and.systems.biology.,stem.cells.in.future.safety.testing.and.in.vitro.ADME.(Physiologically-based.pharmacokinetic/toxicokinetic.(PBP/TK).models.are.ide-ally.suited.for.the.integration.of.data.produced.from.in.vitro.testing.systems/in.silico.models.into.a.biologically.meaningful.framework,.and.for.the.extrapolation.to.in.vivo.condition ..An.EPAA-workshop. on. this. topic. is. planned. for. autumn. 2011) .. Conclusions. from. these. discussions.were.considered.in.the.forward.research.agenda.(such.as.the.call.for.proposals.and.projects.selected.in.the.joint.EC-COLIPA.research.programme.on.systemic.toxicity.under.FP7) ..Addition-ally,.the.EPAA.succeeded.in.engaging.the.wider.scientific.community,.thereby.providing.greater.legitimacy.to.investment.in.research.into.alternatives .
Where.barriers.to.validation.were.detected,.the.EPAA.partners.have.jointly.developed.pro-cedures.that.should.help.submission.and.evaluation.of.applications.by.ECVAM.or.request./provision.of.information.by.companies,.in.particular.through.calls.at.an.early.stage.before.the.finalisation.of.protocols.for.validation.studies .
An.important.objective.of.the.EPAA.is.to.improve.the.implementation.of.3Rs.in.European.regulatory.testing.and.decision.making ..It.therefore.aims.to.identify.optimised.approach-es.on.testing.and.risk.assessment.strategies.in.existing.and.upcoming.legislation.and.their.implementation ..In.this.re-spect,.the.EPAA.strives.to.share.experience.and.evaluate.consistency.across.sectors,.to.analyse.hot.spots,.and.to.identify.policy.drivers.for.testing ..Currently,.the.EPAA.is.following.up.on.suggestions.from.earlier.debates.and.workshops.relating.to.the.involvement.of.regulators.at.an.early.stage.of.method.validation;.better.dissemination.of.information.about.avail-able.alternatives;.and.the.inclusion.of.3Rs.on.the.agendas.of.all.relevant.international.regulatory.meetings ..Cooperation.between.industry.and.regulators.on.the.basis.of.scientifically.solid.case.studies.is.becoming.stronger.and.more.tangible ..Examples.include.implementation.of.the.consistency.approach.in.vaccines.testing.or.reduction.strategies.in.acute.toxicity.testing .
In.terms.of.communication,.the.creation.of.a.joint.understanding.between.industry.and.Commission.partners.of.the.life.cy-cle.of.product.research.and.development,.and.of.the.value.and.limitation.of.alternative.approaches.in.this.context,.makes.it. possible. today. to. have. open. discussion. about. the. challenges. and. how. to. address. them .. Maintaining. understanding.among.all.the.EPAA.partners.is.a.continuous.process,.particularly.in.view.of.its.widening.audience ..Disseminating.informa-tion.to.wider.audience,.including.policy.makers,.is.one.of.the.challenges.for.the.future ..The.EPAA.website.and.newsletter.are.a.good.start ..The.communication.award.was.initiated.by.the.EPAA.to.promote.the.communication.of.complex.scientific.matters.in.lay.language.and.in.a.way.that.can.inform.decision.making.and.policy.debates .
The.EPAA’s.approach.to.dissemination.of.information.on.the.3Rs.has.been.refined.by.the.“market.place”.concept.it.created,.to.bring.information.to.those.who.need.it.through.workshops,.direct.presentations.to.regulatory.bodies,.and.thematic.re-views ..The.lead.theme.of.2010.-.2Rs.-.is.an.example.where.sharing.good.practice.holds.out.the.prospect.of.quicker.results.than.trying.to.change.the.regulatory.set.up .
Annu
al R
epor
t 20
10
10
European Commission.DG.Enterprise.and.Industry.DG.Research.DG.Environment.DG.Joint.Research.Centre.DG.Health.and.Consumer.Protection
With. a. view. to. increasing. efficiency,. EPAA.maximises. coordination. on. the. cross-cut-ting. themes. that. are. central. to. extending.the. use. of. 3Rs .. It. operates. through. three.platforms. -. one. focused. on. scientific. is-sues,.one.on.legislation.and.acceptance.of.alternative. methods,. and. one. on. dissemi-nation.and.communication .
ThE EPAA PARTNERs
Federations..Soaps.and.detergents.(AISE).Chemicals.(CEFIC).Cosmetics.(COLIPA).Crop.Protection.(ECPA).Pharmaceuticals.(EFPIA).Bio-Industries.(EuropaBio)..Animal.Health.Europe.(IFAH-Europe)
Companies.Abbott.Astra.Zeneca.Avon.BASF.Bayer.Beiersdorf.Boehringer.Ingelheim.Chanel.Colgate-Palmolive.Dow.DSM.Elizabeth.Arden.Estée.Lauder.Evonik/Degussa.Glaxo.SmithKline
.Henkel
..Intervet.-.Schering.Plough.Animal.Health.Johnson.&.Johnson.Kanebo.Kimberly-Clark.L’Oréal.LVMH.Merck..Merck.Sharp.and.Dohme.Novartis.Novo.Nordisk.Novozymes.Pfizer.Procter.&.Gamble.Reckitt.Benckiser
..Roche.(F ..Hoffmann-La.Roche)
.Sanofi-Aventis
.Serono
.Shiseido
.Solvay.Chemicals
.Syngenta
.Unilever
Small.&.Medium.size.Enterprises.(SMEs).Euroderm.StratiCELL
ThE EPAA PROjECTs UNdERwAy•.New.perspectives.on.safety.-.follow-up:.Computational.chemistry.and.systems.biology•.New.perspectives.on.safety.-.follow-up:.Stem.cells•.Acute.toxicity.testing•.Consistency.of.production.approach.in.biologicals/vaccines.(veterinary.and.human)•.Address.barriers.to.validation.&.Support.of.ongoing.validation.studies•.Address.barriers.to.regulatory.acceptance•.Validation.and.regulatory.acceptance.of.ITS•.Technology.transfer:.extended.one-generation.study.for.reprotox•.Enhance.dissemination.of.3Rs.information.to.target.audiences•.EPAA.awards•.External.communication•.Internal.communication
gOVERNANCEIn.2010,.the.EPAA.Steering.Committee.met.on.2.February,.28.April,.17.June.and.21.Septem-ber ..A.fourth.meeting.is.scheduled.for.Decem-ber.2010 .
The. Mirror. Group. met. on. 3February. and. 22.September,. expressing. support. for. ongoing.and. envisaged. EPAA. work,. providing. valuable.suggestions. and. advice .. Members. of. the. Mir-ror. Group. were. increasingly. involved. in. EPAA.projects,.as.were.representatives.of.the.organ-isations.personalities.of.which.are.member.of.the.Mirror.Group .
Minutes.are.made.available.on.the.EPAA.web-site .
Since. the. end. of. 2009,. three. platforms. -. Sci-ence,.3Rs.in.Regulation.and.Communication.&.Dissemination.-.organise.the.work.on.different.projects.and.ensure.their.consistency:
Science:.new.perspectives.on.safety
3Rs. in.Regulation:.acute.tox,.consistency.ap-proach. in. vaccines. testing,. post-validation.review
Communication.&.Dissemination:.3Rs’.market.place,.thematic.reviews
Further.info.is.available.at www.epaa.eu.com
Annu
al R
epor
t 20
10
12
Secretariat.45.Avenue.d’Auderghem1040.Brussels.Tel:.+32.2.295.66.00e-mail:.entr-epaa@ec .europa .eu
www.epaa.eu.com
Desi
gn:.G
RAB
IT