Activities Reporting Dr Tzutzuy Ramirez

BASF, Industry Co-Chair of EPAA

Steering Committee

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2014

Regulatory acceptance of alternative

approaches as a Lead theme

Progressed ongoing projects &

initiated 1 new (Exposure prediction)

Restructured for enhanced

governance & leadership by partners

Engaged with:

- new audiences (EP, CARACAL)

- international audiences

(9th World Congress, IIVS)

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at a glance

Preparing

for the Future

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SCA Hygiene products joined as new corporate

member, establishing links between EPAA and the sector

of non-woven products

EPAA brings together 36 companies from 7 sectors,

5 DGs of the European Commission

Partnership Update

Collaboration and interaction in projects continues

also with non-member organisations, e.g. NC3Rs,

several CROs and animal welfare organisations that

share common goals

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ONGOING PROJECTS

Lead theme: Regulatory acceptance of 3Rs approaches

Workshop organised on 22 September, Brussels

“Knowledge sharing to facilitate regulatory decision making”

• 50 participants from national, EU regulators & industry to:

- share knowledge on the use of alternatives and across sectors

- discuss on how to overcome potential hurdles for regulatory

acceptance of alternative approaches

• Recommendations from this Workshop will be presented later on

today’s programme

• Comprehensive report will be published in a peer reviewed journal

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Stem Cells (1/2)

1. Work Group on Fundamental Research on Stem Cells

• Prepared a Research Prospectus (RP) to promote concrete areas of

research based on recommendations of 2013 WS

• The RP was discussed with DG RTD in June

• Full publication reporting from the 2013 WS was prepared for

submission to peer reviewed journal

• The EPAA team encouraged the participants of the WS to submit a

research proposal under H2020 call for Personalizing Health & Care

PHC-33-2015 “New approaches to improve predictive human safety

testing”

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ONGOING PROJECTS A

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2. Work Group on Stem Cells Communication

• Organized the 2nd International Stem Cells Forum hosted by University of

Liverpool UK, 3-4 September

• Sharing of practical experience amongst various research consortia and teams

from EU and US.

• Recommendations will be published in a peer-reviewed journal

Stem Cells (2/2)

ONGOING PROJECTS A

Exposure prediction (ADME)

• Initiated project for developing an open access web tool for user-

friendly in vitro to in vivo and in vivo to in vitro exposure prediction

• Pilot project (18 months) started at HSL (Health and Safety

Laboratory), in UK, in June 2014

• Funded by EPAA, conducted by HSL

• Expected to support development of more reliable in vitro approaches

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ONGOING PROJECTS B

Advancing 3Rs in Regulatory Toxicology:

Carcinogenicity

• Publication reporting from the 2013 Carcinogenicity WS

• Project at University of Wageningen, NL, funded by EPAA

• Extending an existing database (Sistare et al. 2011) with data

on pharmaceutical compounds

• Expected to generate recommendations for ICH to waive the 2-

year carcinogenicity studies for pharma chemicals

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ONGOING PROJECTS C

Science Award 2012 : final steps

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ONGOING PROJECTS D

• Research project of Dr Nils Kluever, Leipzig,

Germany “Increasing the predictive capacity

of the (zebra) fish embryo test”

• Project successfully completed under the

supervision of the Science Award Scientific

Advisory Committee (SASAC)

• Manuscript submitted for publication to a

peer reviewed journal in July 2014

Acute toxicity project

• Following recommendations of EPAA and HSI at CARACAL in

2012, the EC presented a proposal to modify REACH Annex VIII on

Acute toxicity at the CARACAL meeting in July 2014.

• The proposal provides a waiver for acute toxicity testing via the

dermal route for substances which are non-toxic via the oral route

and was received well by the Member States and stakeholders

• Final EC proposal will be discussed with the REACH Committee

• More information will be provided at a next presentation by Tom

Holmes

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ONGOING PROJECTS E

Optimized strategies for skin sensitization

• Discussions across sectors and with ECHA continue to prepare a

next joint EPAA-Cefic LRI WS to share latest progress in 2015

• Poster presented at the 9th World Congress on Alternatives,

Prague, August 2014

EPAA/CEFIC LRI activities progressing non-animal testing strategies

• More information will be presented by Annette Mehling later today

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ONGOING PROJECTS F

Vaccines Consistency of production approach

• Human rabies: Pre-validation study ongoing to identify suitable reagents

for an ELISA test to replace the NIH (National Institutes of Health) in vivo

test on mice. Presentation by J.M. Chapsal at 9th World Congress,

Prague.

• Clostridial vaccines: International collaborative study to assess

concordance of novel in vitro tests with the existing in vivo tests. Initial

analysis of results shows good correlation for the Minimum Lethal Dose

assays.

• Vet rabies: Monitoring the human rabies pre-validation study to assess

suitability for replacing the NIH test with in vitro ELISA for veterinary

rabies vaccines lot release

• Completion of experimental work and data analysis expected by end of

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ONGOING PROJECTS G

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COMMUNICATION ACTIVITIES

Communication activities

Addressing new audiences

• EPAA presentation at the EP breakfast organised by

the MEP Sidonia Jedrzejewska on “Animal Testing –

Science or Tradition: what future to alternatives to

animal testing?” in February

• Article about EPAA published in the E. Parliament

Magazine

• EPAA presentation at the EP event “Putting Animal

Welfare at the Heart of the EU” organized by

Eurogroup for animals in October

• EPAA presentation at the CARACAL meeting on 10

November, in Brussels

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Communication activities

Addressing international audiences

9th World Congress on Alternatives,

Prague, August

EPAA supported the Congress and presented:

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• “EPAA - a key player in shaping the future of 3Rs”

presentation by Gwen Cozigou (EC Co-Chair)

• Poster on Optimized strategies for Skin sensitization

• Reference to EPAA activities made during presentations of members

• Dissemination of EPAA communication material at the DG JRC booth

Training video on the BCOP

(Bovine Corneal Opacity and

Permeability) in vitro eye irritation

test method

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Communication activities Addressing international audiences

-Developed by IIVS (Institute for In Vitro Sciences) in US, sponsored by

EPAA

-The video is available at no cost on the EPAA website

-Will be used with different voiceovers (e.g. Chinese) to provide lab

technicians effective guidance on this alternative OECD accepted method

1 publication in peer-reviewed journal, 3 peer-review publications in preparation

2 EPAA scientific workshops (Lead theme on Regulatory

acceptance, Stem cells International Forum)

4 events addressing external audiences (2 at E. Parliament,

World Congress on Alternative Methods and CARACAL)

7 ongoing projects on Science and Regulation 3 of them focussing on international cooperation

Vaccines Consistency Approach project

Harmonization of 3Rs in Biologicals project

Stem Cells project: International Forum

Concluding Facts and Figures for 2014

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EPAA restructuring

• Enhanced governance and leadership by the partners

• Pre-requisite for having leader from industry and/or the E.Commission

• Clearer criteria for new projects (i.e. impact to the 3Rs, avoid

duplication, realistic, clear short term and long term milestones and

deliverables, go / no-go decision points included in the project plan)

• Streamlined activities / reduced structural complexity

Merged the previous 2 platforms into one Projects Platform aiming at

more efficiency and coordination between the 7 ongoing projects related

to Science and Regulation

• Reviewed the budget (reduced costs) in order to remain sustainable

under the current resources contributed by the parnters

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Preparing for the future

• Current 5-year term ends in December 2015

• Industry & EC agreed to renew EPAA for a 3rd term (2016-2020)

• Partners strongly recommend to keep EPAA as a unique, neutral

platform that enables the exchange of ideas and experiences from

different stakeholders

• The Industry Co-Chair for 2015 will be Dr Patrick Sinnett-Smith (Pfizer)

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Many thanks for your attention!

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