EPAA Projects: 2015

developments Dr Patrick Sinnett-Smith

EPAA Industry Co-chair, Pfizer

Annual Conference 2015 - European Parliament, Brussels

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2015 in a nutshell

Strategy: New Action Programme

Activities: Projects workshops & publications

Dissemination & Collaboration: Stakeholders

interaction

Commitment: Membership update

5 Peer -

reviewed

Publications

Scientific

Workshops 4

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Action Programme

Consensus-based

The next 5 years (2016-2020)

4 Priorities:

1-Regulatory acceptance and the 3Rs

2-International convergence

3-New scientific research needs

4-Dissemination and Communication

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Action Programme Priorities

1- Regulatory Acceptance and the 3Rs

• Bridge the gap between development & acceptance

of alternative methods

• Bring together Regulators and Regulated

• Share Good Practice and knowledge

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Action Programme Priorities

2- International convergence

• Identify remaining barriers to acceptance of 3Rs methods

• Collaborate to facilitate international convergence and

standardisation of new methods

• Promote Integrated Approaches on Testing and Assessment

(IATA)

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Action Programme Priorities

3- New scientific research needs

• Identify research gaps in development of alternative methods

• Highlight priorities for European research in the 3Rs

• Help shape the research funding agenda on alternatives

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Action Programme Priorities

4- Dissemination & Communication

• Improve access to information & existing tools

• Build larger coalitions to promote Alternatives

• Encourage and promote the work of young

European scientists

• Special focus on Refinement

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Governance

Structure

Merger of the Platform on Science and Platform

on 3Rs in Regulation to form a single Project

Platform

This reflects a reduction in the number of

projects we support to allow greater focus.

Review of the Mirror Group

New members

• MEP Julie Girling

• Marko Susnik, UEAPME

• Nick Meade, Genetic Alliance

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Activity report Projects Overview

2015: 7 Projects

1. Optimised strategies for assessing Skin

sensitisation

2. Vaccines consistency approach

3. Acute Toxicity

4. User-friendly in vitro/in vivo exposure predictor

5. Biologicals

6. Advancing 3Rs in Regulatory Toxicology

7. Stem Cells (completed)

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Activity report 4 Workshops in 2015

EPAA-Cefic LRI-Cosmetics Europe Joint cross-sector workshop on Alternatives

for

Skin sensitisation testing and assessment, Helsinki, Finland, 23-24 April 2015

EPAA-EURL ECVAM workshop on replacement of In Vivo Human Rabies

Vaccine Potency Testing by “in vitro” Glycoprotein Quantification Methods:

Results from the International Collaborative Study and Implementation Strategies,

Arcachon, France, 10-11 May 2015

EPAA-EDQM workshop: Clostridial Vaccines workshop BSP 130, Egmond aan

Zee,

the Netherlands, 15-16 September 2015

EPAA Workshop: Modern science for better quality control of medicinal products

‘Towards global harmonization of 3Rs in biologicals, Egmond aan Zee, the

Netherlands, 15-16 September 2015

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Activity report 5 Peer-reviewed publications

• Cozigou et al., The EPAA: Promoting Alternative Methods in Europe

and Beyond, JAALAS, March 2015

• Ramirez et al., Knowledge sharing to facilitate regulatory decision-

making in regard to alternatives to animal testing: Report of an EPAA

workshop, Regul Toxicol Pharmacol. Oct 2015

• Basketter et al., Alternatives for skin sensitisation: Hazard

identification and potency categorisation: Report from an EPAA/CEFIC

LRI/Cosmetics Europe cross sector workshop, ECHA Helsinki, April

23rd and 24th 2015, Regul Toxicol Pharmacol. Nov 2015

• De Mattia F et al., The Vaccines Consistency Approach Project: An

EPAA initiative. Pharmeuropa Bio&SN, May 2015

• Suter-Dick et al., Stem cell-derived systems in toxicology assessment,

Stem Cells Dev. June 2015

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Activity report Communication

EPAA representation at external 3Rs events

• EUSAAT 2015 (European Society for Alternatives to

Animal Testing) 20-23 September, Linz, Austria

• EUROTOX 2015: 51st Congress of the European Societies

of Toxicology Bridging Sciences for Safety, 13 - 16

September 2015, Porto, Portugal

• International Alliance for Biological Standardization

(IABS),16-18 September, Egmond aan Zee, the

Netherlands

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Activity report Dissemination

3Rs Laboratory Technician/Animal Caretaker Prize

EPAA-IIVS training videos on alternative methods:

• BCOP Assay in English w. Chinese & Portuguese subtitles

• Available for free on DG GROW’s Youtube channel

• 3T3 Phototoxicity Assay video training to follow

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Membership

36 companies

7 Sectors

5 DGs of the European Commission

Companies update

Solvay +

Blue-chip Chemicals company, since 1863

26000 employees in 52 countries

15 Major R&D centers

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Governance

INDUSTRY CO-CHAIR

COMMISSION CO-CHAIR

Gwenole Cozigou

DG ENTR Carlo Pettinelli

DG GROW

2014 2015 2016

Tzutzuy Ramirez

BASF Patrick Sinnett-Smith

Pfizer Gianni Dal

Negro

GSK

Industry Co-chair 2016:

Dr Gianni Dal Negro, GSK

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Questions & Answers

Grow-epaa@ec.europa.eu