Institute for

Translational Vaccinology
ILAR Round Table conference
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June 4 5, 2015
ILAR INTERNATIONAL WORKSHOP:
ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:
MEETING THE CHALLENGES
COENRAAD HENDRIKSEN
INSTITUTE FOR TRANSLATIONAL VACCINOLOGY (INTRAVACC) &
UTRECHT UNIVERSITY, THE NETHERLANDS
Institute for
Translational Vaccinology
2003 : ILAR International workshop on Development of
Science Based Guidelines for Laboratory Animal Care (
NRC 2004)
2007 : ILAR International meeting of laboratory animal
medicine specialists to review the regulatory and
guidance documents of several countries (Zurlo et al.
2009)
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2009 : ILAR INTERNATIONAL WORKSHOP ON ANIMAL
RESEARCH IN A GLOBAL ENVIRONMENT: MEETING THE
CHALLENGES (NRC 2011)
(ILAR Workshop, J une 4-5, 2014)
Institute for
Translational Vaccinology
OBJECTIVE WORKSHOP
To identify and promote better understanding of
the challenges of conducting animal research
across country boundaries.
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Background
GLOBAL ENVIRONMENT
Companies getting global
Research getting global
Researchers traveling the world
Animals travelling the world
Regulatory requirements getting global

ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:

MEETING THE CHALLENGES
(ILAR Workshop, J une 4-5, 2014)
Institute for
Translational Vaccinology
Held in Washington D.C., September 23-25, 2008
Up to 200 participants from17 countries.
Invited presentations and discussions .
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ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:
FACTS AND FIGURES
Meeting the challenges : Priority topics
I. Globalization: harmonization and standardization
II. Communication & collaboration
III. Training and Education
IV. Animal welfare principles
V. Animals travelling the world
VI. NHPs and the International Primate Plan
(ILAR Workshop, J une 4-5, 2014)
Institute for
Translational Vaccinology
IMPACT OF INTERNATIONAL HARMONIZATION WORKSHOP
Two critical messages fromthe organisers for preparing
this presentation
highlight why previous ILAR efforts to guide a better and more
objective approach to animal use has not addressed the
reproducibility issue.
.the impact of these efforts has not met expectations, as concerns
about reproducibility have grown rather than lessened.
Two critical messages fromthe organisers for preparing
this presentation
highlight why previous ILAR efforts to guide a better and more
objective approach to animal use has not addressed the
reproducibility issue.
.the impact of these efforts has not met expectations, as concerns
about reproducibility have grown rather than lessened.
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(ILAR Workshop, J une 4-5, 2014)
Institute for
Translational Vaccinology
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ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:
HARMONIZATION VS STANDARDIZATION
when we doing studies in different laboratories in different countries
with varying standards, the interpretation and the integrety of these studies
came into question (Hilton Klein, 2008)
Globalization Harmonization and/or standardization of guidelines???
Ideas presented by a number of organizations and bodies: ILAR, OIE, ICLAS,
AAALAC, IACLAM, EU Commission, CROs, Industry (GSK), Academia.
Harmonization does not mean standardization: each country should maintain
an animal welfare oversight system that reflects its own culture, tradition,
religion, laws and regulations.
(ILAR Workshop, J une 4-5, 2014)
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Translational Vaccinology
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Challenges
There are major gaps in our knowledge and science behind animal care and
welfare and, as a consequence, a lack of consensus on what best practice is
across various cultures
How to meet the commonalities between the cultures and the gaps in knowledge?
Core Principles of Animal Care and Welfare (Landi, 2008)
Access to species-appropriate food and water
Access to species-specific housing, including species appropriate
temperature and humidity
Access to humane care and a program of veretinary care
Ability to demontrate species-specfic behavior
Adherence to principles of Three Rs in design of in vivo studies
Commitment to minimizing pain and distress during in vivo studies
Study design reviewed by institutional ethical review panel
(ILAR Workshop, J une 4-5, 2014)
ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:
HARMONIZATION VS STANDARDIZATION
Institute for
Translational Vaccinology
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Consequence: reference for animal care and welfare is not primarely the
species-specific needs but includes also the cultural context the animals are in.
Harmonization is using general standards with a local flavor of culture,
religion,tradition, regulations and laws.
Presentation of Benard Rollin
Introduced concept of Telos: the telos of a rat is to be a rat (ratness)
Rollin argued that the needs of individual species should be central.
Consequently: there can not be such as a buddhist mouse, catholic rat or
hindu primate
(ILAR Workshop, J une 4-5, 2014)
ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:
HARMONIZATION VS STANDARDIZATION
Institute for
Translational Vaccinology
IMPACT OF INTERNATIONAL HARMONIZATION WORKSHOP
Two critical messages fromthe organisers for preparing
this presentation
highlight why previous ILAR efforts to guide a better and more
objective approach to animal use has not addressed the
reproducibility issue.
.the impact of these efforts has not met expectations, as
concerns about reproducibility have grown rather than
lessened.
Two critical messages fromthe organisers for preparing
this presentation
highlight why previous ILAR efforts to guide a better and more
objective approach to animal use has not addressed the
reproducibility issue.
.the impact of these efforts has not met expectations, as
concerns about reproducibility have grown rather than
lessened.
9
(ILAR Workshop, J une 4-5, 2014)
Institute for
Translational Vaccinology
The weakest link in all our conversations is the conversation we dont
have. It is much more important to talk and disagree than not
speaking and believing that never the twain shall meet. (Landi.
2008)
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Concerns about reproducibility have grown rather than lessened.
Is this because animal research is becoming less reproducible (if
so we have a problem) or because we get more aware of it , the
more we globalize? (in that case there is a challenge)
(ILAR Workshop, J une 4-5, 2014)
ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:
COMMUNICATION AND COLLABORATION
Institute for
Translational Vaccinology
Training and education are really the cornestones of effective
performance standards (Brown, 2008)
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Create an international fund for training supported by IACLAM, ICLAS
and others and also by private companies
Arrange the existing programs in a modular way, facilitate online
distance learning, support continuing education and provide accreditation
Develop tutor supervision of hands-on training
However, be competent and have the competence is not enough. It is also the
attitude which is important: reflect on what we do, challenge the traditions and be
prepared to move forward.
(ILAR Workshop, J une 4-5, 2014)
ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:
EDUCATION & TRAINING
Institute for
Translational Vaccinology
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The 2008 conference included presentations on (current) best
practices of pain relief and euthanasia and on using humane endpoints.
Low and varied use of analgesia in animals (Matt Leach, 2008):
Some consider animals dont feel pain (culture context)
No perceived need to give anagesia
Concern over interactions
Concern over the extent of potential side effects
Tradition or historical data
Promoting good welfare is an important part of delivering good and
ethically justified science (MacArthur Clark, 2008)
(ILAR Workshop, J une 4-5, 2014)
ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:
PROMOTING ANIMAL WELFARE
Institute for
Translational Vaccinology
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Flying human primates is cheaper than flying nonhuman primates.
(ILAR Workshop, J une 4-5, 2014)
Research community should talk with carriers
about SOPs to ensure proper handling
Precondition and acclimate animals for transport
ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:
TRANSPORTATION
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Translational Vaccinology
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Workshop did address harmonization and
standardization and as such reproducibility
Workshop provided a great number of
recommendations to standardize: best
practices, performance standards,
education & training, improving animal
welfare
There is no one for all solution.
But reproducibility can be improved by
using robust models and science-based
standards.
(ILAR Workshop, J une 4-5, 2014)
ANIMAL RESEARCH IN A GLOBAL ENVIRONMENT:
CONCLUSIONS
Institute for
Translational Vaccinology
Thanks for your attention!
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