Lush Prize 2016
Training Prize

Research Paper
Rebecca Ram, Scientific Consultant, Lush Prize

Lush Prize 2016 – Training Prize Research Paper

1Executive Summary
The purpose of this research paper is to provide an overview of the Training Prize,
one of the six categories of the £250,000 Lush Prize successfully awarded every
year since 2012. The Lush Training Prize rewards individuals, teams ororganisations involved in providing training and/or humane education on non-animal
methods of safety (toxicity) testing. £50,000 is available in this category, for one
overall winner or shared between two projects.
Over the last four years, the Training prize has awarded £200,000 to eight
outstanding organisations across Europe, Africa and the USA for their work in
educating researchers, students and regulators in both the acceptance and use of
non-animal technologies. 1
This paper is intended as an update on the Lush Training Prize in 2016. It is also
recommended that previous research papers (2012-2015) are reviewed for further
useful information, including reviews and updates on prizewinning organisations, aswell as background on training and education in non-animal technologies.

1

http://www.lushprize.org/awards/training-prize/

Lush Prize 2016 – Training Prize Research Paper

2

2016 update; ongoing challenges and successes in training,
acceptance and enforcement of non-animal methods

Year on year, awareness of alternative methods increases worldwide, which is to becelebrated. Yet there remains the continuing challenge of not only ensuringresources are available for training and education but making sure that enforcement
and monitoring of how (and if) methods are being implemented is carried out acrossindustry and academia. Given both the scientific and ethical imperatives to replace
animal tests, this responsibility should fall to national competent authorities andadministrative agencies. Yet, several examples demonstrate how this is not thecase, even when a test has been validated for use. This is in some cases due tointense effort devoted to the validation process, but perhaps a lack of appropriate
follow up to see how tests are actually being used after they have been approved.
One such example is the development of the human blood pyrogen test, by Hartunget al, with the potential to replace the same test in rabbits2. First published in 1995, it
was finally validated and accepted for use in 2009, yet instead of a decrease in
rabbit use, annual numbers used for the test actually rose, meaning that since themethod was accepted at regulatory level, more than 800,000 rabbits have sufferedand died needlessly, with 400,000 rabbits still used each year, worldwide.

2 http://www.altex.ch/resources/altex_2015_2_079_100_FFTHartung.pdf

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A similar concern is seen when reviewing the use of the well known LLNA (Local
Lymph Node Assay (OECD 4293) for skin sensitisation. Although a reduction andrefinement method as it still uses animals, its use should have been favoured overthe more severe Guinea Pig Maximisation test (GPMT) since its regulatory approvalin 2002. However, an analysis by Hartung et al. in 2007 showed that of 1450 skinsensitisation tests, only 50 were LLNA, with the remaining 1400 still using guinea
pigs, demonstrating that enforcement, combined with removal of the unnecessary
and outdated test method is the only way to save animals. Furthermore, the skinsensitisation Adverse Outcome Pathway (AOP) as highlighted in the 2015 LushBlack Box Prize4, now offers entirely human based test methods, which are alreadyapproved or (in the case of the human cell line activation (h-CLAT) test) undergoingapproval and awaiting official publication at OECD level567.
The continued use of animals in toxicity tests, despite the availability of humane
alternatives reinforces a vital need for the following:•

A sustained campaign in outreach, training, education and enforcement of
non-animal methods.

•

Equally important is the active deletion of outmoded animal tests from
regulatory guidelines, to ensure uptake of alternatives and the prevention ofanimal suffering as soon as possible.

These represent the values and mission of the Lush Training Prize.

3

http://www.oecd-ilibrary.org/environment/test-no-429-skin-sensitisation_9789264071100-en4

http://www.lushprize.org/awards/black-box-prize/5

http://www.oecd-ilibrary.org/environment/test-no-442c-in-chemico-skin-sensitisation_9789264229709-en

6

http://www.oecd-ilibrary.org/environment/test-no-442d-in-vitro-skin-sensitisation_9789264229822-en7

https://www.oecd.org/env/ehs/testing/151216-Draft-h-CLAT-TG-After-Expert-Meeting-(clean)-Final.pdf

Lush Prize 2016 – Training Prize Research Paper

4Lush Training Prize Winners - 2015
Two exceptional organisations were awarded Training Prizes in 2015, each receiving£25,000:
PETA International Science Consortium Ltd., (PISC) UK
PISC8 has undertaken a long term campaign to minimise animal testing under thelarge scale, EU chemicals testing regulation REACH (Registration Evaulation andAuthorisation of Chemicals) which has resulted in an increase in toxicity tests on
animals since it came into force in 2007. To do this, PISC's award winning work
includes organisation of scientific webinars and face to face training sessions, topromote the use and acceptance of non-animal technologies and integrated testing
strategies (ITS). By employing experts in relevant areas from EU agencies, industry
and academia, the sessions (co-hosted by Chemical Watch) have an audience of
thousands, including scientists, regulators and relevant industry stakeholders in needof education on the methods available.
Dimitry Leporsky9, Ukraine
Dimitry was awarded a 2015 Training Prize for his ongoing work over recent years(in collaboration with international organisation and former prizewinner InterNICHE),
to ensure the use of animals is replaced with alternative methods in universities
across the Ukraine, Belarus, Russia and Kyrgyzstan, by discussion and contract
negotiation with teaching staff and department heads, to phase out and replace theuse of animals by formal agreement. In the Ukraine alone, this has directly achieved
an 85% success level in replacing both live animal use and dissections, saving morethan 48,000 animals since 2008. Furthermore, since 2014, more than 18,000
animals have been replaced in other countries. To date, the cumulative total ofanimals no longer facing experiments or being killed is 684,047 for the Ukraine
alone. Dimitry has also engaged in further educational initiatives with early career
8

www.piscltd.org.uk

9

http://www.gumannoe-obrazovanie.org/

Lush Prize 2016 – Training Prize Research Paper

5scientists to raise awareness of both the scientific and ethical arguments for using
non-animal technologies in their research.

Organisations relevant to the Training Prize in 2016
With each new yearly prize cycle, as well as welcoming independent nominations,the Lush Prize also identifies relevant individuals or organisations who may be
eligible for an award because of the work they have been doing, but may nototherwise nominate themselves. In these cases, the Lush Prize team reviews
achievements and if considered appropriate, contacts such organisations to ask
them if they would like to submit a nomination.
A 2016 update on organisations relevant to the Lush Training Prize is summarised
below, some of which have either previously been awarded or shortlisted because of
their ongoing work in education, training and dissemination of information related to
non-animal methods. As always, some organisations relate to the 3Rs generally,rather than the specific 1R remit of the Prize; however, they are included to provide amore complete overview. This is not an exhaustive list and many other organisations
who have previously been awarded, shortlisted or nominated can be reviewed inboth previous background papers and on the Lush Prize website. The Training Prizecontinues to welcome nominations from other groups or individuals:

Instituto 1R de Promocao e Pesquisa Para Substituicao da Experimentacao
Animal (1R Institute of Promotion and Research for the Replacement of Animal
Experimentation) Brazil10
Established in 2015 from initiatives carried out over the last decade, the 1R Institutebrings together expertise in toxicology, biochemistry, cell biology, biotechnology,
physiology, public health, scientific education, law and rights and applied ethics.

10

http://www.instituto1r.org/

Lush Prize 2016 – Training Prize Research Paper

6Three of the founding members of the institute include Lush Prize judge Professor
Thalez Trés and two previous Young Researcher award winners, Dr Róber
Bachinski (2014) and Dr Bianca Maragliani (2015).
The Insitute describes its objectives as follows:
I – To promote ethics, peace, citizenship and human rights, by working incollaboration with professors, teachers and students to ensure students’ rights topreserve their ethical principles concerning non-harmful animal use in classes.
II – To guide, through technical-scientific and/or juridical consulting and awarenesscampaigns, students, teachers, professors and society in general on humane
methods of teaching/learning and research, especially for training and education. In
this context, it aims to promote liberty and humane equality, following the Article 1 of
the Universal Declaration of Human Rights. It also aims to promote freedom of
expression and freedom of beliefs, assured by the Article 1 of the Brazilian Federal
Constitution, and following the same constitution to promote and ensure the nonprivation of rights for ideological convictions.
III – To promote and encourage the research and development of alternative
methods, focusing on the final objective of replacing animal use in science andeducation.
In 2015 alone, the 1R Institute team have presented and participated in more thantwenty national conferences and round table events, as well as providing numerous
media interviews and released publications on the need for humane education in
Brazil.11 One of the institute's specific initiatives includes The Brazilian National
Network for Humane Education (RedEH), an initiative to identify and gather
professors and researchers involved in humane education and replacement of

11
Bachinski, R, Tréz, T, Alves, GG, et al. 2015. Humane Education in Brazil: Organisation, Challenges
and Opportunities. Alternatives to Laboratory Animals (ATLA) 43, 337-344.

Lush Prize 2016 – Training Prize Research Paper7harmful animal use in teaching and training, now includes 25 professors, including
representatives from Spain, Portugal and Colombia as international contacts 12
Róber Bachinski kindly provided the following update on the Institute's outreach andactivities in 2015;'Early in 2015, academic professors and researchers started in Brazil the 1R Institute ofPromotion and Research for the Replacement of Animal Experimentation. The 1R
Institute came from several projects already developed on Brazil, especially on Humane
Education, expanding for R&I. Founder members come from different fields in theacademia, including biochemistry and cell biology, microphysiology, in vitro and omics
assays, immunology, humane education, law system, public policies and applied ethics.
Through the Humane Education, the 1R Institute understands the academic support to
1R students, concerning to practical activities, scientific initiation opportunities, or evensocial-academic argumentation, as primordial for new scientific construct. Thesestudents will contribute to the change of scientific paradigm, nucleating academic
movements and new research groups. Indeed many students against animal use foreducation are interested on scientific activities based on 1R science, for research anddevelopment and also for new humane education methods and approaches. The 1R
Institute idealized the Brazilian National Network for Humane Education (RedEH)(Bachinski, Tréz, Alves, Garcia, & Simone, 2015), gathering Humane Education
professors and researchers, supporting and spreading humane education methods.
Currently, 28 professors from different Brazilian regions and Biological and Healthscience courses integrate the RedEH. The project is a horizontal self-managed team,
where each one can propose projects or create specific programs. The 1R Institute was
supported for RedEH members requesting a national recognition of Conscious
Objection, addressed to the Brazilian National Council for the Control of Animal
Experimentation (CONCEA), linked to The Ministry of Science, Technology andInnovation (MCTI). CONCEA* published in February 3rd the “Brazilian Guideline forAnimal Care and Use for Activities of Education and Research”, delegating to institutes
that uses animals the responsibility to offer alternative methods for Conscientious
Objector students (5.1.1.O), and the development of an institutional ombudsman office12

http://www.instituto1r.org/#!redeh/cn8r

Lush Prize 2016 – Training Prize Research Paper

8for subjects related to animal use, including to support those students (5.1.1.J)(CONCEA & MCTI, 2016). Aiming the support for new scientific groups, the 1R Institutealso created the 1R Researcher List, looking for Brazilian researchers supporting animal
replacement, especially as potential new scientific groups or academic advisors forstudents and young researchers. Despite other scientific groups working on 3Rs,
especially related to Governmental bodies, the 1R Institute did 24 conferences in
Brazilian universities in Brazil and academic activities for students in Brazil. All
conferences and interviews are moments for talk about new technologies and new
approaches for a human-based and non-animal science.'(* Note: CONCEA is the legal authority regulating animal use in Brazil)

Brazilian Network for Alternative Methods (RENAMA)
RENAMA was developed after a need was finally identified in 2008 for recognition ofalternative methods in Brazil13.
Together with the Brazilian Centre for Validation of Alternative Methods (BraCVAM)RENAMA identifies and prioritises new test methods for validation and regulatory
acceptance and encouraging recognition of non-animal technologies.
Key lab sites are involved in training and development in in-vitro strategies, forexample acceptance and training in OECD-recognised test methods, as well as'Organisation of Interlaboratory comparisons' to ensure consistency andharmonisation with test methods and Good Laboratory Practice(GLP). Increased
recognition of OECD methods is required, yet to achieve this infrastructural setbacks
must still be overcome.
It is also important to note that a key challenge in Brazil is that, even after validation
and acceptance of alternative test methods, companies can take up to 5 years to13

http://www.atla.org.uk/brazilian-center-for-the-validation-of-alternative-methods-bracvam-and-the-process-of-validation-in-brazil/

Lush Prize 2016 – Training Prize Research Paper

9implement them - in the meantime further animals suffer unnecessarily. This is an
issue that key national animal-protection groups are trying to address, as well as
taking into account other practical and logistical factors such as resources, quality
and availability of materials. For example, to overcome ongoing customs and importproblems preventing the use of HRE (Human Reconstituted Epithelium or 'humanskin in a test tube') donated and waste tissue from surgical procedures is used insome cases.

Romanian Centre for Alternative Test Methods (ROCAM)14
ROCAM was established in June 2015 and is hosted by the University of Agricultural
Sciences and Veterinary Medicine (USAMV) in Cluj-Napoca at the Institute of Life
Sciences. The centre describes its main goal as 'to promote excellence in the field of
education, research and innovation' and its efforts focus around three main working
groups (WG) addressing Regulatory Affairs; Research and most relevant to theTraining Prize - Education and Training. Very recently, the centre hosted a training
event in 'In-silico modelling and tools under REACH'15

A Course in Alternatives16
The Alternatives is an organisation headed by Dr. Candida Nastrucci, who incollaboration with the Italian Regional Authority of Tuscany has implemented 'A
Course on Alternatives' with a specific focus on replacement methods in researchand education.

14
15

16

http://rocam.usamvcluj.ro/https://www.eventbrite.com/e/in-silico-modeling-and-tools-under-reach-tickets22774010679?ref=ebtnebregn
www.thealternatives.eu

Lush Prize 2016 – Training Prize Research Paper

10Kirkstall Quasi-Vivo® Training Courses 17
Kirkstall is a UK based, cell culture technology company, formed in collaboration
over the last decade through research from the University of Pisa. Kirkstall's headline
product is Quasi-Vivo, a high throughput and high quality cell-culture system tomimic human metabolism which Kirkstall describes as:17

http://kirkstall.org/

Lush Prize 2016 – Training Prize Research Paper

11• A route to replacement of animal testing with lower costs and the obvious
ethical benefits• More physiologically relevant models that can be a better prediction of what
will happen in the clinical (in vivo) situation• Opportunities for collaborative research at the forefront of advanced in vitro
cell culture and disease modelling

Kirkstall also provide 1 or 3 day training courses in Quasi-Vivo, to provide in-vitro
researchers with an introduction to both theory and practice of advanced cell culture
techniques through a combination of lectures, demonstrations and practical handson experience.

University of Milan, Master of Veterinary Biotechnology Sciences; 'Alternative
Methods in Toxicology’18
In 2015, the University of Milan introduced a mandatory module to its veterinary
masters course, described as including in-vitro replacement methods, in-silico
demonstrations and integrated testing strategies. The course also includes
theoretical study of alternatives in toxicological research and is currently expanding
its practical content to include opportunities for further in-vitro laboratory experience.

ToxRead 19 is a freely accessible software tool to assist chemical researchers in
optimising their read across evaluations of similar groups of substances. The
software, developed by Mario Negri Pharmacological Research in Milan, allows theuser to provide the chemical of interest, the endpoint, and to choose a number ofsimilar chemicals (up to six), to produce easy to read graphical results connecting
the target chemical and the structural alerts with the most similar compounds.
18 Caloni, F. (2015) Teaching alternative methods in Toxicology in Veterinary Science. ALTEX Proceedings
EUSAAT 2015 Vol. 4 (2) [http://eusaatcongress.eu/images/2015/Abstractbook_EUSAAT_2015_Linz_2015_low_res.pdf]
19

http://www.toxgate.eu/index.php

Lush Prize 2016 – Training Prize Research Paper

12The QSAR Databank (QsarDB)20
QsarDB is described as a smart repository for (Q)SAR/QSPR models and datasets,
readily accessible for discovery and exploration research. The databank currently
contains over 360 predictive (Q)SAR models for physical-chemical properties,
environmental toxicity, ecotoxicity, human health, toxicokinetic and other endpoints.
Qsar DB was developed by the Molecular Technology Group at the Institute ofChemistry in the University of Tartu, Estonia, who also provide training workshops
on using the repository, for example at QSAR 2016 21

20 www.qsardb.org
21 http://www.qsar2016.com/#!program/c15y

Lush Prize 2016 – Training Prize Research Paper

13Lush Training Prize outreach in 2015-2016
Lush Prize had a busy couple of weeks in September 2015, attending back to backtoxicology conferences. At EUROTOX 2015, the 51st Congress of the European
Societies of Toxicology (http://www.eurotox2015.com/) we engaged with researchers
and toxicologists to inform and raise awareness on the Training Prize as well as theother five prize categories, all aimed at eliminating the use of animals in toxicity
testing. Lush Prize also presented a posted entitled ‘The Lush Prize – Rewarding
innovative animal-free science around the world’ (www.lushprize.org/poster).
Our abstract submission was also published in the official journal of EUROTOX
2015, Toxicology Letters (http://www.journals.elsevier.com/toxicology-letters/)
The theme of EUROTOX 2015 was 'Bridging Sciences for Safety'. While much of theconference and exhibition focussed on conventionally accepted methods of toxicity
testing using animals, there were some key sessions on the 3R's, incorporating thespecific aim of the Lush Prize - replacement. One particularly interesting session wasa debate (between representatives from ECVAM and Procter & Gamble) on in-vitro
methods that are available now and ready to be relied upon for human safety.
The second conference Lush Prize attended was the 19th European Congress on
Alternatives to Animals hosted by EUSAAT (European Society for Alternatives toAnimal Testing) and held each year at Johann Kepler University in Linz 22. The
congress included a variety of relevant topics, including a “Practical Training Course
on Alternative Methods”23.
Lush Prize again presented its 2015 poster and networked with potential nominees,
researchers and key figures in the field. Attendees were very interested to hear
about the Prize and how they can nominate their own work, or that of others for anaward in Training, Science, Lobbying, Public Awareness or as a Young Researcher.
Training courses will once again be offered at EUSAAT 201624.
22 http://www.eusaat.org/
23 http://eusaat-congress.eu/index.php/congress/2015/2015-practical-training-course
24 http://eusaat-congress.eu/index.php/congress/2016/2016-practical-training-course

Lush Prize 2016 – Training Prize Research Paper

14In April 2016, Lush Prize also attended the Pan American Conference on Alternative
Methods 25 at Johns Hopkins University in Baltimore.
The conference was the first of its kind hosted by former Lush prizewinner CAAT(Centre for Alternatives to Animal Testing). The event addressed not only
developments in the established 'reduction, refinement, replacement', but aimed to
introduce a further '3Rs' in initiatives to replace animal testing, namely 'Roadmaps';'Relevance' and 'Read-Across'.

Conclusion
At the time of writing this paper, the Lush Prize continues to receive and review
nominations for the 2016 Training Prize until the closing deadline of 24 July.
Outreach for the Training Prize will continue into the 2016-2017 prize cycle.

References
Key organisations continue their work in training and education of non-animal
methods, meaning that many references largely remain unchanged. Therefore, in
addition to the organisations and individuals included above, it is highly
recommended to review comprehensive reference and bibliography sections
provided in previous Training Prize papers26.

25 http://caat.jhsph.edu/programs/workshops/PanAmerican/index.html
26 http://www.lushprize.org/awards/background-research-papers/

Lush Prize 2016 – Training Prize Research Paper

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