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collaboration with veterinary specialists which, in the case of

larger animals, should have both ECVS/ACVS and ECVAA/ACVAA

diplomas. The latter are just as important for conducting correct

anaesthesia and analgesia regimens. Too many serious errors

happen and have been witnessed around surgeries and aftercare

by the author, when specialists are not involved.

Quality

If ethical concerns are taken seriously, it starts right there: with

the quality of the experiments performed at the table with each

individual animal, and not only at the drawing board or with

administrative legislation. Involving true specialists would reduce

incidents that include administration of wrong human dosages

to sheep for instance with muscle relaxants, heparin, or other

incompatible drugs leading to experiment-unrelated death of

hundreds of experimental animals in the world, some including

serious suffering of animals (bleeding or suffocating to death).

Quality in animal experiments also includes their standard

documentation and considerations of regulatory affairs if

therapeutic approaches are studied and are part of the project.

This goes hand in hand and should be part of initial planning in

animal experiments to avoid repeating them later. This is imminent

for reducing animal numbers right from the start (3Rs). Regulatory

affairs relate to accreditation of preclinical experiments by either

European agencies (TUV) or the FDA (Food and Drug

Administration) in the United States, a prerequisite for allowance

of clinical trials, Phase I-III and later registration of any

medication, medical devices or combination products. Depending

on the study and the technology tested, preclinical experiments

should comply with Good Laboratory Practice (GLP) and Good

Manufacturing Practice (GMP).

Once clinical studies are attempted these have to be conducted

according to Good Clinical Practice (GCP). Different to the United

States, where projects can be conducted according to GLP given

the correct audits, in Europe the facility has to be officially

acknowledged by the authorities (e.g. Swissmedic in Switzerland)

prior to any GLP experiment being conducted. In most countries

GLP or GMP approved facilities are private companies without the

academic background of universities and other academic

institutions (e.g. Fraunhofer institutes in Germany), where the

expertise for most projects would be considerably broader.

This major gap between academia and later industrial needs is

responsible for many animal experiments that have to be

repeated, or are not accepted by the regulatory bodies due to the

animal model used and missing or incomplete documentation.

Therefore, it is advisable to include companies that should be

involved in production and upscaling of test items, and contact

regulatory bodies right from the start. To include these

considerations in scientific translational and also basic projects

means applying ethical considerations for animal experiments in

everyday business of researchers.

Roadmaps of Horizon 2020 consider regulatory affairs in

connection with animal experiments an important aspect for

translation from bench to bedside.

Brigitte von Rechenberg, Prof Dr med vet, Dipl ECVS

Head of the Musculoskeletal Research Unit (MSRU), Head

of the Competence Center for Applied Biotechnology and

Molecular Medicine (CABMM)

Dean of theVetsuisse Faculty

University of Zürich, Switzerland

tel :

+41 4463 58410

bvonrechenberg@vetclinics.uzh.ch http://www.cabmm.uzh.ch/index.html www.horizon2020projects.com

H O R I Z O N 2 0 2 0 P R O J E C T S : P O R TA L

I S S U E S E V E N

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P R O F I L E

S P E C I A L F E AT U R E : A N I M A L E T H I C S

The official Competence Center for Applied Biotechnology and

Molecular Medicine (CABMM) is a unique professional network at

the University of Zürich, Switzerland, for translational medicine

where medical problems are investigated literally from “bench to

bedside” (see

http://www.cabmm.uzh.ch/index.html). Th

e expert

members of the CABMM deal with either: A) experimental

medicine or surgery; B) molecular medicine; C) regenerative

medicine; or D) applied biotechnology. Basic researchers focus on

molecular regulation mechanisms, and material scientists place

their emphasis on developing new (intelligent) scaffolds/matrices

used for tissue engineering, one of the modern backbones of

modern regenerative medicine.

In vitro

generated tissues are

studied in preclinical experimental animal studies, where

biocompatibility, integration and functionality tested before clinical

trial phases in humans can be initiated.

The main strategic goal of the CABMM is the promotion of

translational research based on excellent interaction between

basic research and clinics, academic institutions and industrial

partners. Through consolidation and optimisation of an already

excellent infrastructure, the methodical knowhow is continuously

improved and the expertise of all members and their national and

international research partners allows the development of products

and appropriate technology transfer. Through the uniqueness of

the CABMM, the University of Zürich is the only European

university with official accreditation in Good Laboratory Practice

(GLP), Good Manufacturing Practice (GMP) and Good Clinical

Practice (GCP). These are required to get products registered at

the FDA for clinical application.