The international Workshop on '3Rs & 2D and 3D Liver, Skin, Eye and Intestinal Regulatory Models' was held at TÜBİTAK MAM on 2-3 November 2017 in collaboration with TÜBİTAK Marmara Research Center (MAM) and Center for Alternatives to Animal Testing-Academy (CAAT-Academy), University of Konstanz and Turkish Society of Toxicology.
The Workshop, led by TÜBİTAK MAM Vice President Assoc. Prof. Dr. Murat Makaracı, was attended by representatives of MatTek In Vitro Life Science Laboratories (USA-Slovakia), EPISKIN Academy (France), Biopredic International (France), which conducts R&D in the field of in vitro model systems in Europe and the USA, has the largest information network in the world and has developed products included in the OECD Test Guidelines (TG).
CAAT-Academy is one of the organizations working on R&D, validation and regulation of in vitro tissue models as an alternative to animal experiments. In the workshop, Dr. Francois Busquet from CAAT-Academy gave information about the 3Rs (reduction, refinement, replacement) applications and approaches in the world and in Europe, revealing the importance of in vitro models today and in the future. The other speaker, Dr. Costanza Rovida from CAAT-Academy, provided information about the European Union Reference Laboratory for alternatives to animal testing (EURL-ECVAM) in collaboration with the European Union Network of Laboratories for the Validation of Alternative Methods (EU-NETVAL) on the validation and regulatory acceptance of in vitro methods.
Dr. Christian Pellevoisin from EPISKIN- Academy gave information about the applications of the 3D Reconstructed human epidermis (RHE) model used in OECD TG 431: In Vitro Skin Corrosion, OECD TG 439: In Vitro Skin Irritation tests in in vitro toxicological analysis. Dr. Valery Shevchenko from BIOPREDIC International explained the validation process of HepaRG, an in vitro model in which metabolic cytochrome P540 enzymes are active in hepatotoxicity analysis of drugs and xenobiotics, and its importance in determining the toxicity potential in biotransformation. Dr. Silvia Letasiova from MatTek In Vitro Life Science Laboratories gave information about the features, validation process and applications of the 3D reconstructed in-vitro cornea-like model used in OECD TG 492: Eye Irritation test. The other speaker Dr. Jan Markus from MatTek In Vitro Life Science Laboratories explained the application of the 3D reconstructed human small intestine model to determine the permeability of drugs and xenobiotics in the intestinal tract and to screen for gastrointestinal toxicants, its validation and the steps involved in the OECD TG draft.
Dr. Yüksel Çetin from TÜBİTAK MAM Gene Engineering and Biotechnology Institute emphasized the necessity and importance of in vitro models as an alternative to animal testing at the national level in terms of ethical, scientific, commercial and regulatory aspects and explained that if we do not take part in the international network, we will be dependent on foreign countries for the use of model systems included in the OECD test guidelines and there will be a great loss of added value. Prof. Dr. Hilmi Orhan from Ege University Faculty of Pharmacy, President of the Turkish Society of Toxicology presented the modular approach and the necessity of using in vitro models in pharmaco-safety tests. Prof. Dr. Ahmet Aydın from Yeditepe University Faculty of Pharmacy provided information on the application of in vitro methods in determining the hazards of drugs, cosmetics and medical devices.
After completing the correlation and validation process by comparing in vitro models developed in the world with tests involving experimental animals, they are included in the regulations and test guidelines published by the OECD, which include the analysis of chemicals, cosmetics, medical devices and pharmaceuticals. This approach, which has developed rapidly in recent years, prohibits the use of experimental animals in the analysis of cosmetic products in the regulations, and international standards are being revised for the use of validated in vitro models in the analysis of chemicals, drugs and medical devices. There are many centers in the world that conduct R&D in the field of alternative methods and complete the validation process by developing products.
TÜBİTAK MAM aims to pioneer at national and international level by revealing the importance of research - development and technology of alternative in vitro 3D tissue models in this process where the use of experimental animals has started to be banned in the regulations in the world in the bioefficacy and biosafety studies of chemicals, cosmetics, medical devices and drugs.
Speakers
Francois Busquet PhD. EU Policy coordinator for CAAT
Costanza Rovida PhD., Scientific Officer at CAAT-Europe
Christian Pellevoisin PhD., Scientific Director of EPISKIN Academy
Valery Shevchenko PhD., Project Manager at Biopredic International
Assoc.Prof.Evren Algin Pharmacist, Ministry of Health, Turkey Pharmaceuticals and Medical Devices Agency
Dr. Jan Markus Senior Scientist and Production Manager at MatTek In Vitro Life Science Laboratories.
Dr. Silvia Letasiova Senior Scientist and Production Manager at MatTek In Vitro Life Science Laboratories.
Dr. Yüksel Çetin Senior Scientist, TÜBİTAK MAM GEBI
Prof. Hilmi Orhan Toxicology Professor and Senior Scientist at the Toxicology Department of Faculty of Pharmacy
Prof. Ahmet Aydın Head of Department of Pharmaceutical Toxicoloy Faculty of Pharmacy, Yeditepe University
