In Vitro Testing Industrial Platform Review 2013 IVTIP Review 2013 IVTIP Board and Secretariat President Erwin Roggen | Novozymes A/S Board Members Horst W Fuchs | CellSystems GmbH Marianna Gaça | British American Tobacco Erin Hill | Institute for In Vitro Sciences Cyrille Krul | TNO Albrecht Poth | Harlan Executive Officer Bart De Wever | ALTEXA Development Secretariat Annemarie de Heer The first point of contact is the IVTIP Secretariat: [email protected] IVTIP Review 2013 Letter from the President By actively interacting with the European Commission and other regulatory authorities, we monitor research activities, industry needs and method validation requirements worldwide. activities of the In Vitro Testing Industrial responsibility Welcome to the first annual review of the animal testing. Additionally, we endorse a meetingschemicals, have cosmetics, been attended consumer by productsdelegates fourth R, towards animals and pharmaceuticals industries. Our open activitiesPlatform (IVTIP).during the As pastthis is3 yearsour first to bringsuch to satisfy the growing demands of society - review, we provide information on our increasedwhile improving visibility methods as a result to assure of high- safety. peanfrom Commissionup to 20 non-member and other organisations.regulatory impactSince public 2008, relationsIVTIP has activities substantially carried By actively interacting with the Euro you up to date with what promises to be industry needs and method validation re- an exciting 2014. - authorities, we monitor research activities, • IVTIP was established in December, out by our committed and driven Board, 1993, with the following aims: havealong organised with the enthusiasm annual open and discussion proac quirements worldwide. By these activities- onto advise industrial European requirements bodies (European for current forumstivity of alongside our members. our closed Additionally, meetings we and endorsing initiatives, such as the 21st andCommission, future research European projects Parliament) in in vitro to address issues that are critical for Century Toxicity Testing (Tox 21) strat testing egy, we aim to facilitate harmonisation, • to optimise the industrial value of standardisation, sharing and validation of European Union funded research test development, implementation and emerging alternative methods. projects acceptance. Finally, communicating our - • views and conclusions emerging from - validation and regulatory acceptance these discussions as peer-reviewed man ofto testsencourage based the on thisfurther research development, uscriptsA positive has by-producthelped grow of IVTIP’s our increased credi bility and visibility. - - tive forum for companies interested in in visibility has been that IVTIP has extend vitroIVTIP testing provides to replacean informal animal and regulatory interac ed beyond merely a European platform, and we now embrace companies and 30%organisations in the past in 5the years USA, to Brazil, more thanIsrael 40 and promotesafety and and efficacy disseminate testing informationin compound on Europe. Membership has increased by state-of-the-artdiscovery and development. technologies Werelated actively to the Erwin L Roggen full members, including test developers, 3Rs —replacing reducing and refining IVTIP President CRO’s and small and medium enterprises , up to large, international companies in the www.ivtip.org 1 IVTIP Review 2013 Past IVTIP meetings Closed meetings IVTIP Autumn meeting Each year IVTIP holds closed meetings in vitro genotox- the possibilities for future regulatory use. November 7–8, 2013 for the membership and Board, but icity testing assays have been accepted By contrast, several Monte Carlo, Monaco some of the presentations go on to become important talking points in the remain about the high risk of false-posi- The topics covered in this meeting began by regulatory authorities,in vitrobut concerns tests are - open meetings. in vivo ity screening assays are hindered by false-positivetive results. As in positive vitro false-positivewith presentations results on and imaging. a preference Toxic for IVTIP Autumn meeting morefollowed animal by testing assays, might andbe being the rates done of short-term results for potently cytotoxic results can be high, November 14–15, 2012 - - - Brussels, Belgium tationthan necessary. on methods Phillipe to reduce Vanparys, the number ALTOX compounds. Toxic effects, however, fre This meeting was dedicated to Joan-Albert ICON, Antwerp, Belgium, gave a presen quently develop over the long term and, Vericat, former IVTIP President, who sadly - therefore, methods are required to assess had passed away earlier in the year. of false-positive results. In a separate broader toxicity potential. Peter James ofdiscussion, reconstructed Cyrille skin Krul, models TNO, Zeist,for testing Neth beO’Brien, used toUniversity improve Collegethe speed Dublin, and sensi Ireland,- erlands, presented information on the use tivitydiscussed of assessing how high-content human toxicity imaging poten may- and discussions on the regulatory status Such models have been developed to try ofThe alternative meeting began methods with in presentations several non-Eu - towith improve the micronucleus the relevance and of COMET exposure assays. conditions in in vitro genotoxicity assays demonstratedtial. In another the presentation technique onof enhancimaging,- ingYvon imaging Julé of Biocellvia,analysis as Marseille,discussed France, in the ropean countries, China, Russia, Brazil and the USA. The afternoon sessions testingfor dermally in case applied of in vitro compounds. positive effectsThis looked at specific techniques, including is a promising approach for follow-up - Southampton open meeting (see later). cell transformation assays, genotoxicity Skin sensitisation was addressed in testing,Cell transformation and an alternative assays micronucleus are current - in the standard genotoxicity tests. Ker several presentations. Erwin Roggen, from test. eggstin testReisinger, for micronucleus from Henkel, induction Düsseldorf, as an Novozymes, Bagsvaerd, Denmark, started off cosmetic and pharmaceutical industries alternativeGermany, discussed to the in vivothe use micronucleus of the hen’s test the session on new developments by putting- andly used academia in the chemical,to screen agrochemical,for and inves- to assess systemic availability and to be forward the current knowledge—and areas tigate basic mechanisms of carcinoge- - where knowledge is lacking—about sensiti- sation induction relevant for risk assessment. micronucleusused as a follow-up or chromosome tests in case aberration of clas onThis the was current followed regulatory by a round state up of from affairs An usingnicity. morphologicalConcerns about characteristics inter-laboratory and togenic effects in the mouse lymphoma, nette Mehling, BASF, Düsseldorf, Germany, unclearreproducibility, understanding the subjective of the molecular nature of in vitro assays mechanisms underlying transformation tests in mammalian cells. tofor assess skin sensitization hypersensitivity testing. to variousTwo product com- of TheEuropean remainder Union of Reference the meeting Labora was - presentations were given on torytaken for up Alternatives with updates to on Animal the activities Testing in vitro Harlanmean they Contract have notResearch been widely Services accepted Cy- pounds. Jim McKim from Ceetox, Kalamazoo, for regulatory purposes. Albrecht Poth, forMI, allergicUSA, presented contact dermatitisan update onthat an uses presented an update on current use and (EURL-ECVAM) (Valerie Zuang) and the three-dimensionalalternative based on reconstructed known mechanisms human totest Cell Research, Rossdorf, Germany, outcomes of an earlier meeting of ESTAF - (Cyrille Krul). anepidermis in vitro skinmodels. explant Shaheda assay Ahmed, that predicts Alcy adverseomics, Newcastle effects on upon the immune Tyne, UK, system discussed Histopathological grading is used to distin- caused by chemicals and novel compounds. guish between high and low potency and sensitiser and non-sensitiser compounds. Francois Busquet, the representative andof CAAT Claudius Europe, Griesinger also joined presented the meeting the to promote alternatives to animal testing, update on EURL-ECVAM activities and the European Union Network of Laboratories for the Validation of Alternative Methods (NETVAL). 2 www.ivtip.org IVTIP Review 2013 Open meetings major issues that had been the driving Since 2008, IVTIP has been holding forces behind the development of alter- presented a novel bioengineered skin Stratatech Corporation, Madison, WI, USA, regular meetings that are open to its by a presentation from Bart De Wever human skin tissue that is being developed members and non-members. Mem- native methods. This talk was followed model, which is a full-thickness model of ber companies also have the chance to host meetings and showcase their and Constantin Turchina, founders of- the for therapeutic and testing purposes. - technologies and facilities. Alternatives à l’Expérimentation Animale Third, Samuel Constant, Epithelix, Sàrl, projectdans la Rechercheaimed at stimulating Appliquée research (ALEX and maintainsGeneva, Switzerland, all morphological described and a function fully dif- In vitro reconstructed human developmentANDRA) Association, of alternative on the methods launch of by a alferentiated characteristics airway of epithelium native tissue model for at that tissue models as alternatives least 1 year and can be used to replace in - vivo to