MB/M(2009)9 MEMBERS OF THE MANAGEMENT BOARD

Alan M. GOLDBERG, Ph.D. Born in Brooklyn, New York, USA, on 20 November 1939.

Professor of Toxicology, Department of Environmental Health Sciences Chairman of the Board, Center for Alternatives to Animal Testing (CAAT), The Johns Hopkins University Bloomberg School of Public Health. 615 N Wolfe Street, W7032, Baltimore, MD 21205 410-614-4990 [email protected] http://caat.jhsph.edu http://altweb.jhsph.edu

Dr. Goldberg received his bachelor’s degree at the Long Island University-Arnold and Marie Schwartz College of Pharmacy in 1961 and his PhD from the University of Minnesota, Department of Pharmacology in 1966. After postdoctoral work in microchemistry and a faculty appointment at Indiana University, he moved to the Johns Hopkins University in 1969, where he became Professor in 1978, and was an associate dean (research and technology transfer) from 1984-1999. As a professor of toxicology, his area of focus was the nervous system, with his major contributions in fundamental aspects of cholinergic biology and radio-enzymatic assay for the measurement of the neurotransmitter acetylcholine. In the late 1970s, Dr. Goldberg’s work began to focus on in vitro systems. In 1981, he founded the Center for Alternatives to Animal Testing. The Center for Alternatives to Animal Testing is focused on working with industry and government to incorporate the latest technologies and the most humane science in decision- making. The Center supports the development of new in vitro methods and refinement alternatives that contribute to basic research, product development, and regulatory decisions. It also provides education to scientists on how one practices the most humane science, aka – the 3Rs of alternatives – refinement, replacement, reduction. As a Dean at the Johns Hopkins Bloomberg School of Public Health, Dr. Goldberg was responsible for technology transfer, conflict of interest, and working with the private sector. Along with Dr. Goldberg’s academic activities, he served on several not-for-profit boards of directors, and has served as a consultant to Clonetics, Molecular Devices, SkinEthic, and Xenogen. Dr. Goldberg has also served as a member of the board of directors for both Clonetics and Xenogen. In all cases, during Dr. Goldberg’s work with these companies, they either had a successful IPO, were purchased by a major company, and/or had a major product launch that Dr. Goldberg participated in. He is a leading authority on the creation, development, and validation of alternative toxicological methods and has served on numerous committees for national and international

Kampendaal 83, B-1653 Dworp (Brussels) Belgium ● email: [email protected] ● tel: +32.23045903 MB/M(2009)9 organizations charged with protecting public health. He is the recipient of many awards, including the inaugural Russell and Burch Award in 1991 from the Humane Society of the United States, the Society of Toxicology's Ambassador of Toxicology Award in 1998, the Society of Toxicology's 2001 Enhancement of Animal Welfare Award, and the 2001 Doerenkamp-Zbinden Foundation Award. He is the author of more than 150 scientific articles and editor of numerous books. During the last several years, Dr. Goldberg was a member of the Pew Commission on the Impact of Industrial (US) Farm Animal Production (www.pcifap.org), which looked at issues of public health, environment, animal welfare and social justice. He is currently working with the School’s Center for a Livable Future, focusing on food animal welfare and sustainability issues.

Dr. Goldberg actively serves on the International Animal Welfare Advisory Boards of Shell, and Procter & Gamble (IAMS), and consults with CeeTox (an in vitro toxicology CRO) and chairs their Scientific Advisory Board, and is Chairman of the Management Board of Orange House Partnership.

Kampendaal 83, B-1653 Dworp (Brussels) Belgium ● email: [email protected] ● tel: +32.23045903 MB/M(2009)9

Herman B.W.M.KOËTER, M.Sc., D.Tox., ERT Born in Maartensdijk, The Netherlands, on 1 October 1947. Email: [email protected]

Herman Koëter holds an MSc in biology and experimental pathology and took his Doctoral Degree in Biological Toxicology (D.Tox.) summa cum laude from Utrecht State University, Utrecht, the Netherlands with majors in reproductive toxicology and functional development. He is an Internationally Recognized Board-Certified Toxicologist (ERT). Herman B.W.M. Koëter is the initiator, co-founder and Managing Director of the Brussels based Orange House Partnership, which is a non-profit partnership organization providing scientific expertise, assistance, advice, training and interim management to the public and private sector primarily in developing countries and emerging economies. The Partnership consists of international senior experts in risk assessment and risk management with governmental, academic and private sector backgrounds who are passionate about sharing their expertise and experience with professionals in countries with limited access to such sources of knowledge. Herman Koëter started his professional career in 1967 at the TNO Toxicology and Nutrition Institute, Zeist, the Netherlands where he held several positions before he was appointed in 1986 as Associate Head of the Department of Biological Toxicology. A major part of his scientific work has been in the area of food and feed safety assessment, occupational health, the development of functional testing in animals, and the replacement, reduction and refinement of experimental animals. From 1991-2003 Herman Koëter was Principal Administrator at the Paris based OECD Environment, Health and Safety Division. There he was responsible for the Programme on Harmonization of Classification and Labeling of Chemical Substances resulting in the adoption by the UN ECOSOC Globally Harmonised System for the Classification of Chemical Substances (GHS). He was also responsible for the OECD Test Guidelines Programme, the OECD Special Activity on Endocrine Disrupters, and OECD’s Special Activity on Animal Welfare Policies. Dr Koëter was also senior adviser for OECD on human health hazard and risk assessment policies. From 2003 through 2008 Herman Koëter held the dual position of Scientific Director and Deputy Executive Director of the European Food Safety Authority (EFSA) in Parma, Italy, and was Acting Executive Director from 2005-2006. He has largely contributed to the establishment of the organization (which became operational in May 2003), providing it with a management structure to adequately tackle the many questions and issues related to food and feed safety in Europe. He established the Science Directorate of EFSA and led EFSA’s scientific work, the output of which forms much of the basis of EU decisions on food, feed, plant health and protection and animal health and welfare. During his career, Dr Koëter has always been active in the field of experimental animal reduction, replacement and refinement. He was the first to receive a research grant from the Dutch Animal Welfare Society in 1982 to develop an alternative method to replace the rabbit

Kampendaal 83, B-1653 Dworp (Brussels) Belgium ● email: [email protected] ● tel: +32.23045903 MB/M(2009)9 eye irritation test. Also in 1982 he was chief editor and co-author of a European Commission Report on the use of animals in toxicity testing. He was co-editor of the book "Animals in Biomedical Research", published in 1991 (Elsevier, New York/Amsterdam). He was a founding member and chairman of the European Research Group for Alternatives in Toxicity Testing (ERGATT) until 1989 and is member of the Advisory Board of the Johns Hopkins University's Center for Alternatives to Animal Testing, Baltimore, US. Dr Koëter was also a member of the Dutch Government Advisory Council on Animal Testing until 2007. He was member of the US National Academy of Science Expert Group on developmental biology and toxicology in the late 1990s. Since 2005 he is member of the US Harvard University Policy Group on “Private and Public, Scientific, Academic and Consumer Food Safety Policies - PAPSAC”. He is recipient of several academic awards in recognition of his achievements in the area of international harmonization of regulatory assessment methodologies. Herman Koëter has published more than one hundred papers in the scientific literature on toxicology issues, occupational health, risk assessment and animal welfare policies. With respect to the latter Dr Koëter has published several papers on validation and new approaches in regulatory risk assessment.

Kampendaal 83, B-1653 Dworp (Brussels) Belgium ● email: [email protected] ● tel: +32.23045903 MB/M(2009)9

Kartika T. LIOTARD, M.Sc. Born in Voorburg, The Netherlands on 26 June 1971. Email: [email protected]

Kartika Liotard holds a Doctoral Degree in Law from the University of Maastricht, The Netherlands with majors in Criminal Law and Administrative Law.

Ms Liotard is a Dutch politician and prominent member of the Socialist Party. She is Member of the European Parliament (MEP) and Vice-Chairwoman of the European Parliament (EP) Confederal Group of the European United Left- Nordic Green Left. Ms Liotard is also member of the EP Committee on Civil Liberties, Justice and Home Affairs and member of the Delegation for relations with the Maghreb countries and the Arab Maghreb Union. She is Substitute Member and Rapporteur of the EP Committee on the Environment, Public Health and Food Safety and Contact Person of the European Parliament with the European Food Safety Authority (EFSA).

In addition, Ms Liotard is Substitute Member of the following EP Committees:  Committee on Women's Rights and Gender Equality  Committee on Agriculture and Rural Development, and  Delegation to the EU-Russia Parliamentary Cooperation Committee

Before being elected as Member of the European Parliament, from 1997-2004 Kartika Liotard was senior lawyer at the Dutch Ministry of Agriculture, Environment and Food Quality where she held the positions of Team Manager Legal Affairs and team Manager Development and Administration, the latter being focussed on European Legislation.

Kampendaal 83, B-1653 Dworp (Brussels) Belgium ● email: [email protected] ● tel: +32.23045903 MB/M(2009)9

Horst SPIELMANN, MD., Born in Lublin, Poland on 3 April 1943 E-mail: [email protected] & [email protected]

Professor Dr. med. Horst Spielmann, retired in 2007 as head of the Department of Scientific Services and of ZEBET (National German Centre for the Documentation and Evaluation of Alternatives to Testing in Animals of the Bundesinstitut für risikobewertung BfR (Federal Institute for Risk Assessment) in Berlin, Germany. He is Professor for Regulatory Toxicology at the Freie Universität Berlin, Germany, and advisor to the President of the Federal BfR in Berlin, Germany.

Research activities Since 1988 chairperson and/or member of the management teams (MT) of national and international validation studies that were funded by the German Minister for Education and Research (BMBF) by the European Commission (DG Environment), by ECVAM (European Centre for the Validation of Alternative Methods at the JRC in Ispra/Italy) and by COLIPA (the European Cosmetic, Toiletry and Perfumery Association).

The successful validation studies resulted in the acceptance of the first in vitro toxicity tests for regulatory purposes at the international level (EU, OECD, Japan, USA), e.g. in vitro alternatives to the Draize eye test (!988 – 1995), in vitro phototoxicity tests (1992-1998) , in vitro corrosivity tests (1996-1998), an in vitro embryotoxicity test using a mouse embryonic stem cell line (1998-2002) and of the ECVAM skin irritation validation study using human skin models (2005-2007).

Membership in national and international boards 1987 Member of ERGATT (European Research Group for Alternatives in Toxicological Testing), chairman since 1992. 1990-2002 Expert on national (BMBF) and European government boards (DG XI, DG XII) for the funding of research on alternatives to the use of laboratory animals 1992-94 Member of the management team (MT)of the world-wide "EU/ Home Office validation study on in vitro alternatives to the Draize rabbit’s eye test",9 tests, 37 laboratories participating (sponsor DG XI). 1992 & 1997 Representative of Germany at ESAC the Scientific Advisory Committee of ECVAM, the European Centre for Validation of Alternative Methods at the EU Joint Research Centre (JRC) in Ispra/ Italy for two terms (1992-97 and 1997-2002). since 1993 Chairman & member of the Scientific Advisory Committee of the German Foundation SET which is funding research on the 3Rs. since 1999 Expert for the 5th , 6th and 7th Framework Programs of the DG RTD of the EU Commission for alternatives to animal testing and in vitro toxicology

Kampendaal 83, B-1653 Dworp (Brussels) Belgium ● email: [email protected] ● tel: +32.23045903 MB/M(2009)9

2000-2005 Member of the Board of Trustees of the of the Doerenkamp-Zbinden- Foundation for “Realistic Animal Protection in Biomedical Research” (Chur, CH) Since 2002 Co-chair of the 4th, 5th and 6th “World Congresses on Alternatives and Animal Use in the Life Sciences”, which were held in New Orleans (2002), Berlin (2005) and Tokyo (2007) 2003-2007 Co-ordinator of EU/ECVAM Project „Validation study to evaluate in vitro test using reconstituted human skin models for assessing the skin irritation potential of test chemicals “ in 8 labs (D, CH, F, UK, USA), budget 1,6 Mio € 2004-2007 "Research Area Leader" für "Prenatal Toxicology" in the EU FP6 IP Project ReProTect, 27 labs, budget 14.9 Mio € for 5 years 2004 Expert Referee in the EU FP6 in the NEST Programm (New and Emerging Science and Technology) 2007 Expert in the EU FP7 and for the ERC (European Research Council) 2008 Expert for the Joint Research Initiative (JRI) between COLIPA and the European Commission in the field of replacement of animal tests in repeated dose systemic toxicity Awards 2007 Honorary Professor for Regulatory Toxicology at the Free University Berlin 2007 Honorary member of the Japanese Society for Alternatives to Animal Experiments (JSAAE) 2007 Recognition Award 2007, Center for Alternatives to Animal Testing (CAAT, Johns Hopkins University, USA) 2005: "Dermopharmazie Innovation Prize 2005" for introducing human skin models into regulatory safety testing 2004: President of ESTIV - European Society for in vitro Toxicology 2001: ETS Award 2001 of the European Teratology Society (ETS) for the "Fundamental contribution to the development and validation of non-animal test in general and developmental toxicology" 2000: Award of the Doerenkamp-Zbinden-Foundation for “Realistic Animal Protection in Biomedical Research” (Chur, CH) for the year 2000 1998: Prize of the Naef Foundation for Alternatives to Animal Testing (Geneva, CH), for successful development and validation of the 3T3 NRU PT in vitro phototoxicity test 1997: Russell & Burch Award of the Humane Society of the USA (HSUS) for a substantial contribution to reduce, refine and replace testing in animals 1997: FISEA Prize, the European Association Against Testing in Animals (Luxembourg), for

developing the embryonic stem cell test (EST), an in vitro embryotoxicity test using two permanent mouse cell lines 1997: Bronze Medal of the Charles University Medical School in Hradec Králové, Czech Republic, for the contribution to establish education in physiology without experimental animals 1994: Medal of the Japanese AZABU University Veterinary School in Shagamihara (Tokyo), Japan

Kampendaal 83, B-1653 Dworp (Brussels) Belgium ● email: [email protected] ● tel: +32.23045903 1992 President of MEGAT (Middle European Society for Alternatives to Animal Testing)

Kampendaal 83, B-1653 Dworp (Brussels) Belgium ● email: [email protected] ● tel: +32.23045903