Dr Constantine Kreatsoulas received his undergraduate degree in 1995 from New York University's Courant Institute of Mathematics where he was a Presidential Scholar. He pursued graduate studies at Princeton University under C.E. Schutt. His thesis research was the development of a model pathogenic motility. He continued on to a post-doctoral research position with Greg Pearl at Bristol-Myers Squibb creating models and informatics tools for a variety of toxicological liabilities. Constantine is currently a senior research chemist in the Chemistry Modeling and Informatics group at Merck and Co., Inc. working with discovery project teams, the drug safety and the compound handling groups. His research interests lie in modeling complex biological systems through the development of novel simulation methodologies.

After spending 8 years in Contract Toxicology and 11 years as a Toxicologist in the Pharmaceutical Industry, I currently work as an Expert Pharmaco-Toxicologist within the Licensing Division of the Medicines and Healthcare products Regulatory Agency (MHRA) in London.

My current role principally involves assessing nonclinical data for Clinical Trial Applications, both non-biological and biological. A further aspect of my job is to offer regulatory advice to companies on behalf of the MHRA or the EU’s Committee for Human Medicinal Products (CHMP). I am one of the UK’s accredited preclinical experts to support the CHMP and am the UK representative on the Safety Working Party (SWP). I represent the EU in the ICH revision of the M3 Guideline.

I am also a guest lecturer at the University of Surrey and the University of Wales and a frequent presenter at conferences around the world.

Dr Eric Blomme received his D.V.M. from The University of Lyon (France), studied Management at McGill University, and completed a residency in Veterinary Pathology at Cornell University and a Ph.D. at Ohio State University. His areas of expertise include the development of new technologies for predictive toxicology and the preclinical safety assessment of new molecular entities using molecular toxicology and pathology. Eric joined Abbott in 2003. The role of his group is to provide predictive, mechanistic and regulatory toxicology data for compounds in discovery and development. In his prior positions at Monsanto/Searle and Pharmacia, Eric worked on various drug discovery and development projects. His publication record includes over 55 peer-reviewed manuscripts, several book chapter and a book (Genomics in Drug Discovery and Development, Wiley).

Dr Franck Atienzar obtained his PhD in Environmental Toxicology at the University of Plymouth (UK) in 2000. After a short experience at Sigma-Aldrich (technical Service: molecular biology specialist, France), he joined UCB Pharma in 2002 as Head of the In Vitro Toxicology Unit. His objectives are to implement strategies and technologies (measure of gene expression, markers of hepatotoxicity, genotoxicity and cytotoxicity, detection of phospholipidosis, ....) in the context of early toxicological assessment of pharmaceutical compounds. Franck, who also acts as an independent expert for the European commission regularly evaluates scientific projects submitted for European funding.

Dr. Friedman has spent over 28 years in the pharmaceutical industry. His experience has ranged from occupational toxicology to drug safety and pharmacovigilance. Most of his career has been in the area of drug development for Abbott Laboratories. Dr. Friedman has been directly involved in the evaluation of discovery compounds and development of a broad range of therapeutic agents. In recent years, Dr. Friedman has been Director of Drug Safety and Metabolism for Ligand Pharmaceuticals and deCODE Genetics. He has spent a good deal of time integrating toxicology, drug metabolism and pharmacokinetic data to identify lead candidates as well as to solve formulation problems and support compound development. His goal is to help today’s pharmaceutical scientists make informed choices on candidate selection to improve the probability of success.

I joined FRAME in 2004 and currently oversee the FRAME Research Programme, working closely with FRAME Scientists and the FRAME Alternatives Laboratory based at the University of Nottingham.

After obtaining my BSc (Hons) in Biochemistry and Pharmacology and PhD in Biochemistry and Molecular Biology (Leeds University 1987-1995), I have worked in an internationally renouned laboratory and led a team of scientists, focused on preclinical pharmaceutical development using in vitro and in silico alternatives to animal studies. This work was undertaken in collaboration with a number of leading pharmaceutical companies and involved many of the techniques that are now used throughout the industry.

Since joining FRAME, I have applied this knowledge to challenge the relevance of animal models, identify new approaches to pharmaceutical development and safety testing and to examine how other industries may benefit from such approaches.

My personal ethos is to ensure that animal welfare and human safety are carefully balanced. As a result, I challenge the way in which studies are performed on human volunteers and patients as well as on animals. This research benefits from the wide-ranging expertise of other FRAME Scientists.

Dr Cook has a background in biochemistry and molecular biology with a PhD from Imperial Collage, London and three years of post-doctoral experience. Dr Cook has worked in the pharmaceutical industry for AstraZeneca for greater than 12 years. He initially worked in the respiratory and inflammation area and was responsible for identifying the mode-of-action for a new class of immunosuppressive. He was one of the founders of AstraZeneca’s systems biology group and led the pathway analysis capability in this department for five years. Dr Cook moved into safety sciences three years ago to lead the development of computational biology approaches in support of predictive toxicology and problem-solving.

Dr Frank Bonner is Chief Executive of Stem Cells for Safer Medicines, a Public-Private partnership which is focussed upon developing stem cell assays for predictive toxicology.

Frank has over 25 years of experience of toxicology and non-clinical drug development, gained in the pharmaceutical, biotechnology and contract research industries. In 2003, he formed an independent consultancy company providing scientific and regulatory advice for drug development.

He is a Fellow of the British Toxicology Society, Past President of the Society and has participated on a number of national committees of the Association of the British Pharmaceutical Industry. He also currently serves on the Scientific Advisory Boards for a number of companies engaged in a variety of life science technologies including systems biology, metabonomics and development of disease models. Earlier in 2009, he was appointed Visiting Professor in the Institute of Cellular Medicine, University of Newcastle where he is involved in postgraduate teaching in Medical and Molecular Biosciences.

Dr. Dykens pursued his graduate education at The College of William and Mary, and he received his Ph.D. from the University of Maine for research on oxidative physiology of corals on Australia’s Great Barrier Reef. He then conducted postdoctoral research on hemoglobin biochemistry in the Pharmacology Department at New York University Medical School.
Jim was in academia for 5 years before joining the Immunopathology Department at Parke-Davis Pharmaceutical Research where he used electron paramagnetic resonance spectroscopy to study mitochondrial free radical production.
In 1996 Jim joined MitoKor, a start-up company focusing on the mitochondrial etiology of degenerative diseases, where he served in several capacities including Senior Scientist and Associate Director of Business Development. In 2004, he was the Director of Business and Drug Development when MitoKor merged to form Migenix, a company headquartered in Vancouver, Canada. Jim later joined Pfizer to focus on drug-induced mitochondrial dysfunction and investigative cell toxicity. He is now leading the Investigational Cellular Toxicity group in Sandwich UK.

Dr Kathryn Chapman specialises in animal use in the pharmaceutical industry and leads the Innovation and Translation Group at the National Centre for Replacement, Refinement and Reduction of animal use (NC3Rs) in the UK. The position is funded by the Association of the British Pharmaceutical Industry. Kathryn joined the NC3Rs three years ago with over ten year's research experience in animal model development in basic research and for drug development at Harvard Medical School, the Wellcome Trust Sanger Centre, Manchester University and GlaxoSmithKline.

The NC3Rs works with scientists from over 40 pharmaceutical and biotechnology companies and regulatory bodies from the UK, elsewhere in Europe and the USA to deliver a comprehensive programme of work in diverse areas of pharmaceutical discovery and development. Kathryn convenes five expert working groups which take an evidence-based approach to explore and validate new opportunities to minimise the use of a variety of species including non-human primates, dogs and rodents.

Dr Mark Cronin is Professor of Predictive Toxicology at the School of Pharmacy and Chemistry, Liverpool John Moores University (LJMU), Liverpool, England. At LJMU Mark Cronin currently leads research into the area of quantitative structure-activity relationships (QSARs) with a particular emphasis towards predicting the toxicity of chemicals. Mark Cronin has over 20 years expertise in the application of quantitative structure-activity relationships (QSARs) to predict the toxicity and fate of chemicals and drugs; in addition to development of strategies (such as integrated testing strategies) to develop alternatives to whole animal testing for toxicity. The alternatives include the whole range of in silico techniques (use of existing data; (Q)SARs; expert systems), data from chemical reactivity (in chemico) assays; and data from in vitro techniques. Research in recent years has centred on the application of these alternatives for regulatory use and for product development. This research effort has resulted in over 150 publications in all areas of the use of (Q)SARs and expert systems to predict toxicity, including one book and a further two books in press. Mark has served on a number of national and international committees including those for the OECD, ECVAM and ECB.

Dr. Martha M. Moore is the Director of the Division of Genetic and Reproductive Toxicology, National Center for Toxicological Research (NCTR), Food and Drug Administration (FDA), Jefferson, Arkansas. Prior to her appointment at NCTR, Dr. Moore was the Chief of the Genetic and Cellular Toxicology Branch, Environmental Carcinogenesis Division, National Health and Environmental Effects Research Laboratory, U.S. Environmental Protection Agency (EPA), Research Triangle Park, North Carolina. Dr. Moore received a BA degree in Biology from Western Maryland College, Westminster, Maryland and a Ph.D. in Genetics from the University of North Carolina at Chapel Hill. She has served on numerous EPA, FDA and other Government Agency advisory groups and committees. Currently she is the chair of an international effort for protocol harmonization for the in vitro gene mutation mouse lymphoma assay. She is a member of the Society of Toxicology, the Environmental Mutagen Society, the United Kingdom Environmental Mutagen Society, The European Environmental Mutagen Society, the Genotoxicity and Environmental Mutagen Society and the Genetic Toxicology Association. Within SOT, Dr. Moore is a member of the Risk Assessment, Carcinogenesis, Regulatory and Safety Evaluation, and the Occupational and Public Health Specialty Sections. Her research interests include: (1) the development and utilization of mechanistically based in vitro and in vivo gene mutation assays (2) the interpretation and use of genetic toxicology data in cancer risk assessment and (3) the integration of rodent and human mutagenicity data in regulatory decision making.

Dr. Suk is Director, Center for Risk and Integrated Sciences and Director, Superfund Research Program, National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). He has served in a number of leadership positions at NIEHS. A primary aspect of these positions is the assessment of current biomedical research and its potential applications in determining adverse effects on human health resulting from exposure to deleterious environmental agents. Dr. Suk has worked extensively with the biomedical scientific research communities, a comprehensive knowledge of public health policy, and an in-depth understanding of technology and information translation, nationally and internationally.

Dr. Suk has served since its inception, as Director of the NIEHS Superfund Hazardous Substances Basic Research and Training Program [Superfund Research Program], a program established by Congress as part of the reauthorization of Superfund in 1986. A unique Program fostering interdisciplinary research approaches to address the problems associated with potentially hazardous environmental exposures. This Program, which presently has an annual budget of over $50 million, has advanced the science of identifying, assessing, evaluating and remediating hazardous substances, and in so doing, it has enhanced the infrastructure of the environmental health sciences.

Dr. Suk is a member of a number of organizations and committees, including, member, roundtable on Environmental Health Sciences, Research, and Medicine of the Institute of Medicine of the National Academy of Sciences; member, International Advisory Board of the Chulabhorn Research Institute, Bangkok, Thailand; co-chaired the World Health Organization Consultation on Scientific Principles and Methodologies for Assessing Health Risks in Children Associated with Chemical Exposures. Dr. Suk has been a member of a number of trans-NIH committees and consortia, most notably the Bioengineering Consortium which is established within the Office of the Director, NIH, to promote and develop the bioengineering activities at NIH. Dr. Suk has assisted in the conceptualization and implementation of research and training programs in exposure biology and in understanding gene-environment interactions.

Dr. Suk received his Ph.D. in microbiology from the George Washington University Medical School, and his Masters in Public Health in health policy from the University of North Carolina at Chapel Hill. He is a member of a number of scientific societies, and has been a National Science Foundation fellow. Dr. Suk has honored at the NIH for his efforts, was privileged with receiving the Roy E. Albert Memorial Award for Translational Research in Environmental Health from the University of Cincinnati, and recently, the Child Health Advocacy Award from the Children’s Environmental Health Network, and the John P. Wyatt Lecture Award in Environmental Health and Disease from the University of Kentucky. Dr. Suk is a Fellow of the Collegium Ramazzini, the international society of scholars in environmental and occupational health.

Born in Switzerland but living in the UK since 2001. Marc Princivalle is a biochemist and a pharmacologist by training having done his PhD at Geneva University Hospital in the Fertility and Sterility Clinic Department. He joined Ferring Research Ltd first in Geneva then moved to Southampton (UK) as a team leader in pharmacology and target validation at the Ferring Drug Discovery Unit with a background in DMPK, safety pharmacology and discovery toxicology. His primary role was to ensure that preclinical programs were suitable for lead optimisation programs and clinical candidate selections. His secondary role was the pharmacological validation of potential new targets for new drug discovery programs.

After 7 years at Ferring, he moved to Stiefel Laboratories as Director of Toxicology. In his current role, he is Head of Preclinical Risk Assessment for EMEA. He is responsible for preclinical programs supporting the development of existing APIs and new chemical entities. He is also responsible to the safety assessment of Cosmetics, Medical Devices and other products in Stiefel Portfolio. He is also responsible for the Preclinical Pharmacology and Toxicology evaluation of new opportunities through acquisition and due diligence programs. Stiefel, being now a GSK company, new Dermatology products will also be coming from the Drug Discovery effort from GSK Centre of Excellence for External Drug Discovery.

Marc Princivalle is currently a member of the American College of Toxicology, the British Toxicology Society, the Royal Society of Medicine, the European Society of Human Reproduction, the European Society for Dermatology Research and the Society of Cosmetic Science.