March 5, 2013

 Harlan Laboratories Contract Research Services has launched a unique initiative with the establishment of an external Scientific Advisory Board.  The board will provide independent advice and guidance both to help support client studies and to provide insight into current and future trends and developments affecting the CRO industry.

 The Harlan Scientific Advisory Board is made up of expert scientists from Europe, the USA and Japan covering the Pharma, agrochemical and chemical industries.  Chaired by Dr John Doe, the six other members are Dr Gerd Bode, Dr Pascal Clayette, Dr Cliff Elcombe, Dr Peter Lord, Dr Jeff Richig, Professor Tetsuo Satoh and Dr Kendall B Wallace.

 Between them, their expertise covers a huge range of specialisms and disciplines including pharmacology, toxicology, pathology, neuropathology, paediatrics, cell and molecular toxicology, non-genotoxic carcinogenicity, immuno-toxicology, preclinical safety electrocardiography and chronic, reproductive and developmental toxicology.

 The Harlan Scientific Advisory Board will act as a forum for Harlan personnel to refer and discuss scientific issues, seek advice and discuss the development of new methods.  In addition, the Board will organise a number of seminars for Harlan clients on topics affecting the CRO industry as well as presenting members’ own relevant research.  It will also offer thought and advice on new regulations and provide position papers on new technologies.

 “We are delighted that such esteemed industry personnel have agreed to join the Advisory Board,” comments John Handley, Vice President Environmental Sciences and Site Management, Harlan Laboratories CRS.  “Their knowledge, expertise and experience will provide a vital additional level of support to clients, further enhancing our services and ensuring we deliver the best outcomes quickly and efficiently, as well as helping us to anticipate, identify and meet market demands and regulatory requirements.”




Member Biographies

 Dr John Doe (Chair), UK

After working as a pharmacologist in the pharmaceutical industry in the areas of asthma, skin allergy and chronic obstructive pulmonary disease, John Doe joined ICI’s Central Toxicology Laboratory (CTL) in the late 1970s.  He initially worked in inhalation toxicology but then managed studies across the full spectrum of regulatory toxicology including chronic, reproductive and developmental toxicology.  He worked in industrial chemical and agrochemical toxicology for many years, becoming Director of CTL in 2003 and Head of Product Safety for Syngenta in 2006.  He was Chairman of ECETOC Scientific Committee from 2006 until 2010. Dr Doe retired from Syngenta in 2010 and is now an independent consultant.  Dr Doe is a member of the UK Animal Procedures Committee.

 Dr Gerd Bode, Germany

 Gerd Bode, M.D, Ph.D. holds board certified specialisations in Pathology, Neuropathology, Legal Medicine, Pharmacology and Toxicology.  After his university career he was head of Drug Safety and Pharmacovigilance at Boehringer Mannheim, Germany; then head of Lead Optimisation (Pharmacology, Toxicology, Kinetics, Metabolism and Clinical Phase I) at Hoechst Marion Roussel/Aventis, Paris, France; and finally head of Preclinical Research and Development at ALTANA Pharma AG, Hamburg, Germany until 2005.  He now works as an independent consultant and serves as lecturer at several universities in Germany, France and Portugal. Dr Bode was for the European Industry (EFPIA) ICH-Topic Leader for Preclinical Safety Guidelines from 1989 to 2005 in the International Conferences on Harmonisation.  Further career highlights include long term Chairman of the German toxicology group (7er Kreis); 5 years chairman of ad hoc Safety Group of EFPIA; Service Award 2004 from the Drug Information Association; Co-Chairman of the Annual Meeting DIA 2007 in Vienna; and Scientific Award 2010 from the Safety Pharmacology Society in Boston.  He has published more than 100 scientific papers, and finalised more than 20 Expert Reports/Common Technical Documents.

Dr Pascal Clayette, France

The first scientific themes developed by Pascal Clayette (PhD. Sc.D.) as group leader of Antiviral Pharmacology/Biosafety Group of the CEA Neurovirology Department concerned a better understanding of the HIV infection pathogenesis, particularly consequences of HIV infection on the immune system, and the evaluation of new anti-HIV and anti-prions solutions.   Since 1998, as head of the Bertin Pharma Immune Pharmacology & Biosafety Dept., these themes - originally focused on HIV and prions - have been open to other therapeutic areas and other public health subjects or risks.  These can be summarised by “exploration of beneficial and deleterious effects of compounds for therapeutical or vaccinal application”. Therefore, they cover several steps in drug development: discovery, preclinical studies including toxicology and immuno-toxicology, and biomonitoring of individuals or patients during clinical trials.

 These researches have led to 80 publications in scientific journals. Pascal Clayette is a member of various SABs and expert groups, particularly in ANSM, the French Regulatory Agency.

 Dr Cliff Elcombe, UK

Dr Cliff Elcombe is co-founder and research director of CXR Biosciences Ltd.    He is also a Senior Lecturer in the Biomedical Research Institute, Ninewells Hospital and Medical School, University of Dundee.  He joined the University of Dundee in 1997 after an 18-year career at Zeneca’s (formerly ICI) Central Toxicology Laboratory where he was a Senior Scientist in Investigative Toxicology.  Dr Elcombe received his BSc and PhD in biochemistry from the University of Surrey.  He received a Royal Society travelling fellowship award to post-doc in Germany and was then appointed an Assistant Professor at the Medical College of Wisconsin. 

 Dr Elcombe is the author or co-author of over 120 peer-reviewed publications and has served on several national and international advisory committees including the UK Advisory Committee on Pesticides and the UK Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment.

 Dr Peter Lord, UK

Peter Lord has a long career in cell and molecular toxicology. His pioneering work on applying molecular biology in drug safety assessment at ICI/Zeneca Pharmaceuticals led to his recruitment to establish a cell and molecular toxicology group at SmithKline Beecham (now GSK) Pharmaceuticals where his first task was to apply DNA microarray technology to investigate cardiac hypertrophy on a high profile development compound. He moved to J&J Pharmaceutical R&D in the US in 2003 to head the Mechanistic Toxicology Group.  Here he championed the use of toxicogenomics in drug safety profiling and coordinated investigative studies on a variety of drug toxicities. On his return to the UK Peter set up a company to provide consultancy services in the field of “Discovery Toxicology”.

A graduate of the University of East Anglia, United Kingdom, Peter received his doctorate in microbial cell biology from the University of Bath, and was a Postdoctoral Fellow in cancer molecular biology at the University of Liverpool. He was a founding member of the ILSI/HESI Committee on "Genomics and Proteomics in Mechanism-based Risk Assessment" also serving a term as Vice-Chairman. His J&J group’s research on predicting non-genotoxic carcinogenesis was used by the Critical Path Institute’s Predictive Safety Testing Consortium and he was an active leader on that committee.

 Dr Jeff Richig, USA

Dr Jeff Richig is an expert in preclinical safety electrocardiography with 25 years experience in the field.  He was staff cardiologist for a major pharmaceutical company for 13 years and is currently CEO of ANILAB, LLC which he founded in 1998.  Since 2009 he has been a consultant to the FDA, Cardiovascular and Renal Drugs Division, and has been on an FDA Advisory Committee.  He is currently writing a textbook entitled “Electrocardiography of Laboratory Animals”, which is scheduled to be published by Elsevier in 2013.

 Professor Tetsuo Satoh, Japan

Professor Tetsuo Satoh, Ph.D. ATS is currently Professor Emeritus, Chiba University, Director, NPO-HAB Research Institute, and Visiting Professor, Department of Toxicology, Faculty of Pharmaceutical Sciences, Showa University, Tokyo, Japan.  During a long and distinguished career he has held professorships at several other leading universities in the USA and Japan.  His many industry awards include the Education Award from the Society of Toxicology (USA) in 2010 and a Merit Award from the International Union of Toxicology (IUTOX) in 2007. 

Professor Satoh has taken a leading role in many scientific societies over the years and he is a Fellow of the Academy of Toxicological Sciences (ATS) and an Emeritus Member of the American Society for Clinical Pharmacology and Therapeutics (ASCPT) and the Pharmaceutical Society of Japan. He has served on several editorial boards and has published approximately 320 scientific articles.  His primary research interests are the molecular mechanisms of metabolic activation of pharmacologically active chemicals.  This includes studies of drug metabolising enzymes, particularly the multiplicity, characterisation and cDNA cloning of carboxylesterase isoforms in animals and humans.

 Dr Kendall B. Wallace, USA

 Dr Wallace is the founding Director of both the University of Minnesota Chemical

Toxicology Research Centre and the all-University Toxicology Graduate Program.

 His specific area of research interest concerns mitochondrial toxicities and metabolic disorders associated with pharmaceutical or environmental exposures, molecular regulation of the adaptive bioenergetic response, and mitochondrial epigenetics.  Dr. Wallace has edited scientific reference books on the topics of Free Radical Toxicology and the Molecular Biology of the Toxic Response. He has been co-Editor in Chief for Toxicology since 2001.

Dr Wallace has served on a number of scientific advisory panels and professional society committees including within the Society of Toxicology (SOT) where he was president in 2005-2006. He also served on the Board of Directors for the American Board of Toxicology (ABT) and as its Chairman in 2001-2002. He is currently Chair of the Board of Trustees for the Health and Environmental Sciences Institute and a member of the Science and Medical Advisory Board for the United Mitochondrial Disease Foundation. He is also currently serving appointments by the U.S. Department of Health and Human Services HRSA to the Medical Expert Panel of the Vaccine Injury Compensation Program (VICP) and on the Food Safety Advisory Committee of the US FDA.


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