Comparative Placental Transfer of Biologics: Preclinical Alternatives to the Nonhuman Primate

Biosimilars, Drug Discovery and Development, Life Sciences, Pharmaceutical, Preclinical,
  • September 24, 2014

Understanding the placental transfer of biologics has traditionally involved studies with nonhuman primates. However, other animal models may be viable alternatives.

Unlike small molecule drugs, large molecule biopharmaceuticals do not undergo placental transfer by simple diffusion and can therefore offer reduced risk of exposure to the developing embryo and fetus. Antibody-like biopharmaceuticals, however, undergo placental transfer utilizing a receptor-mediated mechanism used for the transport of maternal antibodies to the conceptus. Binding to fetal targets has the potential to adversely affect development.

This session will provide latest information concerning mAb placental transfer, including human IgG1 in the mouse, comparing results to other laboratory species such as rats and minipigs. The discussion will seek to put into perspective the relevance of using these animal models during the development of antibody-like biotherapeutics.

Speakers

Edward Marsden, Associate Director and Head of Reproductive and Developmental Toxicology, WIL Research

Edward Marsden is an Associate Director and Head of Reproductive and Developmental Toxicology at WIL Research Europe – Lyon, France, where he has worked since 1994. He is responsible for both the scientific and technical staff, specialising in DART and juvenile toxicology studies and for planning future methods and developments in these fields. Previously, Edward worked in the UK for five years where he trained as a reproductive toxicologist with another major contract research organisation. He is a EUROTOX Registered Toxicologist, a council member of the European Teratology Society and member of the British and French Toxicology Societies. In addition to preparing numerous posters for presentation at scientific meetings, Edward is author/co-author of a number of publications and chapters from books including The Minipig in Biomedical Research and Teratogenicity Testing, Methods and Protocols.

Eddie Sloter, Associate Director of Developmental and Reproductive Toxicology, WIL Research

Eddie D. Sloter, PhD, is Associate Director of Developmental and Reproductive Toxicology at WIL Research in Ashland, Ohio. He graduated with honors from the University of Rio Grande with a Bachelor’s degree in Biology and earned a doctorate in Genetics and Developmental Biology from West Virginia University, in conjunction with six years of graduate research and postdoctoral training in human reproductive health at the University of California, Berkeley, School of Public Health and the Health Effects Division of the Biology and Biotechnology Research Program at Lawrence Livermore National Laboratory. He has 11 years of experience at WIL Research and has served as study director on approximately 250 DART studies. He has published several scientific manuscripts, book chapters, and abstracts and holds professional memberships in the Teratology Society and Middle Atlantic Reproduction and Teratology Association. Eddie is an adjunct professor in the area of applied developmental and reproductive toxicology at Ashland University and the University of Cincinnati and is actively involved in Ohio’s Scholarship of Entrepreneurial Engagement Science and Technology Program.

John DeSesso, Principal Scientist and Office Director in Exponent’s Center for Toxicology and Mechanistic Biology, Exponent

John M. DeSesso, PhD, DABFM, DABFE, FACFEI, CHS-V, Fellow ATS is a Principal Scientist and Office Director in Exponent’s Center for Toxicology and Mechanistic Biology. He holds a Bachelor’s degree in chemistry from Hamilton College and a doctorate in Anatomy and Teratology from the Medical College of Virginia, Virginia Commonwealth University. He has 40 years of experience specializing in the areas of developmental and reproductive toxicology, general toxicology, risk assessment, and human health effects of environmental agents and Pharmaceuticals. His research interests include normal and abnormal development, with emphasis on the mechanisms by which chemical and physical agents gain access to and influence developing organisms. John is an adjunct professor of Biochemistry and Cellular & Molecular Biology at Georgetown University School of Medicine where he has taught for over 30 years. He is active in 14 scientific societies and was elected President of the Teratology Society, the Middle Atlantic Reproduction and Teratology Association (MARTA), and is currently president of the Risk Assessment Specialty Section of the Society if Toxicology; he served nine years as an Executive Board member of the Federation of American Societies of Experimental Biology (FASEB). He is a frequent contributor to continuing education courses that deal with toxicology and risk assessment. He has provided public commentary regarding scientific issues before federal agencies, state legislatures, and congressional committees.

Don Stump, Vice President, Nonclinical Safety Science, WIL Research

Don Stump, PhD, earned his degree in biochemistry from Vanderbilt University in Biochemistry and received post-doctoral training at the National Institutes of Health. He has been employed at WIL Research since 1994 and his current title is Vice President of Nonclinical Safety Science, U.S. In this role he oversees the General Toxicology, Developmental and Reproductive Toxicology, Genetic Toxicology and Pathology departments at WIL Research. Don has published numerous research articles, book chapters and abstracts. He has also made several presentations at regional and national meetings including meetings hosted by the American College of Toxicology, Society of Toxicology, Teratology Society, Korean Society of Nonclinical Study and the North American Congress of Clinical Toxicology. He is currently on the journal editorial board for both Birth Defects Research Part B: Developmental and Reproductive Toxicology and Congenital Anomalies. He is a diplomat of the American Board of Toxicology and a member of the Teratology Society, the European Teratology Society, the Japanese Teratology Society, the Society of Toxicology, the Mid-Atlantic Reproduction and Teratology Society and the Japanese Society of Toxicology.

Who Should Attend?

VPs, Directors, and Managers in the following areas:

  • Preclinical/Clinical Pharmacology
  • Preclinical/Clinical Safety
  • Preclinical/Clinical Research or Clinical Development
  • Preclinical/Clinical Operations
  • Drug Development Research & Development
  • Toxicology

Xtalks Partners

WIL Research

WIL Research provides world-class research and development services for Pharmaceutical and chemical organizations. The company combines scientific expertise with an eagerness to truly listen and understand client needs. With more than 64,000 square meters of laboratory space and offices in North America, Europe and Asia, WIL Research offers extensive resources over a broad range of services. Areas of expertise include general toxicology, developmental and reproductive toxicology, juvenile toxicology, neurotoxicology, inhalation toxicology, infusion toxicology, genetic toxicology, pathology, safety pharmacology, ecotoxicology, environmental fate, immunochemistry, analytical/bioanalytical chemistry and ADME. The experts at WIL Research can also help with worldwide regulatory and compliance issues. The more than 1,100 team members, many with advanced degrees, have completed thousands of projects, often pioneering new techniques along the way. These skilled researchers use their scientific knowledge and their advanced listening skills to develop customized solutions that match the specific requirements of each project.

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