Gerhard F. Weinbauer Livres

The 19th Covance Primate Symposium was held in Münster on May 23-24, 2012, with 70 participants from 43 organizations. This year's focus was on "Challenges in Nonhuman Primate Research in the 21st Century." The diverse attendance and engaging discussions highlighted the relevance of the topic. Expert speakers addressed four key areas: the development of biosimilars, optimizing nonhuman primate use in nonclinical safety assessments, trends in developmental and reproductive toxicology (DART), and the significance of nonhuman primate models in regulatory toxicology. The acceleration of biosimilar development has introduced uncertainties, prompting the need for evolving guidelines. As biopharmaceuticals gain prominence, optimizing the use of nonhuman primates is crucial, necessitating refined study designs and animal numbers while ensuring meaningful preclinical studies. Progress has been noted in this area. Recent guideline changes in DART and juvenile toxicity evaluations have influenced species selection and study designs within preclinical programs. With increasing regulations surrounding the use of nonhuman primates, it is vital to recognize their essential role in drug safety evaluations and medical development.

The 18th Covance Primate Symposium took place in Münster on October 5-6, 2010, with a record attendance of 143 participants from 16 countries and 57 organizations. This year's focus was on “Future Trends in Primate Toxicology and Biotechnology,” highlighting the relevance of the theme through engaging discussions. Expert speakers addressed four key topics: Proteomics & Genomics, Developmental & Reproductive Toxicology (DART), Safety Pharmacology, and Immunotoxicology. The sequencing of primate genomes has provided insights into the origins of laboratory nonhuman primates, facilitating animal selection based on genetic profiles. In DART, advancements in biopharmaceutical development and updated guidelines have led to more sophisticated studies involving juvenile toxicity evaluations and the use of sexually mature monkeys. Safety pharmacology is evolving with refined experimental designs, emphasizing cardiovascular safety in drug development, prompting updates to guidelines. The session on immunotoxicology explored contemporary regulatory perspectives on monoclonal antibodies, including guideline updates and reviews concerning the immune system and drug development. Notable contributors included B. Anand, J. Beyer, and many others, underscoring the collaborative nature of this important field.

The 17th Covance Primate Symposium was held in Münster on April 16 and 17, 2008, with a record attendance of 131 participants from 13 countries and 56 organizations. The focus was on the "Critical Contributions of Primate Models for Biopharmaceutical Drug Development," a timely topic given the rise of biopharmaceuticals, particularly monoclonal antibodies, in preclinical development where nonhuman primates serve as key models. The symposium also addressed changes in environmental conditions for primates in research, particularly in Europe, and their implications for pharmaceutical development. Additional discussions included developmental and juvenile toxicity testing and the potential of stem cell-derived therapeutics. Experts presented on four main topics: the promise of stem cell-derived therapeutics, the European environment for primate research as a potential barrier or opportunity, innovative approaches to developmental and juvenile toxicity testing, and the current challenges faced in biopharmaceutical drug development. Notable contributors included Alexander Breidenbach, Christian Freichel, Werner Frings, and others, reflecting a diverse range of expertise in the field. The demand for research involving nonhuman primates in preclinical development is expected to grow in the coming years.

In continuation of the Covance Primate Symposium Series, the 15th Covance Primate Symposium was held in Münster during September 2004. The symposium's theme was „New Developments and Challenges in Primate Toxicology“ with specific contributions to the topics immunotoxicity testing, reproductive/developmental/juvenile toxicity evaluation, QT prolongation and new trends/techniques/models. There is obviously increased awareness of the advantages and superior relevance of nonhuman primate models for assessing toxicity to specific and selected target organ systems. The advent of biotechnology and the resulting preclinical development of biologics (large molecules, antibodies etc.) with highly confined species specificity frequently render the nonhuman primate the only relevant model available for toxicity studies. Hence, it is pivotal that specialists and experts meet on a regular basis to exchange new ideas, methods and prospects for primate toxicology. This publication represents the 4th book of the Covance Primate Symposium Series. Contributors Andreas Bauer, Martin Bergmann, Gerd Bode, Roland Brandt, Eberhard Buse, Jeanine L. Bussiere, Joy A. Cavagnaro, Werner Frings, Stefanie Friderichs-Gromoll, Jörg Gromoll, Gunnar Habermann, Joachim Kaspareit, C. Marc Luetjens, David R. Mann, Wolfgang Müller, Marc Niehoff, Kerstin Niggemann, Piotr Nowak, Petra Stute, Gerhard F. Weinbauer, Joachim Wistuba, Karl Zilles, Ulrich Zühlke.

Animal models are essential for unravelling basic aspects of mammalian reproduction and for preclinical safety testing of compounds intended for clinical use. From the disatrous experience with thalidomide in the sixties it became clear that for extrapolation to the human the choice of the animal model is critical, and nonhuman primates are being used since then in experimental studies on reproductive physiology and toxicology. This book compiles contributions on selected topics of reproductive physiology and toxicology written by internationally recognized experts in an attempt to address the role and usefulness of nonhuman primates as model systems for human reproduction.