Posts by tburt
The Phase-0/Microdosing Network
The Phase-0 Microdosing Network, a non-profit organization, is an international consortium of inter- and cross-disciplinary drug development stakeholders. These stakeholders share interest in the potential of Phase-0 including microdosing approaches to increase the efficiency and productivity of drug development. It was created to share news and ideas relevant to the research and applications of these approaches and increase…Read More
Phase-0 Including Microdosing Approaches
Phase-0 drug development trials are clinical development approaches that include microdosing trials. These approaches are sometimes called ‘Exploratory Clinical Trials’ ‘Exploratory Investigational New Drug (eIND)’ applications. Phase-0 studies are aimed at providing human data to support selection of preclinical drug candidates prior to entering clinical development. Phase-0 trials use limited exposure to the drug (lower…Read More
Bianca D. van Groen, Pharm.D., Ph.D.
Dr. van Groen is a DMPK/PD project leader at Roche Pharmaceutical Research and Early Development in Basel, Switzerland. She conducted her Ph.D. (cum laude) at the Erasmus MC – Sophia Children’s Hospital, where she was the coordinating scientist for a pediatric microtracer study on the intensive care unit. With this experience and her current position…Read More
Kirsten Anderson is currently Senior Vice President of Clinical Development at Presage Biosciences, responsible for strategic oversight of all aspects of clinical trials, including trial design, regulatory, operations, pharmacovigilance, and biometrics. Kirsten has nearly 30 years of experience in the pharmaceutical industry, with expertise in oncology drug development. She has held clinical trial management positions…Read More
Joseph A. DiMasi, Ph.D.
Dr. DiMasi is Director of Economic Analysis and Research Associate Professor at the Tufts Center for the Study of Drug Development, Tufts Medical School, Tufts University. The Center is an independent non-profit multidisciplinary research organization that is committed to the exploration of scientific, economic, legal, and public policy issues related to pharmaceutical and biotechnology research, development,…Read More
Wouter H.J. Vaes, Ph.D.
Dr. Vaes heads the Dept of Human Biology within the Netherlands Organisation for Applied Scientific Research (TNO). He received his Ph.D. at the Research Inst of Toxicology at Utrecht Univ. Thereafter, he started working at TNO where he has been leading the Nutrients and Biomarker Group for about ten years. Dr. Vaes has managed programs on…Read More
Oliver Langer, Ph.D.
Dr. Langer is Associate Professor at the Medical University of Vienna in Austria (Department of Clinical Pharmacology) and a Senior Scientist at the AIT Austrian Institute of Technology GmbH. He has studied pharmacy at the University of Vienna (Austria) and has received his Ph.D. degree from the Karolinska Institute in Sweden. In his research, he uses preclinical…Read More
Saskia N. de Wildt, M.D., Ph.D.
Dr. de Wildt is a pediatric intensivist and associate professor in pediatric clinical pharmacology at Erasmus MC Sophia Children’s Hospital and serves as the Director of PharmaKids, the Erasmus Expertise Ctr for Pediatric Therapeutics and the Medicines for Children Research Ctr-the Netherlands. She received her Ph.D. from Erasmus Univ and trained as a clinical pharmacologist at the…Read More
Yuichi Sugiyama, Ph.D.
Dr. Sugiyama has been the Head of Sugiyama Laboratory, RIKEN Innovation Ctr, RIKEN Research Cluster for Innovation, Yokohama, Japan since April 2012. He had been Professor, Dept of Molecular Pharmacokinetics at the Univ of Tokyo since 1991 until 2012. His work is internationally recognized by many awards, including the American Association of Pharmaceutical Scientists Distinguished Pharmaceutical…Read More
Malcolm Rowland, Ph.D.
Dr. Rowland is a pioneer of Clinical Pharmacology including microdosing approaches. He is professor Emeritus, University of Manchester, and Adjunct Professor, University of California San Francisco. He received his B.Pharm (1961), Ph.D. (1965), and D.Sc (1982) from University of London. He was a faculty member, School of Pharmacy, University of California San Francisco (1967-75). He…Read More