15 November | 19:00-21:30 pm

New Technologies For Improving Drug Safety Screening

This course will bring together experts who will discuss the use of new technologies and platforms for early, predictive drug safety screening. Focus will be on the use and validation of induced pluripotent stem cells (iPSC), 3D cell cultures and organ-on-a-chip systems. The course will be conducted in an informal, interactive setting and will provide attendees with ample time for networking and asking questions.

19:00 Welcome Remarks and Speaker Introductions

19:15 Design Rules and Fabrication Issues for Organ-on-a-Chip Systems

James J. Hickman, Ph.D., Founding Director, NanoScience Technology Center and Professor, Nanoscience Technology, Chemistry, Biomolecular Science, Material Science and Electrical Engineering, University of Central Florida

• 2D vs 3D, what are the issues?
• How best to design and build multi-organ human systems
• What are the regulatory issues for these systems?

19:45 Coffee and Dessert Break

20:00 From Simple to Complex In vitro Models of the Liver

Christopher Goldring, Ph.D., Senior Lecturer, Molecular and Clinical Pharmacology, Institute of Translational Medicine, University of Liverpool

• The importance of understanding the phenotype of models - otherwise they are black boxes
• Progress - From 2D liver cancer cell lines to primary liver cells, cultured as simple single cell models, to 3D, to complex, multicell models, incorporating flow etc.
• Are they more predictive? Does this matter?

20:30 Use of Different hiPSC-Cardiomyocyte Based Technologies in Early De-risking

Ard C.H. Teisman, Ph.D., Scientific Director, Global Safety Pharmacology, Discovery Sciences, Janssen Research & Development

• Insights in the pros and cons of different stem cell technologies for cardiovascular safety research
• Some real case example(s) of stem cell readouts in a CV de-risking flow chart

21:00 Open Discussion

21:30 End of Course

SPEAKER BIOGRAPHIES

James J. Hickman, Ph.D., Founding Director, NanoScience Technology Center and Professor, Nanoscience Technology, Chemistry, Biomolecular Science, Material Science and Electrical Engineering, University of Central Florida

James J. Hickman is the Founding Director of the NanoScience Technology Center and a Professor of Nanoscience Technology, Chemistry, Biomolecular Science, Material Science and Electrical Engineering at the University of Central Florida. Previously, he held the position of the Hunter Endowed Chair in the Bioengineering Department at Clemson University. Dr. Hickman has a Ph.D. from the Massachusetts Institute of Technology in Chemistry, as well as BS and MS from Penn State University in Chemistry. For the past twenty-five years, he has been studying the interaction of biological species with modified surfaces, first in industry and in the latter years in academia. While in industry he established one of the first bioelectronics labs in the country that focused on cell-based sensors and their integration with electronic devices. He has extensive experience in surface modification and surface analysis for biological and neuroscience applications, and the integration of these systems with MEMS devices and components. He is interested in creating hybrid systems for biosensor and biological computation applications and the creation of functional in vitro systems for human body-on-a-chip applications. He has worked at NSF and DARPA in the area of biological computation. He is also the founder and current Chief Scientist of a biotechnology company, Hesperos, that is focusing on cell-based systems for drug discovery and toxicity. He has 112 publications and 18 book chapters, in addition to 26 patents.

Christopher Goldring, Ph.D., Professor, Molecular and Cellular Pharmacology, MRC Centre for Drug Safety Science, University of Liverpool, U.K.

Chris Goldring has more than twenty years of experience of molecular bioanalysis, working with cell culture and in vivo models. He leads the molecular and cellular toxicology group within the MRC Centre for Drug Safety Science (CDSS), a leading UK centre based at the University of Liverpool, with a critical mass of scientists studying mechanisms of adverse reactions to drugs, and which is the coordinator of the Mechanism-based Improved Prediction of Drug-Induced Liver Injury (MIP-DILI) IMI programme. He plays a leading role in the new IMI project TransQST, which will develop quantitative systems toxicology models to improve our understanding of adverse drug reactions. He is also leading the liver project in the UK Regenerative Medicine Safety platform, developing innovative methods for the assessment of the safety of stem cells and regenerative therapies, including cell labelling using nanoparticles and cell tracking. He has current MRC, IMI, and North-West Cancer research fund support. He is programme director of the Pharmacology degree programme at Liverpool, and he runs Masters teaching programmes on Innovative methods of in vitro safety assessment and Stem Cells in the IMI Safescimet training programme.

Ard C.H. Teisman, Ph.D., Scientific Director, Global Safety Pharmacology, Discovery Sciences, Janssen Research & Development

Ard C.H. Teisman obtained a degree in Biology (1992) at the University of Groningen (The Netherlands) with majors in CNS and Pharmaco-chemistry. After finishing his degree he held an interim position as a junior researcher in Asthma Research (dept. of Molecular Pharmacology; University Center for Pharmacy, University of Groningen). In 1998 Ard obtained his PhD at the dept. of Clinical Pharmacology (Faculty of Medicine, University of Groningen) where he explored potential new therapies for the treatment of Heart Failure. Following this he held a Postdoc position in cardio-renal pharmacology. Then in 2001, Ard joined as a research scientist the Center of Excellence for Cardiovascular Safety Research of Janssen Pharmaceutica NV (Beerse, Belgium), a Johnson & Johnson company. Ard assumed roles of increasing responsibility towards his current role as deputy head of global safety pharmacology and group leader of Discovery De-Risking. In his current position he supports many discovery projects across Janssen R&D, guiding the scientists, from a Safety point of view, in their compound selection decisions. In addition, he is actively involved in general safety related study designs, analysis and interpretation, basic research projects and preclinical to clinical translational exercises. Finally, he gives lectures on safety pharmacology both internally and externally (for university students) and is the chair person for the Janssen campus Ethics Committee for Animal Research.