Nirmala Bhogal

Translation of new technologies: from basic research to drug discovery and development.

Despite increasing investment in drug discovery and development, only around one in every ten new medicinal products that progresses to clinical testing ever reach from the registration stage. Approximately half of all drug failures are attributed to problems with efficacy and toxicity not anticipated from preclinical studies. As a consequence, the pharmaceutical industry is adopting a much more flexible and multi-disciplinary approach to drug discovery and development. Indeed, the line between basic and applied science is constantly being eroded, not least because of the increasing sophistication of therapeutic procedures and the complexity of the diseases that they aim to treat. Here, we look at the new technologies that are being explored as a way of reducing drug attrition rates and the development of chemical drugs and biotherapeutics. Specifically, we will consider the ways in which genomics and related disciplines, engineered cell-based and microfluidics systems, and nanotechnologies are being developed and used alongside in silico platforms during early drug pharmacokinetics and toxicity studies. The way in which information from such systems biology-oriented approaches can be integrated with information from animal based preclinical safety, toxicological and pharmacological studies on investigative medicinal products is considered, in view of its current and possible impact on clinical trial design.

New technologies for toxicity testing

Current Developments in Cell Culture Technology.- Embryonic Stem Cells in Safety Pharmacology and Toxicology.- Trends in Cell Culture Technology.- Tissue Engineering in the Development of Replacement Technologies.- Toxicity Testing of Nanomaterials.- Physiologically-Based Pharmacokinetic (PBPK) Models in Toxicity Testing and Risk Assessment.- In Silico Methods for Toxicity Prediction.- Luminescent Quantum Dots for Molecular Toxicology.- Engineering Quasi-Vivo(R) In-Vitro Organ Models.- ECVAM and New Technologies for Toxicity Testing.- Medium to High Throughput Screening: Microfabricat ion and Chip-Based Technology.- The Use of Genomics in Model In Vitro Systems.- The Use of Integrated and Intelligent Testing Strategies in the Prediction of Toxic Hazard and in Risk Assessment.