Safety Pharmacology Society: 9th Annual Meeting

Abstract

The keynote presentation of the Safety Pharmacology (SP) Society 9th Annual Meeting addressed the urgency, for pharmaceutical organizations, to implement strategies for effectively communicating drug risks to all concerned stakeholders and, in particular, the general public. The application of chronobiology to SP investigational protocols can improve the search of drug-induced adverse effects. The Distinguished Service Award Lecture reviewed a life-long journey through trials and tribulations in the quest of the ever-distant scientific truth. The revision process of Directive 86/609/EC for improving animal welfare should be conducted with the purpose of maintaining a fair balance among animal protection, human health and research imperatives in order to prevent the migration of pharmaceutical activities outside Europe. Additional topics of interest were the behavioral, metabolic and cardiovascular problems experienced by small animals housed at the standard laboratory temperature. A technology for the automated collection of blood and urine samples in rats implanted with telemetry sensors was presented. Non-clinical, clinical, regulatory and legal aspects of abuse liability were expertly reviewed. The ‘degradability’ of pharmaceuticals into environment-friendly chemicals should be an actively searched and optimized feature of future pharmaceuticals in order to prevent drug pollution of ecosystems. Transgenic and diseased animal models should be selected whenever they can facilitate the determination of drug-induced adverse effects. SP strategies to investigate the safety of drug combination products were exemplified and analyzed in depth. The future of SP was proposed to lie not in the performance of regulatory studies of pharmacodynamic nature but in developing and early applying an array of screening assays for clearing clinical candidates against known drug-induced organ function injuries. In conclusion, the 2009 SP Society annual meeting offered a wealth of thought-provoking material to attendees for improving SP investigation strategies.

Keywords::

• abuse liability
• automated blood and urine sampling
• chronopharmacology
• cold stress in mice housed at laboratory temperature
• Directive 86/609EC on animal welfare
• drug combinations
• green chemistry
• green pharmacy
• risk communication strategies
• Safety Pharmacology
• transgenic and diseased animal models

Acknowledgements

The author warmly thanks R Towart for reviewing diligently the entire text. Thanks are also extended to R Bilaicki, K Bruse, J-M Guillon, H Kaplan, L Kinter, I MacKenzie, E Martel, SJ Swoap and Prof TG Hammond, K Kümmerer, R Löfstedt, L Monassier and J Schaeffer for their useful and pertinent suggestions.

P Atterson, R Bilaicki, L Ewart, L Gibson, J-M Guillon, TG Hammond, J Kriegl, K Kümmerer, D Leishman, B Lemmer, R Löfstedt, E Martel, H Matter, A Mead, L Monassier, P Moser, W Redfern, J Schaeffer, SJ Swoap, J-P Valentin are thanked for providing the material of their presentations, which have been summarized or regrettably only very briefly mentioned due to the space allowed for this report.

Finally, the author assumes full responsibility for the entire content of the report and for any portion that may not accurately reflect the content of the reviewed presentations.