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Abstract
The 10th annual meeting of the Safety Pharmacology (SP) Society covered numerous topics of educational and practical research interest. Biopolymers – the theme of the keynote address – were presented as essential components of medical devices, diagnostic tools, biosensors, human tissue engineering and pharmaceutical formulations for optimized drug delivery. Toxicology and SP investigators – the topic of the Distinguished Service Award Lecture – were encouraged to collaborate in the development of SP technologies and protocols applicable to toxicology studies. Pharmaceutical companies, originally organizations bearing all risks for developing their portfolios, are increasingly moving towards fully integrated networks which outsource core activities (including SP studies) to large contract research organizations. Future nonclinical data are now expected to be of such high quality and predictability power that they may obviate the need for certain expensive and time-consuming clinical investigations. In this context, SP is called upon to extend its risk assessment purview to areas which currently are not systematically covered, such as drug-induced QRS interval prolongation, negative emotions and feelings (e.g., depression), and minor chronic cardiovascular and metabolic changes (e.g., as produced by drugs for type 2 diabetes) which can be responsible for delayed morbidity and mortality. The recently approved ICH S9 guidance relaxes the traditional regulatory SP package in order to accelerate the clinical access to anticancer drugs for patients with advanced malignancies. The novel FDA ‘Animal Rule’ guidance proposes that for clinical candidates with well-understood toxicities, marketing approval may be granted exclusively on efficacy data generated in animal studies as human clinical investigations for these types of drugs are either unfeasible or unethical. In conclusion, the core messages of this meeting are that SP should consistently operate according to the ‘fit-for-purpose’ principle and gradually integrate new mechanism-oriented safety paradigms into the traditional ones for ensuring more effectively the safety of drugs for any population of patients in need.
Acknowledgements
The author warmly thanks H Holzgrefe for reviewing thoroughly this text. G Bode, K Bruse, AM Dahlem, G Gintant, JM Guillon, P Hoffman, KI Kaitin, R Langer, J Leighton, E Liebelt, FJ Marsik, C Regan, F Rossi, R Towart, P Siegl, DC Throckmorton, H Vargas and P Zitoun are thanked for their suggestions, which helped the author to ameliorate this report. Particular thanks are extended to AS Bass, A Brown, K Cannon, AM Dahlem, A Easter, C Ferris, P Hoffmann, L Kinter, R Langer, E Liebelt, FJ Marsik, J Ruskin, R Shebuski, F Selke and DC Throckmorton for providing their presentations, which have been of great help in the preparation of some parts of this report. The author assumes full responsibility for the entire content of the report and for any portions that may not accurately reflect the reviewed presentations.