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Abstract
Of the numerous topics discussed during the eighth annual meeting of the Safety Pharmacology (SP) Society the author identified the following key topics: i) the impact of hERG (human ether-à-go-go related gene) channel data on drug development, ii) safety evaluation of biological products, iii) opportunities and expectations from SP, iv) human stem cell derived cardiomyocytes for safety assessment, v) role of cellular calcium pathways in drug-induced arrhythmias, vi) collaboration initiatives for finding solutions to cardiac repolarisation and other recognised SP risks, vii) Pharma and FDA perspectives on ICH S7B guideline, viii) joint PhRMA–FDA dialogue on drug abuse potential assessment, ix) frontloading SP strategies for mitigating non-clinical and clinical attrition; and x) approaches to measure non-clinical assay predictability for human outcome. The establishment of consortia to accelerate the solution of critical SP issues and the implementation of Frontloading SP or Exploratory SP strategies for an early selection of safe clinical candidates are promising avenues for consolidating SP as an indispensable drug development discipline and for transforming established regulatory SP investigations into a risk-known exercise.
Acknowledgements
The author thanks KD Bruse, JD Fitzgerald, N-C Ganderup, H Holzgrefe, S Lindgren, HR Kaplan, PKS Siegl, W Redfern and JP Valentin for reviewing and improving the draft text. W Redfern, G Salama, PKS Siegl and J-P Valentin are thanked for providing their presentations, which greatly assisted me in the preparation of this report.
The author assumes full responsibility for the entire content of the report and for any portion that may not accurately reflect the presented material.