SPS Activities Update

The Board of Directors of the Safety Pharmacology Society (SPS) continues to see how the Society can add value to its members and also to be seen as an influential scientific body.  To achieve the latter members of the Society are engaged in many scientific bodies and academics that seek to advance basic science and also to influence how safety pharmacology can have a greater impact on the drug discovery and development process.  In just one area, cardiovascular research, members of the SPS are involved in a number of initiatives directed at improving our ability to detect signals related to cardiovascular risk. These initiatives range from understanding future clinical risks and how these may be identified in non-clinical studies to defining best practice to detect signals of known risks.  These initiatives include, for example:

• SPS cardiovascular best practices meeting will be focused on identifying technical solutions to improve assay sensitivity and specificity.  This has come about because the safety pharmacology discipline is now asking new questions of the non-clinical studies, that is can we predict small changes in cardiovascular end points (e.g. 10 msec changes in QTc or 2-3 mmHg rises in blood pressure) that may be relevant to Phase II/III toleration and/or are of regulatory concern.  The Safety Pharmacology community is responsible for the design and conduct of SP studies required to meet these new challenges and is best placed to develop new study designs to address these new expectations of our studies,


• ILSI/HESI Cardiac Safety has a number of subgroups investigating biomarkers of cardiac safety, proarrhythmia/QT model and structural and functional cardiotoxicity evaluation.  These groups have representatives from academia, industry and regulators and tend to operate over a longer time period to develop strategic solutions to complex problems.


• Top Institute (TI) Pharma - Cross species sensitivity and cardiovascular outcome. Participant companies, primarily through their SPS members, are involved in PK/PD oriented collaboration to examine the translation of QTc changes from animals to man.  This initiative has the potential to demonstrate the exciting benefits of PK/PD modeling into safety pharmacology.


• Animal Model Framework – this represents a data sharing collaboration involving SPS members to share data from safety pharmacology studies and first in human studies to address key questions on translation and utility.


• Society of Toxicology cardiovascular specialty section has just been launched and is likely to have a bias towards, but not exclusively, cardiovascular safety in toxicology and structural changes that will complement the dynamic end points in safety pharmacology studies. 


• Cardiovascular Toxicity of Medicines sponsored by the UK Medical Research Council.  This workshop brought together representatives from academia, industry and regulators with the goal of identifying areas of cardiovascular safety requiring future research.  This will be followed up through deeper discussion of selected topics.


• Cardiac Safety Consortium is designed to sponsor pragmatic research that will inform regulatory processes and to create common nomenclature, standards and draft regulatory guidance.  This initiative has been built upon the principals of the FDA Critical Path Initiative involving clinical and non-clinical experts.


• Stem cells for safer medicines is seeking to advance scientific techniques that will develop stem cell technologies to support earlier safety testing, for example cardiomyocytes.

As you can see members of the Society are involved in many initiatives, and this is not an exhaustive list of those related to cardiovascular safety.  We would encourage members of the society to participate, when ever possible, in these projects since many of them will influence the way we work in the future.

Board of Directors, Safety Pharmacology Society