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Cardiovascular safety risk assessment for new candidate drugs from functional and pathological data: Conference
Stephanie K Klein1, Will S Redfern1
1Drug Safety & Metabolism, Alderley Park, Macclesfield, Cheshire SK10 4TG, United Kingdom.
Insights
This meeting highlighted the critical role of cardiovascular risk assessment in drug development. Experts fostered interdisciplinary approaches to understand and mitigate drug-induced cardiovascular adverse effects using nonclinical data.
Area of Science:
- Toxicological Pathology
- Cardiovascular Safety Pharmacology
- Drug Development Risk Assessment
Background:
- Cardiovascular adverse effects are a leading cause of drug attrition.
- A joint meeting of the British Society of Toxicological Pathology (BSTP) and the Safety Pharmacology Society (SPS) addressed this critical issue.
- The meeting focused on improving understanding and awareness of cardiovascular risk assessment in drug safety.
Framework:
- Fostering inter-disciplinary collaboration between toxicological pathology and safety pharmacology.
- Integrating functional and pathological assessments of drug-induced cardiovascular effects.
- Enhancing the translation of nonclinical safety data to human risk.
Implementation:
- Presentations covered electrophysiological and hemodynamic changes.
- Discussions included both purely functional and combined functional-pathological adverse effects.
- Focus on nonclinical safety data with human translation where available.
Implications:
- Improved cardiovascular risk assessment strategies in drug development.
- Enhanced understanding of drug-induced cardiovascular toxicity.
- Increased awareness and adoption of new technologies for safety evaluation.
Abstract:
This is a report on a 2-day joint meeting between the British Society of Toxicological Pathology (BSTP) and the Safety Pharmacology Society (SPS) held in the UK in November 2013. Drug induced adverse effects on the cardiovascular system are associated with the attrition of more marketed and candidate drugs than any other safety issue. The objectives of this meeting were to foster inter-disciplinary approaches to address cardiovascular risk assessment, improve understanding of the respective disciplines, and increase awareness of new technologies. These aims were achieved. This well attended meeting covered both 'purely functional' cardiovascular adverse effects of drugs (e.g., electrophysiological and haemodynamic changes) as well as adverse effects encompassing both functional and pathological changes. Most of the presentations focused on nonclinical safety data, with information on translation to human where known. To reflect the content of the presentations we have cited key references and review articles.
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