Ken Kearney has more than 20 years of experience in preclinical drug development, specializing in safety pharmacology and toxicology. His career has taken him from hands-on physiological monitoring and GLP study direction to scientific leadership roles within major contract research organizations and the pharmaceutical industry. Ken has supported drug candidates from early discovery and lead optimization through IND-enabling studies and regulatory submissions, gaining a comprehensive perspective on the nonclinical development process.

Ken works with pharmaceutical, biotechnology, and contract research organizations to strengthen both the scientific and operational foundations of preclinical drug development. For drug developers, he provides strategic guidance to identify potential safety risks, inform development decisions, and support the progression of promising therapies toward clinical evaluation. He also helps CROs establish, expand, and optimize their safety pharmacology and toxicology programs, drawing on his experience in scientific leadership, laboratory operations, and regulated research environments. Having worked on both sides of the sponsor-CRO relationship, Ken understands how to align scientific objectives with the infrastructure, expertise, and processes required for successful execution.

• Safety Pharmacology & Toxicology Strategy: Advising on integrated nonclinical safety strategies spanning cardiovascular, respiratory, CNS, and general toxicology assessments, including oncology development programs. Supporting target safety evaluation, lead optimization, candidate selection, and early identification of potential safety liabilities to inform development decisions.
• Nonclinical Study Design & Regulatory Support: Providing guidance on species selection, group sizes, statistical power, endpoints, and protocol development. Supporting the design and execution of IND-enabling studies, preparation of regulatory documentation, and development of submission strategies.
• Telemetry Program Development & Validation: Helping laboratories establish and expand jacketed and implantable telemetry capabilities, including advising on equipment selection, system configuration, IQ/OQ/PQ qualification, biovalidation, and user acceptance testing.
• Cardiovascular & Physiological Monitoring Strategy: Applying extensive expertise in ECG and EEG interpretation, cardiovascular physiology, respiratory monitoring, and hemodynamic assessment to guide monitoring methodologies, endpoint selection, signal quality requirements, and the sensitivity of preclinical safety studies.
• GLP Readiness & Quality Systems: Supporting the development of GLP-aligned laboratory workflows, validation protocols, SOPs, and data integrity practices. Advising research organizations on quality assurance requirements and the integration of new technologies into regulated study environments.
• Technical Training & Operational Consulting: Training research teams in telemetry operation, study setup, physiological data acquisition, and technical troubleshooting. Advising CROs on staffing, laboratory workflows, equipment utilization, and the development of sustainable safety pharmacology capabilities.

Ken believes effective preclinical safety assessment begins with asking the right scientific questions and establishing reliable methods to answer them. His approach emphasizes thoughtful study design, meaningful endpoints, and a clear understanding of what the resulting data can reveal about potential safety risks. He recognizes that scientific rigor must be supported by practical execution and that well-designed programs can improve efficiency while supporting animal welfare and the principles of the 3Rs. Through his work, Ken strives to help research teams build confidence in their methods, make informed development decisions, and identify potential challenges before they become costly setbacks.

Experimental Design
Data Collection
Data Analysis
Report Generation
Interpretation
Risk Assessment
Regulatory & Compliance
Training Services
Product Development