Caroline Bell
Strategic Safety Pharmacology Consulting Consortium
Caroline Bell, PhD, is president and founder of Strategic Safety Pharmacology Consulting Consortium (SSPCC, Inc.), bringing over 25 years of experience in core safety pharmacology and toxicology to her clients. SSPCC, Inc. provides
- Recommendation of package of preclinical studies needed for new drug applications through to Phase IV regulatory requests
- Development of Safety Assessment Package, as independent 3rd party consultant to provide unbiased selection of appropriate studies, design, and cost analysis
- Liaison and project management of CRO's, pulling together all the individual studies to centralize, oversee, and streamline the process
- Coordination and management of documentation for New Drug
Applications (NDA) and Investigational New Drugs (IND)
- Independent 3rd party review of Good Laboratory Practices (GLP)
- Lab planning and budgeting
Dr. Bell held an academic position as Assistant Professor and Clinical Assistant Professor at New York Medical College conducting research on the regulation of blood pressure and renal function specializing in eicosanoids, the renin-angiotensin and kallikrein-kinin systems. She lectured on pharmacology to graduate and medical students and at affiliated hospitals.
Before founding SSPCC, Inc. in 2001, she was an Assistant Director of Safety Pharmacology at GlaxoSmithKline Pharmaceuticals where she
- Managed generation and interpretation of safety pharmacology data to support assessment of risk/safety profile of all development compounds for IND/NDA submissions,
- Held responsibilities for the oversight of preclinical safety assessment requirements on drug development teams
- Devised and directed introduction of new methods and technologies to ensure efficient, rapid, high quality core safety pharmacology screening, and
- Oversaw preclinical toxicological issues, regulatory reports, and executive management of operations and resources.
Dr. Bell holds a Bachelors of Science with Honors in Pharmacology, Bath University of Science and Technology, UK, and PhD in Pharmacology from New York Medical College, Valhalla, NY. She did her post-doctoral work at Cornell University Medical College, NY.
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