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PharmaFacts
Caroline Bell, PhD, is president and founder of PharmaFacts, an outgrowth of the expanded services of its parent company SSPCC, Inc. (Strategic Safety Pharmacology Consulting Consortium). She has been serving the Pharmaceutical Discovery and Development world since 2001. Although Safety Pharmacology remains an area of expertise, PharmaFacts services now include support on all aspects of the pharmaceutical industry and preclinical requirements (e.g. IND enabling studies and submission). With headquarters in the greater Philadelphia area, the company functions very much in a 21st century virtual mode, bringing together industry experts from all over the world, on an as needed basis, to partner with you in the facilitation and conduct of your entire Drug Discovery/Development Program.
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 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.
Pharmafacts Services:
Late Stage Discovery - Screening and selection of potential drug candidates with associated efficacy and proof of concept across species in appropriate disease models as well as early formulation, stability and pharmacokinetic work.
Strategic IND-enabling GLP, GMP Programs - As a continuum to Discovery efforts, e.g.:
Toxicology
Toxicokinetics
Analytical / bioanalytical support
Formulation and stability
Core and supplemental safety pharmacology
Data management
Statistical assessment services
Investigative Programs - To address specific issues of each unique molecule
Pharmacokinetic / pharmacodynamic modeling,
Design and investigation of optimal dosing regimens, dosing routes or absorption,
Tier 2 preclinical studies paralleling phase I-IV
Mechanism of drug action or toxicity.
Program Management
CROs - selection/quotes/oversight & monitoring
Protocol design, data and report review
Project facilitation
QA
Short term executive support
Regulatory Submissions
Electronic document management and eCTD filing
Regulatory document compilation e.g. IND,CTA, NDA
Strategic regulatory representation
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