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| Name and Educational Degree: |
| Bell, Caroline, BS, Ph.D. |
Post-doc Fellowship 1984-1986 Toxicology &Pharmacology, Cornell University Medical College, NY.
Eicosanoids, cytochrome P450 and TCDD/PCB toxicity.
Ph.D. Thesis 1979 – 1984 Pharmacology, New York Medical College, NY
Thesis Title: Antihypertensive action of captopril, an angiotensin converting enzyme inhibitor; relationship to prostaglandins
B.Sc. Hons. 1973 – 1977 Pharmacology, Bath University, UK
Over 50 abstracts and peer reviewed publications
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21 Pin Oaks Drive
Suite 101
Phoenixville, PA 19460
United States |
• Safety Pharmacology (ICH S7A/B core, cardiovascular, renal, respiratory, CNS, special topics and phase II-IV preclinical investigative evaluations
• Toxicology
• IND Enabling Studies
• Project Management
• Drug Development Programs
• GLP Audit
• Academic Alliances
• CRO Selection
• Study Placement and Monitoring
• Data Analyses
• Report Review and Summary Documents
• Regulatory Submissions
• Scientific Literature Review and Position Pieces
• Senior Core Consultant
• Market Analyses
• Investigative Toxicology (Cardiovascular and Renal issues)
• Mechanisms of Blood Pressure Regulation (Renin-Angiotensin, Eicosanoids and Endothelins)
• Strategic and Technical Laboratory Management
• Experimental and Systems Design (Conscious Animal and Renal Clearance Models, Pharmacodynamic/Pharmacokinetic Studies, Data Acquisition, Integrated Telemetry, Ultrasonic Flow Probe, Echo Ultrasonography and Bioimpedence)
• Discovery Research
• Teaching and Mentorship
• Safety Pharmacology Workshops and Training
• Team Based Task Management
• Personnel Supervision/Career Development
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Dr. Bell can provide over 25 years of experience in regulatory toxicology and safety pharmacology as well as the collective experience of over 30 consultants through PharmaFacts, please see website for more details. See more specifics on Dr.Bell’s experience below:
PHARMAFACTS (Formerly SSPCC), Phoenixville, PA
President and CEO (2001 – present)
· Broad range of experience in consulting, primarily on IND-enabling requirements.
· Creation and Management of network of Independent Consultants providing a wide range of expertise for consultation in Pharmaceutical and Biotech industry advising across all therapeutic areas
· Management and oversight of outsourced studies, protocol design, data assessment and analysis, report integration and review
· Post-drug approval mechanistic safety assessment programs
· Facility audit, assessment of current methodologies
· Gap analysis and recommendations to meet GLP regulatory requirements for conduct of Toxicology and Safety Pharmacology Studies
· Summaries of documents on current basic and medical research and preparation of position papers in response to regulatory questions
· Market analysis reports on outsourcing service providers
· Course Director; Workshops to Pharmaceutical Industry
GLAXOSMITHKLINE PHARMACEUTICALS, King of Prussia, PA
Assistant Director, Safety Pharmacology, Department of Preclinical Safety Assessment 1999 – 2001; Senior Investigator, Safety Pharmacology, Department of Preclinical Safety Assessment 1994 – 1999
· Was part of international, multidisciplinary teams responsible for entire drug development programs, e.g. Angiotensin and Endothelin Antagonists, Insulin Sensitizers, Erythropoietin Agonists, GPIIb/IIIa Preclinical toxicological issues and regulatory reports
· Executive management of operations and resources
· Provided scientific excellence and investigative contributions to allay regulatory concerns resulting in successful outcome of NDA files and support of drug development decisions
· Managed (in-house and CRO) generation and interpretation of safety pharmacology data (specialty in cardiovascular and renal) to support assessment of risk/safety profile of all development compounds for IND/NDA submissions
· GLP Study Director; Devised and directed introduction of new methods and state-of-the-art technologies to ensure efficient, rapid, high quality core safety pharmacology screening
· Conducted combined toxicology/safety pharmacology studies and methods development
· Investigated preclinical studies for compounds in Phase II-IV of development and established alliances with academic institutions for drug-specific investigative studies
NEW YORK MEDICAL COLLEGE, Valhalla, NY
Adjunct Clinical Assistant Professor, Department of Pharmacology (1995 – 2000);
Assistant Professor, Department of Pharmacology (1986 – 1994)
· NIH, AHA and NY State Funded Investigator
· Directed basic research on renal, cardiac and vascular mechanisms of hypertension principally in renin-angiotensin and eicosanoid fields.
· Taught and mentored graduate/medical students and research fellows
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