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| Name and Educational Degree: |
Over 50 abstracts and peer reviewed publications
Post-doc Fellowship 1984-1986, Pharmacology
Dept Pharmacology, Cornell University Medical College, New York, NY
Eicosanoids, cytochrome P450 and TCDD/PCB toxicity.
Ph.D. Thesis 1979 – 1984, Pharmacology
Dept Pharmacology, New York Medical College, Valhalla, NY
Thesis Title: Antihypertensive action of captopril, an angiotensin converting enzyme inhibitor; relationship to prostaglandins
B.Sc. Hons. 1973 – 1977, Pharmacology
Dept Pharmacology & Pharmacy, Bath University; Science & Technology, Bath, Avon, UK |
21 Pin Oaks Drive
Suite 101
Phoenixville, PA 19460
USA |
| Telephone: |
610-933-9689 |
| Mobile Number: |
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| Email Address: |
cpbell@sspcc.com |
| Web Site URL: |
http://www.sspcc.com |
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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 • Safety Pharmacology Workshops and Training • 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 • 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 • Team Based Task Management • Personnel Supervision/Career Development
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| STRATEGIC SAFETY PHARMACOLOGY CONSULTING CONSORTIUM, INC President and CEO 2001 – present Independent consultant to Pharmaceutical and Biotech industry Management and oversight of outsourced studies, protocol design, data assessment and analysis, report integration and review Post-drug approval mechanistic safety assessment program Facility audit, assessment of current methodologies, GAP analysis and recommendations to meet GLP regulatory requirements for conduct of Safety Pharmacology Studies Summary 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 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 Scientific excellence and investigative contributions to allay regulatory concerns resulting in successful outcome of NDA files and support of drug development decisions Manage (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 Devise and direct introduction of new methods and state-of-the-art technologies to ensure efficient, rapid, high quality core Safety Pharmacology screening Conduct combined toxicology/safety pharmacology investigative preclinical studies for compounds in Phase II-IV of development and establish 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 Direct basic research on renal and vascular mechanisms of hypertension principally in renin-angiotensin and eicosanoid fields. Teach and mentor graduate/medical students and research fellows |
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