|
|
|
|
| |
| Name and Educational Degree: |
BS in Biology, Central Michigan University, 1979 Certified Project Management Professional®, 2005 |
14244 Silver Ridge Road
Poway, CA 92064
USA |
| Product development support. Strategic non-clinical program design. Toxicology and specialty study design. Non-clinical development plan preparation. Non-clinical cost estimating and budget preparation. Project timeline preparation. Team meeting facilitation. Team communications management. Management of team dynamics. Risk management planning. Study protocol preparation and review. RFP preparation and proposal review. CRO evaluation and selection. Study monitoring. Data interpretation and integration. Report preparation and review. Coordination of specialty services (pathology peer-review, clinical data management, pharmaceutical sciences, quality assurance services, etc.). Good Laboratory Practices compliance. Toxicology written and tabulated summary preparation for INDs/CTAs, Investigator Brochures, Annual Reports/PSURs, and CTDs. Experienced with FDA, EPA FIFRA and TSCA, EMEA, OECD, Japanese MAFF, MOHW and MITI, and other regulatory agencies. Preparation of Summaries of Toxicological Data for specific products (chemical or pharmaceutical). Literature searching and summary of public information for R&D programs. Nonclinical due diligence for in-license opportunities. Specializing in acute, subchronic, chronic, carcinogenicity, special, developmental, reproductive and inhalation toxicology. |
| 18 years in non-clinical CROs, five years in global project management/leadership at Pfizer and 6 years in independent consulting. Pharmaceutical: Age-related macular degeneration, Antivirals, Biologics, Devices, Diabetes, HIV, Hypercholesterolemia, Irritative bowel disease, Oncology, Pain, Psoriasis, Vaccines. Chemical: Diesel exhaust, Fire extinguishants, Flame retardants, Hazardous Air Pollutants, High Production Volume chemicals, Ozone-depletor replacements, NSRLs, Silicones. Other: Food additives, Medical materials, Veterinary products |
<< Back to Index of Consultants
|
|
|
|
|
|
|
