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| Name and Educational Degree: |
| Kille, John, BA, MS, Ph.D |
A. B. Lafayette College M.S. Villanova University Ph.D. University of Virginia |
P.O. Box 69
Lebanon, NJ 08885
United States |
| Telephone: |
908-236-6182 |
| Fax: |
908-236-0921 |
| Mobile Number: |
908-625-7585 |
| Email Address: |
jwkille@embarqmail.com |
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| Practical cost- and time-conscious approaches to product development based on good science. Regulatory Strategy and program development for safety testing of pharmaceuticals, food additives, and medical devices: CRO selection, GLP study design, study placement and management. Product safety/regulatory issues resolution. Licensing and acquisition evaluation. Document preparation: tox/safety profiles, literature searches/reviews, regulatory submissions (IND/NDA, CTD, Investigational Drug Brochures, FAP, etc.), critical reviews, position papers and manuscripts. Public Relations/Affairs support: scientific outreach to key influencers, safety communication to specialty and lay audiences, product stewardship. Litigation support. |
Six years postdoctoral academic research and teaching (Cambridge Univ., Northwestern Univ.) related to reproductive physiology, developmental biology, genetics, immunology, enzymology. Subsequently over 30 years in toxicology including: 15 years Johnson & Johnson (10 yrs Ortho Pharmaceuticals - drug safety, 5 yrs McNeil Specialty Products - food additives) involving general tox, teratology, reproductive and genetic toxicology, regulatory interaction, and lobbying. Full-time consulting (drugs, food additives/ingredients, devices) since 1994. Primary expertise in developmental and reproductive toxicology. Both US and international experience. Pharmaceutical litigation support.
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