| | | Jane S. Allen, Ph.D., D.A.B.T. | | | | | | | | Expert Toxicology Consultant / Toxicologist | | | - Pharmaceutical and Biotechnology Regulatory Toxicology,
including INDs, NDAs, CTDs, Non-Clinical Strategy and Pre-Clinical Document Preparation - Special Expertise in Alternative Carcinogenicity Testing and Genetic Toxicology
- Diplomate American Board of Toxicology
| | Summary of Professional Experience: | | | INDEPENDENT CONSULTANT, Raleigh, NC 27613 2002-Present Toxicology and management consultant Provide services to pharmaceutical and chemical companies, trade groups and CROs
GLAXOSMITHKLINE/ GLAXO WELLCOME INC./ GLAXO INC., Research Triangle Park, NC USA 2000-2001 Director, Toxicology, GSK 1997-2000 Head, Toxicological Sciences, GW 1995-1997 Group Toxicologist, GW 1990-1995 Principal/Divisional Toxicologist, Drug Safety Assessment, Glaxo 1989-1990 Department Head, Comparative Pathobiology, Glaxo 1987 1989 Senior Staff Toxicologist, Glaxo 1986 1987 Assistant Director, Medical Services, Glaxo
INDEPENDENT CONSULTANT, Raleigh, NC USA 1986-1987
AMERICAN CYANAMID COMPANY, Agricultural Research Division, Princeton, NJ USA 1984 1986 Manager, Global Toxicology 1981 1984 Group Leader, Genetic Toxicology 1979 1981 Group Leader, Biotechnology and Mutagenesis 1977 1979 Research Biologist
DETAILS OF EXPERIENCE:
GLAXO WELLCOME / GLAXO INC., Research Triangle Park, NC
1997-2001 Director, Toxicology, Medicines Safety Evaluation (MSE) Head, Toxicological Sciences | | Description: | | | Dr. Allen has 25 years experience in Regulatory Toxicology, most recently as Director of Toxicology at GlaxoSmithKline. Solid track record of Toxicology Problem-Solving and successful IND, NDA and European Submissions. Presentations to FDA. Member ILSI Committee on Alternative Carcinogenicity Assays. Member US Pharma ICH Genetic Toxicology Task Force. Served on NIEHS and EPA committees. Practical experience with Pharmaceutical, Chemical and Biotechnology Toxicology. | | Contact information | | | Jane S. Allen, Ph.D., D.A.B.T. Jane Allen Consulting, Inc. 2909 Kenwick Ct. Raleigh, NC USA 27613 Phone: 919 846 0874 Fax: 919 518 1425 Email: janeallentox (at) bellsouth.net Website:http://rtctox.com/allen.htm Resume
| | | | | | | Forensic Expert Witness: | | | Not willing to serve as Expert Witness | | | | No experience as Expert Witness | | | | | | Dictionary of Abbreviations and Acronyms used: | | Ctd | Common Technical Document | | | Cro | Contract Research Organization | | | Dabt | Diplomate of the American Board of Toxicology | | Epa | Environmental Protection Agency | | Fda | Food and Drug Administration | | | Glp | Good Laboratory Practices | | | Ich | International Conference on Harmonization | | Ilsi | International Life Sciences Institute | | Ind | Investigational New Drug Application | | Nda | New Drug Application | | | Niehs | National Institute of Environmental Health Sciences | | | | | | | | | | | | |
Keywords: Expert Toxicology Consultant Toxicologist Regulatory Carcinogenicity Testing Genetic Non-Clinical Development Due Diligence Developability Leads in-licensing candidates out-licensing IND NDA Title: Expert Toxicology Consultant JS Allen Carinogenicity Developability Ind Nda Description: Jane Allen Consulting Toxicologist Expert in Carcinogenicity, Developability, Toxicity, for Ind, Nda, Due Diligence, In-Licensing, Out-Licensing Leads Selection Regulatory Strategy Genetic Toxicology | | |