RTCTox Research & Technology Center in Toxicology

Pill Identification

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

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