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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