Jane Allen Consulting, Inc.

About us:

Jane Allen Consulting, Inc. was established in 2002. It provides toxicological services by the Principal, Jane S. Allen, as well as by other highly qualified nonclinical experts who are available as needed.

Jane S. Allen received her Ph.D. at the University of Texas at Austin and did post-doctoral work at Yale University School of Medicine. She has been involved for more than 25 years in pharmaceutical toxicology, including 15 years at GlaxoSmithKline. In 2001 she left her position as Director of Toxicology at GlaxoSmithKline to establish a successful consulting practice.

Dr. Allen has extensive experience with the design, conduct, analysis and reporting of preclinical studies and associated regulatory submissions in North America and the EU. She excels at problem solving for regulatory toxicology issues, is familiar with nonclinical CROs, and has attended many preclinical meetings at the FDA with clients.

Dr. Allen has specialized expertise in the areas of genetic toxicology and alternative carcinogenicity assays.

Dr. Allen is well recognized in her field.

  • She has been elected to prestigious committees for the Society of Toxicology, the Genetic Toxicology Association, the Genetics and Environmental Mutagen Society, and the internationally prominent Environment Mutagen Society.

  • She has been a reviewer for manuscripts submitted to internationally recognized journals such as Toxicological Sciences, Mutation Research, Toxicology in vitro, Environmental and Molecular Mutagenesis, Critical Reviews in Toxicology, Journal of Clinical Investigation, and Food & Chemical Toxicology.

Her track record includes:

  • Successful IND/NDA/BLA/CTA/MAA submissions in a variety of therapeutic areas

  • Due diligence for pharmaceutical firms and for venture capital funds

  • Review of hundreds of reports and submissions

  • Presentations to regulatory agencies

  • Toxicological problem solving

  • Confidential assessments of whether a firm/department may be vulnerable to scientific fraud.