Jane Allen Consulting, Inc.

Dr. Allen has special expertise in Genetic Toxicology, a result of working over 25 years in this field. Her hands-on experience with numerous genetic toxicology assays aids in interpretation of data. She has a very extensive practical knowledge of usual and unusual findings, having reviewed reports for thousands of Ames mutagenicity tests, as well as hundreds of chromosome aberration, micronucleus, mouse lymphoma, and COMET assay reports.

In recognition of Dr. Allen’s expertise in genetic toxicology, she was appointed a member of the US Pharma ICH Genetic Toxicology Task Force that developed the ICH S2A and S2B Guidance documents.

Dr. Allen has held elective positions in respected genetic toxicology professional societies: the Genetic Toxicology Association, the Environmental Mutagen Society, and the North Carolina Genetic and Environmental Mutagen Society. She attends professional society and regulatory agency meetings regularly and can advise on new directions in regulatory genetic toxicology.

She has reviewed manuscripts on genetic toxicology for Toxicological Sciences, Mutation Research, Food and Chemical Toxicology, Environmental and Molecular Mutagenesis, and Toxicology in vitro.

She is familiar with the current strengths and weaknesses of CRO’s doing genetic toxicology work.

Dr. Allen has a particular interest in qualification strategies for genotoxic impurities for FDA and for the EU. She attends scientific and regulatory conferences on this subject and has worked successfully with clients to achieve compliance.

For some clients, she manages the entire genetic toxicology program. For others, she addresses specific concerns. For all, she provides seasoned advice that enables efficient drug development – early elimination of problematic leads combined with a strong practical regulatory strategy to achieve registration of acceptable leads.