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