Jane S. Allen
Ph.D. University of Texas at Austin. Post-doctoral training: Yale University School of Medicine
Biologics/Biotherapeutics/Biotechnology, Carcinogenicity, Drug/Pharmaceutical Development, Formulations, Genetic Toxicology and Cytogenetics, In Vitro Toxicology, Pharmacokinetics/Toxicokinetics, Product Safety Assessment, Regulatory Toxicology, Risk Assessment, Training and Training Courses
Pharmaceuticals General Toxicology; Genetic Toxicology including mutation, chromosome, micronucleus and COMET assays; IND and NDA Preparation; Regulatory Toxicology; Pharmaceutical regulatory strategy and non-clinical development plans. Design/review toxicology and safety pharmacology protocols for drugs and chemicals. Review/edit draft reports and regulatory documents. Prepare IND/NDA non-clinical sections, CTD tables, international regulatory documents, integrated summaries, expert reports, CIB’s, documents for FDA meetings, responses to regulatory toxicology questions from government agencies, white papers on toxicological topics, literature reviews, carcinogenicity assessment committee (CAC) submissions, etc. Assess and resolve impurity and degradent issues and qualifications. Document preparation and calculation of acceptable daily exposure limits (ADE) to support risk-based manufacture of pharmaceutical drugs. Client preparation for FDA meetings. Due diligence; evaluate in-licensing candidates. Prepare/review out-licensing dossiers to maximize value. Assess vulnerability to fraud or GLP compliance.
Over 30 years’ experience in regulatory toxicology, including as Director of Toxicology at GlaxoSmithKline and 15 years as a successful independent consultant. Solid track record of problem-solving and problem-prevention. Resolved regulatory genetic toxicology and impurity issues. Helped clients achieve rapid and cost-efficient IND filings and partnering with big pharma. Preparation of dozens of ADE risk assessment documents for manufacturing. Over 100 approved IND, NDA (FDA CDER and CBER), and European EMA submissions. Experience with a variety of therapeutic categories, including metabolic, cardiovascular, antiviral, oncology, anti-infective, immunomodulatory, dermal, and neurological drugs. Extensive practical experience with pharmaceutical and biotech drug development. Experience with transgenic mouse carcinogenicity assays. Presentations to FDA. Member US Pharma ICH Genetic Toxicology Task Force. Member ILSI Committee on Alternative Carcinogenicity Assays. See company website for more details.
2909 Kenwick Court