Allen P.

I administered the preclinical toxicology program for several novel pharmaceutical diagnostic and therapeutic drugs IND/NDA to treat prostate cancer. I provided regulatory toxicology strategy for all projects.

I directed all preclinical strategy, pharmacologic, toxicologic and pharmacokinetic analysis of a large molecule drug combined with a medical device to support multiple manufacturing and R&D programs. I provided interpretation of existing preclinical data to senior management for gap-analysis of emerging research and development programs.

I administered large molecule toxicology program to support regulatory filings in five clinical indications (fracture repair, spine fusion, osteoarthritis, degenerative disc disease, and systemic diseases). I led pharmacokinetics and toxicokinetics evaluations in pharmacology and toxicology studies. I administered academic collaborations and patent programs for the R&D department. I led a multidisciplinary team for the implementation, execution and completion of outsourced and internal preclinical research.

Responsible for the design of individual toxicology studies including acute and chronic toxicity, repeat dose toxicity, reproductive and development toxicity, immunogenicity, toxicokinetics, and safety pharmacology. Designed GLP vendor approval processes. Authored professional and academic research reports, manuscripts and both internal and external presentations. Awarded Diplomat status in the American Board of Toxicology (DABT) in 2009.

I designed and completed preclinical toxicology GLP studies (preclinical CRO) and non-GLP pharmacology studies. My responsibilities included CRO selection and qualification, experimental design, protocol oversight, study oversight and monitoring, data review for quality control and interpretation, and writing technical reports and regulatory submissions.