Starting in April, perform duties as a study director for toxicology studies at Stillmeadow, Inc, a contract research organization, that specializes in several short term studies for chemical registration, animal heath studies, entomology studies and environmental studies. Bring new business to the company by using expertise with pharmaceutical preclinical studies to improve existing designs or add new studies to those available from Stillmeadow.

Pharma Toxicology Advisors, LLC is focused on helping pharmaceutical businesses with all aspects of drug development pertaining to preclinical data and studies that are in need of toxicology support. We can provide recommendations on screening tiers for drug discovery, studies to investigate a specific toxicology, pharmacokinetics or safety pharmacology concern and studies for regulatory submissions (ICH S9, ICH M3). We can select a contract research organization and design, monitor, interpret, report and summarize the necessary studies. We can provide toxicological assessments of the genotoxic potential of your compounds, synthesis processes, starting materials, reagents, solvents, impurities and degradation products (ICH Q3A, B and C and M7). We perform medical writing services providing reports, regulatory sections, executive summaries and assessments of preclinical safety data. We can also present results to project teams, management and regulatory agencies. Let us fulfill your toxicology needs.

Provided toxicology support for various oncology and inflammation pharmacuetical projects. Outsource in vitro assay for hERG, genotoxicity and receptor evaluations. Wrote safety pharmacology and toxicology sections for INDs. Outsource and monitor GLP studies to suport INDs and NDAs. Report and interpret in vitro and in vivo results to project teams in Discovery to screen for best compound to progress into development. Support CMC by reviewing synthesis process and impurities for genotoxicity and carcinogenicity potential.

Toxicologist for non-prescription drugs for 3 years covering products like Vicks Vaporub, NyQuil, DayQuil, Sinex, Formula 44. Wrote market test assessments, outsourced and conducted programs and studies to support product modifications and to address product issues that arose. Transferred to pharmaceutical division and remained for 12 years, supported numerous drug discovery projects for non steroidal antiinflammatories, antibiotics and compounds for muscle atrophy and obesity.

Conducted non clinical experiments on blood-brain and blood-cerebrospinal fluid barriers to metal ions, such as calcium, cadmium, lead and manganese using radiotracers, atomic absorption and diet manupulation.

Conducted experiments related to graduate research on choroid plexus and ion regulation in brain, assisted graduate students with experiments, assisted supervisor with grant and article review