EXAMPLES OF CONSULTATIVE ASSIGNMENTS DONE

• Preparing non-clinical development strategic plans (up to early Phase II) for biotechnology and small molecule compounds; consulting client during plan execution.

• Writing Pharmacology/Toxicology/ADME summary as part of the IND or NDA submissions; reviewing Investigators’ Drug Brochures; updating drug inserts. 

• Representing client at the FDA for non-clinical safety evaluation of drug candidates. 

• Conducting due-diligence evaluation for non-clinical pharmacology/toxicology/ADME of in- or out-licensing drug candidates; representing client at business discussion meetings.

• Serving on an Expert Panel for safety issues at a pre-NDA approval decision stage. 

• Advising pharmaceutical R&D management on optimizing global drug development; evaluating operational capabilities of pathology, toxicology and experimental medicine. 

• Supporting pharmaceutical International/US Project Teams in non-clinical development and regulatory issues in pharmacology/toxicology/ADME; participate in toxicology International Functional Team.

• Writing/reviewing non-clinical toxicology reports generated by contract laboratories. 

• Supervising necropsy/examining slides/writing reports/conducting pathology peer reviews in non clinical toxicity studies.

• Providing pathology support for laboratory animal services/pharmacology research/ exploratory toxicology. 

• Serving as the principle investigator in electron microscopy non-clinical toxicity study.

• Conducting special histopathologic examinations and evaluating toxicologic effects for the FDA. 

• Evaluating non-clinical findings (experimental and GLPs studies) of intracellular drug storage.

• Providing scientific relevance to human safety for “unusual” findings in animal safety studies.

• Planning strategy for regulatory registration of a veterinary therapeutic agent.

• Giving seminars/lectures on non-clinical toxicological assessment of the nervous and the cardiovascular systems.

• Preparing/teaching a continuing education courses on regulatory safety assessment.

• Providing scientific support for health issues related to Indoor Environment Quality.

• Advising on development of a software program for computing cell proliferation and promoting the product in the scientific community.

• Providing scientific support in toxicology/pathology/medicine to law firms.