Clinical Pharmacology Expert Witness WA 500882


Expertise Description

My experience in academic and industrial clinical research on development of anticancer agents, both classical cytotoxic drugs and targeted agents such as monoclonal antibodies, extends more than 40 years. My work has involved Phase 1 through 4 clinical trials of single agents and combinations, as well as supportive studies such as pharmacokinetic investigations and a clinical QTc study in cancer patients. I have written and supervised the execution of comprehensive clinical development plans that summarized complete development activities leading to NDA and post-marketing development. I have collaborated with investigators at many centers in the US, Canada, and Europe. I have been self-employed as a consultant to industry. I have prior experience providing courtroom testimony, deposition, and consultations as a clinical pharmacology expert witness.

Areas of Expertise


Expert Witness

Pharmaceutical Patent litigation (UK)


Consulting Experience

Clinical trial planning, execution, and reporting
Strategic planning for cancer drugs
Medical input to Institutional Review Board (Ethics Committee)
Lectures on pharmacology, oncology, medical ethics


Education

Degree Subject Institution
Ph.D. Pharmacology Northwestern University Graduate School
M.D. Northwestern University Medical School
B.S. Medicine Northwestern University

Licenses Certifications

American Board of Clinical Pharmacology

Awards & Affiliation

American Society for Clinical Oncology
American Association for Cancer Research
American Society for Clinical Pharmacology and Therapeutics

Primary Affiliation

American Society for Clinical Oncology



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