Holding a Ph.D. in pharmacology and bringing more than 35 years of experience in the field, along with more than 25 years in senior industry management, this expert witness evaluates matters involving pharmaceutical regulation, drug and medical device development, product safety, and health policy. His work includes analysis of regulatory compliance, product labeling, safety communications, and scientific and technical issues associated with pharmaceutical and medical products. In an expert capacity, he has more than 10 years of experience providing consultations, deposition testimony, and courtroom testimony related to pharmaceutical regulation, product safety, and drug and device development.

His professional work includes regulatory strategy and product development for prescription drugs, generic medications, medical devices, and dietary supplements. This experience includes the development and operational management of regulatory programs supporting product approval processes, safety and efficacy evaluations, and labeling development including warnings and label comprehension studies. His work also includes assessment of product quality, safety communications, and regulatory compliance issues affecting pharmaceutical and medical device products, as well as consumer survey research used to evaluate the effectiveness of product labeling and safety communication.

In addition to regulatory and policy work, his experience includes oversight of clinical research operations and quality management systems supporting clinical development programs. His work has included quality assurance and quality control evaluations of clinical research services, audits of clinical trial sites and contract research organizations, and the development and improvement of quality management systems used in clinical research environments. These activities also include health outcomes research and evaluation of clinical and technical data used in support of regulatory submissions for pharmaceutical and medical device products.