Expertise DescriptionI have more than 35 years of experience in the field of Pharmacology and Drug Regulation. My extensive experience includes tracking, controlling, summarizing and reporting submissions to the FDA, drug reviews, clinical studies, drug activity in humans, human risk assessment, regulatory affairs, dispensing, and clinical pharmacy. I have over 30 years expert witness experience with consultations, deposition and courtroom testimony.
Areas of Expertise
I have over thirty-five years of experience in regulatory affairs with respect to pharmaceutical products or food additives. This includes the drug product’s manufacture and scale-up processes, reported to the FDA. Between 1980 and 1983, I was a Medical Review Officer with the FDA. As a Medical Review Officer, I reviewed many drugs products that had indications as skeletal muscle relaxants, antihistamines, and major and minor pain relief. In 1984, I served as a special consultant to the FDA, on a part-time basis, in the review and coordination of Drug Master Files.
Between 1984 and 1986, I worked for a health-surgical institution in the Neurology Branch. The Branch’s Human Subject’s Committee, also referred to as an Institutional Review Board or IRB, had been inspected by the FDA, and a portion of my job was to act as the liaison between the Branch Chief and the FDA to resolve FDA’s inspectional findings.
Thereafter, between 1987 and 1990, I served as the Assistant Director of Clinical Research for an artificial sweetener company, assisting them with the clinical trials and safety of aspartame. Aspartame was regulated by FDA’s Bureau of Foods, FOB-8, at that time; however, the company had taken a research path that closely followed the regulations for prescription drugs. The prescription drug regulations were quite familiar to me from my years at FDA, and I used that knowledge to advise the company on its novel strategy with aspartame.
In 1990, I joined a pharmaceutical products company as a Regulatory Products Manager. In 1993, I became the Associate Director of Regulatory Affairs and served in that position until 2003, when I was promoted to Director of Regulatory Affairs Operations. I continued to serve as the Director of Regulatory Affairs Operations until June 2010 when I retired. During my time in these various positions, I had varying degrees of responsibility for submitting numerous original NDAs, supervising additional ongoing NDAs, submitting original INDs, and supervising numerous additional ongoing INDs. My scope of regulatory practice included the supervision of Regulatory Affairs Practitioners at Level I, entry level, along with my own actions at Level IV, the highest level. I was not only involved in regulatory filings with FDA and other regulatory authorities but also involved with regulatory policy issues with external stakeholders. Between 1990 and 2010, I was responsible for the company’s drug regulatory filings in 11 of FDA’s 15 prescription drug review divisions. Between July 2008 and June 2010, the company’s regulatory resources, for which I had oversight, were either integrated into or in the process of integration into a Research and Development Center in Deerfield, Illinois.
|Pharm.D.||University of Michigan|
|B.S.||Pharmacy||University of Illinois Medical Center|
|Regulatory Affairs Certification|
Awards & Affiliation
|Special Recognition Award|
|Richard E. Greco Award|
|Regulatory Affairs Leadership Award|
Regulatory Affairs Professionals Society
Partial List of Consulting Expert Witness Cases