Expertise DescriptionI have over 30 years experience in pharmaceuticals and am currently a pharmaceutical executive, with extensive knowledge of all phases of drug development, including product approval, manufacturing, labeling, marketing, and distributing. My areas of pharmaceutical expertise include: biotechnology; clinical development; compound evaluation; dosage forms; drug regulatory affairs; facility compliance; FDA approval process; laboratory and manufacturing audits; licensing; medical devices; medicine in the media; microbiological development; microbiology; national and international pharmaceutical projects; patent infringement; pre-clinical / clinical studies; production monitoring; quality control; and regulatory parameters. I have additional expertise in budgeting, financial controls, and strategic planning. I have more than 20 years expert witness experience with consultations, deposition, and courtroom testimony.
Areas of Expertise
My expert witness experience includes criminal prosecution concerning ephedrine tablets.
My consulting services include: Design, development, and security of approval for clinical research policies; International development program for acceptance of product in multiple countries; Analysis of scientific data and preparation of registered documents for multiple anti-infective products, such as antifungals.
I am experienced with healthcare product manufacture and labeling and the regulations which govern these products. I am experienced with healthcare product manufacture and labeling and the regulations which govern these products.
I have been in the drug development area of big pharmaceuticals for 30+ years, having written and reviewed and approved multiple clinical study protocols for a range of therapeutic areas for all 4 phases of research destined for NDA approval at the FDA. I am familiar with the FDA regulations (title 21) for drug evaluation and approval. I have sat on an NIH committee evaluating clinical research proposals. As Vice President, Drug Development at a pharmaceutical subsidiary of Monsanto, I was responsible for complete clinical development of several drugs and have garnered worldwide approval of several. Having earned a Ph.D. degree in Biology/Microbiology in 1976, I can read and understand the primary literature in drug development and have published in the primary, secondary and tertiary literature, and have edited a textbook used throughout the country on fluoroquinolone drugs. I have provided expert service since 1993.
I have been involved in several cases dealing with failure to warn per the label and sales claims. The most recent such case was dealing with Botox in which we (the plaintiff) prevailed. I have reviewed many such labels for potential safety issues in the past to ensure that the safety issues are clearly disclosed in the label.
My expertise includes the evaluation of the newly minted form of a product that may normally need to have multiple daily doses that when modified in the manufacturing setting will have a longer half-life and possibly less frequent dosing or an enhanced safety profile. These include oral dosage forms, IM depot forms and topical transdermal patches all of which have been improved by manufacturing methods rather than by modification of the chemical structure.
I am a clinical scientist with 40 years pharma experience managing CROs for Phase I-IV studies. These include New drugs, new indications for existing drugs and generic forms. Managing a CRO takes exceptional skill and technical understanding of the GCP regulations. I have written and reviewed multiple clinical study protocols in a wide range of therapeutic disciplines and have managed the placement of the protocols at clinical sites chosen by the CRO or the Sponsor. I have also monitored/audited the studies once patient enrolment has begun. I am well trained (for 40 years in the pharma industry and have founded my own CRO in the past), well educated (Ph.D., biology/microbiology, 1976), well published (edited the definitive text on fluoro-quinolone anti-infectives). I have published in the peer reviewed primary, secondary, and tertiary literature in the.
|Ph.D.||Microbiology||University of Dayton||Ohio|
|M.S.||Microbiology||University of Dayton|
Awards & Affiliation
American Society for Microbiology
Partial List of Consulting Expert Witness Cases