Expertise DescriptionI have more than 35 years in Pharmacology and more than 25 years in senior management within the industry. My expertise is in drug safety, drug and device development, regulatory, clinical and technical sciences associated with drug and device approval, QA/QC of clinical research services, health outcomes research, and health policy. My company has provided regulatory program development and operational management for drugs and devices, as well as safety and efficacy programs in support of drug approval and postmarketing surveillance, label development and warnings, and label comprehension studies. I also have experience with clinical site management, including QA/QC facility audits of clinical sites and CROs and renovation of quality management systems. I have over 10 years of expert witness experience with consultation, deposition, and courtroom testimony.
Areas of Expertise
I have provided expert witness services as a drug safety expert for pharmaceutical, medical and legal liability cases, including for example those pertaining to failure to warn of known safety issues, inappropriate off-label use of medicines (Rx), failure to appropriately represent clients in drug safety liability cases, among others.
I have experience with providing consulting and research services for the pharmaceutical, device and health communications industries, government, and law firms.
My professional background includes industry and trade association experience working with FDA on all scientific and regulatory aspects of drug efficacy, safety, and labeling.
I am President of a consulting firm that provides regulatory support for companies interested in the development of new products. I have over 30 years of experience addressing drug safety and adequacy of warnings on FDA approved products, and have testified in deposition, in arbitration and before on the subject, with 6 of the last 9 cases since 2009 addressing inadequate warnings, instructions of use, and other labeling issues.
I am a drug safety and regulatory expert, providing pharmaceutical and medical device companies regulatory services and strategic management of drug and device development programs. I am President of a biomedical consulting company. As part of these drug/device development programs, I create truthful and not misleading labeling with appropriate and adequate warnings to support FDA IND and NDA filings. I am fully aware and apply in my regulatory practice all legal and regulatory requirements for drug labeling, including pertinent aspects of current FDA guidelines, to help ensure safe and effective use of products by physicians and patients. I am also fully aware of the current business and regulatory practices of pharmaceutical companies and their responsibilities to ensure they comply with legal and regulatory requirements.
Prior to starting my own company, I was Professor of Clinical Pharmacy at a top university, where I managed my own Center, and taught courses on FDA’s risk management policies and procedures relating to drug safety and warnings, and how such information impacts the standard of practice by physicians, pharmacists and nurses. I received multiple honors for teaching during the 10 years I worked there.
Prior to teaching, I worked for industry, managing a large network of pharmaceutical task groups addressing FDA concerns about drug efficacy, safety, labelling and quality. During this time I received special honorary citations from FDA for my work on drug labeling and drug quality issues of national import. I was task group leader on many of these task groups that interacted regularly with FDA, and have testified before many FDA advisory committees dealing with drug labeling and safety issues. I also served on the United States Pharmacopeia Expert Committee on Drug Labeling and Nomenclature.
|Ph.D.||Medical Sciences||Cornell Medical College|
Awards & Affiliation
Regulatory Affairs Professionals Society
Research Quality Association
Drug Information Association
Society of Clinical Research Associates
Houston Technology Center, Life Sciences Acceleration Committee
Regulatory Affairs Professionals Society