Catherine E Patterson, PhD Expert Witness
Curriculum Vitae

Contact Information

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Specialties & Experience

General Specialties: Warnings & Labels and Pharmaceutical Regulation

Specialty Focus: Pharmaceutical, Drug, Device, Failure to Warn, Labeling, FDA, Regulatory, Product Liability, OTC, Prescription, Safety, Risk

Education: PhD in Molecular Biology, Princeton University; BS in Molecular and Cell Biology, Penn State University


Additional Information

Dr. Patterson has focused on human disease and treatments with attention to both efficacy and safety. Investigations of medical literature, legal files and regulatory documents for medical conditions, drug products and medical devices as well as comparators are the basis of her regulatory opinions. Any pharmacovigilance, device safety reviews, adverse event and labeling analyses use resources such as PubMED, Embase, FAERS, MAUDE, and internal company documents. Her regulatory experience has included 510(k), PMA, pre-IND, IND, NDA, ANDA and 505(b)(2) submissions. Dr. Patterson routinely writes FDA submissions, white papers, clinical study protocols, medical descriptions and labeling. She has additional experience with peer-review publications and grant writing. She is currently the Chief Scientific Officer for Biotech Research Group in Tampa. Her PhD was awarded from Princeton University in Molecular Biology for her work with viruses. In the past she provided scientific research and legal support for Expert Witness, Dr. Cheryl D. Blume. Dr. Patterson is experienced with a variety of drug and device classes, indications, mechanisms of action and side effects: antiepileptics (AEDs), osteoporosis treatments, diabetes medications, certain cancer treatments, women’s urogenital devices (mesh and Essure), topical pain treatments, depression medications, diarrhea treatments, antibiotics and hormone therapy for men and women, and gadolinium contrast agents. She is also interested in congenital malformations, in utero exposure to drugs, and regulatory ramifications. Dr. Patterson was previously an Assistant Professor at Case Western Reserve University (School of Medicine, Cleveland), a Research Assistant Professor at USF (College of Medicine, Tampa), a Postdoctoral Fellow at Fox Chase Cancer Center (Philadelphia) and an Associate Scientist for DuPont (DuPont Merck) Pharmaceutical Company.