Pharmaceutical Regulation Expert Witnesses

Hospitalist, Internal Medicine - Hospital Medicine, General Internal Medicine, Telemedicine, Perioperative Medicine, Medical Devices, Pharmaceutical Research and Development, Pharmaceutical Regulation, Chemistry, Biochemistry,

Tim Kamerzell, MD, PhD is a board-certified Internal Medicine physician. He is an active Hospitalist and general practice primary care physician at HCA Midwest Health in Overland Park, KS. Dr. Kamerzell received his residency training in Internal Medicine at Washington University in St. Louis and The University of Kansas School of Medicine. He is a core faculty member of the Internal Medicine residency program at HCA Midwest Health and was previously the Associate Program Director of Internal Medicine. He currently serves in various leadership roles including the Vice Chair of the Department of Medicine for Overland Park Regional Medical Center, Physician Advisory Board Member and Facility Lead Physician for the Overland Park Market of HCA Healthcare, Inc. Dr. Kamerzell received a PhD in Pharmaceutical Chemistry from the University of Kansas and has extensive experience working in the pharmaceutical industry as a research scientist at Genentech, Inc. Dr. Kamerzell completed researc...

Pharmaceutical Research, Infectious Diseases - pharmaceutical regulation, FDA, drug development , antimicrobials , antiseptics, disinfectants, clinical trials, post-marketing surveillance, drug labels, biologics, medical devices, microbiology , virology, biochemistry, molecular biology, food poisoning, data fraud, biological defense, dairy micro

25 years of experience in infectious disease including food microbiology, chemical/ biological defense and regulatory science. Initial employment in the Federal Government was with the Agricultural Research Service (ARS) performing genetic engineering of dairy bacteria. From there, he went to the Department of Defense, specifically Naval Surface Warfare Center (NSWC), working in chemical and biological warfare defense. Spent 12 years as a Clinical Microbiology reviewer in the Center of Drug Evaluation and Review (CDER) at FDA. He has extensive experience with FDA submissions including: pre-IND, IND, NDA, labeling supplements, and post-marketing for antibiotics, topical antiseptics, biologics and generic drugs. As an independent consultant, provided guidance on microbiology and regulatory affairs for clients developing antimicrobials, medical devices and biologics allowing clients to navigate through the FDA regulatory process. This guidance included providing advice for deve...