Pharmaceutical Regulation Expert Witnesses

Pharmacist, Pharmaceutical Regulation - Pharmacy standard of care/negligence, Board of Pharmacy relations, national pharmacy regulatory affairs, hospital pharmacy, community pharmacy, mail service, non-resident pharmacy issues, pharmacy technology regulations, and automation issues.

Dennis is an Arizona-based pharmacist with a broad set of practice experiences acquired over 40 years of pharmacy practice. He served in the United States Air Force as a pharmacy officer, and opened and operated a community pharmacy after leaving active duty. Dennis has served as Director of Pharmacy at three hospitals, two in rural areas, and the other, an 800-bed facility with an attached children’s hospital in an urban setting. Dennis was a founding faculty member at the Midwestern University College of Pharmacy-Glendale, eventually serving as its Assistant Dean. As the Pharmacist in Charge of the Humana Mail Pharmacy in Phoenix, managing pharmacy practice for a staff of 700 that filled over 35,000 prescriptions each day. Dennis has worked for the last decade as the Senior Director of Pharmacy Regulatory Affairs for Express Scripts, supervising a team that covered all 50 state boards. He recently retired from that position. Dennis has extensive experience in standard of care an...

Pharmacology- Clinical, Pharmacist - Emergency Medical Toxicology, Emergency Medicine, Pediatric Emergency Medicine, Pulmonary Critical Care Medicine, Geriatrics, Long Term Care, Nursing Homes, Hospice and Palliative Care, Neurology, Infectious Diseases, Nephrology, Pharmaceutical Research, Pharmaceutical Regulation, HIPAA

As a practicing clinical pharmacist with postgraduate critical care training, my expertise spans a unique gamut of healthcare. I received a Doctor of Pharmacy degree in 2014 from the University of the Pacific and have been a registered pharmacist in California since that year. Subsequently, I completed two years of pharmacy residency at VA San Diego Health Care System, with the first year focusing on pharmacy practice in ambulatory care and inpatient hospital settings, including hospice and long-term care, and the second year specializing in critical care pharmacy. I am a board-certified critical care pharmacist (BCCCP) and have held specialty clinical pharmacist positions in emergency medicine and critical care/ICU. I currently practice at VA San Diego Health Care System, and I have practiced in clinical pharmacy at six different healthcare systems. I also have extensive clinical research experience, in both healthcare institutions and the pharmaceutical industry. In 2015, I ...

Chemistry & Chemicals, Pharmaceutical Regulation - Medical devices, pharmaceutical research, patents, drug formulation, quality control, laboratories, manufacturing, drug packaging, cosmetics, food, ISO, International Standards of Harmonization (ISO), environmental conditions, compliance, sterilization, chemical synthesis, fermentation, components

Experienced Chemist with 25+ years of experience in quality control, raw materials, manufacturing, validation, and stability. Experience in pharmaceutical, medical device, cosmetics, and food industries. Former odor panel scientist at Proctor & Gamble as a contractor. Extensive teaching experience. International inspector.

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 Regulation, Infectious Diseases - Food and Drug Administration (FDA), drug/biologics safety/labeling/post-marketing surveillance, FDA drug/biologics regulations/procedures/applications (INDs/NDAs/BLAs), clinical trials, drug development, pharmacy compounding, HIV, MRSA, antibiotics, hepatitis, osteomyelitis, influenza, C. difficile

Dr. Ross is a Yale fellowship-trained, board-certified infectious disease physician. An active clinician in practice for over 25 years, he provides patient care in the areas of infectious disease and primary care. Dr. Ross holds a medical degree from New York University School of Medicine, and an undergraduate degree in Molecular Biophysics and Biochemistry from Yale University. He completed his internal medicine residency training at NYU Medical Center, and infectious disease fellowship training at Yale University. Dr. Ross also holds a M.S. and Ph.D. in Biochemistry from NYU, and a Master’s Degree in Biomedical Informatics from Oregon Health and Sciences University. Dr. Ross spent 10 years with the FDA’s Center of Drug Evaluation and Review (CDER) as a medical officer, senior medical reviewer, medical team leader, and new drug review office management official. He has extremely broad experience with FDA regulatory submissions (INDs, NDAs, BLAs, post-marketing safety, labeling ...

Pharmaceutical Regulation, Medical Devices - FDA, FDA Compliance, FDA Regulations, FDA MAUDE, FDA Drug Safety, FDA Warnings, FDA Drug Warnings, FDA Medical Device, FDA law, FDA regulatory, Drug Safety/FDA, FDA Medical Devices, Biologics Safety FDA, Implant Safety/FDA, Medical device product liability

Dr. Sharlin’s experience: My key skill is identifying and developing facts supporting a legal strategy. (1) Drug reviewer at FDA. (2) Expert witness experience: Cases-37, Expert reports-16, Depositions-8, Testimony-1, Successful Daubert challenges-0. (3) Professional experience: Regulatory consultant (25 years), expert witness (10 years). (4) My cases have involved drug and medical device death and injury, patents, mergers, trade secrets, business interruption insurance, product labeling. (5) My skills: biological scientist, statistician, software developer, data integrity specialist, technical writer, educator, and FDA regulatory expert. (6) Talented technical writer, my writing experience includes:  Expert reports, scientific publications, audit reports for FDA compliance, standard operating procedures, FDA submissions, responses to questions from FDA. (7) I write custom software for data mining of safety information from FDA’s adverse event databases:  I extract f...

Pharmacist, Pharmaceutical Regulation - Hospital, Outpatient Retail Pharmacy Practice, Standards of Pharmacy Practice, Medication Errors, Medication Safety, Adverse Drug Reactions, Drug Interactions, Standard of Care, Anticoagulation, Controlled Substances, Pharmacy Standards, Therapeutic Drug Monitoring, Pharmacy regulations

Extensive knowledge in pharmacy practice, regulatory compliance, medication management and standards of pharmacy practice across a variety of patient care settings. Board Certification in Pharmacotherapy (BCPS). Available as a consultant for both plaintiff and defense cases.

Pharmacist, Pharmaceutical Regulation - USP <797> <795> <800>, Sterile and non-sterile compounding, FDA 503(a) and (b), State Inspections, Accreditation, Compliance, Critical Point Training, NABP, PCAB, Inspections, FDA Drug Compliance Expert

Kathleen Jackson is a licensed and experienced 40+ year pharmacist with specialized training and experience in compounding and compliance with regulations. She owned and operated a community pharmacy with an emphasis on compounding for 22 years. She has most recently received an NABP Inspector Certification (CISCI) in November 2018, expiring June 2023. Kathleen was also previously accepted by FDA to monitor a pharmacy as a Drug Compliance Expert. She has presented at several PCCA International Seminars as well as local community clubs and organizations. Kathleen was awarded "Pharmacist of the Month" in March 2002 by PCCA (Professional Compounding Centers of America). She has performed inspections and prepared reports to Boards of Pharmacy related to license suspensions/probation orders. Kathleen has co-authored two articles on Root Cause Analysis in the IJPC (International Journal of Pharmaceutical Compounding). She has also authored several articles in the Texas Pharmacy magaz...