MORIAH Consultant's Blog

Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA. He has worked in drug development, clinical research and regulatory affairs for over 40 years. He has worked in pharmaceuticals, contract research, government, and biotech industries, in domestic and international regulatory affairs and clinical research. Dr. Hamrell also worked in the Division of AIDS in NIAID at the National Institutes of Health, and as a reviewer in the Center for Drug Evaluation & Research at the Food and Drug Administration (FDA), in the Divisions of Antiviral Drug Products, Oncology Drug Products, and Bioequivalence.

Dr. Hamrell spent a number of years doing basic research, first as a Research Fellow at Duke University and later as an Assistant Professor of Pharmacology at the McGill University Cancer Center.  Dr. Hamrell has a Ph.D. degree in Pharmacology from the University of Southern California and a B.S. in Biochemistry from the University of California, Los Angeles.  Dr. Hamrell has received numerous awards for his research, teaching and professional work and is recognized in Who’s Who. Dr. Hamrell also holds an appointment as Adjunct Professor of Regulatory Sciences at the University of Southern California School of Pharmacy, as Adjunct Associate Professor at the Massachusetts College of Pharmacy & Health Sciences, and Adjunct Assistant Professor at Eastern Michigan University.

He has published numerous papers in pharmacology, regulatory affairs, product development, clinical research, quality, computers and information systems. Dr. Hamrell served as a founding Editorial Board member for Applied Clinical Trials and RA FOCUS, as a member of the Editorial Board of the DIA Journal, and Clinical Research as the Editor-in-Chief of the DIA Forum, Clinical Researcher and the Drug Information Journal.  He currently serves on the Editorial Board of Applied Clinical Trials.

Dr. Hamrell has received Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society and was elected as a Fellow in RAPS (FRAPS).  He is also a Certified CRA from ACRP (CCRA) and an ACRP Fellow and a registered Quality Assurance Professional in GCP (RQAP-GCP) from the Society for Quality Assurance.