How is the emergence of hemp affecting the Clinical space? Synthesis, certification and clinical evaluation of 7-Hydroxy and 7-Carboxy Cannabidiol Certified Reference Materials in plasma samples by LC-MS/MS
Heather Lima, PhD
MilliporeSigma
Dr. Lima joined Cerilliant Corporation at MilliporeSigma as a Senior Scientist in 2012 after earning a Ph.D. in Chemistry at the University of Texas at Arlington. Her graduate research focused on the total synthesis of imidazole-containing natural products, and a manufacturing technology internship at Abbott Laboratories focused on API manufacturing process improvements and scale up. Dr. Lima earned her B.S. in Biochemistry in 2005 also at the University of Texas at Arlington.
As Principal Scientist at MilliporeSigma, Dr. Lima has extensive experience in reference material development and certification. Her expertise includes design and synthesis of drugs, their metabolites and stable isotope labeled internal standards, particularly steroids, cannabinoids, opiates and opioids. She leads the synthesis of new products in a team of fourteen full time synthetic chemists supporting the manufacture of Certified Reference Materials (CRM’s) at the Round Rock site. The synthesis group is responsible for the design and development of the raw materials used in the formulation of solution CRM’s that make up the Cerilliant portfolio.
Raymond Suhandynata, PhD
University of California, San Diego
Dr. Suhandynata is a Clinical Chemistry Fellow at the UC San Diego Center for Advanced Laboratory Medicine, under the direction of Dr. Robert Fitzgerald. He attended the State University of New York at Stony Brook where he received his Ph.D. in Biochemistry and Structural Biology. His graduate work was performed under the mentorship of Dr. Nancy Hollingsworth, where he applied quantitative phospho-proteomics to identify kinase targets by LC-MS/MS. His post-doctoral work was performed at the Ludwig Institute for Cancer Research at the University of California San Diego, and focused on applying quantitative LC-MS/MS to identify sumoylated proteins and the roles they play in chromosome segregation. As a Clinical Chemistry fellow, he is expanding his skills in the areas of small molecule analysis and clinical method validation with future hopes to apply these skills towards a career in clinical toxicology.
Cannabidiol (CBD), a non-psychoactive constituent of hemp, has been increasingly promoted and studied for pharmacological uses as regulations regarding cannabis and hemp evolve rapidly at a state and federal level. In response to these recent regulations, novel Cannabinoid Certified Reference Materials (CRMs) and testing methods have been developed for the main human metabolites of CBD, 7-hydroxy cannabidiol (7-OH CBD) and 7-carboxy cannabidiol (7-COOH CBD). We will touch on recent legal changes for cannabinoid testing in a Clinical setting, as well as discuss the synthesis, certification, and evaluation of these cannabinoid CRMs in patient whole blood samples at the Center for Advanced Laboratory Medicine at UCSD.
Perspectives on Future LC-MS/MS Developments for the Routine Clinical Lab, with Special Focus on 25-OH Vitamin D Testing
Lorin Bachmann, PhD, DABCC
VCU Health System
Lorin Bachmann joined the VCU Department of Pathology in 2007. She currently serves as Co-Director of Clinical Chemistry, Co-Director of Point-of-Care Testing, Director of the New Kent Emergency Department Laboratory, Technical Advisor for the Operating Room Laboratory, Pathology Outreach and Clinical Trials, and Laboratory Director for multiple VCUHS outreach laboratories. Dr. Bachmann received her PhD in Molecular Medicine from the University of Virginia, followed by a fellowship in clinical chemistry and proteomics research at the University of Virginia. Dr. Bachmann is certified by the American Board of Clinical Chemistry.
Dr. Bachmann is active within the American Association for Clinical Chemistry (AACC), where she serves on the Board of Directors. She also serves as the Chair of the Chemistry and Toxicology Expert Panel for the Clinical Laboratory and Standards Institute (CLSI).
Dr. Bachmann’s research interests include evaluation and validation of new clinical laboratory assays, clinical laboratory analyzer design, development of mass spectrometry-based assays for the clinical laboratory and standardization of laboratory testing. She serves as the Chair of the National Kidney Disease Education Program (NKDEP)/International Federation of Clinical Chemistry Laboratory (IFCC) Joint Lab Working Group, whose goal is to accomplish standardization of urine albumin methods to enable utility of clinical decision thresholds.
Dr. Bachmann has received numerous awards for her contributions to professional societies, education and research. She serves as principal investigator for multiple industry-sponsored studies.
Accurate 25-OH Vitamin D measurements are important for assessment and management of patients with hypovitaminosis D. LC-MS/MS measurement procedures are more selective than immunoassay measurement procedures for 25-OH Vitamin D and generally exhibit improved recovery of 25-OH Vitamin D2. However, challenges related to increased labor requirements for preanalytical processing, additional method validation requirements for LDTs and lack of complete automation of quality assurance monitoring have presented significant barriers for implementation of LC-MS/MS in the routine clinical laboratory. Hear from a clinical laboratory and LC-MS/MS expert about the quality assurance needs of the routine clinical laboratory, the challenges associated with managing laboratory developed tests (LDTs) and the perspectives on future LC-MS/MS developments.
*Thermo Fisher Scientific products are distributed globally so uses, applications, and availability of product in each country depend on local regulatory marketing authorization status.