Staci McDonald, PharmD, Senior Director, Scientific Clinical Operations, Celerion 

    Considerations in Sterile Microtracer Preparation for Human Use

Stuart Best, PhD, Senior Director of Operations, Xceleron 

    Method Validation of an AMS Supported IV-Tracer Study

Micro-radiotracer studies in humans that take advantage of the very high sensitivity of Accelerator Mass Spectrometry (AMS) provide new approaches to answering important questions in early clinical drug development.

A key interest is the ability to give a small dose of 14C-labeled drug intravascularly (intravenously) while giving a therapeutic oral dose of non-radiolabeled drug extravascularlly (e.g. oral, dermal, inhaled). The intravenous plasma concentrations of radiolabeled drug are tracked using AMS while the total drug concentration (labeled and unlabeled) is measured using conventional bioanalytical methods such as LC/MS/MS. From these measurements a good estimate of absolute bioavailability for the route of extravascular delivery can be obtained. However, this type of approach raises several questions from a regulatory point of view.

This webinar will review the requirements and practical considerations around preparation and parametric release of drug in a pharmacy clean room to be administered intravenously. In addition, the regulatory requirements around validation and quality control of AMS assays will be reviewed. The audience will have the opportunity to question experts involved in both parametric release of drug product and AMS analyses.

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Dr. McDonald is the Senior Director, Scientific Clinical Operations at Celerion. In this role, Dr. McDonald is responsible for clinical drug development programs at Celerion. She has over 16 years experience in clinical research, including six years experience as a clinical research pharmacist. Most recently, she was the Director, Bioanalytical Services, at Celerion, where she had operational oversight for the Lincoln, Nebraska bioanalytical laboratory.

After joining MDS Harris in 1995, Dr. McDonald held positions of increasing responsibility, before becoming the Director of Operational Resource Management at MDS Pharma Services.

Dr. McDonald holds a Doctor of Pharmacy from the University of Nebraska Medical Center, College of Pharmacy and is a member of the American Society of Hospital Pharmacists, the Nebraska Pharmacists Association and the American Pharmaceutical Association. She obtained her Bachelor’s Degree in Biology from Nebraska Wesleyan University.

Dr. Best has over 20 years experience spanning both regulated bioanalytical investigations and drug discovery screening for multi-national pharmaceutical companies and Contract Research Organizations. His career is distinguished by progressive applications of newer analytical technologies to characterize an expanding and ever more complex chemical space.

Immediately prior to Xceleron, Dr. Best was with Merck in Scotland where he spent seven years with Organon then Schering-Plough. He acted as site lead and supported critical ADME and pharmacology investigations, including analysis of endogenous compounds. Dr. Best’s team employed a range of sample preparation and detectors, including parallel columns systems, UPLC, linear ion trap and QToF systems.

Dr. Best also spent time in the traditional service sector with Charles River (Inveresk) and Bioanalytical Analytical Systems. Most of his analytical time during this period was with LC-MS/MS and GC-MS systems.

Dr. Best completed his PhD at the School of Pharmaceutical Sciences, University of Strathclyde. He has a degree in Pharmacy from the University of Strathclyde and is on the register of the Pharmaceutical Society of Great Britain.