USP conducts early stage evaluations of new and emerging technologies and trends to identify areas and potential needs for compendial standards. These evaluations also include assessment of analytical technologies that may advance reference standards characterization and enhance compendial testing performance. The evaluation process aids in the determination of potential standards and analytical technology applications that can then be developed and integrated through the USP standard-setting processes. We achieve this by leveraging existing USP resources, and augmenting our capacity through collaboration with external organizations and external expertise and capabilities.
We are currently working on the following two projects. Additional topics including digital health, gene/cell therapy, and 3D printing are being explored to better understand their implications and USP’s role in providing guidance and standards.
As an AI fellow in R&I, Chris’s duties are to extend the reach of Machine Learning/Artificial Intelligence to as many parts of the company. By leveraging our subject matter expert knowledge, he will develop data driven decision engines. This includes learning new technologies and implementing them to solve business questions.
Research Fellow - Christopher Dunn
Chris joined USP in 2004 as a validation technician in RS Operations. He completed his MS degree in Bioinformatics at Johns Hopkins University in 2012 and then started a new career path as a Data Management Specialist in 2015. He was promoted to Data Science Manager after developing key predicative models for Risk based sampling in PQM, RS Prioritization (Chem Medicines, Excipients, and Dietary supplements), and also for developing an artificial intelligence algorithm for identification of chemical compounds based on their NMR spectra.
Over the last year at USP, Aline has served as an enterprise-wide taxonomist, and has developed two enterprise-wide subject taxonomies: A compendial and science subject taxonomy and a comprehensive reference standards skills taxonomy. The scope of work ranged from identifying effective ways of visualizing the end product, identifying existing resources and leveraging these into a comprehensive taxonomy with detail and with placeholders for further development, and defining the taxonomy governance process to maintain the ever-expanding vocabulary.
Research Fellow - Aline Martinez
Aline joined USP in 2019 as a Science Fellow for Taxonomy. Aline is a strategic planner and customer-focused knowledge manager with over 20 years’ experience managing, implementing, and improving digital strategies and information findability. Her focus is on strategic planning for taxonomy, metadata and text mining development, implementation, governance and management for enterprise-wide systems. She has a proven record for business solutions aligned with business objectives.
Global Substance Registration System (G-SRS)
USP is exploring opportunities to implement the Global Substance Registration System (G-SRS) as the primary means of modernizing the processes and methods by which USP identifies, curates, and publishes fundamental data elements related to substances. This work will also align with current informatics standards that have regulatory support.
Research Fellow - Andrew Grothen
Andrew Grothen is a pharmacist by training, graduating as a Doctor of Pharmacy from the University of Wyoming School of Pharmacy in 2014. He worked as a community pharmacist in western Nebraska before becoming a Cancer Research Training Award Fellow with the National Cancer Institute, where he gained experience in pharmacy nomenclature and surveillance informatics and helped to develop and curate the Observational Research in Oncology Toolbox as part of the Surveillance Research Program.