Bernard Olsen, PhD

Consultant Advisor

Dr. Bernard Olsen is a consultant advisor for Pearl Pathways, with a focus on analytical chemistry. Dr. Olsen has over 35 years of experience within the life science industry and is an accomplished researcher with over 51 publications to date. His skills and areas of expertise include:

  • Strategic decision-making for drug development especially related to chemistry, manufacturing, and control issues
  • HPLC, GC, chiral chromatography, LC-MS
  • Analytical method development, including chromatographic and other separation techniques, spectroscopic methods, chiral analysis, trace analysis, chemometric methods
  • Method validation
  • Impurity investigations including related substances, degradation products, catalysts, residual solvents
  • Genotoxic impurity strategies
  • Physical property and solid state characterization and development strategy
  • Technology transfer
  • Drug substance and drug product stability
  • Specification setting
  • Preparation of worldwide clinical (IND) and marketing authorization (CTD) regulatory submissions
  • Responding to regulatory questions
  • Patent litigation support as a non-testifying expert or expert witness (deposition and trial experience)
  • Suspect counterfeit drug analysis and authentication
  • Pharmacopeial monograph development and public standard-setting
  • Collaboration, co-development with third parties
  • Training and staff development
  • GMP quality audits for analytical laboratories

Dr. Olsen completed his Ph.D. in Analytical Chemistry at the University of Wisconsin, Madison and his B.S. in Chemistry at Nebraska Wesleyan University in Lincoln, Nebraska.