Gene Ray, Ph.D. Email & Phone Number

An accomplished scientist with expertise that spans drug development and a solid understanding of regulatory requirements in bringing new drugs to market. Over the last 40 years, my work experiences have included raw material characterization; GMP drug formulation analyses; bioanalytical method development; bioanalytical GLP method validation and sample analyses for a wide range drug moieties and their metabolites; mass balance investigations; establishment of numerous biomarker assays; pharmacokinetic analysis and interpretation; protocol design and peer review.Of the positions that I have held over the years, the role of Sr. Scientific Advisor has been the most rewarding. The advisory role has allowed me to work with a wide variety of clients, suggesting the appropriate directions for their technical challenges. In this role I frequently met companies where their existing lab was unable in developing and validating a critical assay that could meet regulatory compliance, the so called “rescue projects”. Two examples of rescue projects that my team and I were able to solve were:• Validation of methods to accurately determine free (non-encapsulated) and total (free + encapsulated) drug concentrations for a complex liposomal drug in blood, in addition to the inclusion of extremely low levels of a cardiotoxic metabolite arising from circulating free drug. • Elucidation that the actual in vivo form of their drug, following oral administration in dogs, was not the parent drug, rather two of its metabolites generated by the gut flora. This effort involved their identification, custom synthesis of each metabolite and their isotopic forms, revalidating method for the study drug and the newly identified metabolites and then re-analysis of study samples in expedited fashion. I am now very excited in joining Agilex Biolabs in the role of Sr. Scientific Advisor. Agilex, the largest and most experienced laboratory in Australia, has extensive capabilities. They have highly respected research scientists, extensive technical depth and state-of-the-art equipment. Agilex has expertise providing high quality LC-MS/MS, immunology and biomarker services; pharmacokinetic and pharmacodynamics assessments; and toxicological support. Agilex is also one of the few global CROs that is active in vaccine research, notably for COVID-19. This solidifies Agilex Biolabs as a world leader in bringing new drugs to market, which I’m now pleased to be a part of.

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  University Of Missouri-Kansas City

  Pharmaceutical Chemistry