Vice President, Nonclinical Disposition and Bioanalysis Bristol Myers Squibb Summit , New Jersey
Ozanimod is a once-daily oral immunomodulator that selectively targets sphingosine 1-phosphate 1 (S1P1) and S1P5 and is approved in the US and EU for the treatment of relapsing forms of multiple sclerosis. Full characterization of drug metabolic pathways and enzymes involved in metabolism is important for understanding clinical safety and efficacy profile of the molecule. As compound progresses through discovery into development, the metabolite characterization and the bioanalytical methods employed are stage appropriate. The presentation presents approaches to bioanalytical methodology employed during development of ozanimod and highlights how the methods evolved as the compound metabolite characterization progressed during development. The example highlights where "fit for purpose" are appropriate and where fully validated methods are employed.