Mike Di Spirito
Mike is the Director, Clinical Pharmacology & Pharmacometrics, at Celerion and leads a team of 30 scientists developing study designs and trial protocols in early clinical research, creating statistical analysis plans, conducting pharmacokinetic and pharmacodynamic analyses, interpreting and discussing study results, and generating clinical study reports. He advises various biotech and pharmaceutical companies on a wide range of clinical pharmacology topics. Over the last 20 years at Celerion and its legacy companies, Mike has worked on hundreds of NDA-enabling studies: First in Human single- and multiple-ascending dose, Radiolabeled ADME mass balance, Drug-drug interactions, Hepatic and Renal insufficiency, TQT, Microdosing, Microtracer, Bioavailability, Bioequivalence, Food-effect, and First in Patient signal effects.
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