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RE: Testimonial: Mitra® work provided by Altasciences

One of the goals of a Phase 1 study is to set your clinical development path up for success in subsequent phases. In an effort to plan for pediatric studies, Appili proposed developing and validating a microsampling method against the traditional plasma sampling method for PK analysis. The goal was to show that both sampling techniques provided identical results and to showcase microsampling as a viable alternative to plasma sampling for pediatric trials.

The Bioanalytical lab at Altasciences is one of the few labs we found with analytical experience employing multiple microsampling techniques. The team provided us with informed recommendations on how to proceed, and suggested that we employ the MITRA® sampling device for the purposes and goals of our study. Altasciences willingly collaborated with the Pharmacokinetic team at the Phase 1 unit to define detection limits for the technique, worked to develop a method that met our specifications, and effortlessly validated the technique against our plasma data.

The devotion, expertise, and degree of professionalism employed by the team in all stages of development, and the support provided during the Clinical trial, were unprecedented. It was a wonderful experience working with this lab on this novel technique; we appreciate the expertise they provide in this niche environment.

Prepared By:

Joanna L Gore, Ph.D., Clinical Research Scientist, Drug Development

Jamie L Doran, MSc, DABT, ERT, VP Drug Development, Appili Therapeutics Inc.

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