Executive Director of Analytical Development and Quality Control at Acorda Therapeutics.
Kevin D. Kee is Executive Director of Analytical Development and Quality Control at Acorda Therapeutics. Since 2001, he has held key roles in the development, manufacture and characterization of multiple DPI candidates spanning early phase/POC/tox through commercial.
Accomplishments include the development of Inbrija® from the POC stage to an approved commercial drug product in both the US and EU markets. During the same period, he helped drive the development of several other DPI candidates formulated with small molecules to large proteins with various clinical success spanning early to late phase milestones.
He also transformed a start-up R&D analytical laboratory into an FDA approved commercial QC release and stability laboratory; planned and executed process optimization and scale-up activities for spray drying, capsule filling and blister packaging; improved clinical study designs by defining and interpreting in-vitro data aimed at understanding how drug product candidates perform under expected clinical use as well as potential take-home patient-use and miss-use scenarios.
Kevin holds a bachelor’s degree in Biology with a minor in Mathematics from Northeastern University.