Nathanael Stocke, PhD

Nathanael Stocke is a pharmaceutical development scientist with a doctorate in healthcare applications of chemical engineering and over 15 years of experience.  Nathanael provides operational, regulatory, quality and compliance support to the healthcare products industry worldwide.  His expertise includes technical and operational oversight of CMC programs; cohesive integration of CMC strategies into cross-functional Sponsor development programs; project management of CMC supply chains; vendor selection, contracting, and oversight, GMP compliance; and regulatory submission preparation.  He has considerable experience leading CMC programs that meet business objectives and minimize costs through a phase-appropriate and product-specific approach.  He has direct experience leading small molecule and/or biologic development programs (DS/DP/analytical/supply) in oral and/or parenteral dosage forms (including device-coupled combination products) and has overseen programs from preclinical/lead optimization through process validation and post-marketing commitments.  Nathanael also has experience leading the development and authoring of INDs, IMPDs, meeting requests/packages, NDAs and MAAs.  Nathanael has a B.S. in Chemical Engineering and a Ph.D. in Chemical Engineering both from the University of Kentucky.