Lee Sample

Background

About Lee Sample

Over 20 years of industry experience with leadership positions in Regulatory and Quality. Provided Regulatory leadership, strategy, and guidance for several biotechnology and medical device companies during early, late stage, and post approval product development efforts. Extensive technical background, acquired from working in Process Development and Quality operations early in my career, has enabled me to effectively assess risk and to provide a clear and rationale strategic plan in regard to internal project planning, submission content, and communications with Health Authorities in the US and other countries. Regulatory and technical experience covers multiple types of products that include commercial skin substitutes, commercial CDx, cellular and antibody cancer vaccines (Phase and gene/cellular therapy products (Phase I/II). In addition, Acquired several years of direct Regulatory experience authoring multiple IND/CTA amendments, Pre-Submission requests, PMA Supplements, Annual Reports and writing responses/scientific advice proposals to US, Canadian, and European Health Authorities.