Mike Nicholas

Independent Consultant @Insignia Strategies, Llc

Overland Park, KS, US

Seasoned drug development professional with over 35 years of regulatory and drug development experience in developing and implementing regulatory strategy for specialty and generic drugs. Brand protection and life cycle management strategies across a wide swath of products, including drugs and biologics across multiple therapeutic categories. Extensive experience in due diligence activities for the assessment of regulatory success. Extensive FDA interactions (directing FDA meetings and communications) and the development of regulatory policy, including numerous Citizen Petitions. Served on Boards of Directors for the University of Kansas and BioKansas. Available for Consulting.

University of Missippi Medical Center

Postdoctoral Fellow

Tennessee Technological University

Bachelors

The University of Tennessee Health Science Center

PhD