Excellent LyoHUB meeting at NIST! Thank you to all of the speakers, panelists and participants!

Presentations included:

•Use of Modeling and Simulation in Drug/Device Development and Regulatory Evaluation including Post-Approval Changes by Tina Morrison, Deputy Director, Division of Applied Mechanics, CDRH, FDA

•Analytical Technologies for Product Quality Measurements by John Schiel, Institute for Bioscience and Biotechnology Research, NIST

•Drug Substance Manufacturing by Scott Lute, Center for Drug Evaluation and Research, Office of Biotechnology Products, FDA

•Regulatory Review Perspective on Lyophilization by Steve Rhieu, U.S. Public Health Service Commissioned Corps Officer, CDER, FDA