Witnesses:

Dr. Anthony Mire-Sluis
Executive Director, Global Product Quality and Quality Compliance, Amgen, Inc.

Dr. Patrick VJJ Vink
Senior Vice President and Global Head of Biologics, Mylan GmbH

Dr. Steven Kozlowski
Director, Office of Biotechnology Products, Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)

Dr. Willie May
Director, Chemical Science and Technology Laboratory, National Institute of Standards and Technology (NIST)