1. Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA
2. Therapeutic Biologics Protein Team, Office of Clinical Pharmacology, Office of Translational Sciences Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA
3. Information Management Services, Inc. Rockville Maryland USA
4. Spaulding Clinical Research West Bend Wisconsin USA
5. Office of Therapeutic Biologics and Biosimilars, Office of New Drugs Center for Drug Evaluation and Research, US Food and Drug Administration Silver Spring Maryland USA