About the Authors

Marisabel Rodriguez Messan

Roles Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Project administration, Visualization, Writing – original draft, Writing – review & editing

Affiliation Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Osman N. Yogurtcu

Roles Conceptualization, Investigation, Methodology, Project administration, Writing – original draft, Writing – review & editing

Affiliation Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Joseph R. McGill

Roles Writing – original draft, Writing – review & editing

Affiliation Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Ujwani Nukala

Roles Writing – original draft, Writing – review & editing

Affiliation Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Zuben E. Sauna

Roles Conceptualization, Supervision, Writing – original draft, Writing – review & editing

Affiliation Office of Tissues and Advanced Therapies, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Hong Yang

Roles Conceptualization, Funding acquisition, Project administration, Resources, Supervision, Writing – original draft, Writing – review & editing

Hong.Yang@fda.hhs.gov

Affiliation Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

Competing Interests

The authors have declared that no competing interests exist.