About the Authors

Shelby S. Fisher

Roles Investigation, Project administration, Writing – original draft

Affiliation RTI International, Durham, North Carolina, United States of America

Arnstein Lindaas

Roles Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Supervision, Writing – review & editing

Affiliation Acumen LLC, Burlingame, California, United States of America

Stella G. Muthuri

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

Affiliation IBM Consulting, Bethesda, Maryland, United States of America

Patricia C. Lloyd

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

Affiliation United States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America

Joann F. Gruber

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

Affiliation United States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America

Morgan M. Richey

Roles Investigation, Project administration, Writing – original draft

Affiliation RTI Health Solutions, Durham, North Carolina, United States of America

Hai Lyu

Roles Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Writing – review & editing

Affiliation Acumen LLC, Burlingame, California, United States of America

Angela S. Cheng

Roles Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Writing – review & editing

Affiliation Acumen LLC, Burlingame, California, United States of America

Lisa S. Kowarski

Roles Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Supervision, Writing – review & editing

Affiliation IBM Consulting, Bethesda, Maryland, United States of America

Mollie M. McKillop

Roles Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Supervision, Writing – review & editing

Affiliation IBM Consulting, Bethesda, Maryland, United States of America

Christine Bui

Roles Conceptualization, Investigation, Methodology, Project administration, Writing – original draft

Affiliation RTI Health Solutions, Durham, North Carolina, United States of America

Tainya C. Clarke

Roles Investigation, Project administration, Writing – review & editing

Affiliation United States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America

Jeffrey Beers

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

Affiliation IBM Consulting, Bethesda, Maryland, United States of America

Timothy Burrell

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

Affiliation IBM Consulting, Bethesda, Maryland, United States of America

Pablo Freyria Duenas

Roles Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Writing – review & editing

Affiliation Acumen LLC, Burlingame, California, United States of America

Yangping Chen

Roles Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Writing – review & editing

Affiliation Acumen LLC, Burlingame, California, United States of America

Minya Sheng

Roles Investigation, Project administration, Writing – review & editing

Affiliation IBM Consulting, Bethesda, Maryland, United States of America

Richard A. Forshee

Roles Investigation, Project administration, Supervision, Writing – review & editing

Affiliation United States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America

Steven A. Anderson

Roles Investigation, Project administration, Writing – review & editing

Affiliation United States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America

Yoganand Chillarige

Roles Conceptualization, Formal analysis, Investigation, Methodology, Project administration, Supervision, Writing – review & editing

Affiliation Acumen LLC, Burlingame, California, United States of America

Mary S. Anthony

Roles Conceptualization, Investigation, Methodology, Supervision, Writing – review & editing

Affiliation RTI Health Solutions, Durham, North Carolina, United States of America

Azadeh Shoaibi

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

Affiliation United States of America Food and Drug Administration, Center for Biologics Evaluation and Research, Silver Spring, Maryland, United States of America

J. Bradley Layton

Roles Conceptualization, Investigation, Methodology, Project administration, Supervision, Writing – original draft

jblayton@rti.org

Affiliation RTI Health Solutions, Durham, North Carolina, United States of America

Competing Interests

This work was conducted as part of the FDA BEST Initiative for which Acumen, IBM Consulting, and RTI International are contractors (or were contractors at the time of the study). AL, HL, ASC, PFD, YaC, and YoC were employees of Acumen, LLC at the time of the study. SGM, LK, MMM, JB, TB, and MS are or were employees of IBM Consulting. SSF, MMR, CB, MSA, and JBL are or were employees of RTI International, a nonprofit, independent research institute. The other authors have no conflicts of interest to declare.