About the Authors

Phu N. Tran

Roles Data curation, Formal analysis, Investigation, Methodology, Writing – review & editing

Affiliations Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America, Division of Immunology and Hematology Devices, Center for Devices and Radiological Health, US Food and Drug Administration. Silver Spring, Maryland, United States of America

Jiansong Sheng

Roles Data curation, Formal analysis, Investigation, Methodology

Affiliations Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America, CiPALab, Gaithersburg, Maryland, United States of America

Aaron L. Randolph

Roles Data curation, Formal analysis, Investigation, Methodology, Writing – review & editing

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America

Claudia Alvarez Baron

Roles Data curation, Formal analysis, Investigation, Writing – review & editing

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America

Nicolas Thiebaud

Roles Data curation, Formal analysis, Investigation, Writing – review & editing

Affiliations Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America, Vertex Pharmaceuticals (Europe) Ltd, Abingdon, Oxfordshire, United Kingdom

Ming Ren

Roles Formal analysis, Writing – review & editing

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America

Min Wu

Roles Formal analysis, Methodology

Affiliations Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America, Division of Immunology and Hematology Devices, Center for Devices and Radiological Health, US Food and Drug Administration. Silver Spring, Maryland, United States of America

Lars Johannesen

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

Affiliation Division of Cardiology and Nephrology, Office of Cardiology, Hematology, Endocrinology and Nephrology, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America

Donna A. Volpe

Roles Resources, Writing – original draft, Writing – review & editing

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America

Dakshesh Patel

Roles Data curation, Formal analysis, Investigation, Methodology

Affiliations Division of Biomedical Physics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, United States of America, Cardiovascular Research Center, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, United States of America

Ksenia Blinova

Roles Formal analysis, Investigation, Visualization, Writing – review & editing

Affiliation Division of Biomedical Physics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, Maryland, United States of America

David G. Strauss

Roles Conceptualization, Funding acquisition, Resources, Writing – review & editing

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America

Wendy W. Wu

Roles Conceptualization, Data curation, Formal analysis, Methodology, Supervision, Validation, Visualization, Writing – original draft, Writing – review & editing

wendy.wu@fda.hhs.gov

Affiliation Division of Applied Regulatory Science, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, United States of America

Competing Interests

JS and NT are currently employed by commercial companies. Both contributed to data collection and analysis for studies in this manuscript while participating in the ORISE Research Participation Programs. ORISE fellowship stipend was funded by the FDA. No commercial company played a role in the study design, data collection and analysis, decision to publish, and preparation of the manuscript, nor did any commercial company provide financial support of any kind for this study. Commercial affiliation through former ORISE fellowship participants’ current appointment in commercial companies does not alter our adherence to all PLOS ONE policies on sharing data and materials.