About the Authors

Alexander R. Giaquinto

Contributed equally to this work with: Alexander R. Giaquinto, Alberto Grignolo, Lawrence Liberti, John C. W. Lim, Tomas Salmonson, Fernand Sauer, Henrietta Ukwu

Alexander R. Giaquinto is a Retired Pharmaceutical Executive (Merck).

Affiliation ARG Consulting, LLC, United States of America

Alberto Grignolo

Contributed equally to this work with: Alexander R. Giaquinto, Alberto Grignolo, Lawrence Liberti, John C. W. Lim, Tomas Salmonson, Fernand Sauer, Henrietta Ukwu

Alberto.Grignolo@parexel.com

Affiliation Parexel, Billerica, Massachusetts, United States of America

Lawrence Liberti

Contributed equally to this work with: Alexander R. Giaquinto, Alberto Grignolo, Lawrence Liberti, John C. W. Lim, Tomas Salmonson, Fernand Sauer, Henrietta Ukwu

Affiliation Centre for Innovation in Regulatory Science, London, United Kingdom

John C. W. Lim

Contributed equally to this work with: Alexander R. Giaquinto, Alberto Grignolo, Lawrence Liberti, John C. W. Lim, Tomas Salmonson, Fernand Sauer, Henrietta Ukwu

Affiliation Centre of Regulatory Excellence, Duke—NUS Medical School, Singapore

Tomas Salmonson

Contributed equally to this work with: Alexander R. Giaquinto, Alberto Grignolo, Lawrence Liberti, John C. W. Lim, Tomas Salmonson, Fernand Sauer, Henrietta Ukwu

Affiliation Consilium Salmonson & Hemmings, Uppsala, Sweden

Fernand Sauer

Contributed equally to this work with: Alexander R. Giaquinto, Alberto Grignolo, Lawrence Liberti, John C. W. Lim, Tomas Salmonson, Fernand Sauer, Henrietta Ukwu

Affiliation Académie Nationale de Pharmacie, Paris, France

Henrietta Ukwu

Contributed equally to this work with: Alexander R. Giaquinto, Alberto Grignolo, Lawrence Liberti, John C. W. Lim, Tomas Salmonson, Fernand Sauer, Henrietta Ukwu

Affiliation Otsuka Pharmaceutical Companies, Princeton, New Jersey, United States of America

Competing Interests

I have read the journal's policy and the authors of this manuscript have the following competing interests: ARG is a retired, former pharmaceutical industry executive and is currently on the Board of, and owns stock in, Biothera Pharmaceuticals Inc. AG is a Corporate Vice President and full-time employee of Parexel, a privately owned Clinical Research Organization supporting drug development in the biopharmaceutical industry through management of clinical trials, regulatory consulting, and other services. He owns stock in a number of pharmaceutical companies. LL is a full-time employee of the Centre for Innovation in Regulatory Science serving as the Head, Regulatory Collaborations. CIRS, a subsidiary of the Clarivate Analytics group, provides an international forum to develop regulatory and reimbursement policy. He serves as a volunteer Board member of the Erudee Foundation, a US-based nonprofit in the education sector. JCWL is a Registrar of the Singapore National Registry of Diseases and Board Chairman of the Singapore Clinical Research Institute and National Health Innovation Centre, a not-for-profit public sector academic research and translational funding organisation. He is an appointed Board member of the Singapore Food Agency, a government statutory board, and an elected Board member of St Andrew’s Mission Hospital, a faith-based charity. TS is the sole owner of Consilium Sweden AB, which supports drug development in the biopharmaceutical industry through regulatory consulting and strategic advice. HU is a Corporate Senior Vice President, Global Head for Global Regulatory Affairs and Global Quality and full-time employee of Otsuka Pharmaceuticals Company. She owns stock in a number of pharmaceutical companies.