Scientific considerations for global drug development

Jennifer L. Wilson; Kit Wun Kathy Cheung; Lawrence Lin; Elizabeth A. E. Green; Analia I. Porrás; Ling Zou; David Mukanga; Paul A. Akpa; Delese Mimi Darko; Rae Yuan; Sheng Ding; Wiltshire C. N. Johnson; Howard A. Lee; Emer Cooke; Carl C. Peck; Steven E. Kern; Dan Hartman; Yoshikazu Hayashi; Peter W. Marks; Russ B. Altman; Murray M. Lumpkin; Kathleen M. Giacomini; Terrence F. Blaschke

doi:10.1126/scitranslmed.aax2550

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Scientific considerations for global drug development

View ORCID ProfileJennifer L. Wilson¹,*,
View ORCID ProfileKit Wun Kathy Cheung¹,*,
View ORCID ProfileLawrence Lin¹,
Elizabeth A. E. Green¹,
View ORCID ProfileAnalia I. Porrás²,
View ORCID ProfileLing Zou¹,
View ORCID ProfileDavid Mukanga³,
Paul A. Akpa⁴,
Delese Mimi Darko⁵,
Rae Yuan⁶,
Sheng Ding⁷,⁸,
Wiltshire C. N. Johnson⁹,
Howard A. Lee¹⁰,¹¹,
Emer Cooke¹²,
View ORCID ProfileCarl C. Peck¹,¹³,
View ORCID ProfileSteven E. Kern³,
View ORCID ProfileDan Hartman³,
Yoshikazu Hayashi¹⁴,
View ORCID ProfilePeter W. Marks¹⁵,
View ORCID ProfileRuss B. Altman ¹⁶,
View ORCID ProfileMurray M. Lumpkin³,
View ORCID ProfileKathleen M. Giacomini ¹,† and
View ORCID ProfileTerrence F. Blaschke¹⁷

¹Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.
²Medicines and Health Technologies Unit, Department of Health Systems and Services, Pan American Health Organization, Regional Office of the World Health Organization, Washington, DC, USA.
³Global Health, Bill and Melinda Gates Foundation, Seattle, WA, USA.
⁴Department of Pharmaceutics, University of Nigeria, Nsukka, Enugu State, Nigeria.
⁵Food and Drugs Authority, Accra, Ghana.
⁶Sinovant Sciences Co., Shanghai, China.
⁷School of Pharmaceutical Sciences, Tsinghua University, Beijing, China.
⁸Gladstone Institute of Cardiovascular Disease, San Francisco, CA, USA.
⁹Pharmacy Board of Sierra Leone, Freetown, Sierra Leone.
¹⁰Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
¹¹Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Suwon, Republic of Korea.
¹²World Health Organization, Geneva, Switzerland.
¹³NDA Partners LLC, San Luis Obispo, CA, USA.
¹⁴Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
¹⁵Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
¹⁶Departments of Bioengineering and Genetics, Stanford University, Stanford, CA, USA.
¹⁷Departments of Medicine and Molecular Pharmacology, Stanford University School of Medicine, Stanford, CA, USA.

↵†Corresponding author. Email: kathy.giacomini{at}ucsf.edu

↵* These authors contributed equally to this work.

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Science Translational Medicine 29 Jul 2020:
Vol. 12, Issue 554, eaax2550
DOI: 10.1126/scitranslmed.aax2550

Jennifer L. Wilson

1Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.

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Kit Wun Kathy Cheung

1Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.

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Lawrence Lin

1Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.

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Elizabeth A. E. Green

1Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.

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Analia I. Porrás

2Medicines and Health Technologies Unit, Department of Health Systems and Services, Pan American Health Organization, Regional Office of the World Health Organization, Washington, DC, USA.

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Ling Zou

1Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.

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David Mukanga

3Global Health, Bill and Melinda Gates Foundation, Seattle, WA, USA.

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Paul A. Akpa

4Department of Pharmaceutics, University of Nigeria, Nsukka, Enugu State, Nigeria.

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Delese Mimi Darko

5Food and Drugs Authority, Accra, Ghana.

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Rae Yuan

6Sinovant Sciences Co., Shanghai, China.

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Sheng Ding

7School of Pharmaceutical Sciences, Tsinghua University, Beijing, China.

8Gladstone Institute of Cardiovascular Disease, San Francisco, CA, USA.

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Wiltshire C. N. Johnson

9Pharmacy Board of Sierra Leone, Freetown, Sierra Leone.

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Howard A. Lee

10Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.

11Department of Transdisciplinary Studies, Graduate School of Convergence Science and Technology, Seoul National University, Suwon, Republic of Korea.

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Emer Cooke

12World Health Organization, Geneva, Switzerland.

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Carl C. Peck

1Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.

13NDA Partners LLC, San Luis Obispo, CA, USA.

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Steven E. Kern

3Global Health, Bill and Melinda Gates Foundation, Seattle, WA, USA.

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Dan Hartman

3Global Health, Bill and Melinda Gates Foundation, Seattle, WA, USA.

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Yoshikazu Hayashi

14Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

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Peter W. Marks

15Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.

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Russ B. Altman

16Departments of Bioengineering and Genetics, Stanford University, Stanford, CA, USA.

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Murray M. Lumpkin

3Global Health, Bill and Melinda Gates Foundation, Seattle, WA, USA.

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Kathleen M. Giacomini

1Department of Bioengineering and Therapeutic Sciences, University of California, San Francisco, San Francisco, CA, USA.

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For correspondence: kathy.giacomini@ucsf.edu

Terrence F. Blaschke

17Departments of Medicine and Molecular Pharmacology, Stanford University School of Medicine, Stanford, CA, USA.

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Abstract

Requiring regional or in-country confirmatory clinical trials before approval of drugs already approved elsewhere delays access to medicines in low- and middle-income countries and raises drug costs. Here, we discuss the scientific and technological advances that may reduce the need for in-country or in-region clinical trials for drugs approved in other countries and limitations of these advances that could necessitate in-region clinical studies.

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Scientific considerations for global drug development

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Science Translational Medicine

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