Clinical trial recommendations for potential Alport syndrome therapies

B. André Weinstock; David L. Feldman; Alessia Fornoni; Oliver Gross; Clifford E. Kashtan; Sharon Lagas; Rachel Lennon; Jeffrey H. Miner; Michelle N. Rheault; James F. Simon; Lisa Bonebrake; Marty Dunleavy; Phil Kumnick; Gina Parziale; Janine Reed; André Weinstock; Susie Gear; Kristen Binaso; Raymond Manuel; James Simon; Gerald Appel; Melanie Blank; Winson Tang; Aliza Thompson; Roser Torra; Kenneth Lieberman; Christoph Licht; Karin Dahan; Kandai Nozu; Hirofumi Kai; Sharon Ricardo; Anne Pariser; David Feldman; Heather Cook; Melanie Chin; Angela Goldsberry; Colin Meyer; Lisa Anne Melia; Radko Komers; Michael Markels; Alex Mercer; Marco Prunotto; Bruce Morgenstern; Ali Hariri; Vijay Modur; Neil Turner; Clifford Kashtan; Michelle Rheault; Colin Baigent; Stephano DeSacco; Laura Perin; Moumita Barua; Koichi Nakanishi; George Jarad; Jeffrey Miner

doi:10.1016/j.kint.2020.02.029

Clinical trial recommendations for potential Alport syndrome therapies

B. André Weinstock, David L. Feldman, Alessia Fornoni, Oliver Gross, Clifford E. Kashtan, Sharon Lagas, Rachel Lennon, Jeffrey H. Miner, Michelle N. Rheault, James F. Simon, Lisa Bonebrake, Marty Dunleavy, Phil Kumnick, Gina Parziale, Janine Reed, André Weinstock, Susie Gear, Kristen Binaso, Raymond Manuel, James SimonGerald Appel, Melanie Blank, Winson Tang, Aliza Thompson, Roser Torra, Kenneth Lieberman, Christoph Licht, Karin Dahan, Kandai Nozu, Hirofumi Kai, Sharon Ricardo, Anne Pariser, David Feldman, Heather Cook, Melanie Chin, Angela Goldsberry, Colin Meyer, Lisa Anne Melia, Radko Komers, Michael Markels, Alex Mercer, Marco Prunotto, Bruce Morgenstern, Ali Hariri, Vijay Modur, Neil Turner, Clifford Kashtan, Michelle Rheault, Colin Baigent, Stephano DeSacco, Laura Perin, Moumita Barua, Koichi Nakanishi, George Jarad, Jeffrey Miner

Pediatric Nephrology

Research output: Contribution to journal › Article › peer-review

7 Scopus citations

Abstract

Alport syndrome is experiencing a remarkable increase in preclinical investigations. To proactively address the needs of the Alport syndrome community, as well as offer clarity for future clinical research sponsors, the Alport Syndrome Foundation hosted a workshop to generate consensus recommendations for prospective trials for conventional drugs. Opinions of key stakeholders were carefully considered, including those of the biopharmaceutical industry representatives, academic researchers, clinicians, regulatory agency representatives, and—most critically—patients with Alport syndrome. Recommendations were established for preclinical researchers, the use and selection of biomarkers, standards of care, clinical trial designs, trial eligibility criteria and outcomes, pediatric trial considerations, and considerations for patient engagement, recruitment, and treatment. This paper outlines their recommendations.

Original language	English (US)
Pages (from-to)	1109-1116
Number of pages	8
Journal	Kidney international
Volume	97
Issue number	6
DOIs	https://doi.org/10.1016/j.kint.2020.02.029
State	Published - Jun 2020

Bibliographical note

Funding Information:
The workshop space at the Pendry Hotel, San Diego, California was provided courtesy of Retrophin Inc. Additional funding for workshop organization and travel stipends were provided by Reata Pharmaceuticals, Inc. Regulus Therapeutics Inc. and the ASF, a 501(c)(3) nonprofit. This paper and its recommendations are not a specific endorsement for Retrophin Inc. Reata Pharmaceuticals, Inc. and/or Regulus Therapeutics Inc. or their potential drug therapies or clinical methodologies. We thank Drs. Aliza Thompson and Melanie Blank of the FDA for their review and input on the final manuscript. We thank Michelle Hewitt for her volunteered editing of this paper.

Funding Information:
BAW is a volunteer and unpaid board member of the Alport Syndrome Foundation (ASF, Scottsdale, AZ) and an employee of Teleflex Medical (Wayne, PA). DLF has served as a consultant for Ironwood Pharmaceuticals (Cambridge, MA), but the consultancy fees were donated to the National Kidney Foundation (New York, NY). AF is an inventor on pending or issued patents intended to diagnose or treat proteinuric kidney diseases, including Alport syndrome. She stands to gain royalties from their future commercialization. Relevant to this topic, AF is Chief Scientific Officer of L&F Health LLC (Miami, FL) and founder of Liponext LLC (Miami, FL). In the past 2 years, she has served as consultant for several pharmaceutical companies working in this space, including Variant Pharmaceuticals (now ZyVersa Therapeutics; Weston, FL), ONO Pharmaceuticals (Osaka, Japan), Reata Pharmaceuticals (Plano, TX), and Novartis (Basel, Switzerland). OG is the initiator and principal investigator of the EARLY PRO-TECT Alport trial, which was sponsored by the German Ministry of Education and Research (01KG1104; Bonn, Germany). He is national principal investigator for Germany for the CARDINAL trial (Reata; Plano, TX) and is the initiator and principal investigator of the European Alport registry (Göttingen, Germany). His employer, The University of Göttingen (Göttingen, Germany), has had or still has consulting relationships with Regulus Therapeutics (San Diego, CA), Reata Pharmaceuticals (Plano, TX), Retrophin (San Diego, CA), Roche (Basel, Switzerland), Novartis (Basel, Switzerland), Boehringer-Ingelheim (Ingelheim am Rhein, Germany), and Ono Pharmaceuticals (Osaka, Japan). CEK has had consulting relationships with Regulus Therapeutics (San Diego, CA), Reata Pharmaceuticals (Plano, TX), Retrophin (San Diego, CA), Boehringer-Ingelheim (Ingelheim am Rhein, Germany), Ono Pharmaceuticals (Osaka, Japan), and Daiichi Sankyo (Tokyo, Japan). He is a site investigator for the CARDINAL trial (Reata; Plano, TX) and the HERA trial (Sanofi-Genzyme; Cambridge, MA), has had research support from the Novartis Institute for Biomedical Research (Cambridge, MA) and National Institutes of Health (1R21DC017019-01A1, P. Santi, principal investigator; Bethesda, MD), and is the Executive Director of the Alport Syndrome Treatments and Outcomes Registry (ASTOR; Minneapolis, MN), which is supported by the ASF (Scottsdale, AZ) and private philanthropy. SL is cofounder, volunteer, and unpaid board member (past president) of the ASF (Phoenix, AZ). RL is supported by a Wellcome Trust Senior Fellowship award (202860/Z/16/Z; London, UK) and has consulted for Retrophin (San Diego, CA) and ONO Pharmaceuticals (Osaka, Japan) regarding AS therapies in the past 12 months. JHM has received grant support from Reneo Pharmaceuticals (San Diego, CA) and Reata Pharmaceuticals (Plano, TX) and has served as a consultant to Regulus Therapeutics (San Diego, CA) and Retrophin (San Diego, CA). MNR is a site primary investigator for clinical trials for Retrophin (San Diego, CA), Reata Pharmaceuticals (Plano, TX), and Genentech (South San Francisco, CA), and has received research funding from Goldfinch Bio (Cambridge, MA), Novartis (Basel, Switzerland), Advicenne (Nimes, France), the National Institute of Diabetes and Digestive and Kidney Diseases (Bethesda, MD), and the US Department of Defense (Alexandria, VA). JFS is a member of the speakers’ bureau for Alexion Pharmaceuticals (Boston, MA).

Publisher Copyright:
© 2020 International Society of Nephrology

Keywords

Alport syndrome
CKD
ESKD
ESRD
chronic kidney disease
clinical trial design
end-stage kidney disease
end-stage renal disease
genetic disease
rare disease

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1016/j.kint.2020.02.029

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Weinstock, B. A., Feldman, D. L., Fornoni, A., Gross, O., Kashtan, C. E., Lagas, S., Lennon, R., Miner, J. H., Rheault, M. N., Simon, J. F., Bonebrake, L., Dunleavy, M., Kumnick, P., Parziale, G., Reed, J., Weinstock, A., Gear, S., Binaso, K., Manuel, R., ... Miner, J. (2020). Clinical trial recommendations for potential Alport syndrome therapies. Kidney international, 97(6), 1109-1116. https://doi.org/10.1016/j.kint.2020.02.029

Weinstock, BA, Feldman, DL, Fornoni, A, Gross, O, Kashtan, CE, Lagas, S, Lennon, R, Miner, JH, Rheault, MN, Simon, JF, Bonebrake, L, Dunleavy, M, Kumnick, P, Parziale, G, Reed, J, Weinstock, A, Gear, S, Binaso, K, Manuel, R, Simon, J, Appel, G, Blank, M, Tang, W, Thompson, A, Torra, R, Lieberman, K, Licht, C, Dahan, K, Nozu, K, Kai, H, Ricardo, S, Pariser, A, Feldman, D, Cook, H, Chin, M, Goldsberry, A, Meyer, C, Melia, LA, Komers, R, Markels, M, Mercer, A, Prunotto, M, Morgenstern, B, Hariri, A, Modur, V, Turner, N, Kashtan, C, Rheault, M, Baigent, C, DeSacco, S, Perin, L, Barua, M, Nakanishi, K, Jarad, G & Miner, J 2020, 'Clinical trial recommendations for potential Alport syndrome therapies', Kidney international, vol. 97, no. 6, pp. 1109-1116. https://doi.org/10.1016/j.kint.2020.02.029

@article{45911b06111940fca4ac4ac84324543e,

title = "Clinical trial recommendations for potential Alport syndrome therapies",

abstract = "Alport syndrome is experiencing a remarkable increase in preclinical investigations. To proactively address the needs of the Alport syndrome community, as well as offer clarity for future clinical research sponsors, the Alport Syndrome Foundation hosted a workshop to generate consensus recommendations for prospective trials for conventional drugs. Opinions of key stakeholders were carefully considered, including those of the biopharmaceutical industry representatives, academic researchers, clinicians, regulatory agency representatives, and—most critically—patients with Alport syndrome. Recommendations were established for preclinical researchers, the use and selection of biomarkers, standards of care, clinical trial designs, trial eligibility criteria and outcomes, pediatric trial considerations, and considerations for patient engagement, recruitment, and treatment. This paper outlines their recommendations.",

keywords = "Alport syndrome, CKD, ESKD, ESRD, chronic kidney disease, clinical trial design, end-stage kidney disease, end-stage renal disease, genetic disease, rare disease",

author = "Weinstock, {B. Andr{\'e}} and Feldman, {David L.} and Alessia Fornoni and Oliver Gross and Kashtan, {Clifford E.} and Sharon Lagas and Rachel Lennon and Miner, {Jeffrey H.} and Rheault, {Michelle N.} and Simon, {James F.} and Lisa Bonebrake and Marty Dunleavy and Phil Kumnick and Gina Parziale and Janine Reed and Andr{\'e} Weinstock and Susie Gear and Kristen Binaso and Raymond Manuel and James Simon and Gerald Appel and Melanie Blank and Winson Tang and Aliza Thompson and Roser Torra and Kenneth Lieberman and Christoph Licht and Karin Dahan and Kandai Nozu and Hirofumi Kai and Sharon Ricardo and Anne Pariser and David Feldman and Heather Cook and Melanie Chin and Angela Goldsberry and Colin Meyer and Melia, {Lisa Anne} and Radko Komers and Michael Markels and Alex Mercer and Marco Prunotto and Bruce Morgenstern and Ali Hariri and Vijay Modur and Neil Turner and Clifford Kashtan and Michelle Rheault and Colin Baigent and Stephano DeSacco and Laura Perin and Moumita Barua and Koichi Nakanishi and George Jarad and Jeffrey Miner",

note = "Funding Information: The workshop space at the Pendry Hotel, San Diego, California was provided courtesy of Retrophin Inc. Additional funding for workshop organization and travel stipends were provided by Reata Pharmaceuticals, Inc. Regulus Therapeutics Inc. and the ASF, a 501(c)(3) nonprofit. This paper and its recommendations are not a specific endorsement for Retrophin Inc. Reata Pharmaceuticals, Inc. and/or Regulus Therapeutics Inc. or their potential drug therapies or clinical methodologies. We thank Drs. Aliza Thompson and Melanie Blank of the FDA for their review and input on the final manuscript. We thank Michelle Hewitt for her volunteered editing of this paper. Funding Information: BAW is a volunteer and unpaid board member of the Alport Syndrome Foundation (ASF, Scottsdale, AZ) and an employee of Teleflex Medical (Wayne, PA). DLF has served as a consultant for Ironwood Pharmaceuticals (Cambridge, MA), but the consultancy fees were donated to the National Kidney Foundation (New York, NY). AF is an inventor on pending or issued patents intended to diagnose or treat proteinuric kidney diseases, including Alport syndrome. She stands to gain royalties from their future commercialization. Relevant to this topic, AF is Chief Scientific Officer of L&F Health LLC (Miami, FL) and founder of Liponext LLC (Miami, FL). In the past 2 years, she has served as consultant for several pharmaceutical companies working in this space, including Variant Pharmaceuticals (now ZyVersa Therapeutics; Weston, FL), ONO Pharmaceuticals (Osaka, Japan), Reata Pharmaceuticals (Plano, TX), and Novartis (Basel, Switzerland). OG is the initiator and principal investigator of the EARLY PRO-TECT Alport trial, which was sponsored by the German Ministry of Education and Research (01KG1104; Bonn, Germany). He is national principal investigator for Germany for the CARDINAL trial (Reata; Plano, TX) and is the initiator and principal investigator of the European Alport registry (G{\"o}ttingen, Germany). His employer, The University of G{\"o}ttingen (G{\"o}ttingen, Germany), has had or still has consulting relationships with Regulus Therapeutics (San Diego, CA), Reata Pharmaceuticals (Plano, TX), Retrophin (San Diego, CA), Roche (Basel, Switzerland), Novartis (Basel, Switzerland), Boehringer-Ingelheim (Ingelheim am Rhein, Germany), and Ono Pharmaceuticals (Osaka, Japan). CEK has had consulting relationships with Regulus Therapeutics (San Diego, CA), Reata Pharmaceuticals (Plano, TX), Retrophin (San Diego, CA), Boehringer-Ingelheim (Ingelheim am Rhein, Germany), Ono Pharmaceuticals (Osaka, Japan), and Daiichi Sankyo (Tokyo, Japan). He is a site investigator for the CARDINAL trial (Reata; Plano, TX) and the HERA trial (Sanofi-Genzyme; Cambridge, MA), has had research support from the Novartis Institute for Biomedical Research (Cambridge, MA) and National Institutes of Health (1R21DC017019-01A1, P. Santi, principal investigator; Bethesda, MD), and is the Executive Director of the Alport Syndrome Treatments and Outcomes Registry (ASTOR; Minneapolis, MN), which is supported by the ASF (Scottsdale, AZ) and private philanthropy. SL is cofounder, volunteer, and unpaid board member (past president) of the ASF (Phoenix, AZ). RL is supported by a Wellcome Trust Senior Fellowship award (202860/Z/16/Z; London, UK) and has consulted for Retrophin (San Diego, CA) and ONO Pharmaceuticals (Osaka, Japan) regarding AS therapies in the past 12 months. JHM has received grant support from Reneo Pharmaceuticals (San Diego, CA) and Reata Pharmaceuticals (Plano, TX) and has served as a consultant to Regulus Therapeutics (San Diego, CA) and Retrophin (San Diego, CA). MNR is a site primary investigator for clinical trials for Retrophin (San Diego, CA), Reata Pharmaceuticals (Plano, TX), and Genentech (South San Francisco, CA), and has received research funding from Goldfinch Bio (Cambridge, MA), Novartis (Basel, Switzerland), Advicenne (Nimes, France), the National Institute of Diabetes and Digestive and Kidney Diseases (Bethesda, MD), and the US Department of Defense (Alexandria, VA). JFS is a member of the speakers{\textquoteright} bureau for Alexion Pharmaceuticals (Boston, MA). Publisher Copyright: {\textcopyright} 2020 International Society of Nephrology",

year = "2020",

month = jun,

doi = "10.1016/j.kint.2020.02.029",

language = "English (US)",

volume = "97",

pages = "1109--1116",

journal = "Kidney international",

issn = "0085-2538",

publisher = "Elsevier B.V.",

number = "6",

}

TY - JOUR

T1 - Clinical trial recommendations for potential Alport syndrome therapies

AU - Weinstock, B. André

AU - Feldman, David L.

AU - Fornoni, Alessia

AU - Gross, Oliver

AU - Kashtan, Clifford E.

AU - Lagas, Sharon

AU - Lennon, Rachel

AU - Miner, Jeffrey H.

AU - Rheault, Michelle N.

AU - Simon, James F.

AU - Bonebrake, Lisa

AU - Dunleavy, Marty

AU - Kumnick, Phil

AU - Parziale, Gina

AU - Reed, Janine

AU - Weinstock, André

AU - Gear, Susie

AU - Binaso, Kristen

AU - Manuel, Raymond

AU - Simon, James

AU - Appel, Gerald

AU - Blank, Melanie

AU - Tang, Winson

AU - Thompson, Aliza

AU - Torra, Roser

AU - Lieberman, Kenneth

AU - Licht, Christoph

AU - Dahan, Karin

AU - Nozu, Kandai

AU - Kai, Hirofumi

AU - Ricardo, Sharon

AU - Pariser, Anne

AU - Feldman, David

AU - Cook, Heather

AU - Chin, Melanie

AU - Goldsberry, Angela

AU - Meyer, Colin

AU - Melia, Lisa Anne

AU - Komers, Radko

AU - Markels, Michael

AU - Mercer, Alex

AU - Prunotto, Marco

AU - Morgenstern, Bruce

AU - Hariri, Ali

AU - Modur, Vijay

AU - Turner, Neil

AU - Kashtan, Clifford

AU - Rheault, Michelle

AU - Baigent, Colin

AU - DeSacco, Stephano

AU - Perin, Laura

AU - Barua, Moumita

AU - Nakanishi, Koichi

AU - Jarad, George

AU - Miner, Jeffrey

N1 - Funding Information: The workshop space at the Pendry Hotel, San Diego, California was provided courtesy of Retrophin Inc. Additional funding for workshop organization and travel stipends were provided by Reata Pharmaceuticals, Inc. Regulus Therapeutics Inc. and the ASF, a 501(c)(3) nonprofit. This paper and its recommendations are not a specific endorsement for Retrophin Inc. Reata Pharmaceuticals, Inc. and/or Regulus Therapeutics Inc. or their potential drug therapies or clinical methodologies. We thank Drs. Aliza Thompson and Melanie Blank of the FDA for their review and input on the final manuscript. We thank Michelle Hewitt for her volunteered editing of this paper. Funding Information: BAW is a volunteer and unpaid board member of the Alport Syndrome Foundation (ASF, Scottsdale, AZ) and an employee of Teleflex Medical (Wayne, PA). DLF has served as a consultant for Ironwood Pharmaceuticals (Cambridge, MA), but the consultancy fees were donated to the National Kidney Foundation (New York, NY). AF is an inventor on pending or issued patents intended to diagnose or treat proteinuric kidney diseases, including Alport syndrome. She stands to gain royalties from their future commercialization. Relevant to this topic, AF is Chief Scientific Officer of L&F Health LLC (Miami, FL) and founder of Liponext LLC (Miami, FL). In the past 2 years, she has served as consultant for several pharmaceutical companies working in this space, including Variant Pharmaceuticals (now ZyVersa Therapeutics; Weston, FL), ONO Pharmaceuticals (Osaka, Japan), Reata Pharmaceuticals (Plano, TX), and Novartis (Basel, Switzerland). OG is the initiator and principal investigator of the EARLY PRO-TECT Alport trial, which was sponsored by the German Ministry of Education and Research (01KG1104; Bonn, Germany). He is national principal investigator for Germany for the CARDINAL trial (Reata; Plano, TX) and is the initiator and principal investigator of the European Alport registry (Göttingen, Germany). His employer, The University of Göttingen (Göttingen, Germany), has had or still has consulting relationships with Regulus Therapeutics (San Diego, CA), Reata Pharmaceuticals (Plano, TX), Retrophin (San Diego, CA), Roche (Basel, Switzerland), Novartis (Basel, Switzerland), Boehringer-Ingelheim (Ingelheim am Rhein, Germany), and Ono Pharmaceuticals (Osaka, Japan). CEK has had consulting relationships with Regulus Therapeutics (San Diego, CA), Reata Pharmaceuticals (Plano, TX), Retrophin (San Diego, CA), Boehringer-Ingelheim (Ingelheim am Rhein, Germany), Ono Pharmaceuticals (Osaka, Japan), and Daiichi Sankyo (Tokyo, Japan). He is a site investigator for the CARDINAL trial (Reata; Plano, TX) and the HERA trial (Sanofi-Genzyme; Cambridge, MA), has had research support from the Novartis Institute for Biomedical Research (Cambridge, MA) and National Institutes of Health (1R21DC017019-01A1, P. Santi, principal investigator; Bethesda, MD), and is the Executive Director of the Alport Syndrome Treatments and Outcomes Registry (ASTOR; Minneapolis, MN), which is supported by the ASF (Scottsdale, AZ) and private philanthropy. SL is cofounder, volunteer, and unpaid board member (past president) of the ASF (Phoenix, AZ). RL is supported by a Wellcome Trust Senior Fellowship award (202860/Z/16/Z; London, UK) and has consulted for Retrophin (San Diego, CA) and ONO Pharmaceuticals (Osaka, Japan) regarding AS therapies in the past 12 months. JHM has received grant support from Reneo Pharmaceuticals (San Diego, CA) and Reata Pharmaceuticals (Plano, TX) and has served as a consultant to Regulus Therapeutics (San Diego, CA) and Retrophin (San Diego, CA). MNR is a site primary investigator for clinical trials for Retrophin (San Diego, CA), Reata Pharmaceuticals (Plano, TX), and Genentech (South San Francisco, CA), and has received research funding from Goldfinch Bio (Cambridge, MA), Novartis (Basel, Switzerland), Advicenne (Nimes, France), the National Institute of Diabetes and Digestive and Kidney Diseases (Bethesda, MD), and the US Department of Defense (Alexandria, VA). JFS is a member of the speakers’ bureau for Alexion Pharmaceuticals (Boston, MA). Publisher Copyright: © 2020 International Society of Nephrology

PY - 2020/6

Y1 - 2020/6

N2 - Alport syndrome is experiencing a remarkable increase in preclinical investigations. To proactively address the needs of the Alport syndrome community, as well as offer clarity for future clinical research sponsors, the Alport Syndrome Foundation hosted a workshop to generate consensus recommendations for prospective trials for conventional drugs. Opinions of key stakeholders were carefully considered, including those of the biopharmaceutical industry representatives, academic researchers, clinicians, regulatory agency representatives, and—most critically—patients with Alport syndrome. Recommendations were established for preclinical researchers, the use and selection of biomarkers, standards of care, clinical trial designs, trial eligibility criteria and outcomes, pediatric trial considerations, and considerations for patient engagement, recruitment, and treatment. This paper outlines their recommendations.

AB - Alport syndrome is experiencing a remarkable increase in preclinical investigations. To proactively address the needs of the Alport syndrome community, as well as offer clarity for future clinical research sponsors, the Alport Syndrome Foundation hosted a workshop to generate consensus recommendations for prospective trials for conventional drugs. Opinions of key stakeholders were carefully considered, including those of the biopharmaceutical industry representatives, academic researchers, clinicians, regulatory agency representatives, and—most critically—patients with Alport syndrome. Recommendations were established for preclinical researchers, the use and selection of biomarkers, standards of care, clinical trial designs, trial eligibility criteria and outcomes, pediatric trial considerations, and considerations for patient engagement, recruitment, and treatment. This paper outlines their recommendations.

KW - Alport syndrome

KW - CKD

KW - ESKD

KW - ESRD

KW - chronic kidney disease

KW - clinical trial design

KW - end-stage kidney disease

KW - end-stage renal disease

KW - genetic disease

KW - rare disease

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UR - http://www.scopus.com/inward/citedby.url?scp=85084449270&partnerID=8YFLogxK

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DO - 10.1016/j.kint.2020.02.029

M3 - Article

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AN - SCOPUS:85084449270

SN - 0085-2538

VL - 97

SP - 1109

EP - 1116

JO - Kidney international

JF - Kidney international

IS - 6

ER -

Clinical trial recommendations for potential Alport syndrome therapies

Abstract

Bibliographical note

Keywords

UN SDGs

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