American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products

Andrew Adams; Linda C. Cendales; David K.C. Cooper; Emanuele Cozzi; John Gill; Eric Judd; Eliezer Katz; Allan D. Kirk; Jay A. Fishman; Peter P. Reese; Anji Wall; James F. Markmann

doi:10.1016/j.ajt.2023.05.010

American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products

Andrew Adams, Linda C. Cendales, David K.C. Cooper, Emanuele Cozzi, John Gill, Eric Judd, Eliezer Katz, Allan D. Kirk, Jay A. Fishman, Peter P. Reese, Anji Wall, James F. Markmann^*

^*Corresponding author for this work

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

5 Scopus citations

Abstract

In June 2022, the US Food and Drug Administration Center for Biologics Evaluation and Research held the 73rd meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee for public discussion of regulatory expectations for xenotransplantation products. The members of a joint American Society of Transplant Surgeons/American Society of Transplantation committee on xenotransplantation compiled a meeting summary focusing on 7 topics believed to be key by the committee: (1) preclinical evidence supporting progression to a clinical trial, (2) porcine kidney function, (3) ethical aspects, (4) design of initial clinical trials, (5) infectious disease issues, (6) industry perspectives, and (7) regulatory oversight.

Original language	English
Pages (from-to)	1290-1299
Number of pages	10
Journal	American Journal of Transplantation
Volume	23
Issue number	9
DOIs	https://doi.org/10.1016/j.ajt.2023.05.010
State	Published - Sep 2023
Externally published	Yes

Keywords

kidney transplant
regulatory
xenotransplantation

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Adams, A., Cendales, L. C., Cooper, D. K. C., Cozzi, E., Gill, J., Judd, E., Katz, E., Kirk, A. D., Fishman, J. A., Reese, P. P., Wall, A., & Markmann, J. F. (2023). American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products. American Journal of Transplantation, 23(9), 1290-1299. https://doi.org/10.1016/j.ajt.2023.05.010

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title = "American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products",

abstract = "In June 2022, the US Food and Drug Administration Center for Biologics Evaluation and Research held the 73rd meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee for public discussion of regulatory expectations for xenotransplantation products. The members of a joint American Society of Transplant Surgeons/American Society of Transplantation committee on xenotransplantation compiled a meeting summary focusing on 7 topics believed to be key by the committee: (1) preclinical evidence supporting progression to a clinical trial, (2) porcine kidney function, (3) ethical aspects, (4) design of initial clinical trials, (5) infectious disease issues, (6) industry perspectives, and (7) regulatory oversight.",

keywords = "kidney transplant, regulatory, xenotransplantation",

author = "Andrew Adams and Cendales, {Linda C.} and Cooper, {David K.C.} and Emanuele Cozzi and John Gill and Eric Judd and Eliezer Katz and Kirk, {Allan D.} and Fishman, {Jay A.} and Reese, {Peter P.} and Anji Wall and Markmann, {James F.}",

note = "Publisher Copyright: {\textcopyright} 2023 American Society of Transplantation & American Society of Transplant Surgeons",

year = "2023",

month = sep,

doi = "10.1016/j.ajt.2023.05.010",

language = "English",

volume = "23",

pages = "1290--1299",

journal = "American Journal of Transplantation",

issn = "1600-6135",

number = "9",

}

Adams, A, Cendales, LC, Cooper, DKC, Cozzi, E, Gill, J, Judd, E, Katz, E, Kirk, AD, Fishman, JA, Reese, PP, Wall, A & Markmann, JF 2023, 'American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products', American Journal of Transplantation, vol. 23, no. 9, pp. 1290-1299. https://doi.org/10.1016/j.ajt.2023.05.010

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T1 - American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products

AU - Adams, Andrew

AU - Cendales, Linda C.

AU - Cooper, David K.C.

AU - Cozzi, Emanuele

AU - Gill, John

AU - Judd, Eric

AU - Katz, Eliezer

AU - Kirk, Allan D.

AU - Fishman, Jay A.

AU - Reese, Peter P.

AU - Wall, Anji

AU - Markmann, James F.

PY - 2023/9

Y1 - 2023/9

N2 - In June 2022, the US Food and Drug Administration Center for Biologics Evaluation and Research held the 73rd meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee for public discussion of regulatory expectations for xenotransplantation products. The members of a joint American Society of Transplant Surgeons/American Society of Transplantation committee on xenotransplantation compiled a meeting summary focusing on 7 topics believed to be key by the committee: (1) preclinical evidence supporting progression to a clinical trial, (2) porcine kidney function, (3) ethical aspects, (4) design of initial clinical trials, (5) infectious disease issues, (6) industry perspectives, and (7) regulatory oversight.

AB - In June 2022, the US Food and Drug Administration Center for Biologics Evaluation and Research held the 73rd meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee for public discussion of regulatory expectations for xenotransplantation products. The members of a joint American Society of Transplant Surgeons/American Society of Transplantation committee on xenotransplantation compiled a meeting summary focusing on 7 topics believed to be key by the committee: (1) preclinical evidence supporting progression to a clinical trial, (2) porcine kidney function, (3) ethical aspects, (4) design of initial clinical trials, (5) infectious disease issues, (6) industry perspectives, and (7) regulatory oversight.

KW - kidney transplant

KW - regulatory

KW - xenotransplantation

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AN - SCOPUS:85163340836

SN - 1600-6135

VL - 23

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EP - 1299

JO - American Journal of Transplantation

JF - American Journal of Transplantation

IS - 9

ER -

American Society of Transplant Surgeons-American Society of Transplantation report of FDA meeting on regulatory expectations for xenotransplantation products

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Keywords

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