Considerations from an International Regulatory and Pharmaceutical Industry (IQ MPS Affiliate) Workshop on the Standardization of Complex In Vitro Models in Drug Development

被引：11

作者：

Tomlinson, Lindsay ^{[1
]}

Ramsden, Diane ^{[2
]}

Leite, Sofia Batista ^{[3
]}

Beken, Sonja ^{[4
]}

Bonzo, Jessica A. ^{[5
]}

Brown, Paul ^{[5
]}

Candarlioglu, Pelin L. ^{[6
]}

Chan, Tom S. ^{[7
]}

Chen, Eugene ^{[8
]}

Choi, Colin K. ^{[9
]}

David, Rhiannon ^{[10
]}

Delrue, Nathalie ^{[11
]}

Devine, Patrick J. ^{[12
]}

Ford, Kevin ^{[13
]}

Garcia, Martha Iveth ^{[13
]}

Gosset, James R. ^{[14
]}

Hewitt, Philip ^{[15
]}

Homan, Kimberly ^{[16
]}

Irrechukwu, Onyi ^{[17
]}

Kopec, Anna K. ^{[18
]}

Liras, Jennifer L. ^{[19
]}

Mandlekar, Sandhya ^{[20
]}

Raczynski, Arek ^{[21
]}

Sadrieh, Nakissa ^{[5
]}

Sakatis, Melanie Z. ^{[22
]}

Siegel, Jeffrey ^{[5
]}

Sung, Kyung ^{[23
]}

Sunyovszki, Ilona ^{[24
]}

Van Vleet, Terry R. ^{[25
]}

Ekert, Jason E. ^{[26
]}

Hardwick, Rhiannon N. ^{[12
]}

机构：

[1] Pfizer Inc, Global Pathol, Cambridge, MA 02140 USA

[2] AstraZeneca, DMPK Oncol, Boston, MA 02451 USA

[3] European Commiss Joint Res Ctr, I-21027 Ispra, Italy

[4] Fed Agcy Med & Hlth Prod, B-1210 Brussels, Belgium

[5] US FDA, Ctr Drug Evaluat & Res, Off New Drugs, Silver Spring, MD 20993 USA

[6] GSK, Complex Vitro Models, Stevenage SG1 2NY, England

[7] Boehringer Ingelheim Pharmaceut Inc, Drug Metab & Pharmacokinet, Ridgefield, CT 06877 USA

[8] Genentech Inc, DMPK, South San Francisco, CA 94080 USA

[9] Biogen, Preclin Safety, Cambridge, MA 02142 USA

[10] AstraZeneca, Clin Pharmacol & Safety Sci, Cambridge CB2 0AA, England

[11] Org Econ Cooperat & Dev, F-75016 Paris, France

[12] Bristol Myers Squibb, Discovery Toxicol, San Diego, CA 09130 USA

[13] US FDA, Div Appl Regulatory Sci, Off Clin Pharmacol, Off Translat Sci,Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA

[14] Pfizer Inc, DMPK, Cambridge, MA 02139 USA

[15] Merck Healthcare KGaA, Chem & Preclin Safety, D-64293 Darmstadt, Germany

[16] Genentech Inc, Complex In Vitro Syst Grp, South San Francisco, CA 94080 USA

[17] Johnson & Johnson Innovat Med, Preclin Sci & Translat Safety, Spring House, PA 19002 USA

[18] Pfizer Inc, Drug Safety Res & Dev, Groton, CT 06340 USA

[19] Pfizer, Pharmacokinet Dynam & Metab Med Design, Cambridge, MA 02139 USA

[20] Genentech Inc, Clin Pharmacol, South San Francisco, CA 94080 USA

[21] Vertex Pharmaceut Inc, Preclin Safety Assessment, Boston, MA 02210 USA

[22] GlaxoSmithKline Res & Dev Ltd, Nonclin Safety, In Vitro In Vivo Translat, Ware SG12 9TJ, England

[23] US FDA, Ctr Biol Evaluat & Res, Off Cellular Therapy & Human Tissue, Cellular & Tissue Therapy Branch, Silver Spring, MD 20993 USA

[24] Biogen, Translat Genome Sci, Cambridge, MA 02142 USA

[25] AbbVie Inc, N Chicago, IL 60064 USA

[26] UCB Pharm, Cambridge, MA 02140 USA

来源：

ADVANCED BIOLOGY | 2024年 / 8卷 / 08期

关键词：

complex in vitro models; drug development; microphysiological systems; standardization; MICROPHYSIOLOGICAL SYSTEMS; SAFETY; TOXICITY; CLEARANCE; DISCOVERY; INTERPLAY; CULTURE; ADME;

D O I：

10.1002/adbi.202300131

中图分类号：

TB3 [工程材料学]; R318.08 [生物材料学];

学科分类号：

0805 ; 080501 ; 080502 ;

摘要：

In May 2022, there is an International Regulatory and Pharmaceutical Industry (Innovation and Quality [IQ] Microphysiological Systems [MPS] Affiliate) Workshop on the standardization of complex in vitro models (CIVMs) in drug development. This manuscript summarizes the discussions and conclusions of this joint workshop organized and executed by the IQ MPS Affiliate and the United States Food and Drug Administration (FDA). A key objective of the workshop is to facilitate discussions around opportunities and/or needs for standardization of MPS and chart potential pathways to increase model utilization in the context of regulatory decision making. Participation in the workshop included 200 attendees from the FDA, IQ MPS Affiliate, and 26 global regulatory organizations and affiliated parties representing Europe, Japan, and Canada. It is agreed that understanding global perspectives regarding the readiness of CIVM/MPS models for regulatory decision making and potential pathways to gaining acceptance is useful to align on globally. The obstacles are currently too great to develop standards for every context of use (COU). Instead, it is suggested that a more tractable approach may be to think of broadly applicable standards that can be applied regardless of COU and/or organ system. Considerations and next steps for this effort are described. There is a strong need for standardization of microphysiological systems in order to increase model utilization and incorporation into the existing paradigm of drug development. These models must also be deemed acceptable to regulators. The results of a workshop with Industry and Global Regulatory participants are shared.image

引用

页数：16

共 4 条

[1] Perspectives on the Evaluation and Adoption of Complex In Vitro Models in Drug Development: Workshop with the FDA and the Pharmaceutical Industry (IQ MPS Affiliate)
Baran, Szczepan W.
Brown, Paul C.
Baudy, Andreas R.
Fitzpatrick, Suzanne C.
Frantz, Christopher
Fullerton, Aaron
Gan, Jinping
Hardwick, Rhiannon N.
Hillgren, Kathleen M.
Kopec, Anna K.
Liras, Jennifer L.
Mendrick, Donna L.
Nagao, Ryan
Proctor, William R.
Ramsden, Diane
Ribeiro, Alexandre J. S.
Stresser, David
Sung, Kyung E.
Sura, Radhakrishna
Tetsuka, Kazuhiro
Tomlinson, Lindsay
Van Vleet, Terry
Wagoner, Matthew P.
Wang, Qin
Arslan, Sevim Yildiz
Yoder, Gorm
Ekert, Jason E.
ALTEX-ALTERNATIVES TO ANIMAL EXPERIMENTATION, 2022, 39 (02) : 297 - 314
[2] How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organizations
Marianne Botoft Hansen
Lotte Stig Nørgaard
Christine Erikstrup Hallgreen
Therapeutic Innovation & Regulatory Science, 2020, 54 : 577 - 585
[3] How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organizations
Hansen, Marianne Botoft
Norgaard, Lotte Stig
Hallgreen, Christine Erikstrup
THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2020, 54 (03) : 577 - 585
[4] How and Why to Involve Patients in Drug Development: Perspectives From the Pharmaceutical Industry, Regulatory Authorities, and Patient Organizations
Hansen, Marianne Botoft
Norgaard, Lotte Stig
Hallgreen, Christine Erikstrup
THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2019,

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