TY - JOUR
KW - context of use
AU - Szczepan W. Baran
AU - Paul C. Brown
AU - Andreas R. Baudy
AU - Suzanne C. Fitzpatrick
AU - Christopher Frantz
AU - Aaron Fullerton
AU - Jinping Gan
AU - Rhiannon N. Hardwick
AU - Kathleen M. Hillgren
AU - Anna K. Kopec
AU - Jennifer L. Liras
AU - Donna L. Mendrick
AU - Ryan Nagao
AU - William R. Proctor
AU - Diane Ramsden
AU - Alexandre J. S. Ribeiro
AU - David Stresser
AU - Kyung E. Sung
AU - Radhakrishna Sura
AU - Kazuhiro Tetsuka
AU - Lindsay Tomlinson
AU - Terry Van Vleet
AU - Matthew P. Wagoner
AU - Qin Wang
AU - Sevim Yildiz Arslan
AU - Gorm Yoder
AU - Jason E. Ekert
AB - Complex in vitro models (CIVM) offer the potential to improve pharmaceutical clinical drug attrition due to safety and/ or efficacy concerns. For this technology to have an impact, the establishment of robust characterization and qualifi­cation plans constructed around specific contexts of use (COU) is required. This article covers the output from a workshop between the Food and Drug Administration (FDA) and Innovation and Quality Microphysiological Systems (IQ MPS) Affiliate. The intent of the workshop was to understand how CIVM technologies are currently being applied by pharma­ceutical companies during drug development and are being tested at the FDA through various case studies in order to identify hurdles (real or perceived) to the adoption of microphysiological systems (MPS) technologies, and to address evaluation/qualification pathways for these technologies. Output from the workshop includes the alignment on a working definition of MPS, a detailed description of the eleven CIVM case studies presented at the workshop, in-depth analysis, and key take aways from breakout sessions on ADME (absorption, distribution, metabolism, and excretion), pharmacology, and safety that covered topics such as qualification and performance criteria, species differences and concordance, and how industry can overcome barriers to regulatory submission of CIVM data. In conclusion, IQ MPS Affiliate and FDA scientists were able to build a general consensus on the need for animal CIVMs for preclinical species to better determine species concordance. Furthermore, there was acceptance that CIVM technologies for use in ADME, pharmacology and safety assessment will require qualification, which will vary depending on the specific COU.
BT - Alternatives to Animal Experimentation
DA - 2022-04-11
DO - 10.14573/altex.2112203
IS - 2
LA - en
N2 - Complex in vitro models (CIVM) offer the potential to improve pharmaceutical clinical drug attrition due to safety and/ or efficacy concerns. For this technology to have an impact, the establishment of robust characterization and qualifi­cation plans constructed around specific contexts of use (COU) is required. This article covers the output from a workshop between the Food and Drug Administration (FDA) and Innovation and Quality Microphysiological Systems (IQ MPS) Affiliate. The intent of the workshop was to understand how CIVM technologies are currently being applied by pharma­ceutical companies during drug development and are being tested at the FDA through various case studies in order to identify hurdles (real or perceived) to the adoption of microphysiological systems (MPS) technologies, and to address evaluation/qualification pathways for these technologies. Output from the workshop includes the alignment on a working definition of MPS, a detailed description of the eleven CIVM case studies presented at the workshop, in-depth analysis, and key take aways from breakout sessions on ADME (absorption, distribution, metabolism, and excretion), pharmacology, and safety that covered topics such as qualification and performance criteria, species differences and concordance, and how industry can overcome barriers to regulatory submission of CIVM data. In conclusion, IQ MPS Affiliate and FDA scientists were able to build a general consensus on the need for animal CIVMs for preclinical species to better determine species concordance. Furthermore, there was acceptance that CIVM technologies for use in ADME, pharmacology and safety assessment will require qualification, which will vary depending on the specific COU.
PY - 2022
SP - 297
EP - 314
ST - Perspectives on the evaluation and adoption of complex in vitro models in drug development
T2 - Alternatives to Animal Experimentation
TI - 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)
UR - https://www.altex.org/index.php/altex/article/view/2406
VL - 39
Y2 - 2023-08-10
SN - 1868-8551
ER -