03127nas a2200481   4500000000100000000000100001008004100002260001500043653001900058100002200077700001800099700002100117700002700138700002300165700002000188700001600208700002500224700002500249700001800274700002200292700002200314700001500336700002300351700001800374700002800392700001900420700001800439700002200457700002100479700002200500700002000522700002300542700001300565700002400578700001500602700001900617245016900636856006000805300001200865490000700877520174700884022001402631       2022                            d  c2022-04-1110acontext of use1 aSzczepan W. Baran1 aPaul C. Brown1 aAndreas R. Baudy1 aSuzanne C. Fitzpatrick1 aChristopher Frantz1 aAaron Fullerton1 aJinping Gan1 aRhiannon N. Hardwick1 aKathleen M. Hillgren1 aAnna K. Kopec1 aJennifer L. Liras1 aDonna L. Mendrick1 aRyan Nagao1 aWilliam R. Proctor1 aDiane Ramsden1 aAlexandre J. S. Ribeiro1 aDavid Stresser1 aKyung E. Sung1 aRadhakrishna Sura1 aKazuhiro Tetsuka1 aLindsay Tomlinson1 aTerry Van Vleet1 aMatthew P. Wagoner1 aQin Wang1 aSevim Yildiz Arslan1 aGorm Yoder1 aJason E. Ekert00aPerspectives on the evaluation and adoption of complex in vitro models in drug development: Workshop with the FDA and the pharmaceutical industry (IQ MPS Affiliate)  uhttps://www.altex.org/index.php/altex/article/view/2406  a297-3140 v393 aComplex 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.  a1868-8551