IQ MPS 

In 2023, the IQ MPS Affiliate collaborated with the U.S. Food and Drug Administration (FDA) to organize a virtual workshop to discuss the potential benefits of animal-cell based MPS in drug discovery and development, such the ability to bridge between animal in vivo data and human MPS results and other opportunities to advance 3Rs initiatives. Presentations given by IQ MPS, FDA, and NC3Rs (UK) representatives highlighted potential use cases for animal cell-based MPS and important considerations for their application. Breakout discussions provided an opportunity for other stakeholders to weigh in, including representatives from NIH/NCATS, NIHS, NIST, NIEHS/ICEATM, EURL ECVAM, Danish Medicines Agency, European Commission, Health Canada, and PMDA. Workshop organizers and presenters collaborated after the event to prepare a proceedings manuscript. READ HERE!

CRISPR-Cas9 gene editing technology offers promising potential for treating genetic diseases by correcting mutations. However, its safe application faces challenges due to limitations in testing models. Traditional laboratory methods using immortalized cells or animal studies often fail to accurately reflect human responses. Microphysiological systems (MPS), also known as "organs-on-chips," represent an innovative alternative that can better mimic human tissue structure and function. This review explores how combining CRISPR technology with MPS can enhance both fields: MPS provides more relevant testing platforms for CRISPR therapies, while CRISPR enables creation of disease models in MPS. This synergy could lead to safer, more effective gene therapies and reduce the need for animal testing. By offering more accurate prediction of human responses, this approach addresses current limitations in translating laboratory findings to clinical applications, ultimately benefiting patients with genetic disorders. READ HERE!

The IQ MPS Affiliate is excited to welcome its newest member, Zoetis! As the world’s leading animal health company, Zoetis lives its purpose to nurture our world and humankind by advancing care for animals. Zoetis will be represented on the IQ MPS Steering Committee by Charli Fant and Logeswari Ponnusamy.

To gain a better understanding of how pharmaceutical companies within the IQ consortium are currently using MPS models, the IQ MPS Affiliate conducted two comprehensive benchmarking surveys - one in 2019 and one in 2021. For each survey, IQ members answered more than 100 questions providing insight into technical characteristics of the models they have worked with, as well as current applications of MPS technologies in internal decision-making. The 2021 survey also included questions aimed at revealing more granular details about company experiences building confidence in model performance and translatability and perceived obstacles to utilizing MPS data in regulatory filings. The results of those surveys and key takeaways are summarized in this manuscript, published in Drug Metabolism and Disposition in Feb 2024. Read more here.

The IQ MPS Affiliate is excited to welcome its newest member, Daiichi Sankyo! Daiichi Sankyo is a global pharmaceutical company with corporate origins in Japan. We provide innovative products and services in 29 countries/regions around the world. With more than 120 years of scientific expertise, our company draws upon a rich legacy of innovation and a robust pipeline of promising new medicines to help patients. Daiichi Sankyo will be represented on the IQ MPS Steering Committee by Thomas Fischer.

In May 2022, there was 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). Read more here.

The IQ MPS Affiliate is excited to welcome its newest member, Servier! Servier is a privately held international pharmaceutical company headquartered in France with a passion for innovation that has improved patients’ lives around the world. Servier will be represented on the IQ MPS Steering Committee by Chloe Korlowski and Amelie Moreau.

The IQ MPS Affiliate is excited to welcome its newest member, Roche! Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. Roche will be represented on the IQ MPS Steering Committee by Nadine Stokar and Remi Villenave.

In this manuscript, the authors provide a pharmaceutical industry perspective on the state of the science of MPS disease models, including models for cancer, liver/kidney diseases, respiratory diseases, neurodegenerative diseases, gastrointestinal diseases, and select rare diseases. The authors also describe their technical limitations and provide recommendations for future model development that would expand application opportunities within the pharmaceutical industry. Read more here.

The IQ MPS Affiliate is excited to welcome its newest member, Incyte! Incyte is a global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of novel medicines. Incyte will be represented on the IQ MPS Steering Committee by Manti Guha and Alejandro Amador.

The IQ MPS Affiliate is excited to welcome its newest member, UCB! UCB Pharma is a leading global biopharmaceutical company focused on creating value for people living with severe diseases in immunology and neurology now and into the future. UCB Pharma will be represented on the IQ MPS Steering Committee by Jason Ekert.

On May 23 and 24, up to 200 representatives from US FDA, the IQ MPS Affiliate, and various global regulatory agencies and standards-setting organizations met virtually to discuss the development of performance standards and guidelines for Microphysiological Systems in drug development. Many thanks to the US FDA and IQ MPS representatives who helped organize this event and our panelists, speakers, and moderators for making this an informative and productive workshop. A manuscript summarizing the proceedings, including lessons learned and recommendations, is forthcoming!

Complex in vitro models (CIVM) offer the potential to improve pharmaceutical clinical drug attrition due to safety and/or efficacy, but for this technology to have an impact, the establishment of robust characterization and qualification plans constructed around specific context of use (COU) are required. This perspective article will cover the important output from a workshop between the Food and Drug Administration (FDA) and Innovation and Quality Microphysiological Systems (IQ MPS) Affiliate. Read more here.

IQ MPS Affiliate welcomes Boehringer Ingelheim as the newest member of the Affiliate. Contact us to learn more about how your company can join and collaborate in the MPS Affiliate.

The IQ MPS Affiliate announces its 8th manuscript in Lab on a Chip, “Cardiovascular Microphysiological Systems (CVMPS) for Safety Studies- A Pharma Perspective.” To enable to the adoption of CVMPS for evaluating novel drug candidates, industry will need evidence of their “fit for purpose” applications targeted at different levels of complexity and integration. Meeting this challenge will require development of mature bioengineered components with meaningful vascular linkages that provide more value than current in vivo models, an effort best served by partnerships between government-funded initiatives, academics, and private companies. Read the publication here.

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IQ Microphysiological Systems (MPS) Affiliate manuscripts published in Lab on a Chip are now available as a special online edition of the Journal. Manuscripts contain information on likely initial contexts of use (CoU) for MPS and key characterization data needed for incorporation of these tools in pharmaceutical safety screening and drug development. Individual manuscripts also provide a list of characteristic functions, cell types, toxicities, and test agents that can serve as a guide for developers of lung, liver, skin, kidney, and gastrointestinal MPS as well as MPS for applications in biologics drug development and ADME. For more information, read the introductory manuscript here. Find the full special collection here.

To guide the design of GI-MPS assays to meet safety assessment needs for drug-induced gastrointestinal toxicities, this review provides an industry perspective on assay features of high priority. The topics discussed include screening assays for early detection, investigative models for mechanistic elucidation, tool compounds for assessing predictive performance, gaps and opportunities emerging with epithelial-only GI microtissues, specific microphysiologies that need to be emulated to align with top GI AEs, kinetic data to support mathematical modelling, and guidance on assay endpoint selection. Read more here.

Pharmaceutical industry scientists provide their perspective on the phenotypic and physiochemical attributes of microphysiological kidney models that could improve confidence in safety and ADME evaluations of experimental therapies and key considerations for effectively implementing these models in nephrotoxicity testing. Read the publication here .

IQ MPS Affiliate scientists describe the opportunities and challenges in developing tissue-specific MPS for preclinical research of large molecule therapeutics. Read more here .

This manuscript provides a pharmaceutical industry perspective on qualification standards and future directions for contemporary complex in vitro models in ADME applications with a focus on four organs of interest (liver, intestine, kidney, and brain) and linked-organ systems. Read more here.

In this manuscript, pharmaceutical industry scientists describe a 3-part strategy for optimizing and bench-marking liver MPS performance, so as to help model developers and end users identify what would be the most valuable models for safety risk assessment. This critical review also describes all of the features of the ideal liver MPS model, provides an overview of currently used safety assays, and highlights the best-suited contexts of use for various liver MPS categories. Read more here .

In this manuscript, pharmaceutical industry scientists provide an overview of current complex skin model capabilities and limitations within the drug development scheme. Recommendations are also provided for future model development and assay qualification with the intent to facilitate wider adoption within the pharmaceutical industry. Read more here.

This article summarizes, from a biopharmaceutical industry perspective, essential elements for the development and qualification of lung MPS models. Its purpose is to guide MPS developers and manufacturers to expedite MPS utilization for safety assessment in the biopharmaceutical industry. Read more here

Scientists from several biopharmaceutical companies, through the International Consortium for Innovation and Quality in Pharmaceutical Development Microphysiological Systems (IQ MPS) Affiliate, will prepare a series of organotypic manuscripts to provide relevant information to MPS developers and users on the characterization parameters and data needed to expedite implementation of MPS in safety screening in drug discovery and development. Individual manuscripts will provide information on the cell types and tissue functions, test agents (representing major mechanisms of toxicity), relevant assessment endpoints/biomarkers and likely initial contexts of use, with the intent that MPS developers incorporate these into their models to facilitate uptake of MPS platforms by the biopharmaceutical industry and health authorities/regulators. Manuscripts will focus on lung, liver, kidney, skin, gastrointestinal, cardiovascular, and blood brain barrier/central nervous system. In addition, an introductory article and two manuscripts focusing on biologically-based therapeutics and ADME considerations will be prepared as part of this effort. These manuscripts will be published in Lab on a Chip.