Tackling challenges of extracellular vesicle-based therapeutic development February 12, 2020

Webcast | Virtual

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• Date: February 12, 2020

University of Maryland CERSI

Wednesday, February 12, 2020

Presented By

Steven M. Jay, Ph.D.
Associate Professor,
Fischell Department of Bioengineering
University of Maryland

About the Presentation

Adult stem cell-based therapies have been extensively studied in clinical trials, but translation to clinical products has been hindered by quality control and safety concerns. Recently, much of the therapeutic potential of adult stem cell-based therapies has been attributed to their secreted extracellular vesicles (EVs), which are natural vectors of intercellular protein and RNA transfer. In general, EVs have several potential advantages over cells with regard to translational potential, including increased safety (EVs cannot divide or differentiate uncontrollably after administration) and improved reproducibility (EVs are less dynamic than cells, theoretically enabling more effective batch-to-batch quality control measures). Indeed, EVs from a myriad of cell types have been proposed and tested pre-clinically as therapeutic solutions for a wide variety of conditions. Yet, there are still many challenges that limit efficacy and translation of EVs for therapy, including an incomplete understanding of mechanism of action, a lack of scalable production methods, and insufficient potency. This talk detailed my research group’s efforts to address and overcome these challenges by developing new drug loading methods to improve potency and via development of new EV production systems that offer scalability and reproducibility by leveraging 3D printing technology.

About the Presenter

Dr. Jay is an Associate Professor in the Fischell Department of Bioengineering at the University of Maryland (UMD). He joined UMD in 2013 following PhD training in biomedical engineering at Yale University under Mark Saltzman and postdoctoral training in cardiovascular biology and molecular engineering jointly with Richard Lee at Harvard and Linda Griffith at MIT. His current research at UMD is supported by funding from NIH and NSF and focuses on developing rationally designed therapeutic biotechnology based on extracellular vesicles (EVs, aka exosomes). Particular issues of interest include drug loading into EVs and introducing quality control and standardization into EV biomanufacturing.

Recording

https://collaboration.fda.gov/phcsrjb2q0f0/

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Please contact Jessika Alfaro at Jessika.Alfaro@fda.hhs.gov