Regulatory Affairs Task Force

The TF is composed of global experts whose experience spans academia, clinical development, industry, and regulatory affairs in the EV research and therapy field. The Task Force is focusing on the discovery of EV-based therapeutic strategies and their clinical translation. The identification of the relevant regulatory guidance and their application to EVs as investigational new drugs (INDs) in clinical studies is a major goal as well as to support safe and effective EV-based treatment concepts worldwide.

The 2 subgroups should facilitate bench-to-bedside transfer by identifying analytical tools for measurement of EV’s safety and efficacy and define reporting standards that relate to the modification of EVs to enhance therapeutic potency or improve and monitor biodistribution, targeting and cellular uptake.

Working Groups

Chair Contact Info

Output

• FDA Public Safety Notification on Exosome Products - published 2019 December
• ISEV and ISCT statement on EVs from MSCs and other cells: considerations for potential therapeutic agents to suppress COVID-19 - published 2020 May
• 1st Response to Exosomes Derived from Bone Marrow Mesenchymal Stem Cells as Treatment for Severe COVID-19 by Sengupta et al. - published 2020 July
• Patient information and safety notice: extracellular vesicles/exosomes and unproven therapies - published 2020 August
• Weiss Response to Sengupta et al (2nd Comment of Task Force Members on: Exosomes Derived from Bone Marrow Mesenchymal Stem Cells as Treatment for Severe COVID-19) - published 2020 December   
• Advanced Drug Delivery Reviews: A call for the standardised reporting of factors affecting the exogenous loading of extracellular vesicles with therapeutic cargos - published April 2021 
• Introduction to the ‘Task Force on Regulatory Affairs and Clinical Use of EV-based Therapeutics’ of the International Society for Extracellular Vesicles (ISEV) - 2021 April
• "Meeting Report: Large-scale production of extracellular vesicles: Report on the 'massivEVs' ISEV workshop”, JExBio 2022

Activities

• Task Force representation at Gordon Research Conference (Maine, US, 07/2022)
• Task Force representation at ISCT (San Francisco, US, 05/2022); contribution to the proceedings article: A report on the ISCT 2022 Scientific Signature Series, “Therapeutic advances with native and engineered human extracellular vesicles.”
• Contribution to MISEV2022/Therapeutics section
• E. Rohde is member of the ISCT exosome committee, ISEV/ISCT joint planning activities of scientific meetings

Members