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

To be posted

Chair Contact Info


Eva Rohde
 | Marta Monguió-Tortajada 


Output

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

Jonathon Anderson | Francesc E. Borras | Benedetta Bussolati | Edit Buzas | Dave Carter | Rachel Ciccocioppo | Owen Davies | Juan M. Falcon-Perez | Bernd Giebel | Mario Gimona | Rebecca Lim | Sai Kiang Lim | Marta Monguió-Tortajada | Anna Nowocin | Lorraine O'Driscoll | Xenia Sango | Ralf Sanzenbacher | Hidetoshi Tahara | Clotilde Thery | Wei Seong Toh | Marca Wauben | Daniel Weiss | Kenneth Witwer

Authority Representatives

Ilona Reischl | Ralf Sanzenbacher