Talks by SOCRATES Members
FDA Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) 14 March 2023
Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop
Tuesday, March 14, 9:00 a.m.–4:45 p.m. ET
From the organizer: The U.S. Food and Drug Administration (FDA) will host a virtual workshop for FDA staff and cellular and gene therapy stakeholders. The goal of the workshop is to obtain specialized knowledge from experts in the field of advanced manufacturing and analytical technologies (AMAT) for regenerative medicine therapies (RMT), discuss innovative manufacturing technologies and alternative testing methods, and share experiences, challenges, and best practices critical for chemistry, manufacturing, and controls (CMC) of RMT.
This workshop will be comprised of keynote speakers, presentations, and panel discussions with experts in the AMAT field.
Dr. Lim Sai Kiang, President of SOCRATES was the invited Key Opinion Leader on EVs. Below is the link to the recorded workshop.
ISEV – SOCRATES EV Club (Sai Kiang Lim)
In this EVClub, Sai Kiang Lim presents “MSC-sEV: Navigating the regulatory path to clinical trial”.
ISEV – SOCRATES EV Club (Wei Seong Toh)
Wei Seong Toh, Associate Professor at National University of Singapore, presents this EVClub on “MSC-sEVs for joint repair: A roadmap to the clinic,”
ISEV – SOCRATES EV Club (Boon Cher Goh)
Professor Boon Cher Goh presents his work on “Circulating extracellular vesicles as intercellular communicators and their potential for cancer diagnostics in lung cancer.”
ISEV – SOCRATES EV Club (Jiong-Wei Wang)
Jiong-Wei Wang presents “Extracellular vesicles derived from milk: oral therapeutic nanoparticles for gut inflammation”.
ISEV – SOCRATES EV Club (Huilin Shao)
Huilin Shao presents on “Nanosensor technologies for molecular analysis of circulating biomarkers.”
ISEV – SOCRATES EV Club (Giorgia Pastorin)
Giorgia Pastorin speaks about “recent advances in nano-Cell Vesicle Technology Systems (nCVTs), obtained through the fusion of cell-derived components with synthetic materials.”
ISEV – SOCRATES EV Club (Jia Tong Loh)
Jia Tong Loh presents on “Mechanism for the attenuation of neutrophil and complement hyperactivity by MSC-sEVs”
ISEV – SOCRATES EV Club (Shawn Chen)
Xiaoyuan (Shawn) Chen of the National University Singapore presents “Biomimetic Cell Membrane-Coated Nanoparticles. This is the first joint SOCRATES and ISEV Extracellular Vesicle Club meeting.