Cell Therapies

Harnessing the power of the immune system: from bispecific antibodies to CAR-Ts and beyond

by Diane Seimetz

The first class of therapeutic products harnessing the power of T cells for target-specific treatment of oncological diseases was bispecific antibodies. Eight years later, the first autologous chimeric antigen receptor (CAR)-T cells received regulatory approval. In this article, Diane Seimetz reviews the current landscape of CAR-Ts, recent approvals  and further important developments in the cell- and gene therapy space.

Cell and gene therapies are changing the face of modern medicine – But how to find the right dose?

by Diane Seimetz

Finding the right dose for the first in human study can be a challenging undertaking for biopharmaceuticals. For cell and gene therapy products (commonly referred to as ATMPs), this is even more challenging. In this article, Diane Seimetz reminds us what Paracelsus’ toxicology principle has taught us, and she explains what the key questions for ATMPs are to guide a tailored dose-finding exercise.

RMAT: FDA started new expedited program for cell therapies

FDA recently introduced the new Regenerative Medicine Advanced Therapy (RMAT) Designation in the framework of the 21st Century Cures Act. This new FDA pathway enables companies developing cell- and tissue-based therapies, tissue-engineering products, and combination treatments to have earlier and more frequently interactions with the agency and benefit from proactive collaboration with FDA.