Dr Tulasi Yadati
Dr Tulasi Yadati is Associate Consultant at Scendea.
JournalNavigating regulatory pathways for live biotherapeutics in the US and EU: Challenges and opportunities
This article summarises the current US and EU regulatory landscape for live biotherapeutics and provides practical considerations to help sponsors plan development programmes.
JournalConsiderations in the development of allogenic and autologous cell therapies
Autologous cell therapy involves the use of a patient’s own cells which are harvested, modified or expanded ex vivo and then reintroduced into the patient. Allogeneic therapies use cells from a donor modified or expanded ex vivo and then administered to the patient.