Dr Bethany Aykroyd
Dr Bethany Aykroyd PhD is Team Lead of Scendea UK and a Senior Consultant.
JournalDrug development and regulatory pathways across therapeutic areas
This article evaluates how drug development and regulatory pathways differ across oncology, rare diseases, paediatric indications and life-threatening conditions in the US, UK and EU. Drawing on regulatory guidance and industry practices, it explores how therapeutic context shapes development, trial design and approval strategies, highlighting key differences in regulatory expectations and acceleration incentives.
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.