Zeb Younes
Zeb Younes is Chief Regulatory Officer, CMC, at Granata Bio.
EditorialNavigating complexity: Regulation at the interface of innovation, technology and confidence
This issue focuses on complex products, with articles on brain-computer interfaces, radiopharmaceuticals and sophisticated generic products, and explores how regulatory systems can remain robust and predictable while enabling novel technologies to reach patients.
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.
JournalConsiderations for generics developers moving into the field of biosimilars
Many generic developers have experience in both manufacturing and gaining US and EU approval for generics which are small molecule alternatives to the authorised original products. These developers possess the relevant skillsets to allow them to pursue the development of biosimilars, which are large molecule biologics highly similar to the authorised original products.
JournalNavigating early drug development investment: a detailed guide to due diligence
Funding is undoubtedly one of the major challenges small and medium-sized companies face when developing a new therapy from the bench to the clinic and eventually to the market. Suitable partnerships and potential mergers and acquisitions are key drivers to take a drug development programme to the next stage. The ...