Cell therapies, despite their transformative potential, face significant barriers that can hinder their development and commercialization. Safety concerns, manufacturing challenges, analytical complexities and scale-up difficulties present substantial risks. Competition from other drug modalities, coupled with the inherent complexity of clinical development, further complicates the pathway to market. Distribution and supply chain challenges add another layer…
Olu Aloba
Cell therapy development faces significant challenges on the path from concept to clinical application. From navigating the regulatory landscape to ensuring product consistency and standardization, the initial phases of developing cell therapies require careful planning and close collaboration among cross-functional teams. In this blog, we explore the complexities of early cell therapy development, with a…
Consulting
CMC Considerations for Pre-IND Meetings
The pre-IND meeting is an opportunity for highly productive interactions between sponsors and the FDA, allowing for discussion of key material attributes and development strategy plus requests for Agency review and advice on specific topics. In general, such meetings are multidisciplinary and cover the regulatory, Chemistry, Manufacturing, and Controls (CMC), nonclinical, and clinical plans for…