Determining the right regulatory pathway for a drug product is a critical early decision that can shape the entire development strategy. While many products may appear to fit the generic model, nuances in formulation, dosage form, route of administration, or...
Olu Aloba
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...
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...
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...
During the development of new small molecule drug products, developers must conduct impurity and degradant evaluation at several points in the program and to varying degrees. These evaluations include the active pharmaceutical ingredient (API), also known as the drug substance,...