Gene and cell therapy developers are contending with the implications of the evolving regulatory environment while trying to progress programs as quickly as possible to address unmet needs and secure first-mover advantage in competitive indications. Regulators are facilitating efforts to truncate development timelines through a series of designations that can expedite programs while also making efforts to implement standardization.
Our expert panel will discuss the key quality areas that are gaining more scrutiny from regulators, and the reasons and thinking behind it.
The audience will gain insight into:
- Construct design elements—eliminating extraneous sequences while optimizing yield and expression.
- Changes in the field and current efforts underway to drive a reduction of time from start to finish for producing high-quality product at a commercial scale.
- Evaluation of key in-process and standardized release testing with validation glidepath.