In the competitive and fast-moving Cell and Gene Therapy (CGT) field, developers face a range of scientific, technical, and regulatory challenges that can quickly become overwhelming and costly. In spite of this, CGT/ATMP holds great promise to deliver transformative outcomes for a wide range of traditionally hard-to-treat diseases.
There are nearly 400 cell and gene therapies currently in development, representing a 20% increase from 2018. We will discuss how you can accelerate your CGT product development by creating a clear roadmap for achieving critical milestones that will benefit the patients who need them.
Participants will gain a better understanding of:
Building an effective quality management system (QMS)
Designing the right nonclinical studies
Engaging regulators globally