The rapid advancement of cell and gene therapies (CGT) continues to reshape the clinical development landscape. As these innovative modalities move beyond ultra-rare diseases and academic institutions, clinical trial stakeholders must contend with a new set of operational realities—chief among...
Expertise: Cell & Gene Therapy 57 results
Cell & Gene Therapy
Cell & Gene Meeting on the Mesa
Cell & Gene Therapy
Improving Vigilance: A Guide to Shaping Safer AAV Gene Therapy Trials
Adeno-Associated Virus (AAV) gene therapy represents a breakthrough in the treatment of genetic diseases. Yet, recent clinical trials have highlighted safety concerns, including severe adverse events. These incidents underscore the critical importance of embedding safety-focused practices into every stage of...
Cell & Gene Therapy
Advancing Cell & Gene Therapy Clinical Development
Selecting the right CRO partner is a critical factor in the success of any cell and gene therapy (CGT) program. With global reach and deep therapeutic expertise, Premier helps navigate complex regulatory and development landscapes—reducing risk and accelerating timelines in CGT...
Cell & Gene Therapy
Cell and Gene Meeting on the Med
Cell & Gene Therapy
Advanced Therapies
Rare Disease
Paulla Dennis
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...