The Cell and Gene Therapy (CGT) sector continues to progress toward a demonstrably execution-centric development paradigm, in which asset valuation is increasingly influenced by the capacity to integrate scientific innovation with operational precision, manufacturing robustness, and evidence strategies that withstand...
Expertise: Cell & Gene Therapy 54 results
Cell & Gene Therapy
Scaling CGT Trials: The Critical Role of Emerging Research Centers
The cell and gene therapy (CGT) landscape has entered a period of unprecedented growth. Dozens of CGT products have already been approved globally, and more than 4,300 therapies—from AAV gene therapies to RNA-based and gene-modified cell therapies—are moving through development.i...
Cell & Gene Therapy
Where Will Your CGT Study Go? Solving the Site Capacity Challenge
Cell & Gene Therapy
Where Will Your CGT Study Go? Solving the Site Capacity Challenge
In the rapidly evolving field of adeno-associated virus (AAV) gene therapy, patient advocacy groups (PAGs) have emerged as critical partners driving scientific, operational, and regulatory progress. Their influence extends far beyond awareness and fundraising—they help shape trial design, regulatory engagement,...
Cell & Gene Therapy
Personalized, Decentralized Approaches to Long-Term Follow-Up in CGT Trials
Cell and gene therapies require 6–15 years of follow-up to monitor long-term safety and efficacy. Traditional sites can struggle to sustain contact and compliance over such extended timelines. This guide shows how decentralized solutions make long-term follow-up (LTFU) more sustainable,...
Long-term follow-up (LTFU) is a defining feature of oncology and cell and gene therapy (CGT) trials, where post-treatment monitoring often spans 2 to 15 years. These extended timelines allow regulators to assess long-term safety and efficacy from detecting delayed adverse...
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...
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...