Moving CGTx Clinical Development Forward In 2023

Cell and gene therapy (CGTx) developers face a complicated, challenging path to clinical success. The increased clinical trial volume and influx of less-experienced sponsors are adding further complexity to the clinical trial space. Sponsors must consider factors such as CMC vendor selection, early planning for eventual commercialization, clinical trial design, and patient access strategy to maximize the potential of success for their advanced therapeutic.

Building and maintaining a strong relationship with a reliable CMC vendor is essential to avoid delays and additional costs on the path toward regulatory filing, and a collaborative relationship between the FDA, manufacturers, and treatment centers is key for overcoming challenges with scalability, logistics, and gaps in capabilities as products transition from clinical trials to commercialization.

Gain insights on CGTx clinical trial design and commercialization strategies as a panel of industry experts share their considerations.