Applied Clinical Trials Digital Edition - March 2012

Primary results from the Phase II TRANSCEND FL trial show Breyanzi (lisocabtagene maraleucel) achieved a 95.5% response rate and durable efficacy in relapsed or refractory marginal zone lymphoma, supporting its potential as a transformative CAR T-cell therapy.

In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.

Under the new initiative, companies may receive a voucher enabling FDA review to be shortened from the standard 10–12 months to just 1–2 months following final application submission if the drug addresses US national health priorities.

Using a recent survey on the adoption of AI/ML conducted by the Tufts CSDD as context, pharma leaders discussed how they are using these technologies to optimize trial execution.

View the Applied Clinical Trials June 2025 issue in an interactive format.