Archives: Agenda

Learning from industry successes in reducing emissions, improving circularity, and maintaining affordability

Interviewee: Fatih Savci, Fleet management of rail vehicle technology and maintenance, WESTbahn

Interviewer: Patrick Atack, Editor of Railway Technology, GlobalData

• Cell therapies market landscape – current and future
• Key industry trends
• Industry forecast

• An overview of the FDA’s latest guidelines and requirements for DCTs, highlighting key aspects such as the integration of digital health technologies, remote monitoring, and the adherence to Good Clinical Practice (GCP) principles, as well as ensuring innovative trials maintain the highest standards of safety, efficacy, and data integrity.
• Discussion of the FDA’s collaborative efforts with other regulatory bodies, promoting harmonized standards and facilitating global acceptance of DCT methodologies.
• Adhering to the FDA’s comprehensive regulatory requirements so sponsors can navigate the complexities of DCTs and contribute to the evolution of clinical trials and the accelerated development of innovative medical treatments

• Sharing best practices for recruiting and integrating populations that are not well represented in oncology trials
• Lessons from Advancing Inclusive Research Site Alliance collaborations
• What strategies that pharma/biotech and vendor companies can design and support to help sites reach a more diverse patient population

• Understanding site processes and expectations to reduce delays in site initiation, activation, and screening for potential patients
• Championing collaborative sites for a streamlined trial
• Can we ever be appropriately equipped for adverse effects with off-site testing?