02.26.24 -- Ruthless Resourcing Rules For CEOs

On Cell & Gene: The Podcast, Christopher McDonald, global head of technical operations at Kite, a Gilead company, talks about their recent FDA approval of manufacturing process change resulting in reduced median turnaround time for Yescarta. Hear about the significant steps Kite Pharma took to reach this approval.

Review the evolving regulations for entering China's medical device market and learn how collaborating with experts can help to position your company to capitalize on this dynamic market.

Obtain a complete understanding of enrollment, screening, consent, and data collection by diving into this introductory handbook on decentralized clinical trials.

Learn about the first end-to-end cGMP facility developed for mRNA manufacturing to address the shortage of CDMOs and the inadequate and inefficient supply chain options for sourcing GMP mRNA.

Experts discuss the best time to start thinking about patient centricity, the steps developers can take to achieve patient-centric drug design, and how formulation and dosage forms can make a difference.

A CDMO with in-house plasmid manufacturing capabilities can help companies accelerate timelines and ensure material availability, ultimately saving time and money throughout their product life cycle.

Discover this three-stage execution plan established by a CRO that allowed organizational and process changes to occur in lockstep with a risk-based quality management platform rollout.

Biotechs must work to expand patient access while securing financial sustainability when navigating global commercialization. A strategic approach that prioritizes global expansion is crucial.