Sue Marchant, director of product at MasterControl, will discuss how AI technology is helping pharmaceutical companies address CAPA and root cause investigations. The CAPA process has historically been more corrective than preventive, hard to track and implemented without context. During the podcast, we will be discussing the options available today to connect quality data and subsequently what problems can be solved using AI. These technologies will turn the tables making CAPA more preventive than corrective with the ability to track process in real time and understand the contributing factors and considerations surrounding an event. Additionally, Marchant will explain how AI combines and analyzes data, pinpoints relationships, and provides valuable process improvement. Companies should not be intimidated or hesitant about implementing AI technology. Today’s technology has AI capabilities embedded in the software to accelerate AI development. Companies no longer need specialists to get started and take advantage of the benefits.
If you are interested in learning more about the advancement of AI and the practical uses for pharmaceutical companies, please download our recent webinar here.
In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
FDA clears the IND for Biolojic Design’s BD200, an AI-designed Trop2/Nectin-4 multibody ADC; Blackstone Life Sciences agrees to provide Pfizer up to $1.5 billion to develop its monthly GLP-1 receptor agonist berobenatide; and enGene Therapeutics plans a year-end BLA for detalimogene voraplasmid in BCG-unresponsive non-muscle invasive bladder cancer.
FDA has cleared Biolojic Design’s IND for BD200, a bispecific antibody-drug conjugate targeting Trop2 and Nectin-4 whose arms can each bind either target. A global Phase 1 study in solid tumors is expected to begin in the coming weeks.
Blackstone Life Sciences will fund up to $1.5 billion of development costs through 2028 for Pfizer’s monthly GLP-1 receptor agonist berobenatide, in exchange for milestone payments tied to approval and sales. Pfizer keeps full control of the program.