How to Safely Handle Your Antibody Drug Conjugate

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars targeting the needs of all health care professionals and students, including physicians, physician assistants, nurses, pharmacists, and pharmacy technicians.

Typically, Manufacturing Operations and Support Personnel spend too much time trying to navigate a complex information landscape to locate data, extract it and combine it with data from other systems to gain insights about the assets and drug manufacturing processes they support and service. At Eli Lilly, as a part of their Digital Plant journey, a program called “DaVinci” (among many others) was created to address this problem head-on. DaVinci is a comprehensive data integration platform with embedded data visualization, analytics, and knowledge sharing capability that also provides the flexibility for users to bring their own data and tools to the platform via “plug and play” functionality. It also provides a shared workbench to conduct quick analytics on near-real-time data to gain timely insights on manufacturing processes.

Patient-centricity gets a lot of buzz, but what are the benefits of involving patients in the planning of a clinical trial?

Most informed consent forms are not patient focused and do not support the needs of the study participant! Use of electronic consent can help improve the current paper document approach, but there is more to it than just replacing paper with a multi-media eConsent. What does it take to make eConsent patient centric?