The efficiencies and insights of artificial intelligence (AI), machine learning (ML), predictive analytics, and other emerging technologies offer abundant opportunities to laboratories. To help customers leverage digital transformation and prepare for the lab of the future, LabVantage Solutions has devised a five-step process for successfully implementing and profiting from AI in the lab.
Mitigating nitrosamine risk requires assessing each product individually and chasing zero nitrite in pharmaceutical excipients is often impractical and costly.
In October, FDA reorganized rare disease development around a fit-for-purpose framework and a new pathway for individualized gene editing. Regulators in Europe and the UK set out long-term plans for clinical trials, AI, and moving away from animal testing.
Clinical, manufacturing, safety, and commercial teams all lean on shared data. They need to agree on who publishes each data product, who can use it, and what evidence goes with it.
The FDA approves VOCERYQ, the first DNA medicine, for RRP surgery reduction, raising plasmid, drug-device, and confirmatory trial manufacturing demands.