The Billion Cell Atlas, backed by Eli Lilly, MSD and AstraZeneca, maps mechanisms to support informed drug discovery.
The BLA was resubmitted in 2025, after Atara and the FDA aligned on the criteria and addressed the initial CRL conditions.
CES attendees saw health-tracking gadgets making bold promises: toothbrushes detecting diabetes, mirrors assessing 20-year ...
BioPharma Consulting Group today announced the launch of a new digital transformation advisory framework designed to ...
Abstract: The Verification and Validation (V&V) processes are used to determine whether the development products of a given activity conform to the requirements of that activity and whether the ...
Abstract: Spatial transcriptomics has emerged as a transformative technology for mapping gene expression within tissue contexts, offering unprecedented insights into disease mechanisms. However, ...
The course presents opportunities to enhance validation of automated pipelines, ensuring data integrity and audit readiness amidst rapid changes. It equips teams with methods for digital validation ...
This course offers a strategic edge by refining cloud system classification through CSA principles, preventing compliance pitfalls and inefficiencies. It empowers teams to enhance validation precision ...
Embrace Computer Software Assurance (CSA) for modern life-sciences by focusing on meaningful evidence rather than burdensome documentation. This approach enhances efficiency, aligns with FDA ...