Are investigations supporting or hindering performance excellence?
Every biopharm company conducts investigations for undesirable outcomes related to safety, quality, and reliability of product and processes. The question is to what degree do these investigations support or hinder performance excellence? A sub-team that was formed as part of the BioPhorum Operations Group (BPOG) human performance workstream sought to answer this question. The findings suggest that biopharm is behind other industries with respect to investigation best practices. This article provides a pathway for the industry to improve its investigations, and in so doing, improve overall organizational learning and performance.
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FDA Approves Pfizer Combination Regimen for Treating R/R Diffuse Large B-Cell Lymphoma
February 14th 2025The approval of an ADCETRIS combination regimen is based on positive data from a Phase III trial where the combination regimen demonstrated a clinically meaningful reduction in the risk of death.