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What this means for clinical research: Early clinical programs will enter Phase I faster and with different evidence packages, shifting risk assessment earlier and increasing the importance of translational and modeling capabilities at the clinical interface

"It is essential that you thoroughly investigate the recurring identification of gram-negative microbes in your aseptic processing environment to determine the root causes and fully remediate with appropriate actions," the agency added

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Timothy Garvey, a lead investigator in the trials, noted that the findings are directly relatable to clinical practice precisely because of that flexibility