When the Pressure is High the Dementia is Low
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Tuning Up or Taming Immune Responses
New Immunotherapeutic Strategies Include Bispecific Antibodies, Engineered Adenoviruses, and Specifically Formulated Vaccines against Cancer
The Promise of Tumor Mutational Burden for Cancer Immunotherapy
Quantitative Biomarkers Could Be the Next Step for Precision Oncology
Just Enough Downstream Innovation
Downstream Operations Can Relieve the Pressure of Higher Titers and Cell Densities without Undue Disruption
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Adroit Crafting of “Intended Use” Critical
Regulatory Fate of a New IVD May Well Depend on a Few Dozen Words
- In vitro diagnostic (IVD) devices are comprehensively regulated by the FDA. The FDA, however, does not regulate just the physical materials and software comprising an IVD. When developing a new assay, IVD companies tend to focus on key physical aspects: the composition of the assay, what it detects ...
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