Recent news that the US Food and Drug Administration (FDA) will ask cell and gene therapy (CGT) developers to provide more consistent evidence with their submissions has resulted in drug makers delaying development plans — and working on new ways to address the agency’s concerns
Single-cell technologies have positioned themselves at the forefront of biomedical research. These platforms allow researchers to bypass the uncertainties of bulk data and instead interrogate biological systems at a level of detail that was previously unreachable. But the value of these systems risks being impaired by bottlenecks in data analysis
Paradigm4’s Marilyn Matz and Zachary Pitluk discuss the challenges of integrating data from heterogeneous sources and how the company’s plaform and apps combine the cutting edge of computer science and a sensibility geared toward the unique needs of pharma and biopharma to provide end-to-end solutions.
Addressing the vital economic challenge of uncovering new critical quality attributes (CQAs), Paradigm4’s REVEALTM Analytical Development app enables data analysts…
