Cell And Gene Therapy Data Management

By Steve Goodman and Robert Di Scipio

At the Phacilitate Leaders World and World Stem Cell Summit 2019, held 22–25 January, Steve Goodman (head of drug product manufacturing at bluebird bio) and Robert Di Scipio (CEO of Skyland Analytics) shared the podium to address what the product and process data-management ecosystem looks like for cell and gene therapy (CGT) development and manufacturing. A starting point for their presentation was that CGT development presents significant data challenges: capturing and analyzing product development and manufacturing data, tracking the collection, transporting and maintaining the quality of apheresis material, and analyzing these data coherently with the pertinent patient medical records. Skyland and bluebird are collaborating to ensure that bluebird has a CFR Part 11 compliant data management system that supports data transparency and analytics throughout its supply chain — as well as enabling CPV (continued process verification) and APR (annual performance reports).