Digital integration of sponsor and contract organizations
The Digital Integration of Sponsor and Contract Organizations workstream is a collaboration between leading biopharmaceutical manufacturers, contract organizations and software vendors, working together to bring about a shared vision of digital maturity in their operational ways of collaborative working.
Biomanufacturing sponsor organizations are increasingly operating with a network of contract organizations and partners to innovate and manufacture at speed and at scale. And one big challenge is digital ways of working between the companies. In every case they do some physical work but increasingly it is the data that is really significant. Our focus is on the data interactions for tech transfer, manufacturing, quality and the supply chain.
Often the best solution available today for digital integration is to transfer PDF files – which make data really hard to use. And although there have been some unique point-to-point solutions, that doesn’t scale. We are starting to define, exactly, what are the integration points where something better would make a real difference and bring benefits? What would data structures and standards look like. How do we transport the data? What about cybersecurity? How do we handle data integrity and deep analytics across organizations; what does the future beyond the PDF look like; how do we get deeper data about our raw materials. How do we architect this so that it can support the rapid turnaround times of personalized cell and gene therapies? The group is deciding its future priorities to help answer some of these questions, define solutions, and accelerate and deepen the digital integration across the pharmaceutical industry. It’s going to have a big impact on setup time, integration cost, cycle time, right first time and data risk. And it creates a practical way of reaching digital maturity across an extended network of partner organizations.