Digital integration of sponsor and contract organizations
The Digital Integration of Sponsor and Contract Organizations (DISCO) program is a collaboration between leading biopharmaceutical manufacturers, contract organizations and IT solution providers, working together to bring about a shared vision of digital maturity in their operational ways of collaborative working.
DIGITAL TRANSFORMATION LEAD, NOVO NORDISK
“We see CDMOs as strategic partners to deliver our future commitments. For those partnerships to work, our ambition is to have the same transparency externally as we do with our internal production. However, that can only exist if as an industry we move to common approaches and data sharing models.”
However, the expectations for deeper integration and visibility, automation and flexibility have increased and the lack of a standard framework has led to bespoke solutions which are unsustainable. What is needed is something like a bridge – capable of carrying all kinds of traffic, fast and slow, built once to serve many, robust and secure, and designed for longevity, a solution that lasts into the future.
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? Our focus is on the data interactions in the inter-linked areas of quality, supply chain, manufacturing and tech transfer.
This is explained in the Vision for digital maturity in the integration between biomanufacturers and partner organizations which explains the current approaches to connecting biomanufacturing organizations, and the key benefits of improved digital integration. It articulates principles and patterns in the form of a simple maturity model that can be used to assess current state and plan for a more digitally aligned future. It is intended as a call to action for biomanufacturing sponsor organizations, contract organizations and IT solution providers.
We are working to bring that vision to life in three ways
- Communicating it to the industry as a stake in the ground and a reference point for assessing current state and formulating plans for the future
- Sponsors and contract organizations are sharing their own strategies for digital integration and working to align with each other and with the vision – which makes their plans more credible, sustainable and thorough, and creates the basis for industry-wide change
- Finally, we are pushing forward some of the key topics, defining the design options and data structures, identifying where new standards are required, establishing the collaborative basis for those future standards, articulating benefits of change to all the stakeholders. This will accelerate analysis, design and build, and reduce risk.