The use of CMOs for clinical and commercial biopharma production is widespread and significant. More that 50% of global drug product capacity is with CMOs and the story is not much different in drug substance. Add to this the diversity of CMOs and the contacting out of available capacity and the number and complexity of relationships is staggering. Yet there are no effective data standards meaning all too often sponsors are dependant on handballed reports and suffer little or no real-time visibility of production. While in at the same time in their own facilities they are driving forward with ambitious real-time control strategies.
The CMO Summit in November 2019 provided a cross-section of leaders and subject-matter experts (SMEs) the opportunity to share experiences and mutual challenges on the increasingly important topic of Sponsor—CMO data exchange. The meeting was preceded by pathfinder work whereby SMEs conducted a brief exploratory to identify current practices and initiatives in member companies and focus areas for potential collaboration. The meeting was attended by 24 leaders/SMEs from 15 Sponsor and CMO member companies and they were joined by leaders from 3 vendor/supplier companies that are developing new thinking and solutions in this space. The face-to-face meeting resulted in highly interactive and productive working sessions with meeting participants sharing a variety of case studies to glean insights from evolving practices, company initiatives and challenges along the way. The meeting participants pooled their experience and insights to collaboratively develop a strategic landscape to shed light on the key market trends and business drivers catalyzing the need for change, the needs and gaps in the in-scope business capabilities and finally, and the ideas to address the needs.
What became clear is that the increasing complexity in operations and process execution combined with the time-to-market pressures are driving the need to transition from today’s inefficient, mainly manual mode methods, sooner rather than later. Through the case study sharing and building of a common strategic landscape, the leaders and SMEs realized that many, if not all, partners in the biomanufacturing ecosystem are facing similar challenges. Even more notable was the high energy, commitment and the ideas that flowed in the room to drive change and to make something happen. The meeting participants leveraged this energy, shifted gears and broke into teams to scope an initial set of use cases and stories, to frame the needs and gaps. Developing user stories was highly valued and led to a greater mutual understanding of challenges and opportunities among the Sponsor and CMO companies. Moreover, the user stories form a foundation for understanding data requirements and standard definitions and, importantly, stand to frame value impact and priorities moving forward. This work enabled the participants to converge on collaboration opportunities to bring into a proposed program of work.
The team will work with the BPIT Phorum leader and facilitation team, transitioning the energy in the room into virtual sprints, to mobilize the immediate actions.