“Right First Time Manufacturing” Going Slower to Move Faster
In this presentation, we will discuss how incorporating dynamic computer modeling and simulations early on in the design process eliminated potential bottlenecks, improved the understanding of manufacturing and optimized material and personnel movement. The presentation will highlight Ultragenyx’s new gene therapy facility for rare and ultra-rare diseases that reinforces GMP compliance, improves operator experience and is designed for overall flexibility to accommodate multiple products and cell lines. As more gene therapy products move towards regulatory approval and commercial scale-out, manufacturers are turning to a new kind of production facility, one that’s flexible and future-ready, capable of adapting quickly as the industry evolves and new technologies emerge.

Faster Project Delivery Using Data Driven Enabling Tools
Commissioning and Qualification (C&Q) has been a substantial portion of pharmaceutical projects. How can we deliver it better and faster? Digitalisation could be one of the answers. Through the case studies, this session will demonstrate the application of a digital tool which enables Data Driven decisions, and which reduces C&Q project costs, accelerates time to C&Q turnover, and improves quality.

The Critical Convergence of Work Force Planning, Leadership and Digital Transformation
Digital transformation is now considered fundamental to competitive advantage and profitability. It is not merely a deployment of technology, however. To achieve business success in digital transformation, you must harness the power of people to drive that transformation and embed diversity and inclusion in your culture. The convergence of an aligned workforce, strategic leadership and digital transformation can propel organizations into profitable, efficient, and resilient conditions. Increase your understanding of the changing nature of the workforce and work environment and learn innovative methods to engage and equip people to lead and contribute to digital transformation.

Multi-Modalilty Manufacturing: A CDMO Perspective
New therapeutic modalities are constantly emerging in our industry. This talk will delve into how these modalities differ by technology, scale and other factors, and considerations for facility design and opportunities to co-locate in order to optimize the manufacturing network.