How can manufacturing software accelerate life sciences innovation? By combining MES with an operations digital twin.

Please enjoy the summary* below. For the full research, please visit our sponsor Dassault Systemes(registration required).

Table of Contents

• Rapid Life Sciences Innovation
• New Realities and Opportunities
• Manufacturing Must Keep Pace
• Digital Twins: Marrying Virtual and Real
• Operations Digital Twin Examples
• Digital Twin of Operations Accelerates Progress
• Twin Benefits in Operations
• Virtual Uses through Validation
• Virtual Uses Post-Approval
• Benefits of Virtual to and from Real
• Closing the Virtual-to-Real Loop
• Considerations for Useful Virtual
• Enterprise Transformation
• Clearing the Way for Acceleration
• Recommendations
• Acknowledgments

Rapid Life Sciences Innovation

Speed to Market

Innovation has always been at the heart of life sciences companies’ success. Being quick to market helps both profits and patients. Of course, fast is relative, with most drugs and biologics taking 10-15 years from Phase I to approval, and medical devices taking three to seven years from concept to approval.  

The question is: Can life sciences companies accelerate this innovation process and make it more reliable? We have seen that they can by using current software and methods. It’s important to remember that innovation and supporting software serve not only R&D but also operations.

Quality by Design

Every aspect of innovation must increasingly aim for Quality by Design (QbD). For drugs, the EMA website defines it: “Quality by design is an approach that aims to ensure the quality of medicines by employing statistical, analytical and risk-management methodology in the design, development, and manufacturing of medicines.”

Modeling and simulation allow a virtual test of a design against quality and regulatory requirements. This can result in improved product quality and patient safety before physical prototypes are built.

In short, ensuring data-driven approaches early on can generate better outcomes at every stage of the product lifecycle. The chart below shows that concept.

Figure 1. Accelerating Innovation Has Profits Benefits Throughout the Life Sciences Lifecycle

Recommendations

Recommendations and Next Steps 

Based on this research and our experience, we recommend that Life Sciences companies in biologics, pharmaceuticals, or medical devices:

• Treat this as a transformational operations innovation acceleration initiative, not an IT project.
• Educate and create a vision everyone shares for a more agile manufacturing operation that accelerates innovation.
• Distinguish operations twinning from a Metaverse or gaming approach: it is for running the business, not training or purely visual representation.
• Carefully review your options to ensure the digital twin platform will support the organization now and in the future.
• Get started with twinning high-impact areas and build on the success to get maximum value and momentum.
• If you don’t have enterprise-capable manufacturing planning, scheduling, S&OP, and execution software, be sure those investments are in the plan.
• Be sure the top executive team sponsors and fully resources the program – including dedicating some of your best people and incenting everyone.
• Set an expectation that the twin will become a crucial aspect of daily operations: you will see what happens as things change and conduct what-ifs to gain speed and confidence in decisions.
• Keep the end in mind: virtual and real, constantly driving quality, innovation, improvement, and speed.

*This summary is an abbreviated version of the research and does not contain the full content. For the full research, please visit our sponsor Dassault Systemes (registration required).

If you have difficulty obtaining a copy of the report, please contact us.