We helped a leading pharma company enhance technology transfer and reduce time to clinical trials by implementing digital knowledge management for small and large molecule substances, advanced biologics, targeted drug delivery devices and combination products.

Phase 1. Our client’s initial goal was to dramatically improve the lead optimization phase, by managing the knowledge during the synthesis of lead compounds, identifying new analogs with improved potency, and reducing off target activities. The client had divested their pilot plants and wanted to accelerate getting new compounds ready for clinical trials and commercialization by leveraging CDMOs to reduce time to market, cost, and improve speed to clinical trials.

The client was experiencing knowledge sharing, collaboration challenges and inefficiencies with the CDMOs due to difficulties in exchanging product requirements and critical formulation data, which was stored in paper-based documents and siloed, externally inaccessible systems. They realized that without the ability to easily and securely share relevant materials and process critical quality requirements for how the product should be produced, they would not be able to achieve the targeted time and cost benefits of partnering with CMDOs.

We worked with our client to implement a digital knowledge management solution, creating a unified repository for market requirements by region, materials, process models, recipes, site and market variations, with clear traceability to each market specific SKU.

Our work made it possible to capture and manage knowledge digitally, which improved collaboration internally and externally across the value chain, accelerating technology transfer, speed to trial and product approval.

Phase 2. Capitalizing on the momentum of digital knowledge management in small molecules, we then shifted focus to enabling the same capability for their drug delivery devices and combination products business units. Because the company was first and foremost a medicines company, established practices were rooted in drug development and we had to adapt and expand them to incorporate discrete device product development management. We worked with our client to implement a solution that manages requirements, product data, CAD data, and risk under change control.

We tailored our approach to encompass not only establishing the right systems, processes and data, but also education and shifting mindsets to align with leading practices in medical device development.

Phase 3. We are now working with our client to build additional digital mechanisms beyond digital knowledge management to further streamline technology transfer and scale up. A technology transfer hub is being established to map ISA 88/95 data structures across the extended network and also publish standardized recipe to internal and partner downstream systems such as ERP and MES. This improves change propagation across sites and systems enabling more efficient feedback, recipe data publication and collaboration.

Together, we enabled:

• Effective collaboration across an extended manufacturing network
• Streamlined sourcing
• Reduced manual effort and risk
• Accelerated speed to clinical trials
• Faster development in molecule pipeline
• Drug development quality management
• Data-driven decisions on network performance