Operational excellence in technology transfer: Connect to Frankfurt on-demand

In this Connect to Frankfurt session, Clarissa J. Van Allen, Global Senior Manager, Technology Transfer, Oral Solid Dose at Thermo Fisher Scientific (Des Moines, USA), discusses the value of an effective and efficient technology transfer project in the drug development and commercialization process, and how Thermo Fisher offers solutions to tech transfer project management. 

Technology transfer project management: why is it important? 

Technology transfer refers to the process by which an original innovator makes their production technology available to commercial partners, including any aspects of the drug production process and business processes. Internal technology transfers occur between a drug’s development and commercial stages within the same organization, while external technology transfers are from an external developer to a commercial-scale manufacturing facility. technology transfers constitute a crucial part of the progression of a successful product – from its discovery, development, and clinical testing right through to a products full-scale commercialization.  

Van Allen’s presentation emphasized the importance of an effective and efficient technology transfer project management strategy. 

The right method for consistent and reliable technology transfer execution 

In her presentation, Van Allen highlighted some key parameters for ensuring a technology transfer project’s success. A robust methodology was at the centre of Van Allen’s strategy for rapid and predictable delivery of technology transfer project timelines and expectations. The key points she discussed included: 

1) Proactive risk mitigation.

Actions under this parameter included a documented action plan to resolve each risk and flagging support needs for each site and facility.

2) Optimized governance and escalation pathways stemming from site-level governance and global networks to troubleshoot and mitigate issues. 

3) Local project review boards. 

4) Seamless execution between project phases.

This should be achieved through dependable ‘right first-time’ delivery. 

5) A single point-of-contact for seamless project management. 

6) A global network of trusted partner’s throughout the development and commercial pipelines. 

Van Allen also included Thermo Fisher Scientific’s suite of digital toolkits for enhanced process oversight in order to provide what she termed “trust, transparency, and accountability”.  

Case studies 

Two case studies were presented as part of Van Allen’s presentation. The first covered a small, multinational pharmaceutical company looking to produce a COVID-19 treatment in a three-month timeline. With limited resources, the company turned to Thermo Fisher Scientific to conduct multiple, concurrent technology transfer projects across three sites while meeting regulatory requirements for both the US and EU markets. With a single point-of-contact and internal information sharing across the sites, successful technology transfer projects were executed in the span of 4–6 months. 

In another instance, the US FDA issued an emergency use authorization for COVID-19 dual tablet treatments. Speed-to-market was crucial to the technology transfer project for this case, as competitors of the client were in the process of developing similar products. By managing the technology transfer to commercialization in tandem with development activities, the team were able to deliver an effective COVID-19 treatment to market with efficiency and robustness and a successful launch. 

The future of technology transfer 

With an effective execution strategy and robust methodology, Van Allen emphasized the value of technology transfer programs as an integral part of drug development and commercialization. With appropriate tools and management systems, technology transfers can aid in synergising complimentary needs at every step of a product’s development through to its launch in the global market. 

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