Creating a roadmap for growth for a blood products company

A subsidiary of a top 20 pharmaceutical company was scaling to meet demand for their plasma-derived therapies. The parent company developed more than 20 treatments for a variety of conditions including rare diseases. Plasma cannot be lab-manufactured, therefore the sponsor relies on plasma donations to manufacture their products. To fulfil their patients’ needs, the sponsor was opening donation centres in new locations. The sponsor asked ICON to review their end-to-end processes and create an action plan to manage future growth.

As they moved into new geographic regions the sponsor’s high functioning regulatory team had an increasing workload and unfamiliar regulatory requirements to contend with. Despite the significant growth – from previously opening 4-6 new centres a year to around 20 a year – the regulatory team size had not changed. Because of this the team were constantly at capacity and lacked resources to explore potential process improvements or technologies to enhance productivity. 

Regulations differed depending on where the centres were located and the team had to understand the unique regional requirements. While over time this learning curve would level off initially it added pressure to an already stretched team. Regulations are not static, the team were also expected to stay updated on changing regulations and to build and maintain relationships with health authorities and industry bodies.

ICON performed a detailed evaluation of the regulatory team’s working procedures. The team reviewed all written materials including standard operating procedures, business process documentation, training materials and working guides. ICON’s team facilitated workshops with the in-house regulatory team, including representative members from different levels to understand their processes and pain points. Stakeholder interviews provided additional feedback and insights into the challenges and current ways of working. ICON also conducted a technology review to identify potential improvements. 

The initial workshops identified that there were no overall process flows for different elements of the plasma collection and no overarching process flow connecting the different elements. 

ICON created, reviewed and finalized process flows for the team’s future use. A summary presentation of the findings was delivered with a comprehensive written report. The report included observations, recommendations and a detailed action plan. ICON’s team identified areas for optimization leveraging both existing and potential new technologies along with options for automation. The plan also outlined potential outsourcing options to support rapid changes in resourcing requirements. 

The action plan was developed with scalability in mind, offering the sponsor a roadmap to scale up or down as necessary. Recommendations were categorised and weighted to deliver efficiencies as both quick wins and longer-term solutions.