Innovations in Clinical Trial Supply Chains - A Closer Look with Michael O'Kane

In a recent episode of the Interlinks podcast, hosted by Patrick Daly, Michael O'Kane, Commercial Strategic Director at Yourway Clinical, shared valuable insights into the complexities of the international clinical trials supply chain and discussed the upcoming launch of Yourway's new strategic facility in Dublin, Ireland.

Michael O'Kane, a veteran with nearly 15 years in the specialty pharma supply chain sector, is excited about the June 2024 launch of Yourway Clinical's state-of-the-art facility located strategically beside Dublin Airport. This facility is designed to enhance the clinical trial value chain significantly. Michael emphasizes, "The facility... integrates clinical packaging, temperature-controlled storage, and distribution to support the entire clinical trial value chain with agility, reliability, and efficiency."

The Dublin facility, described by Michael as Yourway's "newest flagship depot," spans 70,000 square feet and features temperature-controlled storage ranging from controlled ambient levels down to -185 degrees Celsius, with a capacity for 6,000 pallets. Its advanced technology ensures the utmost safety and security for diverse therapeutics, which is crucial not only in Ireland but on a global scale.

Addressing the unique needs of the pharmaceutical and biotech sectors, the facility is tailored for clinical material storage, clinical packaging, labelling, and project management on a Good Manufacturing Practice (GMP) level. This setup aligns perfectly with the stringent quality levels expected in the industry.

During the podcast, Michael highlighted the critical role of cold chain logistics in biopharma, noting the increasing demand for temperature-controlled shipping and the regulatory requirements for comprehensive temperature performance monitoring. "Cold chain is vital to understanding how [a product] has been monitored from the minute it's dispatched...to ensure everything is serialised, tracked, and monitored," Michael explains.

The strategic importance of this facility extends beyond logistics and storage. Michael points out that the Dublin site will play a pivotal role in addressing the challenges and opportunities in patient recruitment and retention amidst global conflicts, adapting to regulatory changes, and the impact of emerging guidelines like the EU Clinical Trial Regulation (CTR).

Looking forward to the facility's official opening on June 6th, 2024, Yourway plans to host an open day inviting stakeholders across the pharmaceutical, biotech, cell and gene, and advanced therapy manufacturing sectors. This event will feature a tour of the facility and discussions on the role of artificial intelligence and machine learning in optimizing clinical trials.

Michael O'Kane's leadership at Yourway Clinical and his strategic foresight into the demands and advancements in clinical trials supply chains underscore the significant potential of the new Dublin facility. It represents a major step forward for Yourway in enhancing its global and European operations, positioning Ireland as a key player in the high-end pharmaceutical and biotech industries.

For more information about the facility and the upcoming open day, visit Yourway's official website or connect with Michael O'Kane on LinkedIn for further updates.

You can listen to the full conversation between Patrick Daly and Michael O'Kane on the Interlinks podcast here.