Case Studies
Ensuring a timely start and smooth run of a crucial Phase I clinical trial

Ensuring a timely start and smooth run of a crucial Phase I clinical trial

Client Overview

Nectero Medical is a biotech company based in Arizona developing a novel treatment with the potential to stabilize growth and minimize the risk of rupture of small- to mid-sized abdominal aortic aneurysms (AAA). The Nectero EAST® System may help AAA patients live out their normal lifespan without facing the challenges of endovascular repair (EVAR) or open surgery to address their aneurysm.

Challenge

Nectero Medical is developing a treatment for a serious and life-threatening disease afflicting millions of patients worldwide – the abdominal aortic aneurysm. The timely start of the Phase I trial with sites in Latvia (Europe), Hong Kong, and New Zealand was of crucial importance for the biotech company. The challenge was to find the best partner for clinical trial packaging and distribution, specifically managing the storage, labeling, kitting, and distribution to enrolled subjects within the desired timeline.

The Myonex Solution

Myonex’s flexible and tailor-made Clinical Trial Packaging & Distribution team provided a comprehensive resource for Nectero Medical — with labeling, kitting, and distribution from a single source. In this way, the company saved time, prevented handover-challenges, and ensured that the shipment arrived in time for the first subject to be treated. The tight timelines could only be met thanks to the end-to-end Packaging & Distribution solution from Myonex with a dedicated project manager to coordinate all processes.

 

Implementation – getting it done – in time

Like most complex global clinical trials, there were obstacles along the way. The Myonex Packaging and Distribution team was able to address these challenges by overseeing the entire distribution landscape — delays in the supply chain as well as challenges with couriers and customs needed to be overcome to ensure deadlines were met. Within just one week of receiving the goods, the Myonex team completed the quality check, released the goods, packaged and then shipped the kits to the site on time.

The Results:
Two important successes were achieved because of this joint project from Nectero and Myonex:

1. Crucial Timelines Met: For biotech companies, achieving timelines in clinical studies is essential to a company’s success. Myonex ensured the right kits were labeled properly and shipped safely to arrive at the clinical trial site in Latvia for timely enrollment of the first subject.

2. Securing Future Projects: The Phase I study was just the first step in the clinical trial program. Instead of the need to look for (potentially several) partners for the Phase II/III trial, the solution-oriented, and quick work of the Myonex team set the groundwork for additional collaborations. The work on the Phase II/III trial can start right away with the established communication channels and the same dedicated team.

  • “We cannot thank Myonex enough for their help in getting the product out the door on time. A number of challenges were encountered and successfully addressed along the way. We are off to a great start and the Nectero Medical team is excited about the long-term relationship with Myonex. We look forward to many more success stories.”

    —Jack Springer, CEO of Nectero Medical

  • “Myonex always had creative solutions to our requests. I was very impressed with their expertise and ability to address all our distribution requirements.”

    —Kimberly Williams, Vice President of Operations at Nectero Medical

Conclusion:

Myonex’s extensive clinical trial expertise, client-centric, flexible, and time-sensitive approach were crucial to support the Phase I study. The high dedication, commitment, and the solution-driven approach from the Packaging and Distribution team positioned Myonex as a reliable, trusted, and efficient partner. Successful collaboration on the Phase I study, gave Nectero Medical the confidence that Myonex is the right partner to support the Phase II/III clinical trial in the company’s quest to establish Nectero EAST® System as the first available treatment for patients with small- to mid-sized AAA.