Expert perspective: How Thermo Fisher Scientific’s packaging and labeling innovations simplify biotech clinical trials

Q: What are some common challenges associated with clinical packaging and labeling that biotechs face?

Stull: Biotechs often struggle with the agility needed across all trial phases. Early-stage trials need quick execution and flexibility, while later stages demand consistency and scale. Many biotechs don't have the infrastructure for a reliable supply chain, making it critical to have a system that integrates compliance, quality, and speed to avoid delays.

Another big hurdle is navigating regulatory requirements, especially when entering global markets. Biotechs might not know what specific countries require on labels, what languages are needed, or have access to translation services. This inexperience can lead to costly delays.

Scarth: It's also important to note that the cheapest option isn't always the best value. What may seem like good value can come with inexperience or mistakes that lead to costly delays. Partnering with an experienced provider like Thermo Fisher can help navigate these complexities efficiently and keep trials on track.

Q: What sets Thermo Fisher’s packaging and labeling solutions apart from other providers?

Stull: One of the key differentiators is our ability to label and print in-house. Unlike others who require separate vendors for labeling and packaging, we offer an end-to-end solution. The logistics of having to juggle multiple vendors can be a large time and resource sink. We have the resources to help significantly reduce the time to prepare for clinical trial, ensuring a seamless process from start to finish.

Scarth: Additionally, our proprietary ATLAS^SM (Alternative Translation and Label Approval System) is a validated label translation system that automates and optimizes multi-lingual labeling. ATLAS has consistently reduced text translation time by up to over 5070%. This is crucial for global trials where time is of the essence.

Q: What are some key features of your packaging solutions that ensure product integrity?

Scarth: Our advanced packaging solutions include tamper-evident and cold chain packaging. These are essential for maintaining product integrity under extreme conditions like ultracold temperatures, which is crucial for biologics and vaccines. We also offer modular packaging solutions that allow for quick adjustments to protocol changes. This flexibility helps minimize waste and prevent trial disruptions, ensuring that the trials can proceed smoothly even when changes occur.

Q: How can smaller biotechs benefit from partnering with Thermo Fisher?

Stull: Smaller biotechs often lack the resources and expertise to manage complex clinical trials. By partnering with us, they gain access to our extensive experience and integrated services. This means they don’t have to worry about coordinating multiple vendors for labeling and packaging, which can be a significant burden. Also, when scaling up or expanding to different markets, we can handle all that—you don’t have to worry about what needs to go on what label for which country in which language—we take care of that for you. 

Scarth: We also offer consultative project management services, providing tailored guidance for whatever the needs. We can help navigate complex regulatory challenges, offer solutions to mitigate risks, and ensure trials stay on track. 

Q: Can you share a real-world example of how Thermo Fisher’s solutions have made a difference in a clinical trial?

Stull: Certainly. We had a biotech client from Japan who faced significant delays due to another provider that mishandled their packaging, translation, and labeling needs. That’s where we stepped into rescue this clinical trial. Our ATLAS translation system was able to significantly accelerate the translating and labeling process, reducing the label approval cycle by 75%. This allowed the trial to proceed without further delays, demonstrating our ability to quickly adapt and provide effective solutions to rescue clinical trials.
Scarth: Obviously, we don’t want companies to have to be rescued by us, so we encourage partnering with us early, so that you don’t end up in a situation where you need to get be rescued. 

Conclusion: Why Thermo Fisher is the partner of choice

For biotech companies, choosing the right partner for clinical trials is critical. They require a reliable partner that offer speed, risk mitigation, flexibility, and cost-effective solutions. Thermo Fisher’s comprehensive suite of packaging and labeling solutions, combined with their deep expertise and consultative approach, makes them the ideal partner. They are not just a service provider but a strategic ally, helping biotechs navigate the complexities of clinical trials with confidence. By partnering with Thermo Fisher, biotech companies can streamline their clinical trials, reduce risks, and accelerate their path to market, ultimately bringing life-saving therapies to patients faster.