10 Years of Modality Solutions: What We’ve Learned, Part 2

In our previous post, we looked at some of the ways the biopharmaceutical industry has embraced the role of Cold Chain Engineering™ in optimizing and managing the cold chain to ensure safe shipment of drug product.

Since Modality Solutions was founded in 2011, we have seen a ton of progress towards making intelligent and streamlined cold chain optimization an industry standard—but there is still a ways to go. Over the last 10 years, we have learned what it takes to move the industry forward. There is a future in which testing the most advanced therapies can be efficient, cost-effective, and accessible. Here are some of the ways the industry is progressing towards this vision for the cold chain.

Regulators are partners, not gatekeepers

Something our clients are often surprised to learn is that good science and good engineering go a long way to win regulators over. That may not sound especially groundbreaking, but our clients tend to think there is a sort of “regulatory speak” they can summon to help gain approval—magic words just out of reach.

Yet we’ve demonstrated over and over again that, as long as you have good science and good engineering, you can open up a productive conversation. Yes, the regulators get used to seeing sets of data presented a certain way. Historically, this has meant rejection when methodology does not meet stringent requirements. Over the last 10 years, however, their expectations have shifted as the industry becomes aware that a unique approach is needed for many biologics.

Today, regulators are much more open to a discussion, as long as the science behind your findings is sound. Rather than dismissing anything that does not follow a prescriptive approach, they want to listen to the science and work with you as a partner, not a gatekeeper.

Young engineers and scientists shape the industry

We have seen firsthand that young scientists and engineers are the future of cold chain. When we started Modality Solutions, we had a hard time finding established experts who believed in Cold Chain Engineering™ as a valuable area of focus. We had the opportunity to help train multi-disciplinary teams of young engineers who saw the promise in this industry and how it could contribute to emerging research.

Today, Modality has been on the forefront of bringing the cold chain to engineering. What has driven us is honesty, ethics, and the courage of our convictions, so these young engineers have been able to translate that into their work and, therefore, the industry at large. We have trained them to do good engineering work and stand behind the work they’ve done. As a result, they are driving impactful changes in the processes, techniques, tools and technologies behind the cold chain.

No company is too small to make a difference

As the cold chain becomes more and more complex, the largest drug manufacturers hold the keys to regulatory approval. With access to funding and technologies that allow for mass shipping studies, many smaller companies end up outsourcing testing to big pharma companies, who may take their time deciding whether a project is worth their time.

We have found that the companies operating on a shoestring budget are often the most passionate about their therapies, and they deserve the same access to resources and industry knowledge. In our niche role as a contractor with engineering services, we consciously decided there’s no company too small to make a difference. With more access to these types of outsourced services available to companies of all sizes, we will see a lasting impact on the industry.

Looking ahead to the next 10 years

Our leadership role in the industry means we have an opportunity to take it in the right direction. We see the industry shifting to focus more on good science and engineering and less on prescriptive solutions and dated protocols.

The cold chain will only continue to get more and more complex over the next ten years. New advanced therapies are significantly different than the biologics of just a few years ago. To learn how these new therapies actually react in the cold chain, we need innovative approaches, which may include the use of technologies like AI and machine learning.

COVID-19 has made it necessary to find new solutions to an unpredictable supply chain. We will no longer be able to wallpaper over the inefficiencies that have come to light during the challenges of the pandemic. The innovation that has come from this period will change the way we look at work for years to come, and Modality Solutions is thrilled to be a part of it.