Ambition, Innovation, Impact: The Future of Cleanroom Standards

Where did it all begin for you?
 

I come from quite humble beginnings but was fortunate to have a supportive family and was the first in my family to attend university, where I obtained a degree in Mechanical Engineering from the University of Central Florida. I was interested in engineering because I grew up in a little town called Titusville, Florida – where the rockets launch at Kennedy Space Center – in the 70s and 80s during the Space Shuttle Program. I was literally surrounded by engineers and rocket scientists; it was a very interesting place to grow up. 

I started my engineering career at Getinge Group. It was great to work for a European multinational life sciences company and I was able to work across almost every function over many years, learning along the way. I had a lot of great mentors that helped me on my journey and pointed me in directions that gave me a really broad skill set. 

At Germfree, we still serve the space program to this day! We have helped NASA with design solutions for returning samples from Mars, which is an exciting project to be part of. When they bring these samples back, they require BSL-4 level containment and protection in pristine cleanroom conditions. I think we're going to learn a lot about the red planet through this science!

What makes the cleanroom sector a dynamic area to do business in?
 

Our clients are doing the world's most important work, and our job is to help them do it! They don't just need a cleanroom in which to work, they need a complete solution that is delivered process-ready and specific to their needs. The challenge is for us to deliver “mini-factories” with the right process, personnel, and waste flows combined with a suite of equipment, the IT/IS to connect it all, and the qualification and services team to get it running and support it for life. This involves a lot of amazing people who I get to work with every day; they’re engineers, project managers, construction specialists, and equipment and services providers. 

Look, it’s clear that everyone you and I know has been impacted by cancer or some other terrible disease, and a lot of these diseases seem to be trending younger and younger across societies. I feel very honored to be in a position to face these challenges, and I believe that we're in a new era of medicine that is more targeted, more personalized, and often curative. We owe the delivery of these solutions to the next generation. I get to lead a great team of both newer and seasoned professionals who serve these patients and address these needs – and it’s a blessing to be in this position. 

In what ways has the industry changed since the COVID-19 pandemic?
 

I'd start with the increased knowledge of infectious diseases in general. Not everyone was aware of the complexities of biocontainment, disease surveillance, or the drug development process prior to COVID-19. Now, people have educated themselves and, for me, this makes for much more interesting conversations across our space. One of Germfree’s high containment labs in Southeast Asia was used to isolate the genomics of the SARS virus, for example, and now many people understand the importance of that work!

Another big change that came along was speed. Disease surveillance and drug discovery moved a lot faster during the pandemic. For instance, we deployed an offsite-built, process-ready cleanroom within weeks for a biopharma company that was developing a monoclonal antibody therapy to treat COVID-19 patients. It usually takes months or even years; for this and many other reasons related to quality and cost, we see modular/podular solutions as a big part of the future of medicine. One major driver of the increased ability for speed comes down to deeper industry partnerships and a stronger willingness to integrate technologies across companies. The industry came together to serve the world during COVID-19, and that is a great thing that continues to this day!

Where would you like to see your career go next?
 

I love big challenges. I want to take the work we do at Germfree and make it the global industry standard. We see decentralized manufacturing of increasingly personalized medicines as a step change in patient care. Cleanrooms are required to deliver these cures with the highest quality and compliance while reducing cost and enabling patient access. There is still a technology and regulatory journey to go on, and a lot of work to do, but we're on the path of making decentralization and equitable patient access a reality.

We're also looking to tackle drug shortages and patient access at a high level. Many of us saw how Hurricane Helene exposed vulnerabilities in supply chains quite far from the ocean in the US; decentralized factories can help alleviate these situations as well. 

What does the cleanroom of the future look like?
 

It is factory-built, 100 percent turnkey, and fully automated using AI and Machine Learning with very limited human interaction. The data from critical process parameters is used for automated parametric release to patients through an integrated quality management system. This cleanroom can be stand alone or part of a decentralized network that is manufacturing compliant, targeted, personalized medicines close to the patient. It will enable clients to run processes more efficiently and remotely, with fewer people and in better compliance and near the patient. Ultimately, it’s smaller, more automated, and more tech-heavy. It will be purely offsite-built and modular to ensure quality while alleviating the time factor of commissioning on site.

What do you do when you're not orchestrating a cleanroom design and deployment service?
 

I'm the Dad of a remarkable teenage daughter. She and I study Aikido together, which is both super challenging and a lot of fun. I’m also a life-long surfer and snowboarder so, I like to stay active and take on challenges that keep the body and mind moving. My extracurriculars all require a bit of a “go for it” attitude and I like to take that type of approach forward in business. Let’s go solve the world’s biggest problems!